Pharmacy Education And Research .Com

Clinical trials underway for new autism treatment- New drug research updates.

2011-02-28T11:10:00.001-05:00

Dr.Shruti Bhat, Star formulator and Ace leader within pharmaceutical R&D,a specialist with hiTech formulations and quality-by-design. Shruti brings to you some highlights from current pharma and clinical research news, views and data.

FDA approves expanded indication for maraviroc.

The US Food and Drug Administration (FDA) has approved an expanded indication for maraviroc (Selzentry tablets, ViiV Healthcare) for combination antiretroviral treatment of treatment-naive as well as treatment-experienced adults infected with chemokine (C-C motif) receptor 5 (CCR5)-tropic HIV-1 (also known as R5 virus)." The approval "was based on an analysis of 96-week efficacy data" from a phase three study "showing that treatment with maraviroc was as effective as efavirenz for achieving virologic suppression to undetectable levels (Clinical trials underway for new autism treatment.

Curemark LLC is currently "conducting clinical trials at the Southwest Autism and Resource Center in Phoenix and 11 other sites across the US on a treatment that helps children digest proteins." The treatment, "CM-AT, is a medicine that can be sprinkled on the food of" children with autism.

Gingko biloba may not prevent heart attacks, stroke, death.

Among people aged 75 and older, the herbal supplement ginkgo biloba does not prevent heart attacks, stroke, or death," according to a study published online in the journal Circulation: Cardiovascular Quality and Outcomes. After randomizing "3,069 patients to 120 milligrams of highly purified ginkgo biloba or placebo, twice a day," University of Pittsburgh researchers found "no significant difference between those taking ginkgo or placebo" for outcomes relating to death, heart attacks, strokes, and transient ischemic attacks. However, "among the 35 people who were treated for peripheral artery disease," the "the herb may have some benefit."

The main purpose of the original study was to evaluate the effect of the supplement on the development of dementia. No effect on dementia was found. The current findings" on stroke and heart attacks "come from additional analysis from the original study."

Antiviral therapy rates among American HCV patients declining.

Only a fraction of the 3.9 million Americans infected with hepatitis C virus (HCV) -- 663,000 -- received antiviral therapy between 2002 and 2007, and treatment rates are declining," according to a paper in Hepatology. University of Michigan researchers said that "if this trend continues, only 14.5% of liver-related deaths caused by hepatitis C between now and 2030 will be prevented."

Investigators said that "main barrier to treatment...appears to be lack of diagnosis, with only about half of infected people aware of their disease," What's more, those who are infected "were likely to lack health insurance and a consistent source of medical care." Notably, "the analysis is the first look at nationwide practice patterns for treatment of hepatitis C."

Rituximab seen as promising for type 1 diabetes.

According to a study in the New England Journal of Medicine, the "arthritis and lymphoma medicine Rituxan [rituximab] cut the need for insulin treatment among patients with type 1 diabetes after a year."

In a phase 2 trial, researchers from Indiana University randomly assigned "87 patients with newly diagnosed type 1 diabetes...to receive rituximab infusions or a placebo at one-week intervals for four weeks. The investigators discovered that "after one year, C-peptide levels -- an indicator of how much insulin is being produced by the body -- were higher in people taking rituximab versus those in the placebo group," with "those in the rituximab group also" needing "less external insulin." In other words, rituximab "helped patients keep producing some of their own insulin.

A single course of Rituxan wasn't enough to stop diabetes. After a year, B cells in treated patients increased to 69% of their original values." Nevertheless, "the study does show that a treatment targeting B cells can preserve beta-cell function in early type 1 diabetes."

The molecule [rituximab] is not free of side effects, and that "important long-term side effects are unknown."

Disclaimer- The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

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Scientists find new ways to tackle pancreatic cancer- New drug research updates.

2011-02-27T11:10:00.000-05:00

Dr.Shruti Bhat, Star formulator and Ace leader within pharmaceutical R&D,a specialist with hiTech formulations and quality-by-design. Shruti brings to you some highlights from current pharma and clinical research news, views and data.

Scientists find new ways to tackle pancreatic cancer.

Medscape reported that even though the "protective wall of fibrous tissue" surrounding pancreatic tumors "makes it 'extraordinarily difficult' for drugs to get through," scientists are finding ways around the "intractable problem." For instance, Johns Hopkins scientists discovered "that an already marketed product, nab-paclitaxel (Abraxane), was effective at weakening the stroma surrounding the pancreatic tumor and enhanced penetration of the standard chemotherapy, gemcitabine (Gemzar)." Meanwhile, researchers at Massachusetts General Hospital and Harvard "described how they used nanotechnology to deliver the antiangiogenesis agent bevacizumab (Avastin), together with a photodynamic therapy, directly into pancreatic tumor cells." A third approach, developed by University of Michigan scientists, involved "the use of microRNA, proteins that regulate gene expression, to suppress tumor growth."

Safety of psychostimulant medication studied in adolescents with AD/HD, co-occurring SUDs.

According to a study presented at a pediatric psychiatry meeting, "long-acting psychostimulant medication to treat adolescents with attention-deficit/hyperactivity disorder (AD/HD) who have co-occurring substance use disorders (SUDs) appears to be safe, even if the adolescents have not achieved abstinence." In addition, "long-acting psychostimulant medication for AD/HD appears to carry a low risk of abuse or diversion liability in adolescents concurrently receiving outpatient drug treatment." Researchers from the University of Colorado-Denver reached these conclusions in a study of "303 participants" aged 13 to 18 years who met DSM criteria for AD/HD and "for at least one non-nicotine SUD, excluding methamphetamine and opioid abuse and/or dependence."

FDA approves ziprasidone to treat bipolar disorder.

MedPage Today reported, "The FDA has cleared ziprasidone (Geodon) for maintenance treatment of bipolar I disorder as an adjunct to lithium or valproate." The drug "joins several other antipsychotic drugs -- including quetiapine (Seroquel), aripiprazole (Abilify), and olanzapine (Zyprexa) -- approved for this indication." The approval was based on "a six-month, double-blind, randomized, placebo-controlled trial in adult patients with bipolar I disorder, according to the drug's manufacturer, Pfizer."

Pradaxa may be as effective, safe as standard therapy for potentially deadly clots.

Boehringer Ingelheim GmbH's blood- thinning pill Pradaxa [dabigatran etexilate] was as effective and safe as the standard therapy for potentially deadly clots, according to the results of a head-to-head study." Only "2.4 percent of patients given Pradaxa for six months after their initial treatment developed clots in the legs and lungs, similar to the 2.2 percent rate for those given the generic drug warfarin, according to an abstract of the so-called Recover study posted on the American Society of Hematology website last week." Meanwhile, "there was no increased risk of major bleeding."

Nilotinib may be more effective than imatinib in treating leukemia.

The UK's Telegraph reported that a redesigned version of Glivec (imatinib), called Tasigna (nilotinib), "was more effective than its parent and produced few of the side effects of Glivec" in a clinical trial of 18 patients with chronic myeloid leukemia. "And crucially, doctors believe they may be able to use the process as a blueprint for making other cancer drugs more effective." The trial may increase its enrollment to between 60 and 80 patients.

Pharmasset to continue enrolling patients in hepatitis C drug trial.

Pharmasset Inc. stated that it will continue enrolling patients in a clinical trial of RG7128, a drug that is designed to treat the liver disease hepatitis C." An independent committee's review of data "from the first 100 subjects enrolled in the midstage study, which compares a combination of RG7128 and standard treatments to standard treatment and a placebo...found that side effects, discontinuations, and other events were similar in both groups." Pharmasset also "said Roche will begin a separate study of RG7128 in subjects with different strains of hepatitis C."

Disclaimer- The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

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Advances in cancer research said to bring more inequality to health- New drug research updates.

2011-02-25T11:10:00.000-05:00

Dr.Shruti Bhat, Star formulator and Ace leader within pharmaceutical R&D,a specialist with hiTech formulations and quality-by-design. Shruti brings to you some highlights from current pharma and clinical research news, views and data.

Durect says Posidur showed positive results in midstage trial.

Drug developer Durect Corp. Stated that its experimental long-acting post-surgical pain anesthesia showed positive results in a midstage study." The company reported that "Posidur consistently reduced pain in patients in the 72-hour period following shoulder surgery, compared to placebo." Researchers also found that "the drug...showed a reduction in opioid pain drug use following surgery."

Advances in cancer research said to bring more inequality to health.

University of Buckingham Medical School, reported that "news of the complete DNA sequencing of" lung and skin cancers "promises great improvements in our ability to cure cancer by 2020, but it comes with a hefty price tag." While therapies "will be precisely targeted to the defined abnormalities found in individual patients," Sikora contends that "the future will be decided by the interaction of...technological success, society's willingness to pay, future healthcare delivery systems and the financial mechanisms that underpin them." But, because "innovation will inevitably bring more inequality to health," Sikora concludes that "it is the job of governments to ensure health equity for all of their constituents."

Adalimumab may reduce psoriatic arthritis as well as psoriasis symptoms.

According to a study published online in Dermatology, "psoriasis patients taking adalimumab for the treatment of moderate-to-severe psoriasis may also experience a reduction in comorbid psoriatic arthritis symptoms." After examining the "effect of adalimumab on psoriatic arthritis in" 274 "patients with moderate-to-severe arthritis using data from three randomized, placebo-controlled trials," researchers found that "the risk for psoriatic arthropathy adverse events fell by 75%, compared with that in placebo-treated patients." In addition, "adalimumab-treated patients also experienced significantly greater reductions in psoriasis/psoriatic arthritis-related pain between baseline and week 16 of treatment."

Anti-epileptic medications appear not to increase suicide risk in bipolar disorder.

MedWire reported that "anti-epileptic" medications "do not increase suicide risk among bipolar disorder patients," according to a study published in the Dec. issue of the Archives of General Psychiatry. After analyzing "data from a medical claims database on 47,918 bipolar disorder patients," researchers found "no significant difference in suicide attempts following treatment between patients given an" anti-epileptic medication "and those not treated with an" anti-epileptic medication "or lithium, at 13 per 1000 person-years in both groups." Notably, "the rate of suicide attempts was significantly greater before any" anti-epileptic medication "treatment than after."

Experimental diabetes drug taspoglutide meets late-stage study goals.

Bloomberg News reported that Ipsen SA said that "results from Roche Holding AG on" the GLP-1 analog "taspoglutide show that the experimental diabetes medicine met the main goals of late-stage studies comparing it to Sanofi-Aventis SA's Lantus [insulin glargine] and placebo." Specifically, the "fourth and fifth of eight planned studies showed that taspoglutide succeeded in reducing levels of HbA1c...as well as Lantus and better than placebo." Bloomberg News noted that "GLP-1 analogues mimic a hormone, incretin, which stimulates the pancreas to produce insulin when blood sugar levels rise too much."

Thiazolidinediones may not influence stroke risk in type 2 diabetes.

According to a study published in the journal Pharmacoepidemiology and Drug Safety, "patients with type 2 diabetes do not face an altered risk for stroke if they take thiazolidinediones (TZDs)." Analyzing data from the UK General Practice Research Database (GPRD) on "75,717 users of anti-diabetic drugs, 2,417 of whom suffered a stroke while being prescribed the drugs," Canadian found that the "stroke rate ratios among patients currently taking a TZD were nonsignificant, at 1.20 for monotherapy, 0.78 for combination therapy, and 0.87 for both groups combined."

Disclaimer- The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

Http://www.drshrutibhat.com
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Drug holds promise as potential Down syndrome cure- New drug research updates.

2011-02-22T11:10:00.000-05:00

Dr.Shruti Bhat, Star formulator and Ace leader within pharmaceutical R&D,a specialist with hiTech formulations and quality-by-design. Shruti brings to you some highlights from current pharma and clinical research news, views and data.

Avanafil reaches goal in late-stage study as ED treatment.

Vivus Inc. "stated that its erectile dysfunction drug candidate avanafil reached its key goal in a late-stage clinical study." The first of four late-stage studies on the drug found that "men who took avanafil experienced a greater improvement in their erectile dysfunction symptoms than patients who took a placebo." Vivus will seek FDA "approval in late 2010 or early 2011."

Avanafil "helped men in a study achieve erections in 30 minutes." In addition, "the most-common side effects were headaches, experienced by 7 percent of the men, facial flushing, experienced by 4.6 percent and nasal congestion, experienced by 2.3 percent." In the 646-patient trial, about three-quarters of patients taking either a 100 mg or a 200 mg dose of the drug had erections sufficient for intercourse, and fifty-seven percent experienced "successful intercourse," compared with 27 percent of placebo patients.

Experimental blood thinner may be safe, effective in heart patients.

Boehringer Ingelheim GmbH's Pradaxa [dabigatran etexilate] was safe and effective when added to aspirin and Plavix [clopidogrel] in reducing clots in patients with chest pains and minor heart attacks," according to a study presented at the American Heart Association meeting. Researchers "looked at four doses of Pradaxa in patients with acute coronary syndrome." The drug "didn't cause major bleeding during a six-month study," which included "more than 1,800 patients." A previous trial had demonstrated that dabigatran outperformed warfarin in preventing strokes in patients with atrial fibrillation."

Drug holds promise as potential Down syndrome cure.

Drugs that stimulate norepinephrine signaling might allow for normal cognitive development in children with Down syndrome," according to a paper in Science Translational Medicine. Working with "animals with three copies of chromosome 16 -- a model of the chromosome 21 trisomy responsible for human Down syndrome" -- Stanford scientists discovered that "an oral prodrug for norepinephrine called Droxidopa [xamoterol] almost normalized the mice's performance on standardized cognitive function tests."

The drug may increase norepinephrine levels. Low levels of the neurotransmitter were found in the locus coeruleus among rodents exhibiting Down-like behavior. And, "when the locus coeruleus broke down, the mice failed at simple cognitive tests that required them to be aware of changes in their environment. For example, they did not build nests when placed in an unknown cage, whereas normal mice typically do when placed in a new environment." But, when the rodents received "norepinephrine precursors, which are converted in the brain into the key neurotransmitter and hormone, the problem was fixed."

But, even if the scientific community succeeds in "developing a cure," a survey conducted by Canadian investigators reveals that "nearly 60% of parents whose children have Down syndrome might take a pass." The University of British Columbia team also pointed out that "many parents expressed concern that a cure would change their child's personality." That sentiment, however, "was not universal. Forty-one percent of parents said they would definitely treat their children for Down syndrome. Those parents said they were motivated by a desire to make their kids more independent and to give them more opportunities in life."

Genzyme canceling development of Renvela successor.

Genzyme Corp. announced that "it is canceling development of a successor to its kidney treatment Renvela [sevelamer carbonate], as the new drug did not work much better than Renvela." According to Genzyme, in a trial including 349 dialysis patients, "the newer product, called an advanced phosphate binder, met a main trial goal by being more effective than a placebo at lowering serum phosphorous levels in patients with chronic kidney disease," but did not "outperform Renvela, which was launched in early 2008."

The decision to cancel development of the successor drug comes at the same time the company is still dealing with the shutdown of one of its plants that was caused by an apparent viral contamination. Sevelamer carbonate is used for treating hyperphosphatemia, a condition that increases the risk for cardiovascular problems in people suffering from chronic kidney disease.

Lipitor, Vytorin may not reduce risk of heart attack compared with generic statin.

Lipitor (atorvastatin) and Vytorin (ezetimibe and simvastatin) "worked no better than simvastatin...at keeping patients out of the hospital for heart attacks or stroke," according to a study presented at the American Heart Association meeting. Investigators "analyzed medical claims of 30,000 patients taking one of the three drugs." The researchers "found no difference in rates of heart attacks or stroke among the three groups."

FDA approves aripiprazole to treat autism-related irritability in children.

FDA "has approved top-selling Abilify [aripiprazole] as a treatment for autism-related irritability in children from the ages of 6 to 17, drugmaker Bristol-Myers Squibb Co. said Friday." The agency's "latest approval allows the drug to be used to treat symptoms associated with autism such as aggression toward others, deliberate infliction of self-injury, tempter tantrums and moodiness." Bristol-Myers and Otsuka Pharmaceutical Co., collaborators on the development and distribution of Abilify in the US and Europe, "said in a statement that it was intended to be used as part of a more comprehensive treatment program that includes educational, psychological and social aspects." The approval was based on two eight-week studies.

Purchasing drugs in bulk seen as reducing costs for patients, insurers.

MedPage Today reported, "Buying prescription drugs in bulk reduces costs for both patients and their insurers, researchers" reported in the Nov. 20 issue of Applied Health Economics & Health Policy. The researchers said patients "saved about 30% by stocking up on their chronic medications in three-month supplies, rather than buying a month's supply." MedPage added, "Third-party payers saved about 18% when patients bought drugs in bulk."

Investigators reached those conclusions, HealthDay reported, after analyzing "26,852 prescriptions filled for 395 drugs between 2000 and 2005." In addition, if "all the prescriptions in the study had been dispensed in three-month supplies, the total out-of-pocket savings would have been about $148.6 million, and total saving would have been $245.1 million, the study authors explained."

HCV treatment meets goals in midstage trial.

Anadys Pharmaceuticals Inc. said its experimental hepatitis C drug is meeting key goals in a midstage clinical trial." The company notes that an "independent committee recommended escalating the study to a dose of 400 milligrams from 200 milligrams. The company expects to start the additional dose in January."

The preliminary data from the mid-stage study of ANA598 showed that 56% of patients taking the drug with standard of care treatments achieved undetectable levels of the virus, versus 20% of patients in a control group. The drug also was described as well tolerated through four weeks, with no serious adverse events reported. The San Diego Business Journal also reported that "six of the 29 patients given ANA598 reported mild rashes, although none severe enough to cause them to drop out of the trial."

Disclaimer- The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

Http://www.drshrutibhat.com
Expert at leading Pharmaceutical R&D.
Translates innovative concepts to PROFITS.
YouTube Channel : Http://www.youtube.com/user/ShrutiBhat10

Short walks plus glucosamine may relieve pain, improve mobility in patients with arthritis- New drug research updates.

2011-02-20T11:10:00.000-05:00

Decreased efficacy of adalimumab treatment may be associated with antibody development.

According to a study published in the Archives of Dermatology, "about 45% of patients who took adalimumab for treatment of plaque psoriasis developed antibodies to the drug, and those with high concentrations of antibodies failed to respond to treatment." In a study of "29 consecutive patients with plaque psoriasis," researchers found that "patients with no antibodies to adalimumab tended to respond better to the drug and those with low levels of antibodies responded better than those with high levels." An accompanying editorial "acknowledged that the study suggests adalimumab antibodies play a role in undermining the effectiveness of the drug for treating psoriasis."

High, low-dose regimens of cyclophosphamide may be equivalent in treating lupus.

"Short-term, high-dose cyclophosphamide appeared equivalent to the traditional lower dose monthly regimen for moderate-to-severe systemic lupus erythematosus (SLE), a prospective trial found." The study found that at "six months, 52% of patients receiving high-dose cyclophosphamide and 35% of those receiving the standard regimen had achieved a complete response," and "at 30 months, 48% and 65% of patients in the high-dose and traditional groups, respectively, had complete responses. Not only were there no significant differences between the two main groups at six months, but there also were no differences in response rates to the two treatment regimens among the different organ subgroups."

Acyclovir may help in patients with HIV-1 and type 2 herpes.

"New research suggests that people who are infected with both HIV-1, a strain of the AIDS virus, and herpes simplex virus type 2 could benefit in more than one way by taking a herpes drug called acyclovir." The study, published online in The Lancet, "analyzed what happened to almost 3,400 people in Africa who were infected with both diseases." Half of the patients were "assigned to take 400 milligrams of acyclovir twice a day" and found their "risk of HIV progression was reduced by 16 percent," while the other half were assigned to a placebo.

It was important to note that [acyclovir] did not seem to make HIV patients less infectious." The researchers also "pointed out that HIV treatment with antiretroviral drugs would probably have a greater effect on reducing HIV disease progression than was seen with [acyclovir]."

NSAID painkillers may offer no protection against cutaneous SCC.

According to a study published online in the Archives of Dermatology, NSAID painkillers "offer no protection against a common skin cancer," cutaneous squamous cell carcinoma. After studying questionnaire answers on "self-reported NSAID-use history" from "a randomly selected pool of 415 patients between the ages of 43 and 85 who were diagnosed with skin cancer in 2004," then comparing that information with that of 415 healthy controls, researchers found that "anti-inflammatory drugs were not...associated with a drop in skin cancer risk."

For self-reported NSAID exposure, there was no clear effect of dose, duration, or combined dose-duration variables for any of the four NSAID exposure categories on squamous cutaneous carcinoma [SCC].

Anti-depressant skin patch may reduce risk of common side-effects of antidepressants.

A skin patch for depression which has fewer side-effects than oral drugs could transform the treatment of the condition." The patch, "impregnated with the drug selegiline," avoids "the side-effects of the drug" and "cuts the risk of other common side-effects associated with all antidepressants, such as sexual dysfunction, headaches, anxiety, insomnia and nausea.

One of every 10 Americans prescribed a GI medication on an outpatient basis in 2007.

One of every 10 Americans was prescribed at least one gastrointestinal (GI) medication on an outpatient basis in 2007, compared with one of every 15 Americans in 1997, according to a recent report from the US Department of Health and Human Services." The "60% rise in the number of Americans who were prescribed GI agents accompanied a 170% increase in total expenditures on these medications, which was $18.9 billion in 2007 compared with $7 billion in 1997 (adjusted to 2007 dollars)." The "findings emerged from the Medical Expenditure Panel Survey, sponsored by the Agency for Healthcare Research and Quality and the National Center for Health Statistics."

Short walks plus glucosamine may relieve pain, improve mobility in patients with arthritis.

Findings reported in the journal Arthritis Research and Therapy indicate that "short walks, combined with an easy-to-buy nutritional supplement, could provide a cheap and easy way of relieving pain and improving mobility" in patients with arthritis. Researchers found that "six weeks of walking and taking" glucosamine decreased "pain and stiffness...by 13 percent." Participants "also felt less depressed and anxious."

Data on Revlimid as first-choice treatment against tumors to be presented.

Findings from a study "designed to show whether using" Celgene Corp.'s "Revlimid [lenalidomide] and two older cancer therapies helped patients live longer than taking only the other drugs" will be reported at the American Society of Hematology meeting. Celgene will present data to "show how well the pill works as a first-choice treatment, in long-term use, and against other tumors." Preliminary results, suggested Revlimid helped patients live longer." Revlimid was approved "for patients with myelodysplastic syndromes" in December 2005," and "it was cleared six months later for use as a secondary multiple myeloma therapy."

Raloxifene may improve verbal memory in late postmenopausal women.

According to a study published online in the journal Menopause, "late postmenopausal women who take the selective estrogen receptor modulator (SERM) raloxifene show significant improvements in verbal memory, suggesting that this compound may slow cognitive decline in elderly women." After randomizing "213 healthy postmenopausal women aged older than 70 years...to receive raloxifene 60 mg or placebo daily for 12 months," Dutch researchers found that "total direct recall of simple and abstract words was significantly higher in women taking raloxifene after three, six, and 12 months of treatment, compared with those receiving placebo."

Taxol may increase risk of chronic neuropathic pain in breast cancer survivors.

The chemotherapy drug paclitaxel (Taxol) increases the risk of chronic neuropathic pain in breast cancer survivors," according to a study published in the Journal of Pain. The study of 240 women showed that "those who experienced chemotherapy-induced peripheral neuropathy during their treatment with Taxol were three times more likely to eventually be diagnosed with chronic neuropathic pain." Researchers concluded that "patients treated with Taxol should be regularly monitored for neuropathic pain after their chemotherapy ends."

Disclaimer- The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

Http://www.drshrutibhat.com
Expert at leading Pharmaceutical R&D.
Translates innovative concepts to PROFITS.
YouTube Channel : Http://www.youtube.com/user/ShrutiBhat10

Placebo treatments may have actual biological effect in the body- New drug research updates.

2011-02-17T11:10:00.000-05:00

Dr.Shruti Bhat, Star formulator and Ace leader within pharmaceutical R&D,a specialist with hiTech formulations and quality-by-design. Shruti brings to you some highlights from current pharma and clinical research news, views and data.

Raltegravir, efavirenz may offer comparable outcomes in patients with HIV.

MedPage Today reported "that patients infected with human immunodeficiency virus and treated with the integrase inhibitor raltegravir (Isentress) fare as well as patients treated with efavirenz (Sustiva)." Although "the side effects on lipids favor raltegravir," Peruvian scientists explained that "74% of patients treated with a raltegravir-based regimen and 74% of patients treated with an efavirenz-based regimen continue to suppress HIV to undetectable levels, measured by the 50 copies/mL assay."

Drug to treat diabetic macular edema meets midstage study goals.

Regeneron Pharmaceuticals Inc. and Bayer HealthCare AG announced that "their VEGF Trap-Eye drug" now under development for treatment of diabetic macular edema "met key vision improvement goals in a midstage study." In the 24-week study, researchers "compared VEGF Trap-Eye with laser therapy."

Diabetic macular edema is a common cause of vision loss in some patients with diabetes.

Placebo treatments may have actual biological effect in the body.
According to a review published online Feb. 19 in The Lancet, "there is increasing evidence that fake treatments, or placebos, have an actual biological effect in the body." In a "review of previous research on placebos," researchers found that "the doctor-patient relationship, plus the expectation of recovery, may sometimes be enough to change a patient's brain, body, and behavior." The review's authors specifically cited studies in which patients with Parkinson's disease who were given a placebo still experienced a dopamine release in the brain, as well as other brain-activity changes.

Hormonal contraception appears to be safe for women with HIV.

According to a study presented at the Conference on Retroviruses and Opportunistic Infections, "hormonal contraception carries no harm for women with HIV." In a study of "625 women in the Rakai community of Uganda who had more than 10 years of follow-up," researchers found that "hormonal contraception was associated with a 32% lower risk of AIDS and death than no contraception." Similarly, "hormonal contraception appeared to lower risk of progression to AIDS or death by 30%, compared with not using hormonal contraception specifically."

FDA denies approval of drug to treat restless leg syndrome.

GlaxoSmithKline Plc and XenoPort Inc. "failed to gain US approval for an experimental treatment," called Horizant (gabapentin encarbil), "for a condition that causes sufferers to have an urgent need to move their legs." The FDA "issued a complete response letter" indicating that "a preclinical finding of pancreatic acinar cell tumors in rats was of 'sufficient concern' to preclude approval of the drug" to treat restless leg syndrome.

Gilead's four-in-one combination AIDS drug may be more effective than Atripla.

Gilead Sciences Inc.'s four-in-one combination pill for AIDS had fewer side effects and may be more effective than its three-drug treatment Atripla [efavirenz, emtricitabine, tenofovir] the world's best-selling HIV therapy, a study found." The drug was shown to reduce "the virus to undetectable levels in 90 percent of patients after 24 weeks, compared with 83 percent on Atripla, according to research presented today at a medical meeting."

Gilead drug "contains four Gilead compounds, including the potential HIV drug elvitegravir, a potential 'boosting' agent called cobicistat, and Truvada [emtricitabine, tenofovir]." The company is reported to be also studying cobicistat as a stand-alone boosting agent for other antiretroviral medications.

Ibuprofen may have a neuroprotective effect against Parkinson's disease.

MedPage Today reported, "Regular use of ibuprofen (Advil, Motrin) again appeared to have a neuroprotective effect against Parkinson's disease in observational study results." Researchers from the Harvard School of Public Health found that use of ibuprofen "at least twice a week was associated with a 38% lower risk of new-onset Parkinson's disease over six years, compared with taking the painkiller less than twice a week." Still, the lead researcher "cautioned in an interview that it's too early to make any clinical recommendations based on the observational data, which not only need confirmation in prospective trials but also cannot prove causality."

HealthDay reported that the "findings came from an analysis of data on 136,474 people who did not have Parkinson's at the start of the study. In a six-year span, 293 were diagnosed with the disease."

Disclaimer- The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

Http://www.drshrutibhat.com
Expert at leading Pharmaceutical R&D.
Translates innovative concepts to PROFITS.
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Dietary Supplement May Help Interrupt Growth-Promoting Pathways In Prostate Cancer- New drug research updates.

2011-02-13T11:10:00.000-05:00

Dr.Shruti Bhat, Star formulator and Ace leader within pharmaceutical R&D,a specialist with hiTech formulations and quality-by-design. Shruti brings to you some highlights from current pharma and clinical research news, views and data.

Researcher Says New Diabetes Treatment May Have Fewer Side Effects.

Reports Dr. Robert Unger, a "longtime diabetes researcher at UT Southwestern Medical School," is "setting up human tests for a new treatment he says might have fewer side effects than standard insulin therapy." The "tests using leptin, a natural hormone produced by fat cells, would build on results of experiments performed by Unger's research team and published" Monday in the Proceedings of the National Academy of Sciences. According to the Morning News, the research that led to the paper "was funded by the Veterans Administration, the National Institute of Diabetes and Digestive and Kidney Diseases, and several private donors."

Female Stroke Patients Who Fail To Receive tPA May Experience Poor Outcomes.

HealthDay reported, "Female stroke patients who aren't given the clot-busting drug tissue plasminogen activator (tPA) have worse outcomes than men who don't receive the drug," according to a paper in Neurology. Alongside the possibility of "biological reasons," Dr. Michael D. Hill, of the University of Calgary, said, "One social reason may be that more than 30 percent of women were widowed, compared to seven percent of men at the time of stroke, and therefore did not have a spouse who could act as a caregiver." What's more, "post-stroke depression is more common in women than in men, which slows down recovery."

FDA Approves Inhaled Antibiotic For Lung Infections In Patients With CF.

Gilead Sciences Inc. "won US approval of" Cayston (aztreonam lysine), "an inhaled antibiotic for lung infections in cystic fibrosis patients." FDA approval "will expand access to Gilead's medicine, which has been available since August 2007 to patients with limited treatment options who are at risk for their cystic fibrosis getting worse."

Statins May Significantly Reduce Prostate Tumor Inflammation.

HealthDay reported that "cholesterol-lowering statins significantly reduce prostate tumor inflammation, which may help lower the risk of disease progression," according to a study published online in the journal Cancer Epidemiology, Biomarkers & Prevention. Investigators "examined tissue samples of prostate tumors from 236 men undergoing prostate cancer surgery." The researchers "concluded that statin use was associated with reduced inflammation within tumors."

Dietary Supplement May Help Interrupt Growth-Promoting Pathways In Prostate Cancer.

MedWire reported, "Australian researchers have developed a dietary supplement which interrupts growth-promoting signaling pathways in prostate cancer cells." Specifically, there was "a dose-dependent reduction in in vitro LNCaP and PC3 growth of 83 and 93%, respectively, after 72 hours of treatment with 0.64% concentration of supplement." According to the paper in the Journal of Nutrition, the "supplement is designed for men on active surveillance programs for low-risk prostate cancer and contains ingredients commonly consumed in Mediterranean and East-Asian countries where prostate cancer incidence is lower than in Western societies."

Skin Patch Containing Minute Doses Of Nitroglycerine May Effectively Treat Prostate Cancer.

The UK's Daily Mail reported, "A chemical once used as a deadly explosive could be a powerful new treatment for prostate cancer," UK researchers found after studying 24 patients. Participants wore a "skin patch containing minute doses of nitroglycerine" 24 hours a day for two years, and were also "checked...every few months for their PSA doubling time." According to the paper in Urology, "within six months, PSA levels had stabilized in all but five of the 24 volunteers. After a year, most were either still stable or even declining."

In Story Of Genetically-Targeted Melanoma Drug, Results Look Promising.

In the second of three articles, the New York Times recounted in a front-page story on the trials for PLX4032, a genetically targeted drug for melanoma patients. Dr. Keith Flaherty, University of Pennsylvania oncologist, sees "impressive" results in the Phase 1 trial, and sought FDA approval for a Phase 2 trial. "The trial of PLX4032 offers a glimpse at how doctors, patients and drug developers navigate a medical frontier as more drugs tailored to the genetic profile of a cancer are being widely tested on humans for the first time," according to the Times. In the trials, researchers find side effects at the 1,120-milligram dose, but at lower doses, patients seem to be improving.

Merck will not seek FDA approval for antiretroviral drug vicriviroc.

MedPage Today reported, "The failure of the investigational antiretroviral drug vicriviroc to distinguish itself in a phase III clinical trial has derailed plans by Merck to seek FDA approval for the agent in treatment-experienced patients." Merck "announced that it will not file a New Drug Application for vicriviroc" after two phase III studies "indicated there was no difference in outcomes measured by HIV replication" when "patients who had previous treatments with antiretroviral medicines were assigned to receive vicriviroc plus optimized background therapy or just optimized background therapy alone."

Treatment may reduce HIV transmissibility among discordant couples.

MedPage Today reported, "Antiretroviral treatment is highly effective at reducing risk of HIV transmission to uninfected partners," scientists at the Fred Hutchinson Cancer Research Center found after evaluating "3,408 heterosexual couples in which only one partner was confirmed to have" the virus. In fact, the "92% reduction in risk of transmission dropped the incidence of in-couple transmission from 2.23 to 0.39%." Although the "drop-off in serum and genital viral loads that accompanies treatment has long been suspected...to counteract transmissibility," the findings presented at the Conference on Retroviruses and Opportunistic Infections "are among the first data to confirm mathematical model projections."

Belatacept may benefit kidney transplant recipients more than cyclosporine.

MedPage Today reported that, according to two studies published in the March issue of the American Journal of Transplantation, "kidney transplant recipients had similar survival and better renal function with the investigational immunosuppressive agent belatacept compared with cyclosporine." In one study of 686 adults, "two intensity levels of belatacept-based immunosuppression led to one-year patient/graft survival of 95% to 97% compared with 93% with a cyclosporine-based regimen." In another study involving 578 patients, "the same two belatacept regimens matched cyclosporine for patient/graft survival with better renal function in a trial involving recipients of extended-criteria donor kidneys."

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EMA Releases New Guidance on Stem Cell Products

2011-02-10T12:19:00.002-05:00

On Feb. 4, 2011, the European Medicines Agency released new document on drug products that are manufactured using stem cells. Titled, Reflection Paper on Stem Cell-Based Medicinal Products, the document advises manufacturers on quality-control issues regarding these products and provides an overview of the use of stem cells in drug development. The final document is based on a draft paper issued in March 2010.

The paper applies directly to those companies pursuing marketing authorization for stem cell-based products.

According to the document, the paper “should be read in conjunction with existing guidance on cell-based medicinal products (Guideline on human cell-based medicinal products [EMEA/CHMP/410869/2006]) which addresses general aspects of cell-based medicinal products.”

Specifically, the paper provides key quality considerations for manufacturers, including purity of the stem cells. The document states that, “the aim should be to maximize the active components and minimize features which do not contribute, or may negatively impact on therapeutic activity/safety.”

For example, the document points out that tumor formation is an inherent risk when using pluripotent stem cells. This possibility should be assessed during product development and the presence of pluripotent cells should be limited and justified, states the document. The guidance also addresses cell rejection, including using potential immune responses of drug product to assess the risk of rejection and elimination of the stem cell.

EMA’s Committee for Advanced Therapies adopted the final reflection paper on Jan. 14, 2011.

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Novel Antiviral Compound May Be Effective Against H5N1 Influenza Viruses- New drug research updates.

2011-02-10T11:10:00.000-05:00

Dr.Shruti Bhat, Star formulator and Ace leader within pharmaceutical R&D,a specialist with hiTech formulations and quality-by-design. Shruti brings to you some highlights from current pharma and clinical research news, views and data.

Merck Reports 43 Drugs In Mid- Or Late-Stage Testing.

"Merck & Co. said Monday that it now has 43 experimental drugs in mid-or late-stage testing -- nearly double what it had before buying joint venture partner Schering-Plough Corp. last fall." The AP notes that "19 drugs in late-stage development include four treatments for heart disease, an injection for dangerous Staph infections and two pills -- instead of the shots now used - to gradually eliminate symptoms of grass and ragweed allergies." Peter S. Kim, president of Merck Research Laboratories, also "said top prospects among the drugs acquired from Schering-Plough include two that would each be the first in a new class, an anticlotting drug referred to as TRA and a hepatitis C drug called boceprevir."

Pharmaceutical Industry Pursuing Few Drugs For Gram-Negative Bacteria.

The New York Times reported that, "for a combination of business reasons and scientific challenges, the pharmaceuticals industry is pursuing very few drugs for Acinetobacter and other organisms of its type, known as Gram-negative bacteria." In the meantime, however, "the germs are evolving and becoming ever more immune to existing antibiotics." The cell structure of Gram-negative bacteria "makes them more difficult to attack with antibiotics than Gram-positive organisms like MRSA." As a result, "doctors treating resistant strains of Gram-negative bacteria are often forced to rely on two similar antibiotics developed in the 1940s -- colistin and polymyxin B," which "were largely abandoned decades ago because they can cause kidney and nerve damage."

Mainstay Of Anti-Clotting Therapy May Be Facing Competition From Newcomers.

HealthDay reported that "new studies provide more proof that the mainstays of anti-clotting therapy, namely warfarin and aspirin, are facing some severe competition from newcomers." Investigators "presenting their findings during a Friday news conference at the American Stroke Association's annual meeting...show that one new drug, dabigatran (Pradaxa), which is not yet approved in the United States, equaled warfarin for treating stroke patients, while cilostazol (Pletal), which has been approved by the US Food and Drug Administration for the treatment of peripheral arterial disease (PAD), outperformed aspirin in preventing recurrent strokes."

Investigators To Examine Flu Vaccines, Asthma Medications' Effect On Pregnancy.

The Boston Globe "White Coat Notes" blog reported, "Researchers from Boston University are embarking on a national study of women who take medications or get vaccinated while they are pregnant, starting with flu and asthma treatments because they are widely taken and a common cause of concern." During "the effort, called the Vaccines and Medications in Pregnancy Surveillance System," investigators "will compare women whose babies have major birth defects to mothers of normal babies." Then, "based on information obtained from hospitals and birth registries, the researchers will interview mothers by telephone in Massachusetts, Philadelphia, San Diego, and New York state."

Novel Antiviral Compound May Be Effective Against H5N1 Influenza Viruses.

MedWire reported, "A novel antiviral compound is effective against H5N1 avian influenza (bird flu), including highly pathogenic and oseltamivir-resistant strains of the virus." According to the paper in PLoS Pathogens, "mice that received a single intranasal 1500-µg/kg dose of CS-8958 given two hours after H5N1 infection had significantly higher survival rates and lower virus titers in the lungs and brain than control mice and mice treated with the five-day course of oseltamivir." University of Tokyo researchers "also found that a single dose of CS-8958 given seven days before infection protected the mice against lethal H5N1 infection."

Statins Linked To Improvements In Peak Flow, Reduction In Asthma Rescue Inhaler Use.

MedPage Today reported, "Statins may have yet another beneficial role besides lowering lipids: asthma control." In fact, "adult asthma patients who started a lipid-lowering drug for cardiovascular reasons saw a meaningful improvement in peak flow and reduction in asthma rescue inhaler use soon afterward, Odelya E. Pagovich, MD, of Beth Israel Medical Center in New York City, and colleagues told attendees at American Academy of Allergy, Asthma, and Immunology meeting." While "statins as asthma monotherapy are out of the question, they might be valuable add-on treatments if the results are validated in a clinical trial, Pagovich said."

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New Treatments Attacking Cancer At Molecular Level- New drug research updates

2011-02-06T11:10:00.000-05:00

Dr.Shruti Bhat, Star formulator and Ace leader within pharmaceutical R&D,a specialist with hiTech formulations and quality-by-design. Shruti brings to you some highlights from current pharma and clinical research news, views and data.

Severe Liver Injuries Among Patients Taking Isoniazid For Latent TB Considered Rare.

According to the CDC's Morbidity and Mortality Weekly Report, "severe liver injuries among patients taking isoniazid for latent tuberculosis are rare." In fact, just 17 "cases of isoniazid-related liver injury were identified using passive surveillance over a five-year period, during which an estimated 1.5 to 2.2 million patients received treatment." According to an "accompanying comment" written by the MMWR editors, "the findings underscore the importance of following recommendations from the American Thoracic Society and CDC for selecting appropriate patients for isoniazid treatment and monitoring them regularly during treatment."

Formoterol-Containing Treatments May Help COPD Patients Reverse Airflow Obstruction.

"Chronic obstructive pulmonary disease (COPD) patients treated with formoterol-containing treatments appear to significantly reverse airflow obstruction, even with severe cases of COPD," UCLA researchers explained. "Depending upon the criteria used, treatment with formoterol achieved a response in 51% to 54% of patients using the American Thoracic Society criteria or in 66% to 83% of patients using the ≥15% improvement assessment." Yet, lead investigator Donald Tashkin, MD, was quick to point out that "while more than half the patients improved on the formoterol treatments, patients appeared to do better with the combination" of budesonide and formoterol.

New Treatments Attacking Cancer At Molecular Level.

Sutent (sutinib) "is part of an explosion of treatments that attack cancer at the molecular level, holding the promise of turning intractable malignancies into chronic diseases like diabetes or HIV." These therapies "are already extending life -- and adding to the cost of end-of-life care, which in the case of Sutent could be on the order of $48,720 a year." But due to Sutent's and other similar drugs' "limited periods of effectiveness," they are "so expensive that some governments resist paying for them."

Experimental Blood Thinner Outperforms Lovenox In Study.

"Bristol-Myers Squibb Co.'s and Pfizer Inc.'s experimental blood thinner prevented dangerous blood clots from forming after knee replacement surgery better than Sanofi-Aventis SA's Lovenox [enoxaparin] in" a study published in The Lancet. The study, "dubbed Advance-2, found patients given apixaban pills twice daily were 38 percent less likely to develop clots deep in the legs, in the lungs, or die within two weeks than those given intravenous Lovenox starting before the operation." Pfizer and Bristol-Myers "plan to apply for European approval of apixaban based in part on the study."

Drug May Prove Effective In Protecting Against Bouts Of Emphysema Or COPD.

"Preclinical research suggests that an analogue of an anti-AIDS drug might prove effective in protecting against bouts of emphysema or chronic obstructive pulmonary disease (COPD)." Researchers at the University of Omaha explained that the "drug, UK-484900, mitigates the role of interleukin-13, a factor in the cascade of molecular events that produces airway hyper-responsiveness." And, "just as it blocks the impact of IL-13 in a mouse model of emphysema and COPD, researchers" discovered that UK-484900 "effectively protects against it" in humans.

Dopamine Linked To Adverse Events In Shock Patients When Used As First-Line Treatment.

"While there were no significant differences in death rates between shock patients who received dopamine and norepinephrine, those who got dopamine as a first-line treatment had more adverse events." In fact, "patients given dopamine had significantly more arrhythmic events, especially instances of atrial fibrillation," according to a Belgian study published in the New England Journal of Medicine. An accompanying editorial said the "findings challenge consensus guidelines that recommend dopamine as the initial vasopressor for increasing arterial pressure in the case of septic or cardiogenic shock."

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New Drug May Help Relieve Cracked, Itchy Hands In Patients With Severe Eczema- New Drug updates

2011-02-04T11:10:00.001-05:00

Dr.Shruti Bhat, Star formulator and Ace leader within pharmaceutical R&D,a specialist with hiTech formulations and quality-by-design. Shruti brings to you some highlights from current pharma and clinical research news, views and data.

AstraZeneca Colon Cancer Drug Fails To Match Avastin Therapy In Test.

"AstraZeneca Plc's experimental Recentin [cediranib] medicine failed to equal Roche Holding AG's Avastin [bevacizumab] in tests for use as an initial treatment against colon cancer." The study was intended to prove Recentin "wasn't inferior to Avastin in keeping patients alive without their disease progressing."

AstraZeneca "said it will wait for the results of a second study on Recentin -- this time testing its effectiveness in combination with chemotherapy compared with chemotherapy alone -- before deciding whether to submit the drug to regulators for marketing approval."

Drug Used In Blood Cancer Medicines May Block Process Essential To Limb Development.

"Scientists have uncovered how a drug used in blood cancer medicines leads to short or missing limbs in babies, moving closer to developing treatments without the risk of these birth defects." According to a study on zebrafish and chicks published in the journal Science, "thalidomide, the drug known for causing deformed arms and legs in fetuses, binds with the cereblon protein to inhibit its activity, blocking a process essential to limb development." The drug was once "used as a morning-sickness treatment in the 1960s and then banned after women who took the drug in early pregnancy gave birth to children with short or missing arms and legs, the US Department of Health and Human Services said."

Companies Say Acurox Met Abuse-Resistance Goals In Study.

"Acura Pharmaceuticals Inc. and King Pharmaceuticals Inc. stated that the potential abuse-resistant painkiller Acurox [oxycodone HCl/niacin] met key goals in a pivotal study." The companies also "said the drug candidate met all five key goals of abuse-resistance, compared with equivalent doses of oxycodone HCI." The FDA, which "declined to approve the drug in June 2009," agreed with the companies "that data and studies supporting the drug would be presented to an FDA advisory committee, though the timing of that meeting has not been confirmed."

Statins May Help Improve Symptoms Of Psoriasis.

"Already linked to a reduced risk of rheumatoid arthritis, diabetes, multiple sclerosis, and cancer, statins also may help to improve symptoms of psoriasis," according to research presented at that American Academy of Dermatology annual meeting. Investigators, "in a study of 232 people taking medication for psoriasis," found that participants "who also took statins had fewer of the thick, red, scaly, itchy patches that are the hallmark sign of psoriasis, compared with people who didn't take the cholesterol-lowering drugs."

New Drug May Help Relieve Cracked, Itchy Hands In Patients With Severe Eczema.

A new drug called alitretinoin can help relieve cracked, itchy, irritated hands in people with severe hand eczema. At the American Academy of Dermatology annual meeting, Charles Lynde, MD, assistant professor of dermatology at the University of Toronto, "summarized findings from three studies showing that alitretinoin is effective in a substantial proportion of these patients." Dr Lynde said, "The first and second studies show that itching, redness, fissures, and dryness go away. The third shows it will help if you relapse."

Researchers To Test Whether AST-120 Improves Brain Function In Mild Hepatic Encephalopathy Patients.

"Ocera Therapeutics Inc.is testing" a drug for "for a little-known neuropsychiatric condition called mild hepatic encephalopathy." Apparently, AST-120, "marketed in Japan under the name Kremezin," works "like a sponge to soak up the toxins in the gastrointestinal tract before they can work their way up to the brain and impair brain function." CEO Laurent Fischer also "said Ocera's drug would have the advantage over an antibiotic, because long-term antibiotic use has been associated with hard-to-treat infections, such as Clostridium difficile." The San-Diego based firm plans to enroll "150 people in an eight-week trial known as ASTUTE to determine whether it can effectively improve brain function," and the "data is expected in mid-2010."

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Cancer biomarker offers clues into when it will spread.

2011-02-04T02:17:00.002-05:00

Dr.Shruti Bhat, Star formulator and Ace leader within pharmaceutical R&D,a specialist with hiTech formulations and quality-by-design. Shruti brings to you some highlights from current pharma and clinical research news, views and data.

An eight-year study of cancer patients has yielded an important biomarker that can detect if cancer has spread or if it will recur, according to a team at the National Institutes of Health and the University of Hong Kong. Next, they will work to develop a test for the protein CPE-delta N, which ordinarily plays a role in processing insulin and other hormones. It turns out, it does more than that.

"This form is present in large amounts in primary tumors that have spread or metastasized," said Y. Peng Loh of the NIH's National Institute of Child Health and Human Development.

"This biomarker may be useful for many types of cancers," she told AFP. "It is very important to know when a cancer is likely to spread. Currently there are no accurate biomarkers that can achieve such predictions and prognosis is determined by staging of the cancer."

If the results are confirmed, patients with high CPE-delta N levels could get extra chemotherapy or radiation to control the risk of spread

Read more: http://www.fiercebiomarkers.com/story/cancer-biomarker-offers-clues-when-it-will-spread/2011-02-01

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Vitamin D crucial for immunity

2011-02-02T11:10:00.001-05:00

Danish scientists have determined sufficient intake of vitamin D is vital for the killer T cells of the immune system to fend off serious infections. And these findings could prove useful in the fight against infectious diseases, as well as during the development of new vaccines.

T cells work by either attacking and destroying all cells carrying traces of a foreign pathogen or assisting the immune system in acquiring memory. The so-called helper cells send messages to the immune system, passing on knowledge about the pathogen so that the system can recognize and remember it at their next encounter and launch a more efficient and enhanced immune response.

"When a T cell is exposed to a foreign pathogen, it has an immediate biochemical reaction and extends a signaling device or 'antenna' known as a vitamin D receptor, with which it [searches] for vitamin D. This means that the T cell must have vitamin D or activation of the cell will cease. If the T cells cannot find enough vitamin D in the blood, they won't even begin to mobilize," explains Professor Carsten Geisler of the University of Copenhagen.

Scientists have long known that vitamin D is important for calcium absorption and implicated in cancer and multiple sclerosis, "but what we didn't realize is how crucial vitamin D is for actually activating the immune system--which we know now," Geisler says. Most Vitamin D is produced as a natural byproduct of the skin's exposure to sunlight. It can also be found in fish liver oil, eggs and fatty fish such as salmon, herring and mackerel or can be taken as a dietary supplement.

FDA Approves Rituximab As Follicular Lymphoma Maintenance Treatment.

2011-01-31T12:09:00.002-05:00

Dr.Shruti Bhat, Star formulator and Ace leader within pharmaceutical R&D,a specialist with hiTech formulations and quality-by-design. Shruti brings to you some highlights from current pharma and clinical research news, views and data.

FDA Approves Rituximab As Follicular Lymphoma Maintenance Treatment.

The FDA has "approved an additional use for blockbuster cancer drug Rituxan [rituximab] as a first-line maintenance treatment for patients with follicular lymphoma." The approval is for the drug's use in patients with "previously untreated advanced follicular lymphoma who responded to initial treatment with a combination of Rituxan and chemotherapy." In data submitted to regulators, the drug "nearly doubled the length of time people lived without the disease getting worse."

FDA Approves Gabapentin For Shingles-Releated Pain.

The Food and Drug Administration has approved Depomed's Gralise [gabapentin] to treat pain following the viral infection shingles. The FDA approved Gralise as a "once-daily treatment for post-herpetic neuralgia." Depomed CEO Carl Pelzel "said the drug's approval is a 'major step' toward Depomed's goal of sustainable profitability starting this year."

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Roche allegedly reported Avastin failed to meet goal in prostate cancer study.

2011-01-31T11:00:00.001-05:00

Dr.Shruti Bhat, Star formulator and Ace leader within pharmaceutical R&D,a specialist with hiTech formulations and quality-by-design. Shruti brings to you some highlights from current pharma and clinical research news, views and data.

The Wall Street Journal reported that Roche Holding AG said that its drug Avastin (bevacizumab) did not meet a key goal in a prostate cancer study.

According to Roche, "a combination of the biologic, chemotherapy, and the prednisone medication didn't extend overall survival compared with treatment with the latter two drugs alone." Bloomberg notes that "the final-stage study was sponsored by the US Cancer and Leukemia Group B and the National Cancer Institute."

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Pfizer Reports Two Cancer Drugs Failed In Clinical Trials.

2011-01-30T11:00:00.000-05:00

Dr.Shruti Bhat, Star formulator and Ace leader within pharmaceutical R&D,a specialist with hiTech formulations and quality-by-design. Shruti brings to you some highlights from current pharma and clinical research news, views and data.

Pfizer Inc. said the cancer drug Sutent [sunitinib] failed to halt the progression of advanced breast tumors in two studies.Researchers found that "Sutent used as an initial treatment in combination with chemotherapy didn't show a 'statistically significant' improvement in slowing the growth of advanced breast cancer compared with chemotherapy alone." Meanwhile, a second study showed that "Sutent used with a different chemotherapy drug didn't slow the spread of breast cancer in previously treated patients when compared with chemotherapy alone."

“The drug is already sold as a treatment for advanced kidney cancer and gastrointestinal stromal cancer." Dr. Mace Rothenberg, senior vice president of clinical development and medical affairs at Pfizer's oncology business unit, said that although the company is "disappointed in the results, these trials have helped us define the limits and opportunities for the compound."

Pfizer also "said...it discontinued a late-stage study of the drug candidate figitumumab in patients with late-stage lung cancer, citing a lack of effectiveness," the AP (3/12) reports in a separate article. The move follows a recommendation from "an independent monitoring committee" to halt the study. The panel "concluded that figitumumab in conjunction with Tarceva [erlotinib] will likely not significantly improve the overall survival rate of patients."

But,the company said it intends to continue clinical trials of figitumumab for prostate, breast, and lung cancers.

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Two more drugs fail in Trials

2011-01-29T11:00:00.000-05:00

Dr.Shruti Bhat, Star formulator and Ace leader within pharmaceutical R&D,a specialist with hiTech formulations and quality-by-design. Shruti brings to you some highlights from current pharma and clinical research news, views and data.

Biogen Idec’s rheumatoid arthritis/lupus collaboration with Roche was suspended due to deaths caused by serious infections in clinical studies. The drug, ocrelizumab, was studied in six trials; the main conclusion was that the “safety risks outweighed the benefits observed in these specific patient populations.”

While the companies have not released just how many fatalities stemmed from the trials they did state that a “detailed analysis” of the data is underway.

The same day, AstraZeneca announced that its Avastin competitor Recentin did not reach necessary endpoints in Phase II/III trials. The drug was given as a first line treatment to patients suffering from colon cancer, but didn’t prove to be any better than Roche’s Avastin in trials. The key differentiator is that Recentin is in pill form versus Avastin’s intravenous delivery system. AZ was banking on the drug’s ease of delivery to give it the edge over Roche.

This is the second time clinical trials involving this treatment have been stopped. According to Bloomberg, two years ago, patients taking Recentin for lung cancer had more adverse reactions to the drug versus those on chemotherapy alone.

Recentin is still being given to patients in a second trial to determine whether the treatment can be useful in treating colon cancer patients who are also receiving chemotherapy. The outcome of that trial will determine whether or not AstraZeneca submits the drug to FDA for consideration.

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Infections and deaths force Biogen, Roche to suspend blockbuster program

2011-01-27T11:00:00.000-05:00

Dr.Shruti Bhat, Star formulator and Ace leader within pharmaceutical R&D,a specialist with hiTech formulations and quality-by-design. Shruti brings to you some highlights from current pharma and clinical research news, views and data.

In a significant setback, Biogen Idec and Roche have suspended the troubled development program of ocrelizumab for rheumatoid arthritis, and analysts are already questioning if work related to multiple sclerosis may soon follow.

The companies made their move after an independent safety board said that the risks outweighed the potential benefit from the experimental therapy, noting that serious and opportunistic infections had afflicted patients taking the therapy, some of whom died. Safety concerns had already forced researchers to halt two clinical trials for rheumatoid arthritis and lupus.

"The news wasn't completely unexpected since some trials were on hold before," notes Birgit Kulhoff, an analyst at Rahn & Bodmer. "However, with the obvious fatalities the drug has a high likelihood of not being approvable. I would expect that the MS trials will be stopped as well."

"Patient safety is of the utmost importance in all of our drug development programs," says Roche's Chief Medical Officer Hal Barron. Kulhoff had projected blockbuster sales if the drug had gone on to an approval for all three indications. Infections and deaths force Biogen, Roche to suspend blockbuster program.

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Is there a new game changer in the pharmaceutical market?

2011-01-26T11:00:00.000-05:00

Dr.Shruti Bhat, Star formulator and Ace leader within pharmaceutical R&D,a specialist with hiTech formulations and quality-by-design. Shruti brings to you some highlights from current pharma and clinical research news, views and data.

Vertex Pharmaceuticals (VRTX) has added a fresh haul of solid Phase III data to support its rolling application for telaprevir, a potential blockbuster that some analysts believe is a likely game changer in the market. An overwhelming majority of hepatitis C patients who registered a quick response to a telaprevir-based cocktail were effectively cleared of the virus after 24 weeks, according to researchers, making further treatments unnecessary. And that indicates the new hep C drug could cut the current standard treatment time in half for a large group of patients.

Investigators set out to determine if patients who achieved undetectable levels of the virus after four and 12 weeks of treatment would benefit by going past the 24-week mark and push on to 48 weeks of therapy. But they found that subjects with an extended rapid viral response, or eRVR, had a cure rate of 92 percent at 24 weeks and 88 percent at 48 weeks.

"The viral cure rates seen in (the Phase III Illuminate trial) showed that there was no benefit to extending telaprevir-based therapy to 48 weeks for the majority of people," said Kenneth Sherman, the principal investigator of the trial. "Patients who had a rapid response to telaprevir-based regimens at weeks four and 12 had a high likelihood of achieving a cure with 24 weeks of total treatment, which may provide important information to motivate people to continue therapy."

Vertex plans to release more late-stage data next month in the lead-up to completing their rolling FDA application by the end of this year. Seeking Alpha says it expects an approval of the drug in early 2011 with a huge market to tap. The market, though, has evidently seen enough positive data to discount any new releases like this. Vertex shares were up a little more than one percent this morning.

http://www.fiercebiotech.com/story/vertexs-telaprevir-cuts-hep-c-treatment-time-half/2010-08-10?utm_medium=nl&utm_source=internal

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Using Inhaled Corticosteroids May Increase Risk For Developing Type 2 Diabetes.

2011-01-25T11:00:00.000-05:00

Dr.Shruti Bhat, Star formulator and Ace leader within pharmaceutical R&D,a specialist with hiTech formulations and quality-by-design. Shruti brings to you some highlights from current pharma and clinical research news, views and data.

Using inhaled corticosteroids to treat chronic breathing problems may slightly increase a person's risk of developing type 2 diabetes, according to a study published in the American Journal of Medicine. After analyzing "the drug records of more than 388,000 patients who were prescribed inhaled corticosteroids," researchers "found that the risk of needing medication to control high blood sugar increased about 34% in patients taking any dose of daily inhaled corticosteroids.

In those on the highest doses, the risk increased by 64%." Despite the study's findings, the authors "say the increase in risk probably doesn't outweigh the benefits to people taking daily puffs of inhaled corticosteroids to control asthma."

HTTP://DIABETES.WEBMD.COM/NEWS/20101214/INHALED-STEROIDS-MAY-INCREASE-DIABETES-RISK

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FDA To Set New Guidelines For Cancer Drug Cocktails.

2011-01-24T11:00:00.000-05:00

Dr.Shruti Bhat, Star formulator and Ace leader within pharmaceutical R&D,a specialist with hiTech formulations and quality-by-design. Shruti brings to you some highlights from current pharma and clinical research news, views and data.

The San Francisco Chronicle /Bloomberg Businessweek reports the FDA is now "ready to allow innovative testing of drug cocktails" for cancer treatment, according to Richard Pazdur, the agency's top cancer regulator. The "new research guidelines, which will be posted for public comment before approval, describe three basic principles for early combinations," Pazdur said. If "conditions are met, companies may develop components simultaneously and forgo differentiating the drugs on the last and most expensive trials needed for regulatory approval," the paper added. "

About 800 targeted drugs are in various stages of development in cancer, aimed at about 300 genes relevant to the disease," said John Mendelsohn, president of the University of Texas M.D. Anderson Cancer Center.

http://www.sfgate.com/cgi-bin/article.cgi?f=/c/a/2010/08/29/BU6O1F3RD8.DTL

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Does Stem cell research promise magic hair re-growth for the unfortunate bald?

2011-01-23T11:00:00.000-05:00

Dr.Shruti Bhat, Star formulator and Ace leader within pharmaceutical R&D,a specialist with hiTech formulations and quality-by-design. Shruti brings to you some highlights from current pharma and clinical research news, views and data.

In search of a new stem cell therapy for burn victims, a group of Swiss and Scottish scientists have made a startling and completely unexpected discovery. By taking stem cells from the thymus and transplanting them into the developing skin of rats, they were transformed into new follicle cells capable of growing hair. The transformation was also achieved without any genetic switch-up in the cells, implying that the same cell type could make the same leap in other organs.

"These cells really change track, expressing different genes and becoming more potent," says lead researcher Professor Yann Barrandon, who runs the stem cell lab at the University of Lausanne in Switzerland. His team's findings have been published in Nature.

Naturally occurring hair follicle stem cells support hair for three weeks, but these transplanted cells worked for up to a year producing hair--pointing to a possible cure for baldness. The thymus plays a key role in spurring the immune system. But the scientists were even more enthusiastic about the potential of a new cell that can be transformed by its environment.

"It's not just that a latent capacity is triggered or uncovered when these stem cells come in to contact with skin," says Clare Blackburn, of the University of Edinburgh's Medical Research Council Centre for Regenerative Medicine, going on to echo Barrandon on the cells' potency. "It will be interesting to see whether microenvironments other than skin have a similar effect."

Read more: Stem cell research breakthrough could cure baldness -FierceBiotech Research http://www.fiercebiotechresearch.com/story/stem-cell-research-breakthrough-could-cure-baldness/2010-08-23#ixzz0xYTMoLn5

http://www.fiercebiotechresearch.com/story/stem-cell-research-breakthrough-could-cure-baldness/2010-08-23

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Drug product updates:

2011-01-21T11:00:00.000-05:00

Dr.Shruti Bhat, Star formulator and Ace leader within pharmaceutical R&D,a specialist with hiTech formulations and quality-by-design. Shruti brings to you some highlights from current pharma and clinical research news, views and data.

Teriflunomide Meets Goal In Late-Stage MS Study.

Bloomberg News reports, "Sanofi-Aventis SA's experimental oral medicine teriflunomide significantly reduced the relapse rate in multiple sclerosis patients, meeting the goal of a late- stage study." The company said patients "taking the medicine had fewer relapses than those taking a placebo."
http://www.bloomberg.com/news/2010-08-30/sanofi-s-experimental-oral-multiple-sclerosis-treatment-reduces-relapses.html

Drugmakers Competing To Develop Medications To Prevent Blood-Clotting Problems.

The New York Times reports that "leading drugmakers are competing to reach the market with a new class of pills to prevent the kind of dangerous blood clots in the veins and lungs that can travel to the brain, causing strokes." Currently, the FDA is "reviewing an application for Johnson & Johnson for rivaroxaban to reduce the risk of dangerous blood clots in people undergoing knee or hip replacement surgery." The agency is also "reviewing an application from Boehringer Ingelheim for dabigatran as a stroke prevention drug in patients with atrial fibrillation, the company said in a statement Monday."

http://www.nytimes.com/2010/08/31/health/research/31drug.html?_r=1&ref=health

Researchers Looking For Alternatives To Anabolic Steroids To Help Build Muscle.

The New York Times reports, "The hunt is on for alternatives to anabolic steroids, which build muscle by mimicking the effects of the hormone testosterone but whose reputation has been tarnished by athletic doping scandals and side effects like liver damage." For example, "companies like GTx and Ligand Pharmaceuticals are trying to develop" selective androgen receptor modulator drug "that possess the muscle-building ability of testosterone without its side effects, like the development of facial hair and other masculine features in women." To date, such drugs are only in the earliest phases of testing.
http://www.nytimes.com/2010/08/31/health/research/31muscleside.html?ref=health

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GLAXOSMITHKLINE HALTS ALL FURTHER DEVELOPMENT OF RESVERATROL DRUG SRT501

2011-01-20T11:00:00.000-05:00

Dr.Shruti Bhat, Star formulator and Ace leader within pharmaceutical R&D, a specialist with hiTech formulations and quality-by-design. Shruti brings to you some highlights from current pharma and clinical research news, views and data.

GlaxoSmithKline has announced that it is halting all further development of its proprietary formulation of resveratrol known as SRT501.

A key factor in this decision, according to the company, was that it no longer feels the drug offers an adequate efficacy / safety trade-off as a potential treatment for multiple myeloma.

Earlier this year, Glaxo suspended its Phase 2 trial of SRT501 in multiple myeloma because several patients in the trial developed kidney failure.

At the time, it was unclear if the kidney failure cases were due to SRT501, or if they were a natural consequence of the patients’ multiple myeloma. The form of kidney failure that was observed – cast nephropathy – is a common complication of multiple myeloma, so much so that it is often described as “myeloma kidney.”

According to a GlaxoSmithKline spokesperson, an internal analysis of the kidney failure cases has concluded that they “most likely were due to the underlying disease … However, the formulation of SRT501 was not well tolerated, and side effects of nausea / vomiting / diarrhea may have indirectly led to dehydration, which exacerbated the development of the acute [kidney] failure.”

For this reason, the company decided to terminate the Phase 2 trial of SRT501 in multiple myeloma and halt development of the drug as a potential myeloma treatment. The SRT501 formulation of resveratrol “may only offer minimal efficacy,” explained the Glaxo spokesperson, while increasing the chances of kidney failure.

It is currently uncertain why GlaxoSmithKline decided to terminate all further development of SRT501. The company could have ended trials of the drug as a possible myeloma treatment, but continued to test the drug in trials for other diseases.

The resveratrol in SRT501 is from a plant-based source. It is micronized, or milled into very small uniform particles, to maximize uptake into the body. Patients in the SRT501 multiple myeloma trial received a relatively high dose of resveratrol – 5 grams of SRT501 – once per day.

Resveratrol is a molecule found in small quantities in the skin of red grapes and in red wine. It is thought to be the source of red wine’s reported health benefits.

Previous studies have indicated that resveratrol may be effective at killing cancer cells, including multiple myeloma cells.

Scientific evidence for these claims has been controversial and confined mostly to the laboratory. The SRT501 trial was the first attempt to determine the effectiveness of resveratrol in treating multiple myeloma patients.

Update #1– The full text of GlaxoSmithKline’s statement to The Myeloma Beacon regarding its decision to halt further development of SRT501 is as follows:
GSK will terminate its phase IIa study of SRT501 in advanced multiple myeloma. We have taken this decision following a comprehensive analysis of the data which suggested this formulation of resveratrol may only offer minimal efficacy while having a potential to indirectly exacerbate a renal complication common in this patient population.

This same analysis also reviewed the cases of acute renal failure in five study patients, which had triggered the suspension of new patient enrolment in April this year. This analysis concluded that these renal failure cases were most likely due to the underlying disease, as kidney complications related to myeloma occur in up to 50% of cases. However, the formulation of SRT501 was not well tolerated, and side effects of nausea / vomiting / diarrhea may have indirectly led to dehydration, which exacerbated the development of the acute renal failure.

Investigators and regulators in the UK and Denmark, where the study was being conducted, were consulted on the analysis of the data and unanimously supported the decision to terminate the trial at this time. There are no further plans to develop SRT501.

Update #2 – In a separate statement to The Myeloma Beacon, a Glaxo spokesperson explained the rationale for the company’s decision to halt all development of SRT501. Ending all work on SRT501, the spokesperson said, will allow Glaxo to focus its resources on the development of drugs that act similarly to SRT501, but have more favorable properties. The spokesperson mentioned, in particular, SRT2104 and SRT2379 as drugs similar to SRT501 that the company is developing. Neither of these drugs, however, is currently being tested as a potential treatment for multiple myeloma.

The full Glaxo statement to the Beacon on this matter was as follows: ”We are focusing our efforts now on more selective SIRT1 activator compounds that have no chemical relationship to SRT501 and more favorable drug-like properties. Currently we have two of these latest generation compounds (SRT2104 and SRT2379) in several exploratory clinical trials.”

The information about the trial is viewable at the ClinicalTrials.Gov website, which is maintained by the United States National Institutes of Health.

The suspended trial appears to be the first SRT501 trial carried out with multiple myeloma patients. Earlier trials, which were completed without any reports of safety issues, involved either healthy participants, patients suffering from diabetes, or patients with colorectal cancer.

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Using Inhaled Corticosteroids May Increase Risk For Developing Type 2 Diabetes.

2011-01-18T11:00:00.000-05:00

Dr.Shruti Bhat, Star formulator and Ace leader within pharmaceutical R&D,a specialist with hiTech formulations and quality-by-design. Shruti brings to you some highlights from current pharma and clinical research news, views and data.

Using inhaled corticosteroids to treat chronic breathing problems may slightly increase a person's risk of developing type 2 diabetes, according to a study published in the American Journal of Medicine. After analyzing "the drug records of more than 388,000 patients who were prescribed inhaled corticosteroids," researchers "found that the risk of needing medication to control high blood sugar increased about 34% in patients taking any dose of daily inhaled corticosteroids.

In those on the highest doses, the risk increased by 64%." Despite the study's findings, the authors "say the increase in risk probably doesn't outweigh the benefits to people taking daily puffs of inhaled corticosteroids to control asthma."

HTTP://DIABETES.WEBMD.COM/NEWS/20101214/INHALED-STEROIDS-MAY-INCREASE-DIABETES-RISK

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Scientists May Be Close To Delivering World's First Malaria Vaccine.

2011-01-16T11:00:00.001-05:00

Dr.Shruti Bhat, Star formulator and Ace leader within pharmaceutical R&D,a specialist with hiTech formulations and quality-by-design. Shruti brings to you some highlights from current pharma and clinical research news, views and data.

Announcement from GlaxoSmithKline mentions that their scientific experts are on the verge of a breakthrough that could save thousands upon thousands of lives. Over the course of 23 years, the efficacy of the malaria vaccine, known as RTS,S or Mosquirix, has been exemplified in major trials conducted in seven countries. Now, researchers are facing what may be their largest obstacle yet: convincing first-world politicians that the vaccine would not only compliment existing so-called low-tech strategies, but that it is worth the money.

HTTP://WWW.REUTERS.COM/ARTICLE/IDUSTRE6BD1VA20101214HTTP://WWW.REUTERS.COM/ARTICLE/IDUSTRE6BD1VA20101214

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New Study Finds Warfarin Could Be Better Utilized For Stroke Prevention.

2011-01-13T11:00:00.000-05:00

Dr.Shruti Bhat, Star formulator and Ace leader within pharmaceutical R&D,a specialist with hiTech formulations and quality-by-design. Shruti brings to you some highlights from current pharma and clinical research news, views and data.

A new study found the blood thinner warfarin is only used by about half of elderly patients with abnormal heart rhythms who could use the drug to prevent strokes. The study also found warfarin users had more doctor visits but fewer hospitalizations.

HTTP://WWW.REUTERS.COM/ARTICLE/IDUSTRE6BS2PF20101229

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Door opens to new frontiers to treating diseases-

2011-01-12T11:36:00.004-05:00

Dr.Shruti Bhat, Star formulator and Ace leader within pharmaceutical R&D,a specialist with hiTech formulations and quality-by-design. Shruti brings to you some highlights from current pharma and clinical research news, views and data.

A challenge constantly faced by researchers developing new drug delivery methods is how to create particles that will stay in the blood stream for an extended amount of time, according to Joseph DeSimone, a researcher at the University of North Carolina, Chapel Hill. He and his colleagues found one solution that, according to DeSimone, "represents a real game changer for the future of nanomedicine." What they did was create a kind of Blood Cell 2.0--synthetic particles that are as flexible as real red blood cells and can stay in the body longer.

Researchers used technology called Particle Replication in Non-wetting Templates (PRINT) to produce very soft hydrogel particles that imitate the size, shape and flexibility of red blood cells, allowing them to circulate in the body for extended periods of time. While tests of the particles' ability to transport oxygen or carry therapeutic drugs have not been conducted, researchers say the findings--especially regarding flexibility--are significant because red blood cells naturally deform in order to pass through microscopic pores in organs and narrow blood vessels.

Nanotech pioneer Chad Mirkin seems to be impressed. "These findings are significant since the ability to reproducibly synthesize micron-scale particles with tunable deformability that can move through the body unrestricted as do red blood cells, opens the door to a new frontier in treating disease," said Mirkin in a statement. Mirkin is director of Northwestern University's International Institute for Nanotechnology and a member of President Obama's Council of Advisors on Science and Technology.

The study, "Using Mechano-biological Mimicry of Red Blood Cells to Extend Circulation Times of Hydrogel Microparticles," appears in the Proceedings of the National Academy of Sciences.

http://www.pnas.org/content/108/2/586.abstract

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Researchers Explore Rates Of Clopidogrel Discontinuation, Reasons For Stopping.

2011-01-12T11:00:00.000-05:00

Dr.Shruti Bhat, Star formulator and Ace leader within pharmaceutical R&D,a specialist with hiTech formulations and quality-by-design. Shruti brings to you some highlights from current pharma and clinical research news, views and data.

In a paper published online December 22, 2010 in the American Journal of Cardiology, Dr Alexandre S Quadros (Institute of Cardiology of Rio Grande do Sul, Brazil) and colleagues explored rates of clopidogrel discontinuation -- and reasons for stopping -- among consecutive patients treated with elective or emergent stenting at their high-volume center in Rio Grande do Sul, Brazil."

Altogether, 66 out of 400 patients discontinued use of the drug within a month. The researchers found that "the number-one reason given was the cost of the drug (two-thirds of those who stopped), followed by a sense that they were not provided with adequate information at discharge as to why they should stay on the medication (almost one in five patients who stopped).

In 15% of cases, those who stopped did so on the recommendation of another physician."

HTTP://WWW.THEHEART.ORG/ARTICLE/1168151.DO

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FDA Grants Orphan Status To FAP Drug.

2011-01-10T12:31:00.000-05:00

Dr.Shruti Bhat, Star formulator and Ace leader within pharmaceutical R&D,a specialist with hiTech formulations and quality-by-design. Shruti brings to you some highlights from current pharma and clinical research news, views and data.

The Puget Sound Business Journal (12/30) reports, "Marina Biotech, Inc. said its drug aimed to treat Familial Adenomatous Polyposis (FAP) has been granted 'orphan status' by the US Food and Drug Administration." Notably, "Familial Adenomatous Polyposis affects one out of every 10,000 people worldwide, and 95 percent of those affected develop polyps and most will have increased risk of bleeding and the potential for anemia. In severe cases, obstruction of the intestines can occur and patients are also at an increased risk for various cancers."

HTTP://WWW.BIZJOURNALS.COM/SEATTLE/NEWS/2010/12/29/MARINA-BIOTECH-DRUG-PASSES-FDA-TEST.HTML

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Drug To Help Curb Alcohol Consumption- Alcoholics May Stop at One Drink With Help From Lundbeck Anti-Abuse Drug

2011-01-09T11:00:00.000-05:00

Dr.Shruti Bhat, Star formulator and Ace leader within pharmaceutical R&D,a specialist with hiTech formulations and quality-by-design. Shruti brings to you some highlights from current pharma and clinical research news, views and data.

"The first pill designed to curb a person's urge to have more than a few drinks at a sitting is undergoing tests in Europe, promising doctors and public-health authorities a new approach to fighting alcoholism." This "drug, nalmefene from H. Lundbeck A/S in Valby, Denmark, blocks brain signals that make activities such as sex and drinking feel good. Should trials succeed, the medicine may win clearance in Europe as early as 2012, becoming the first new alcoholism treatment approved there in more than 15 years."

http://www.bloomberg.com/news/2010-12-22/alcoholics-may-stop-at-one-drink-with-help-from-lundbeck-anti-abuse-drug.html

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FDA Approves High Blood Pressure Combination Pill.

2011-01-07T12:18:00.000-05:00

Dr.Shruti Bhat, Star formulator and Ace leader within pharmaceutical R&D,a specialist with hiTech formulations and quality-by-design. Shruti brings to you some highlights from current pharma and clinical research news, views and data.

USFDA has "approved Amturnide, a high blood pressure combination pill that includes Novartis' drug Tekturna [aliskiren]." In addition, the combination pill includes "the calcium channel blocker amlodipine and the diuretic hydrochlorothiazide."

The FDA based its approval on a four-arm, randomized trial conducted among 1,181 patients with moderate or severe hypertension -- a mean systolic pressure of 160 to 179 mm Hg or 180 mm Hg and up. In that trial, patients receiving the combination drug had a greater reduction in blood pressure compared with those assigned to amlodipine monotherapy, to dual treatment with aliskiren and amlodipine, or to aliskiren and hydrochlorothiazide."

http://finance.yahoo.com/news/FDA-clears-new-Novartis-blood-apf-2614874747.html?x=0&.v=1
http://www.theheart.org/article/1167533.do
http://www.medpagetoday.com/Cardiology/Hypertension/24063

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FDA Delays Release Of Guidelines For Drugmakers' Use Of Social Media.

2011-01-05T11:00:00.000-05:00

Dr.Shruti Bhat, Star formulator and Ace leader within pharmaceutical R&D,a specialist with hiTech formulations and quality-by-design. Shruti brings to you some highlights from current pharma and clinical research news, views and data.

"Tweets are supposed to be quick and to the point, but the Food and Drug Administration (FDA) is neither in its ever lengthening quest to tell the world's drugmakers how they can promote their potions via Twitter, Facebook, and other social media." The FDA is delaying its regulations "until sometime early next year, perhaps later." The "pharmaceutical industry had hoped the FDA would stick to its pledge and issue guidelines this year. ... But last week, the FDA office responsible for drafting the new regs said, without elaboration, that it is going to wait at least until the first quarter of 2011 before issuing them."
http://www.time.com/time/business/article/0,8599,2039794,00.html?xid=rss-business

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Drug Approvals Slipped in 2010 - Some Potential Blockbusters Suffered Delays Amid FDA's Tougher Safety Stance

2011-01-04T14:54:00.005-05:00

The Food and Drug Administration approved about 21 drugs in 2010, a relatively modest figure that shows the pharmaceutical industry hasn't yet escaped its drought in recent years.

A few potential blockbusters won approval during the year, but some of the most highly anticipated new products got delayed into next year or beyond. That partly reflects a tougher environment at the FDA, with regulators stepping up their scrutiny of safety issues in drugs for obesity, diabetes and other conditions.

According to monthly drug-approval reports on the FDA's website, 21 new drugs were approved in 2010, down from 25 in 2009 and 24 in 2008, but higher from a recent low of 18 in 2007.

The final approval figures, as well as the number of applications received by the agency in 2010, won't be available until next month. The approval figures don't include dozens of approvals granted for new formulations or new uses of existing drugs.

Although the 2010 figures are a bit lower than previous years, FDA spokeswoman Sandy Walsh said there's "no systemic change in how the FDA is approaching drug approvals."

The figures include several major biologic drugs, which are created from living cells and represent a growing portion of the pharmaceutical market. Amgen Inc. won approval for Prolia, a drug that is injected twice yearly to treat osteoporosis in postmenopausal women. Roche Holding AG's biotechnology unit, Genentech, won approval for Actemra, a drug that's administered intravenously to treat rheumatoid arthritis.

Boehringer Ingelheim GmbH received approval for Pradaxa, a new type of blood-thinning drug to prevent strokes in patients with irregular heart rhythms. The company got a head start in a race among big drug makers to replace warfarin, an anticoagulent approved in 1954 that is still widely used.

AstraZeneca PLC suffered a setback in that race when the FDA earlier this month asked for more information about a study backing its application for the blood-thinning drug Brilinta. The delay drove down AstraZeneca shares more than 5%.

Patients with multiple sclerosis saw advances in treatment with the October approval of Novartis AG's Gilenya, an oral product. Multiple sclerosis has traditionally been treated by injections or infusions. Earlier in the year, the FDA also approved Acorda Therapeutics Inc.'s drug Ampyra to improve walking in MS patients.

In August, the FDA approved Ella, a longer-lasting emergency contraceptive that's designed to block pregnancy up to five days after intercourse. The product was developed by HRA Pharma, a closely held company in Paris, and was introduced in the U.S. earlier this month by Watson Pharmaceuticals Inc.

In April, Dendreon Corp. won approval for its prostate cancer therapy Provenge, which had previously been rejected by the agency. Provenge is designed to use a patient's own cells to stimulate the body's immune system to fight the cancer and may be the first in a new class of cancer-fighting drugs.

However, 2010 may be more notable for drugs that weren't approved, as well as for drugs the agency restricted or pulled off the market.

In addition to putting off a decision on Brilinta, the FDA also rejected a long-acting version of diabetes drug Byetta, sold by Amylin Pharmaceuticals Inc. and Eli Lilly & Co., saying more clinical data are needed to address cardiovascular safety concerns.

In October, the FDA declined to approve two proposed weight-loss drugs from Arena Pharmaceuticals Inc. and Vivus Inc.

The FDA closed the books on one of the highest profile drug-safety matters in recent years by sharply curtailing the use of GlaxoSmithKline PLC's diabetes drug Avandia in September after it was linked to increased risks of heart attacks.

In October, the agency removed Abbott Laboratories' weight-loss drug Meridia from the market, saying the drug didn't work well enough to justify potential heart problems.

A month later, the makers of painkillers Darvon and Darvocet agreed to take those drugs off the market, after many years of concerns about an increased risk of serious abnormal heart rhythms.

In December, the FDA said it would move to revoke the approval of Roche's cancer drug Avastin for use in breast cancer, saying the product didn't appear to help patients live longer. Roche is appealing the move, which won't affect the use of Avastin in other types of cancer.

The agency said this week it needed more time to review MannKind Corp.'s inhaled-insulin product to treat diabetes.

It also said it needed until next March to review Benlysta, a highly anticipated lupus drug from Human Genome Sciences Inc. and GlaxoSmithKline.

http://www.bloomberg.com/news/2010-12-30/new-drug-approvals-fell-in-2010-as-safety-concerns-slow-u-s-fda-decisions.html
http://online.wsj.com/article/SB10001424052748704543004576052170335871018.html?mod=googlenews_wsj

New Vaccine Appears To Offer Protection Against Several Strains Of Influenza A Virus In Mice.

2011-01-04T11:00:00.000-05:00

Dr.Shruti Bhat, Star formulator and Ace leader within pharmaceutical R&D,a specialist with hiTech formulations and quality-by-design. Shruti brings to you some highlights from current pharma and clinical research news, views and data.

"A new vaccine appears to offer protection against several strains of the influenza A virus in mice," according to a study published online Dec. 27 in the Proceedings of the National Academy of Sciences. After immunizing "several groups of mice intranasally with 2 mcg of inactivated virus alone or inactivated virus plus 10 mcg of M2 virus-like particles," researchers found that "adding specific virus-like particles to inactivated virus immunized mice against H3N2, H5N1, and H1N1." What's more, the rodents were protected for about seven months.

http://www.medpagetoday.com/InfectiousDisease/URItheFlu/24087
http://www.pnas.org/content/early/2010/12/20/1012199108

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Glaxo Study Compares Two Kidney Cancer Drugs.

2011-01-02T11:00:00.000-05:00

Dr.Shruti Bhat, Star formulator and Ace leader within pharmaceutical R&D,a specialist with hiTech formulations and quality-by-design. Shruti brings to you some highlights from current pharma and clinical research news, views and data.

"GlaxoSmithKline has been reported to literally putting money on the outcome of a clinical trial now in progress, pitting its pazopanib (Votrient) for advanced renal cell carcinoma against sunitinib (Sutent)." In efforts "to persuade the UK's National Health Service to pay for pazopanib, which GSK has priced somewhat higher than sunitinib, the company has promised to rebate some of the NHS' expenditures for the drug if the ongoing trial shows that pazopanib is inferior to its rival." The article noted that "on the basis of existing studies, Britain's National Institute for Health and Clinical Excellence (NICE), determined that pazopanib would not be cost-effective unless GSK agreed to match sunitinib's retail price and provide the rebate if pazopanib turns out to be inferior in the head-to-head study."

http://www.medpagetoday.com/PublicHealthPolicy/ClinicalTrials/24089

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FDA Delays Decision On MannKind's Inhaled Insulin.

2011-01-01T11:00:00.000-05:00

Dr.Shruti Bhat, Star formulator and Ace leader within pharmaceutical R&D,a specialist with hiTech formulations and quality-by-design. Shruti brings to you some highlights from current pharma and clinical research news, views and data.

MannKind Corp., the biotechnology company founded by the billionaire inventor Alfred Mann, rose in Nasdaq trading after US regulators delayed a decision on the company's inhaled insulin Affrezza (insulin human)." MannKind "aims to have the only inhaled insulin on the market for more than 20 million Americans and 170 million people worldwide with diabetes." One analyst said "he is skeptical of the company's prospects for gaining approval."

The AP (12/29) reports, "There have been a number of failures to develop a drug that would not require injections and a successful launch by MannKind would give the company its only drug on the market." MannKind "had asked for approval of the product in March 2009, but the decision was postponed after the agency asked for more information about the drug."

According to Dow Jones Newswire (12/29, Stynes), the FDA said its review will require an additional four weeks. The Hill (12/28, Millman) "Healthwatch" blog explained that MannKind's inhaler device "delivers insulin through single-dose cartridges."

The Los Angeles Business Journal (12/28, Crowe) reported, "Regulators were expected to be cautious about approving Afrezza because rival Pfizer had pulled its inhaled insulin Exubera [Insulin Human (rDNA origin)] off the market in 2007 in part for safety reasons." In addition, MannKind "faces a lawsuit filed in October by its former senior director for regulatory affairs, alleging that the company withheld from the FDA information about possible 'scientific misconduct' at clinical study clinics in Russia and Bulgaria." The Wall Street Journal (12/29, Conway) and Reuters (12/29, Clarke) also report the story.

http://www.bloomberg.com/news/2010-12-28/mannkind-rises-after-u-s-fda-delays-ruling-on-inhaled-insulin-clearance.html
http://www.bloomberg.com/news/2010-12-28/mannkind-rises-after-u-s-fda-delays-ruling-on-inhaled-insulin-clearance.html
http://thehill.com/blogs/healthwatch/prescription-drug-policy/135243-ruling-on-new-diabetes-treatment-delayed
http://www.bloomberg.com/news/2010-12-28/fda-needs-4-more-weeks-for-to-review-mannkind-drug.html
http://www.labusinessjournal.com/news/2010/dec/28/fda-delays-afrezza-decision/
http://online.wsj.com/article/SB10001424052970204467204576048123255441918.html?mod=googlenews_wsj
http://www.reuters.com/article/idUSSGE6BR07C20101228

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UK Regulators Seek To Pull Avandia From Market.

2010-12-23T11:00:00.000-05:00

Dr.Shruti Bhat, Star formulator and Ace leader within pharmaceutical R&D,a specialist with hiTech formulations and quality-by-design. Shruti brings to you some highlights from current pharma and clinical research news, views and data.

The AP reports that the UK's Medicines and Healthcare products Regulatory Agency "says an independent panel of experts concluded that the risks of Avandia [rosiglitazone] outweigh its benefits, and that it should no longer be sold in Britain."

Bloomberg News also reports that the British Medical Journal's Editor-in-Chief Fiona Godlee wrote to the European regulators, who are preparing to review the drug's safety on Sept. 8, and asked for Avandia to be withdrawn from the market.

The Wall Street Journal notes that the BMJ article also said Avandia never should have been approved for use, although GlaxoSmithKline, the maker of Avandia, rejects such a claim. The Journal also highlights concerns about the quality of the data used to show that Avandia does not lead to increased heart problems compared with other drugs.

The Guardian (UK) reports that the "MHRA said it had not passed on the recommendation to withdraw Avandia because it would create confusion, and was awaiting a decision by the [European Medicines Agency]." The Financial Times, the UK's Press Association, MedPage Today and the UK's Daily Mail also cover the story.

References:

http://www.usatoday.com/news/health/2010-09-06-avandia-uk_N.htm
http://www.bloomberg.com/news/2010-09-06/glaxo-s-avandia-should-be-pulled-from-u-k-market-bmj-chief-editor-says.html
http://online.wsj.com/article/SB10001424052748703713504575475890852659492.html.html

http://www.guardian.co.uk/society/2010/sep/06/diabetes-drug-on-nhs-despite-warning
http://www.google.com/hostednews/ukpress/article/ALeqM5goRJLbotRm-RivKulymomgY_NNsQ
http://www.medpagetoday.com/Cardiology/Diabetes/22050
http://www.dailymail.co.uk/health/article-1309340/Heart-attack-risk-diabetes-drug-Experts-Avandia-withdrawn.html?ito=feeds-newsxml

FDA To Set New Guidelines For Cancer Drug Cocktails.

2010-12-21T12:38:00.000-05:00

Dr.Shruti Bhat, Star formulator and Ace leader within pharmaceutical R&D,a specialist with hiTech formulations and quality-by-design. Shruti brings to you some highlights from current pharma and clinical research news, views and data.

The San Francisco Chronicle /Bloomberg Businessweek reports the FDA is now "ready to allow innovative testing of drug cocktails" for cancer treatment, according to Richard Pazdur, the agency's top cancer regulator. The "new research guidelines, which will be posted for public comment before approval, describe three basic principles for early combinations," Pazdur said. If "conditions are met, companies may develop components simultaneously and forgo differentiating the drugs on the last and most expensive trials needed for regulatory approval," the paper added. "About 800 targeted drugs are in various stages of development in cancer, aimed at about 300 genes relevant to the disease," said John Mendelsohn, president of the University of Texas M.D. Anderson Cancer Center.

http://www.sfgate.com/cgi-bin/article.cgi?f=/c/a/2010/08/29/BU6O1F3RD8.DTL

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Former FDA Official Urges Agency To Look Into LASIK.

2010-12-19T12:01:00.000-05:00

Dr.Shruti Bhat, Star formulator and Ace leader within pharmaceutical R&D,a specialist with hiTech formulations and quality-by-design. Shruti brings to you some highlights from current pharma and clinical research news, views and data.

On its website, ABC News reported, "A former Food and Drug Administration official who helped get the vision correction surgery LASIK approved back in the 1990s but later spoke out against the procedure is taking his concerns directly to current regulators at the FDA." Yesterday, "Morris Waxler, who is now an independent regulatory consultant, filed a citizen's petition...urging the agency to take steps to stop what he calls 'the epidemic of permanent vision problems' caused by LASIK."

According to "Waxler's analysis of FDA data, half of LASIK patients experience side effects, and more than a third continue to need glasses or contacts," ABC World News (9/22, story 6, 1:55, Sawyer) reported. After being asked if he "would you ever recommend LASIK to somebody" he cares about, "knowing what" he "knows now," Dr. Waxler replied, "No, absolutely not." While the "industry counters that most LASIK side effects are minor or temporary, and that complications are much lower with today's modern LASIK," the agency nevertheless is "now reviewing the procedure."

http://abcnews.go.com/Health/EyeHealth/lasik-advocate-files-petition-criticizing-procedure/story?id=11689793

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Drug product updates:

2010-12-17T12:29:00.000-05:00

Teriflunomide Meets Goal In Late-Stage MS Study.

Bloomberg News reports, "Sanofi-Aventis SA's experimental oral medicine teriflunomide significantly reduced the relapse rate in multiple sclerosis patients, meeting the goal of a late- stage study." The company said patients "taking the medicine had fewer relapses than those taking a placebo."
http://www.bloomberg.com/news/2010-08-30/sanofi-s-experimental-oral-multiple-sclerosis-treatment-reduces-relapses.html

Drugmakers Competing To Develop Medications To Prevent Blood-Clotting Problems.

The New York Times reports that "leading drugmakers are competing to reach the market with a new class of pills to prevent the kind of dangerous blood clots in the veins and lungs that can travel to the brain, causing strokes." Currently, the FDA is "reviewing an application for Johnson & Johnson for rivaroxaban to reduce the risk of dangerous blood clots in people undergoing knee or hip replacement surgery." The agency is also "reviewing an application from Boehringer Ingelheim for dabigatran as a stroke prevention drug in patients with atrial fibrillation, the company said in a statement Monday."
http://www.nytimes.com/2010/08/31/health/research/31drug.html?_r=1&ref=health

Researchers Looking For Alternatives To Anabolic Steroids To Help Build Muscle.

Scientists enlist cockroaches in the war against superbugs.

2010-12-15T12:26:00.000-05:00

Dr.Shruti Bhat, Star formulator and Ace leader within pharmaceutical R&D,a specialist with hiTech formulations and quality-by-design. Shruti brings to you some highlights from current pharma and clinical research news, views and data.

It turns out that cockroaches may be good for something other than stepping on. Scientists say that the "brains" of the cockroach, one of the globe's most tenacious survivors, are loaded with chemicals that can kill MRSA and other nasty bugs. And they want to enlist the insect in the fight to develop a new generation of more effective antibiotics.

"They must have some sort of defense against micro-organisms," says Simon Lee from Nottingham University, who has found nine chemicals that may help advance new antibiotics. "We think their nervous system needs to be continuously protected because if the nervous system goes down the insect dies. But they can suffer damage to their peripheral structures without dying."

According to the CDC, hospital-acquired infections are killing 15,000 patients in the U.S. each year and sicken another 90,000. As the current generation of antibiotics grows progressively weaker, as they must, researchers need to find new and more effective ways to combat the threat. And that fight has attracted a number of biotech companies.

Disclaimer- The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

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Study Links Low Daily Dose Of Aspirin To Reduced Bowel Cancer Risk.

2010-12-11T12:07:00.000-05:00

Dr.Shruti Bhat, Star formulator and Ace leader within pharmaceutical R&D,a specialist with hiTech formulations and quality-by-design. Shruti brings to you some highlights from current pharma and clinical research news, views and data.

Bloomberg News reports that a study in the medical journal Gut found that "people who take even a very low dose of aspirin every day for five years can cut the risk of developing colon cancer by almost a third." According to researchers, "as little as 75 milligrams of aspirin a day...lowered the risk of colon cancer by 22 percent after just a year." While it was already know that aspirin can protect the colon, the "study showed for the first time that a low dose of aspirin is sufficient to ward off cancer, and that the drug needs to be taken for at least five years to get the full benefit."

According to MedPage Today "Aspirin has not as yet been recommended for primary chemoprevention of colorectal cancer...because of unanswered questions on dose, duration, and effects on survival." WebMD the UK's Press Association and the UK's Daily Mail also covered this study.

References:
http://www.bloomberg.com/news/2010-09-15/low-dose-of-aspirin-taken-daily-cuts-colon-cancer-risk-researchers-find.html
http://www.medpagetoday.com/HematologyOncology/ColonCancer/22207
http://www.webmd.com/cancer/news/20100915/low-dose-aspirin-lowers-risk-of-colorectal-cancer?src=RSS_PUBLIC
http://www.google.com/hostednews/ukpress/article/ALeqM5hFNKz7ksAdXZuXyQDViwYLSYFdBw
http://www.dailymail.co.uk/health/article-1312475/Aspirin-cuts-bowel-cancer-risk-22.html

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Gut microbes could offer new therapeutic platform.

2010-12-09T12:14:00.000-05:00

Dr.Shruti Bhat, Star formulator and Ace leader within pharmaceutical R&D,a specialist with hiTech formulations and quality-by-design. Shruti brings to you some highlights from current pharma and clinical research news, views and data.

The bacteria that thrive in our guts could become the key ingredients for a new generation of treatments that fight everything from life-threatening infections to diabetes, obesity, depression and bowel diseases, according to a team of scientists who have experienced some intriguing early successes with transplants.

According to a report in MIT's Technology Review, the scientists were able to cure an infection in a female patient with bacteria transplanted from her husband's gut. Transplanting microbial populations from a healthy person to the sick could transform their entire intestinal system--something that has implications for a broad range of diseases. And it would be a far more radical approach than encouraging people to eat yogurt or take other dietary actions designed to foster healthy microbes.

The researchers have also tested this approach in rats and found that they could make significant changes in their intestinal ecosystems. Significantly, the scientists say they saw no evidence that the rat's body rejected the transplant.

Read more: Gut microbes could offer new therapeutic platform - FierceBiotech Research http://www.fiercebiotechresearch.com/story/gut-microbes-could-offer-new-therapeutic-platform/2010-09-07?utm_medium=nl&utm_source=internal#ixzz0yrPIRrEj

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Researchers Looking At Ways To Better Personalize Treatment For High Blood Pressure.

2010-12-07T12:22:00.001-05:00

The AP reports that "it's hard to predict which pills will best lower which patient's high blood pressure, but researchers are hunting ways to better personalize therapy - perhaps even using a blood test." A "trio of studies shows some drug combinations work better for certain populations and raises the possibility that measuring blood levels of a hormone involved in hypertension might help optimize some people's care." But, patients shouldn't "expect a routine test for that hormone, called renin, any time soon," because "initial research a few decades ago failed to show a clear benefit." Other researchers, however, believe that starting everybody "on two-drug combinations that hit hypertension from two directions is the way to go."

http://www.google.com/hostednews/ap/article/ALeqM5hj7_xdeywoc2ipzx1CdTQurULgIwD9I2F2E80

What’s is in a color? A pill's hue is the color of money for drugmakers.

2010-12-04T11:00:00.002-05:00

Dr.Shruti Bhat, Star formulator and Ace leader within pharmaceutical R&D,a specialist with hiTech formulations and quality-by-design. Shruti brings to you some highlights from current pharma and clinical research news, views and data.

Drug manufacturers do not pay enough attention to the colour of their drugs, according to researchers examining the importance of aesthetics in pharmaceutical over-the-counter (OTC) products.

Researchers from the University of Bombay, India, claim a drug’s colour can influence patient compliance and increase brand loyalty, yet “surprisingly little attention is paid to the sensory attributes of a vast majority of dosage forms in the pharmaceutical industry.”

“Unfortunately,” they say, “a drug product’s aesthetic characteristics are not fully considered and utilised by many companies.” Colours have the power to stimulate, excite or even depress, however, this is dependent on a number of variables, including gender, age, religion and mood. Furthermore, colour associations and preferences vary across the globe.

Western Europeans, for example, associate the colour white with purity and happiness, whereas the Association of Southeast Asian Nations (ASEAN) relates the colour with death and mourning. In Anglo-Saxon countries the colour blue represents high quality, corporateness and masculinity, yet in Malaysia it is symbolic of cold and evil.

Despite such obstacles for drugmakers in selecting a universally well-liked colour, the researchers suggest an attractive colour - coupled with a healthy dose of the placebo effect - can help boost a tablet’s efficacy as well as possibly reducing side-effects.

More importantly, they argued, for those consumers who take more than one drug at a time, pills in assorted colours may help people recognise the difference between their medications more clearly. This “probably reduces accidental poisonings,” the researchers said.

Palatability influenced by colour:

After questioning 600 users of OTC medications, the academics claim that colour is the most important memory tag for drug compliance for 75 per cent of consumers and that people’s palatability can be influenced by a drug firm’s choice of pigment.

The survey found that 14 per cent of people think pink tablets taste sweeter than red ones whereas yellow tablets are perceived to be salty. White or blue tablets taste bitter according to 11 per cent of those surveyed and 10 per cent said orange-coloured tablets are sour.

The study suggested that women prefer red pills while men like blue, however both genders favour white coloured tablets. Twice as many people aged between 55- 65 favour red tablets to those between the ages of 18-24 who would rather take pink pills.

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Reformulation trend capturing pharma

2010-12-02T12:10:00.001-05:00

Dr.Shruti Bhat, Star formulator and Ace leader within pharmaceutical R&D,a specialist with hiTech formulations and quality-by-design. Shruti brings to you some highlights from current pharma and clinical research news, views and data.

More and more drug makers are turning to reformulation to prolong the lifecycle of their top sellers and protect precious revenue from generic copies, as well as supplement dwindling pipelines.

The fact that 39 per cent of the total product launches from the 50 top manufacturers between 2002 and 2005 were reformulations is a clear indication of the presence of this trend.

Central nervous system (CNS), alimentary and metabolic therapies are the most frequently targeted for reformulation, according to a new research report by Datamonitor.

Within the CNS market, reformulated products are predominantly antipsychotics, antidepressants, and ADHD and pain therapies. Reformulated stomach ulcer and insulin therapies make up the bulk of alimentary and metabolic reformulations, while respiratory, anti-infective and genito-urinary and sex hormone therapies have also experienced frequent reformulation, the report says.

"This reflects the large patient populations within the major indications of these therapy areas, the high commercial value of many of the products and the highly competitive nature of the markets," said Alistair Sinclair, Datamonitor pharmaceutical markets analyst and report author.

"All of which drive companies to be more active in gaining a competitive advantage within the respective markets, but most of all; with product development pipelines looking increasingly barren, on top of spiralling R&D costs, pharmaceutical companies must ensure they maximise revenues of existing brands."

Reformulations within these categories include soluble tablets, chewable tablets, extended release tablets, oral liquids and suspensions, pre-filled syringes, transdermal patches, and a variety of gels and creams. Converting injectable drugs into non-injectable forms of delivery is proving particularly popular.

However, for all the strategy and planning involved, the success of a reformulation is heavily dependent on the manufacturer's ability to develop an improved version of the original drug, said the report, titled: "Reformulation Strategies - Comparisons of Past and Future Reformulation Strategies."

"The key to a successful reformulation is to provide clear therapeutic benefits over their predecessor", said Sinclair.

"First and foremost, manufacturers need to ensure there is a market need for their reformulated products, and then ensure the drug displays sufficient differentiation from the original, particularly in terms of efficacy and side effects; launch timing is also of key importance."

For many firms this is a daunting task, as they may not have sufficient in-house resources or expertise to rise to the challenge.

Therefore, this reformulation trend is good news for the drug formulation industry, which has seen a 38 per cent growth in the past five years and is expected to continue to boom, as drug companies wishing to reformulate are outsourcing the function to specialist formulation companies.

Reformulation is still quite a niche field and there are relatively few companies in the world that specialise in individual reformulation areas. Firms that do are now finding themselves inundated with new business.

For example, UK form Medpharm said it has been experiencing a growing business demand for topical formulations of drugs, in which it specialises.

According to the firm, there is only one other company in the US that specialises in topical drug formulation and provides the full range of services, from mathematical modelling of a drug profile, through to formulation development and optimisation and manufacturing.

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GLAXOSMITHKLINE HALTS ALL FURTHER DEVELOPMENT OF RESVERATROL DRUG SRT501.

2010-12-02T11:00:00.000-05:00

GlaxoSmithKline has announced that it is halting all further development of its proprietary formulation of resveratrol known as SRT501.

A key factor in this decision, according to the company, was that it no longer feels the drug offers an adequate efficacy / safety trade-off as a potential treatment for multiple myeloma.

Earlier this year, Glaxo suspended its Phase 2 trial of SRT501 in multiple myeloma because several patients in the trial developed kidney failure.

At the time, it was unclear if the kidney failure cases were due to SRT501, or if they were a natural consequence of the patients’ multiple myeloma. The form of kidney failure that was observed – cast nephropathy – is a common complication of multiple myeloma, so much so that it is often described as “myeloma kidney.”

According to a GlaxoSmithKline spokesperson, an internal analysis of the kidney failure cases has concluded that they “most likely were due to the underlying disease … However, the formulation of SRT501 was not well tolerated, and side effects of nausea / vomiting / diarrhea may have indirectly led to dehydration, which exacerbated the development of the acute [kidney] failure.”

For this reason, the company decided to terminate the Phase 2 trial of SRT501 in multiple myeloma and halt development of the drug as a potential myeloma treatment. The SRT501 formulation of resveratrol “may only offer minimal efficacy,” explained the Glaxo spokesperson, while increasing the chances of kidney failure.

It is currently uncertain why GlaxoSmithKline decided to terminate all further development of SRT501. The company could have ended trials of the drug as a possible myeloma treatment, but continued to test the drug in trials for other diseases. [See Update #2 below.]

The resveratrol in SRT501 is from a plant-based source. It is micronized, or milled into very small uniform particles, to maximize uptake into the body. Patients in the SRT501 multiple myeloma trial received a relatively high dose of resveratrol – 5 grams of SRT501 – once per day.

Resveratrol is a molecule found in small quantities in the skin of red grapes and in red wine. It is thought to be the source of red wine’s reported health benefits.

Previous studies have indicated that resveratrol may be effective at killing cancer cells, including multiple myeloma cells.

Scientific evidence for these claims has been controversial and confined mostly to the laboratory. The SRT501 trial was the first attempt to determine the effectiveness of resveratrol in treating multiple myeloma patients.

Update #1 (November 30, 2010; 4:10 pm) – The full text of GlaxoSmithKline’s statement to The Myeloma Beacon regarding its decision to halt further development of SRT501 is as follows:
GSK will terminate its phase IIa study of SRT501 in advanced multiple myeloma. We have taken this decision following a comprehensive analysis of the data which suggested this formulation of resveratrol may only offer minimal efficacy while having a potential to indirectly exacerbate a renal complication common in this patient population.

This same analysis also reviewed the cases of acute renal failure in five study patients, which had triggered the suspension of new patient enrolment in April this year. This analysis concluded that these renal failure cases were most likely due to the underlying disease, as kidney complications related to myeloma occur in up to 50% of cases. However, the formulation of SRT501 was not well tolerated, and side effects of nausea / vomiting / diarrhea may have indirectly led to dehydration, which exacerbated the development of the acute renal failure.

Investigators and regulators in the UK and Denmark, where the study was being conducted, were consulted on the analysis of the data and unanimously supported the decision to terminate the trial at this time. There are no further plans to develop SRT501.

Update #2 (November 30, 2010; 5:30 pm) – In a separate statement to The Myeloma Beacon, a Glaxo spokesperson explained the rationale for the company’s decision to halt all development of SRT501. Ending all work on SRT501, the spokesperson said, will allow Glaxo to focus its resources on the development of drugs that act similarly to SRT501, but have more favorable properties. The spokesperson mentioned, in particular, SRT2104 and SRT2379 as drugs similar to SRT501 that the company is developing. Neither of these drugs, however, is currently being tested as a potential treatment for multiple myeloma.

The full Glaxo statement to the Beacon on this matter was as follows: ”We are focusing our efforts now on more selective SIRT1 activator compounds that have no chemical relationship to SRT501 and more favorable drug-like properties. Currently we have two of these latest generation compounds (SRT2104 and SRT2379) in several exploratory clinical trials.”

The information about the trial is viewable at the http://www.clinicaltrials.gov/ website, which is maintained by the United States National Institutes of Health.

The suspended trial appears to be the first SRT501 trial carried out with multiple myeloma patients. Earlier trials, which were completed without any reports of safety issues, involved either healthy participants, patients suffering from diabetes, or patients with colorectal cancer.

Blockbuster antibodies now face quick onslaught of biosimilars.

2010-12-01T11:00:00.000-05:00

Dr.Shruti Bhat, Star formulator and Ace leader within pharmaceutical R&D,a specialist with hiTech formulations and quality-by-design. Shruti brings to you some highlights from current pharma and clinical research news, views and data.

A lineup of blockbuster monoclonal antibodies produced by a group of the world's top biopharma companies are now squarely in the crosshairs of the world's top biosimilar developers.

Last Friday the European Medicines Agency laid out exactly what developers will need to do to gain approvals for follow-on antibody therapies. And Roche, with its lineup of aging cancer therapies like Rituxan, Herceptin and Avastin, was quickly singled out as the most vulnerable to a new lineup of competitive treatments that could hit the European market as early as 2012. The Financial Times also notes that Merck KGaA, Johnson & Johnson ($JNJ) and Abbott ($ABT) also face near-term competition from the biosimilar crowd. GlaxoSmithKline ($GSK) and AstraZeneca ($AZN) are likely to face new competition at a later stage.

Several big outfits like Novartis ($NVS), Teva and Hospira ($HSP) are likely to lead the charge in creating biosimilar versions of the blockbuster antibodies. But it won't be cheap. The research group Collins Stewart has estimated that developers will need to budget $100 million for the kinds of clinical trials that will be required to gain an approval. And once they hit the market, the follow-ons are expected to offer discounts of 10 to 15 percent.

Roche wants regulators to be cautious and slow. "We believe that patient safety must be of highest concern when evaluating the development, approval and marketing of biosimilar products." In the U.S., the FDA is just beginning the process of laying out the rules for developing biosimilars.

EU adopts new biosimilar guideline :

European regulators have adopted a guideline on biosimilar antibody drugs; industry can expect its publication in a couple of weeks. However, many experts already anticipate a cautious approach, requiring separate clinical trials for different diseases addressed by the same antibody, as Reuters notes.

In a release, the EMA briefly touched on the guidelines, titled 'Similar Biological Medicinal Products Containing Monoclonal Antibodies,' which will be released for a five-month public consultation period. "This guideline lays down the nonclinical and clinical requirements for monoclonal antibody-containing medicines claiming to be similar to another one already marketed," it explains.

Earlier this week, Lincoln Tsang, a partner at London law firm Arnold & Porter, told Reuters he expects the EMA to play it safe by requiring extensive testing. "My hunch is that they will be cautious in saying that if you can establish clinical efficacy and safety of a given product for a given indication you can't readily seek approval for another indication," he said. "Given it is such a big therapeutic area, I think they will not like to be seen to be too generous."

As Reuters notes, such testing could drive up the costs of producing biosimilars, thus making it hard for smaller companies to enter the arena. If costs are too high, only well-established players like Teva, Novartis and Hospira might have the ability to bring such products to market.

Disclaimer- The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

http://www.drshrutibhat.com/
Expert at leading Pharmaceutical R&D.
Translates innovative concepts to PROFITS.
YouTube Channel : Http://www.youtube.com/user/ShrutiBhat10

Does Stem cell research promise magic hair re-growth for the unfortunate bald?

2010-11-30T12:33:00.000-05:00

Dr.Shruti Bhat, Star formulator and Ace leader within pharmaceutical R&D,a specialist with hiTech formulations and quality-by-design. Shruti brings to you some highlights from current pharma and clinical research news, views and data.

In search of a new stem cell therapy for burn victims, a group of Swiss and Scottish scientists have made a startling and completely unexpected discovery. By taking stem cells from the thymus and transplanting them into the developing skin of rats, they were transformed into new follicle cells capable of growing hair. The transformation was also achieved without any genetic switch-up in the cells, implying that the same cell type could make the same leap in other organs.

"These cells really change track, expressing different genes and becoming more potent," says lead researcher Professor Yann Barrandon, who runs the stem cell lab at the University of Lausanne in Switzerland. His team's findings have been published in Nature.

Naturally occurring hair follicle stem cells support hair for three weeks, but these transplanted cells worked for up to a year producing hair--pointing to a possible cure for baldness. The thymus plays a key role in spurring the immune system. But the scientists were even more enthusiastic about the potential of a new cell that can be transformed by its environment.

"It's not just that a latent capacity is triggered or uncovered when these stem cells come in to contact with skin," says Clare Blackburn, of the University of Edinburgh's Medical Research Council Centre for Regenerative Medicine, going on to echo Barrandon on the cells' potency. "It will be interesting to see whether microenvironments other than skin have a similar effect."

References:

http://www.fiercebiotechresearch.com/story/stem-cell-research-breakthrough-could-cure-baldness/2010-08-23#ixzz0xYTMoLn5

http://www.fiercebiotechresearch.com/story/stem-cell-research-breakthrough-could-cure-baldness/2010-08-23

Disclaimer- The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

http://www.drshrutibhat.com/
Expert at leading Pharmaceutical R&D.
Translates innovative concepts to PROFITS.
YouTube Channel : Http://www.youtube.com/user/ShrutiBhat10

Is Genzyme history?

2010-11-29T11:33:00.009-05:00

Frederick Frank, a leading biotechnology banker and vice chairman of investment advisory firm Peter J. Solomon, said Genzyme Corp (GENZ.O) has no chance of remaining an independent company.

French drugmaker Sanofi-Aventis SA (SASY.PA) has made a hostile tender offer of $18.5 billion, or $69 a share, for the Cambridge, Massachusetts-based maker of drugs for rare diseases. Genzyme has rejected the bid but Sanofi is expected ultimately to prevail.

"Genzyme is history," Frank said at the Reuters Health Summit on Monday. "It's only a question of when and at what price."

Genzyme's shares closed on Monday at $71.06, and Frank said that if a deal were to fall through the stock price would likely fall into the mid-$50 range.

"I would estimate that 40 to 50 percent of the shares are held in the arbitrage community," he said, referring to short-term investors who specialize in takeover targets. "That's a big load to be sold."

Frank, former vice chairman of Lehman Brothers and, until 2009, of Barclays Capital, has advised on countless transactions in the pharmaceuticals and biotech sector.

He said he expects mergers and acquisitions in the space to continue, since big pharmaceuticals companies are eager to acquire products to replace those that are losing patent protection.

But once Genzyme is gone, there will only be a handful of large biotech companies left, including Amgen Inc (AMGN.O), Gilead Sciences Inc (GILD.O) and Biogen Idec Inc (BIIB.O). If and when they too disappear, it is unlikely the industry will see new companies of their ilk emerge, he said.

"Today, venture capitalists are willing to finance a company through mid-stage trials but with the goal of selling it at that point," he said. "You're not going to see a lot of new Amgens or Genentechs."

Genentech, the oldest and second-biggest biotech after Amgen, was fully acquired by Swiss drugmaker Roche Holding AG (ROG.VX) in early 2009.

Still, Frank said acquisitions will depend on valuations. Biogen Idec Inc (BIIB.O), which makes the multiple sclerosis drugs Avonex and Tysabri, has long been considered an acquisition target. But in 2007 the company tried and failed to sell itself.

Frank said he was approached by a big pharmaceuticals company to represent them in a possible purchase of Biogen but he recommended against it.

"On the surface the numbers look very attractive," he said, "but their wonderful drug Tysabri, for a very small group of people, has the potential to kill you."

Tysabri has been linked with PML, a potentially deadly brain infection, and is competing in an ever-more crowded space. Recently U.S. regulators approved the first oral MS drug, Gilenya, made by Novartis AG (NOVN.VX) that is widely expected to become a leading player in the space.

Biogen is working on a test that could potentially screen patients at higher risk for developing PML, but uncertainty remains.

Despite Sanofi's hostile bid for Genzyme, Frank does not expect hostile offers to increase.
"I don't think you'll see a lot of them," he said. "These companies are very management intensive; you do a hostile tender offer, you tend to lose the management."

For big pharmaceuticals companies, a new era is at hand, in which insurance companies are increasingly in the driver's seat, he said.

"In the past, the payer community was not very active; the pharma companies set their prices and their prices were largely paid. Now the focus of power has changed."

No longer can drug companies develop products with only marginal improvements over rival drugs. Payers won't pay, he said.

"We're entering a new world," he said. "Pharma companies are going to spend a lot of time developing first-in-class drugs."

Cancer drug sales fast sliding ! 3.5% in first nine months of 2010 < 9% in 2008 & 2009 < 14% in 2007 < 23% in 2006.

2010-11-09T23:22:00.002-05:00

New cancer drugs are a top priority for most pharmaceutical companies these days, but the sector's sales trajectory has flattened as key medicines lose patent protection and new breakthrough products prove scarce. U.S. sales of oncology drugs increased just 3.5 percent in the first nine months of this year, according to pharmaceutical market information company IMS Health.

The sector saw sales growth of 23 percent in 2006, after Roche Holding AG's Avastin was launched. It grew by 14 percent in 2007 and 9 percent in both 2008 and 2009.

"This is an unprecedented slowdown," IMS representatives said at the Reuters Health Summit. "Growth is largely being driven by pricing increases," as well as the entrance of lower-cost generic drugs.

Scientific advances in cancer treatment have encouraged many large drug companies to step up their investment in oncology research in recent years, resulting in rapidly expanding pipelines of targeted therapies.

Most older cancer drugs are chemotherapy agents, designed to kill fast-growing cancer cells. Such cytotoxic drugs also kill healthy cells that multiply rapidly, resulting in serious side effects such as sickness, hair loss and risk of infection.

Sanofi-Aventis SA's chemotherapy drug Eloxatin, or oxaliplatin, lost its patent protection this year.

By contrast, modern drugs are much more precise -- and higher-priced -- weapons because they target specific molecular switches involved in tumor growth, giving rise to fewer side effects. Avastin, for instance, is designed to block off the blood supply tumors need to thrive and grow.

Given the limited treatment options for many cancers, oncology "is a key part” of many companies strategy for future growth. There is a lot in the pipeline that looks very exciting."

But many recent targeted drugs are variations of existing products which end up jostling for a share of the current market, rather than offering new treatment options for patients.

The growth rate for global sales of biologic drugs -- meaning medicines made from biological components -- is expected to fall below 10 percent for the first time this year to $130 billion, according to IMS.

Ultimately, the oncology market has to be driven by innovation...will we have another miracle anti-cancer moiety soon ?

Drug recalls in USA reached a record high: 1,742 in 2009. Why so many recalls?

2010-09-04T10:19:00.010-04:00

Drug recalls reached a record high 1,742 in 2009 — more than four times the amount in 2008. Bowman Cox, managing editor of the Gold Sheet told CNN Money that in light of the 296 recalls issued in the first six months of 2010, there could be 600 or more recalls this year-

Why So Many Recalls?

Analysts and legislators are examining the recall statistics to find sources and solutions to the pharmaceutical safety issue.

1. Drug repackaging:

Advantage Dose, a now-defunct Shreveport, LA based drug re-packager, was responsible for more than 1,000 of the 2009 recalls. Companies like Advantage Dose repackage and re-label drugs into smaller units for resale or distribution to health care facilities. After excluding Advantage Dose from the count, there still remains a 50% jump in recalls from 2008 to 2009.

2. The generic rush:

Gold Sheet’s Cox suggests that generic manufacturers cut drug design costs in their rush to be first to market after a branded-drug’s patent protection expires, decreasing quality. “The first generic applicant typically gets the lion’s share of the business for the new drug…the 180 day exclusivity… So they get the application. They make and market the drug, but they could still have problems down the road if they haven’t really understood the optimum way to make that drug(product).” One example of a design failure is Caraco Pharmaceutical Laboratories’ “tablet thickness” recalls in March 2009.

3. Manufacturing lapses:

Some experts say the biggest culprits include the quality of raw materials and contamination. Some months ago, HealthReformWatch.com reported in Pharmaceutical Outsourcing: Trading Quality for Lower Costs? that India’s largest pharmaceutical manufacturer had been cited several times in recent years for manufacturing violations. Additional recalls include vaccines produced by Shantha Biotechnics for Sanofi-Aventis and injectible drugs made by Claris Lifesciences for Pfizer. The FDA stated its intent on May 5, 2010 to “propose stronger regulation for pharmaceutical companies that outsource manufacturing, putting more responsibility on the companies to ensure the purity and safety of the products…”

4. Increased FDA scrutiny of manufacturing facilities:

Which came first, the chicken or the egg? Increased FDA oversight may or may not have led to the increased number of recalls; however, the recalls will probably lead to increased FDA regulatory power.

As Jennifer Jascoll reported, Senator Michael F. Bennet (D-CO) proposed the Drug Safety and Accountability Act of 2010 on August 3, 2010. According to Bennet’s press release, “[t]he bill would strengthen manufacturer quality standards, enhance the USFDA’s ability to protect Americans through improved tracking of foreign manufacturing sites, and give the FDA much-needed authority to recall potentially dangerous drugs.” Currently, the FDA is empowered to issue warnings and recommend that a manufacturer issue a recall.

According to CNN Money, the FDA has not identified any alarming pattern. FDA spokeswoman Elaine Gansz Bobo stated, “[s]ince every recall situation is unique, it would be difficult to assess whether there are any trends or increases in recalls this year… At this time, however, we have not identified any trends.” Despite the FDA’s lack of concern, other federal agencies are interested in the practices of pharmaceutical companies.

Further Federal Investigations :

According to the N.Y.Times, federal prosecutors and securities regulators are investigating pharmaceutical companies for potential violations of the Foreign Corrupt Practices Act (FCPA). The FCPA is an anti-bribery law which bars companies from offering foreign government officials items of value for profit. For instance, Pfizer disclosed in April “that it paid $35m over six months to 4,500 doctors in private practice for education and the development and marketing of new drugs.” Although this practice is legal in the U.S., such payments are illegal in many foreign countries where physicians are employed by the government.

On November 17, 2009, Assistant Attorney General Lanny A. Breuer stated that the Department of Justice intended to focus its attention on the pharmaceutical industry:

In some foreign countries and under certain circumstances, nearly every aspect of the approval, manufacture, import, export, pricing, sale and marketing of a drug product may involve a “foreign official” within the meaning of the FCPA. The depth of government involvement in foreign health systems, combined with fierce industry competition and the closed nature of many public formularies, creates, in our view, a significant risk that corrupt payments will infect the process. Our remarkable FCPA unit and our terrific health care fraud unit will be working together to investigate FCPA violations in the pharmaceutical industry in an effort to maximize our ability to effectively enforce the law in this high-risk area.

“Corrupt practices” under the FCPA are not limited to cash in envelopes. Inappropriate payments for lavish hospitality, consulting, licensing agreements, and even charitable donations may raise red flags for government investigators.

Could bribery be contributing to decreased quality and the sudden rise in recalls? According to the Financial Times, the DoJ is focusing its efforts elsewhere:

[T]he DoJ is particularly interested in corrupt payments that may have influenced the reliability or integrity of data in clinical trials performed outside the US. A recent report by the Department of Health and Human Services found 80 percent of marketing applications for drugs approved by the Food and Drug Administration in the US had relied on at least one foreign trial.

It appears that the DoJ’s scrutiny of clinical trials is not without merit. The N.YTimes reports that “[l]ast month, a federal drug official reported that he found repeated instances in a landmark clinical trial of Avandia, a controversial diabetes medicine, in which patients taking Avandia appeared to suffer serious heart problems that were not counted in the study’s crucial tally of adverse events.” The clinical trials for Avandia included many foreign trial sites, which were submitted in support of the drugs’ application to enter and remain on the U.S. market. GlaxoSmithKline, the trial’s sponsor, has not been accused of fraud.

According to recent regulatory filings, the following companies are under investigation for possible violations of the FCPA:

- Merck is cooperating with a federal investigation of company activities in multiple foreign nations.

-Medtronic is cooperating with investigations of company activities in Greece, Poland, Germany, Turkey, Italy, and Malaysia.

- Eli Lilly is cooperating with the investigations of subsidiaries in several countries, including Poland.

- Federal investigators are looking into improper payments related to the sale of Zimmer products abroad.

- Johnson & Johnson voluntary disclosed the possibility that company subsidiaries abroad had made improper payments to government officials in two countries relating to the sale of medical devices.

-Pfizer and Bristol-Myers Squibb have also disclosed that they are subject to federal investigations. AstraZeneca, GlaxoSmithKline, and Baxter SciClone have also received inquiries from federal enforcement agencies.

Disclaimer- The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

Http://www.drshrutibhat.com
Expert at leading Pharmaceutical R&D.
Translates innovative concepts to PROFITS.
YouTube Channel : Http://www.youtube.com/user/ShrutiBhat10

Introducing ! A new blog- http://www.pharmaceuticalcareerdevelopment.blogspot.com/ which contains articles on motivation, career counselling and coaching, job search strategies, personal branding etc. especially for pharma professionals.

Trastuzumab May Help Extend Stomach Cancer Patients' Survival By Nearly Three Months.

2010-08-24T11:57:00.002-04:00

Dr.Shruti Bhat, Star formulator and Ace leader within pharmaceutical R&D, a specialist with hiTech formulations and quality-by-design. Shruti brings to you some highlights from current pharma and clinical research news, views and data.

Misoprostol May Be As Effective As Oxytocin In Speeding Labor For Women With Inadequate Contractions.
"Titrated oral doses of misoprostol (Cytotec) may be as effective as intravenous oxytocin in speeding labor in women who have inadequate contractions, according to" a study published in J. Obstetrics & Gynecology. Taiwanese researchers found that in "a randomized trial of more than 200 Chinese women, the median times from treatment to vaginal delivery were virtually identical at 5.2 hours whether oral misoprostol or intravenous oxytocin was used." They also noted that there "were also no differences in adverse effects and birth outcomes, allaying concerns that oral misoprostol might not be as safe as intravenous oxytocin."

Trastuzumab May Help Extend Stomach Cancer Patients' Survival By Nearly Three Months.
Patients with HER2-positive advanced gastric cancer might benefit from a drug produced by Roche Holding AG. “Use of the drug trastuzumab in addition to chemotherapy can extend stomach cancer patients' survival by nearly three months," researchers in Seoul found after evaluating "584 patients at 122 centers in 24" nations. The "addition of trastuzumab to standard cisplatin/fluoropyrimidine chemotherapy resulted in a median survival of 13.8 months, compared with 11.1 months for patients who received chemotherapy alone -- a 26 percent difference." But, an editorial accompanying The Lancet paper questions the cost-effectiveness of that treatment.

"In the 24 countries that contributed to the study, yearly health expenditure per citizen varies from $40 (£25) to $5,500, which reiterates the important moral question -- what is the justification for introducing a treatment that might enable one individual to live a few months longer, but will consume, for each person treated, the total yearly health expenditure for scores of their fellow citizens?"

Breast Cancer Drug Fulvestrant Appears More Effective In The Presence Of CK8 And CK18.
Women’s responsiveness to the second-line breast cancer drug fulvestrant may depend on whether the cancer cells are expressing two key proteins, Indiana University Bloomington scientists report in this month’s Cancer Biology & Therapy.

Fulvestrant appeared to exert maximum anti-cancer effects in vitro when cells produced normal or elevated quantities of the cytokeratins CK8 and CK18, structural proteins that help give the nucleus its shape.

For fulvestrant to work well, the cells must also be responsive to estrogen, and producing the estrogen receptor ER-alpha. ER-alpha’s importance to fulvestrant’s anti-estrogenic action had been established in previous reports. The present study confirms fulvestrant’s binding relationship to ER-alpha, while also showing two other proteins, cytokeratins 8 and 18, can strongly enhance fulvestrant’s anti-estrogenic activity. Testing for the presence of these three proteins, and perhaps many others, could help doctors decide whether fulvestrant should be prescribed to their patients.

Eprotirome May Lower Cholesterol Levels Without Feared Side Effects Of Thyroid-Based Drugs.
"A thyroid-derived cholesterol-lowering drug," called eprotirome, "that could be an alternative to the widely used statin medications has done well in a small, early trial, Swedish and American researchers report." For the 12-week trial, various doses of eprotirome "were added to statin treatment for 168 people whose high levels of LDL cholesterol had not been lowered by previous use of statins," and the combination was found to "lower cholesterol levels" and "did not cause the feared side effects...that have plagued similar thyroid-based treatments." Eprotirome, which is still several years away from the market, is unlikely to replace statins.

Third Study Shows Bisphosphonates May Cut Risk Of Breast Cancer.
According to a study appearing in the British Journal of Cancer, researchers "found a reduction in the risk for breast cancer among postmenopausal women taking bisphosphonates for the treatment of osteoporosis." The study showed that "the use of bisphosphonates was associated with a 30% reduction in the risk for breast cancer." The findings back results "reported in two other studies." Still, researchers remain unclear "how bisphosphonates could prevent breast cancer."

Intravitreous Dexamethasone Effective Treatment For DME.
According to a study published in the Archives of Ophthalmology, "intravitreous treatment with dexamethasone is well tolerated and significantly improves visual acuity in patients with persistent diabetic macular edema (DME)." In a trial in which 315 DME patients were randomized to intravitreous "dexamethasone 700 µg (n=105) or 350 µg (n=105) to one eye, or observation (n=105)," researchers found that "at day 90, a BCVA improvement of 10 letters or more was seen in 33.3%, 21.1%, and 12.3% of the dexamethasone 700 µg, 350 µg, and observation groups, respectively."

Anti-TNF Therapy For Psoriatic Arthritis May Improve Physical Disability, Quality Of Life.
According to a study published in the March issue of Arthritis Care & Research, "treatment with anti-tumor necrosis factor (TNF) agents can significantly improve physical disability and quality of life for patients with psoriatic arthritis." In a study of 596 patients, researchers found that "at six months, patients undergoing anti-TNF therapy had improved on the physical component scale of the Short Form (SF)-36 health survey instrument from a mean score of 19.1 to a mean of 29.3." In addition, scores "on the mental component scale...had risen from a mean of 41.7 to 48.8." Anti-TNF therapy drugs included in the study were etanercept, infliximab, and adalimumab.

Combination Therapy For Some Alzheimer's Patients May Help Ease Caregiver Distress.
According to research presented at a geriatric psychiatry meeting, "caregiver distress is significantly attenuated when patients with moderate to severe Alzheimer's disease (AD) are treated with a combination of extended-release memantine plus a cholinesterase inhibitor (ChEI) vs. ChEI monotherapy." Researchers came to this conclusion after randomizing "335 patients with a diagnosis of probable AD who had been undergoing stable ChEI therapy for at least three months...to extended-release memantine, 28 mg daily, and another 342 patients" to placebo, then following them for 24 weeks.

Quetiapine Associated With More Rapid Onset Of Metabolic Disturbances In Elderly Patients.
According to a study presented at a geriatric psychiatry meeting, "the antipsychotic quetiapine (Seroquel, AstraZeneca) is associated with a more rapid onset of metabolic disturbances than other antipsychotics in elderly patients with no baseline metabolic abnormalities before treatment initiation." In a study of 231 outpatients aged 70 and older treated for "psychosis, depression, bipolar disorders, or dementia," researchers found that "time to onset of hyperglycemia was significantly shorter among patients treated with quetiapine at 17.5 months, compared with patients who were treated with olanzapine at 32.6 months or risperidone at 36.3 months."

References:

http://www.medscape.com/viewarticle/718261
http://www.medpagetoday.com/OBGYN/Pregnancy/21833
http://online.wsj.com/article/BT-CO-20100819-715016.html
http://consumer.healthday.com/Article.asp?AID=642267
http://www.guardian.co.uk/society/2010/aug/20/price-cancer-drug-herceptin
http://newsinfo.iu.edu/news/page/normal/13738.html

Disclaimer- The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

http://www.drshrutibhat.com/
Expert at leading Pharmaceutical R&D.
Translates innovative concepts to PROFITS.
YouTube Channel : Http://www.youtube.com/user/ShrutiBhat10

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Malaria sufferers might be able to protect themselves against life-threatening bouts of the disease by taking a single course of antibiotics.

2010-08-19T06:32:00.006-04:00

Dr.Shruti Bhat, Star formulator and Ace leader within pharmaceutical R&D, a specialist with hiTech formulations and quality-by-design. Shruti brings to you some highlights from current pharma and clinical research news, views and data.

Malaria sufferers might be able to protect themselves against life-threatening bouts of the disease by taking a single course of antibiotics, research in mice has shown.
Preventive treatment with 'needle-free' antibiotic vaccines could be used to control the infection in areas with high levels of transmission, a study published in Science Translational Medicine suggests. There are still no available vaccines against malaria. And although some antibiotics with anti-malarial properties, such as doxycycline, that kill the parasites directly are already in use as one-off, short-term prophylaxis, their prolonged use is not an option for millions of people in the developing world where malaria is endemic.

Now, azithromycin and clindamycin, two common antibiotics, have been shown to provide additional and long-term protection against malaria, even after they are no longer taken.

"The combination of the prophylactic effect with the subsequent immune-mediated protection may be enough to protect population groups at risk, such as infants and young children, from severe forms of malaria," according to Steffen Borrmann, a lead author of the study and parasitologist at the Kenya Medical Research Institute, told SciDev.Net.

The team treated mice with the antibiotics before infecting them with malaria. After taking the drugs, the mice developed vaccine-like immunity lasting at least 40 days, and almost all were protected from complications that are often lethal.

It is still not clear how long the immunity would last in humans, but Borrmann told SciDev.Net that "life-long would be the ultimate goal but we would be happy to achieve 1-2 year protection, [to last] during the most critical years in early childhood in high transmission areas".

The antibiotics work by causing small cavities in malaria parasites during their passage into the liver of the infected host. This stops the parasites from entering the blood stream, giving time for the immune system to launch a sustained defence against the parasites.This mode of action is similar to experimental vaccines that use weakened whole parasites to elicit an immune response. The tested antibiotics are available as safe, generic drugs and there are no patent issues preventing their use in clinical trials or in clinical practise. But they would likely not work in areas with low transmission levels since the degree of immunity to subsequent infections depends on the quantity of malarial parasites already infecting the patient.

FDA Proposes To Remove Orthostatic Hypotension Drug From Market.
The Wall Street Journal reported that the FDA proposed to remove brand and generic versions of low-blood pressure drug ProAmatine (midodrine hydrochloride) from the market because required post-marketing studies on the drug's effectiveness have yet to be conducted. The drug was approved under the FDA's accelerated approval program, and according to the Journal, this is the first time the agency is requesting a drug to be removed from the market because a company failed to conduct the follow-up studies that are required.

Patients who use midodrine should stop taking it after consulting their doctors about other types of anti-hypotension treatment, the FDA said in a statement." Norman Stockbridge, an FDA official said, "Since, evidence to confirm the drug's benefit has not be yet provided to the FDA, it is pursuing a withdrawal of the product." Shire "has been given 15 days to respond in writing or lose its right to appeal. Makers of the generic versions of the drug were given 30 days."

The FDA "letter does not cite any safety or effectiveness problems with the drug, and suggests the action is primarily aimed at enforcing drug approval regulations that have not always been enforced." The drug was approved to treat "orthostatic hypotension."

Oral Contraceptives May Reduce Risk Of Death From Any Cause In Women.
"Women who have taken the Pill at any stage in their life are less likely to die from any cause -- including heart disease and all types of cancer -- than those who have never taken the oral contraceptive," according to research published online in the British Medical Journal. The study of "more than 46,000 women...revealed a slightly higher risk of dying among under-45s."

But, the slightly increased risk in younger women disappears within 10 years of stopping the pill. Researchers calculated that "there were 52 fewer deaths per 100,000 'women years' -- a composite measure of the number of women and the lengths of their lives -- among all women who had ever used the pill compared with those who had never used it."

The effects may only be true for women who have taken older-style pills rather than those on newer type drugs." In younger women, "the effects...were also mainly seen in those who smoked, had high blood pressure, or were otherwise at risk of heart disease." "Women on the pill did have higher rates of violent and accidental death, through the researchers said they couldn't explain the findings." Notably, "the risk was seen in earlier analyses of the data, and has persisted through the years.

Hormonal Contraceptives May Not Be Effective In Overweight Or Obese Women.
Hormonal contraceptives may not be effective for contraception in overweight or obese women," according to a review published online in the Cochrane Database of Systematic Reviews. After performing a literature review encompassing "11 trials enrolling a total of 39,531 women," researchers found that "pregnancy risk for overweight or obese women was higher in one of three studies using BMI." In fact, "compared with women with a BMI of less than 25 kg/m2, women with a BMI of 25 kg/m2 or more had higher risk for pregnancy in this trial of two combination oral contraceptives."

Osteoporosis drug linked to irregular heart beat.
Women who take popular osteoporosis drug alendronate, known more commonly as Fosamax, are twice as likely to develop a common form of irregular heartbeat compared to those who have never taken it, suggests a new study published in the journal Archives of Internal Medicine.

Researchers analyzed data from more than 700 women who had been diagnosed with atrial fibrillation, or irregular heartbeat, in a three-year period and compared them to a control group of more than 900 randomly selected women. They found a nearly two-fold increase in risk for developing atrial fibrillation among those women who had ever taken alendronate.

The findings were compiled by researchers from Group Health and the University of Washington by analyzing records of patients enrolled in Group Health, a Seattle-based non-profit health-care centre. Alendronate is part of a family of drugs known as bisphosphonates, which are widely used to protect against bone loss and prevent bone fracture in osteoporosis patients. However, the researchers did not find a difference in risk among those who had taken Fosamax in the past versus current users. “We do not conclude that the risk is higher for past use than current use. We conclude that the risk is higher for ever use than for never use, which was our original hypothesis,” reported lead study author Dr. Susan Heckbert, a professor of epidemiology and scientific investigator in the cardiovascular health research unit at the University of Washington.

Heckbert stated that the next step would be for scientists to investigate the mechanism for how alendronate may influence the onset of atrial fibrillation. Marlene Gauthier, manager of public affairs for Merck Frosst Canada, responded to the findings by saying that a clinical trial, rather than an observational study such as this one, is the best way to evaluate a drug’s benefits and risks.

“While observational analyses are usually conducted in as rigorous a manner as possible, they are associated with inherent limitations, including factors that cannot be adequately controlled for and an ability to fully account for differences in risk factors between groups. this underscores why data from randomized, controlled clinical trials are considered to be the most reliable source of information about the efficacy and safety of medicines.” The statement continued: “We strongly recommend that if patients have concerns about Fosamax that they talk to their physician. Osteoporosis is a serious medical condition and requires appropriate treatment with physician oversight. Their physician is in the best position to understand the needs of the patient and explain the benefits and risks of any given therapy to the patient.”

“This is an observational study. It is not as strong a design as a clinical trial,” Heckbert acknowledged. “But on the other hand, it does represent what’s happening in actual clinical medicine.” Heckbert stated that her team knew of previous study findings that suggested a link between bisphosphonates and an increased risk for atrial fibrillation. In fact, in the United States there are more than 400 cases pending against Merck in both state and federal court, in which people who have taken Fosamax claim that the drug has contributed to the development of osteonecrosis of the jaw. This happens when bone tissue dies after it loses its blood supply, and can occur after trauma to the bone, such as a dental procedure.

However, Heckbert warned that patients who take alendronate should not stop taking it due to her study’s findings. If individuals are concerned they should speak with their physician or their health-care provider. For patients who are at high risk of fracture, the benefits of alendronate or other bisphosphonates will generally outweigh the risk of atrial fibrillation.”

References:
http://online.wsj.com/article/SB10001424052748704868604575433703888376436.html
http://www.google.com/hostednews/afp/article/ALeqM5gX0oxFR_ZpHn-RyPL8JkXqWD4PNg
http://www.usatoday.com/news/health/2010-08-16-fda-unproven-drug_N.htm
http://www.medpagetoday.com/ProductAlert/Prescriptions/21699
http://www.latimes.com/health/boostershots/la-heb-hypotension-drug-20100816,0,53066.story?track=rss
http://www.startribune.com/business/100813309.html
http://www.bizjournals.com/philadelphia/stories/2010/08/16/daily8.html
http://www.theheart.org/article/1110411.do
http://www.medscape.com/viewarticle/725103
http://www.ncbi.nlm.nih.gov/pubmed/20614470?dopt=Abstract

http://stm.sciencemag.org/content/2/40/40ra49.full?ijkey=OAfu5Q9bUdH4Q&keytype=ref&siteid=scitransmed

Disclaimer- The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

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Translates innovative concepts to PROFITS.
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Scientists Create New Family Of "Super-Antibotics."

2010-08-06T20:30:00.002-04:00

Scientists Create New Family Of "Super-Antibotics."
A new family of "'super-antibotics' capable of beating MRSA (Methicillin resistant Staph. aureus) and other deadly infections” reports a study published in the journal ‘Nature’. In tests, one of the drugs killed strains of the hospital superbug resistant to antibiotics already in use. Others were more than a match for other potentially lethal germs, including food poisoning bug E. coli, and acinetobacter, [which] is even harder to treat than MRSA." The drugs have been heralded as "an important step forward in the race against antibiotic resistance." The new drugs work in a similar way to quinolones. However, the new drugs attach to an enzyme needed for reproduction in a different place, "meaning they can kill bugs that are resistant."

New Antibiotic Designed To Circumvent Drug Resistance.
GlaxoSmithKline Plc, the UK's biggest drugmaker, said it has come up with a new antibiotic designed to circumvent the drug resistance that makes many hospital-acquired infections difficult to treat." Glaxo's new compound "latches onto topoisomerase, which helps bacteria produce proteins and replicate," according to the paper published in Nature. It "connects at a different location on the enzyme from existing drugs." Glaxo's "finding, still years from being commercialized, is significant" at a time "few pharmaceutical companies are producing new medicines to combat rising rates of drug-resistant infections in hospitals”.

FDA Approves First-Ever Human Test Of Embryonic Stem Cell-Based Therapy.
The USFDA has approved "the world's first authorized test in people of a therapy derived from human embryonic stem cells." The clinical trial "could offer the first glimpse of the safety and possible effectiveness of a technology that has been hailed for its vast medical promise but also embroiled in political and ethical controversy." The trial "will test cells developed by the Geron Corporation and the University of California, Irvine in patients with new spinal cord injuries." Geron "plans to enroll eight to 10 patients in the study at sites nationwide. The trial" for its GRNOPC1 therapy "will take about two years, with each patient being studied for one year."

The Wall Street Journal noted that Geron began the study in early 2009, but it was stopped due to concerns in an animal study showing an increased frequency of small cysts within the injury site. Thomas Okarma, Geron's president and chief executive officer, said the FDA's decision strengthens the company's ability to start similar trials in the future.

Misoprostol May Revolutionize Abortion Around The World.
Researchers are finding an alternative" to abortions "that is safe, cheap, and very difficult for governments to restrict -- misoprostol." Misoprostol "pills are beginning to revolutionize abortion around the world, especially in poor countries." The drug "is very widely available and can't easily be banned, because it is also used for ulcers and can save lives of women with postpartum hemorrhages."

References-

http://www.nytimes.com/2010/08/01/opinion/01kristof.html?src=mv
http://www.dailymail.co.uk/health/article-1300484/MRSA-E-Coli-treated-new-breed-antibiotics.html
http://www.bloomberg.com/news/2010-08-04/glaxo-antibiotic-finding-looms-large-in-drug-market-with-few-new-products.html
http://www.nytimes.com/2010/07/31/health/research/31stem.html?_r=1&ref=us
http://www.google.com/hostednews/ap/article/ALeqM5gON1ck-mYcLt7R0U9XC_71Lzo1LQD9H9HQB80
http://online.wsj.com/article/SB10001424052748703999304575399312648917190.html
http://www.bloomberg.com/news/2010-07-30/geron-cleared-by-fda-to-test-embryonic-stem-cell-treatment-shares-climb.html
http://pagingdrgupta.blogs.cnn.com/2010/07/30/landmark-embryonic-stem-cell-study-to-proceed/
http://content.usatoday.com/communities/sciencefair/post/2010/07/stem-cell-spinal-cord-injury-clinical-trial-human-fda/1
http://www.ft.com/cms/s/322baf24-9c01-11df-a7a4-00144feab49a,Authorised=false.html?_i_location=http%3A%2F%2Fwww.ft.com%2Fcms%2Fs%2F0%2F322baf24-9c01-11df-a7a4-00144feab49a.html%3Fftcamp%3Drss&_i_referer=http%3A%2F%2Fsn129w.snt129.mail.live.com%2Fmail%2FInboxLight.aspx%3Fn%3D757275366&ftcamp=rss
http://www.politicsdaily.com/2010/07/30/fda-oks-embryonic-stem-cell-trials-for-humans/

Disclaimer- The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

http://www.drshrutibhat.com/
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Translates innovative concepts to PROFITS.
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Calcium supplements are a good way to keep your bones strong, but, they could lead to an increased risk for heart attack

2010-08-01T06:14:00.003-04:00

Dr.Shruti Bhat, Star formulator and Ace leader within pharmaceutical R&D, a specialist with hiTech formulations and quality-by-design.

Shruti brings to you some highlights from current pharma and clinical research news, views and data.

Calcium Supplements May Be Linked To Increased Risk Of Heart Attack.
Research data published in the online in the BMJ suggests that "Calcium supplements are a good way to keep your bones strong, but, they could lead to an increased risk for heart attack."

Combined results from 11 randomized controlled trials of calcium supplements...involving more than 12,000 patients." The researchers "found a 31% increase in the risk of heart attack and smaller, non-significant increases in the risk of stroke and death." Although "equal numbers of women received calcium or placebo, 143 of those who received calcium suffered a heart attack, compared to 111 who received a placebo."

The researchers said they excluded from their analysis studies that compared coadministered calcium and vitamin D supplements with placebo. The findings may not be applicable to those supplements. The reason for the increased risk of heart attack is not clear, but it is thought the extra calcium circulating in the blood could lead to a hardening of the arteries."

Earlier studies did not find a similar risk when people get calcium through eating foods rich in the mineral, which suggests that supplements may be an independent risk factor. These "findings...have some experts questioning whether calcium supplements should be used as widely as they are now, especially by elderly women, who suffer disproportionately from both heart disease and osteoporosis."

"Given the modest benefits of calcium supplements on bone density and fracture prevention, a reassessment of the role of calcium supplements in the management of osteoporosis is warranted," researchers mentioned online in the British Medical Journal.

Starting HIV Therapy Earlier May Help Reduce Mortality Risk, Thwart TB Infection.
The World Health Organization recommends patients start antiretroviral therapy when their CD4+ count drops to 350," as a "higher CD4+ count means greater infection-fighting ability because the immune system hasn't yet been depressed by the virus."

A new paper appearing in the New England Journal of Medicine is partly responsible for that guideline, considering it found that "early treatment for HIV cuts patients' risk of death." Researchers at the Weill Cornell Medical College also found that earlier treatment "reduces the likelihood of tuberculosis, a leading cause of death among HIV patients."

Before reaching that conclusion, investigators "enrolled 816 asymptomatic" Haitians "with HIV and CD4 cell counts of between 200 and 350 cells per cubic millimeter of blood. Half were started on triple-drug treatment within two weeks of enrollment; the 'standard treatment' group did not start therapy until their CD4 count fell to 200 or they developed an AIDS-defining illness." In short, the researchers found that "early treatment reduced the risk of death by 75% and the rate of new tuberculosis diagnoses by half."

References-

http://www.latimes.com/news/health/boostershots/la-heb-calcium-supplements-20100729,0,3937993.story
http://www.bloomberg.com/news/2010-07-29/calcium-supplements-raise-heart-attack-risk-by-30-in-study-of-11-trials.html
http://www.bbc.co.uk/news/health-10805062
http://consumer.healthday.com/Article.asp?AID=641629
http://www.cnn.com/2010/HEALTH/07/29/calcium.supplements.up.heart.risk/
http://www.dailymail.co.uk/health/article-1298862/Women-calcium-supplements-increase-risk-heart-attack-30.html
http://www.medpagetoday.com/Cardiology/MyocardialInfarction/21448
http://www.google.com/hostednews/ukpress/article/ALeqM5jjUVek1QdfuUUBovmN9THaC_Oo9w
http://www.reuters.com/article/idUSTRE66S6GU20100729
http://www.webmd.com/heart/news/20100729/study-calcium-may-increase-heart-attack-risk?src=RSS_PUBLIC
http://www.telegraph.co.uk/health/healthnews/7916657/Calcium-pills-increase-heart-attack-risk.html
http://www.bloomberg.com/news/2010-07-14/death-rate-from-hiv-falls-75-with-early-antiviral-treatment-study-finds.html
http://content.nejm.org/cgi/content/full/363/3/257
http://www.medpagetoday.com/clinical-context/HIVAIDS/21164

Disclaimer- The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

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Extended Stroke Treatment Window Appears To Be A Safe Option For Saving Lives.

2010-07-28T11:50:00.003-04:00

Dr.Shruti Bhat, Star formulator and Ace leader within pharmaceutical R&D, a specialist with hiTech formulations and quality-by-design. Shruti brings to you some highlights from current pharma and clinical research news, views and data.

Extended Stroke Treatment Window Appears To Be A Safe Option For Saving Lives.
Extending the time window to treat stroke patients with the clot-dissolving drug tPA from three hours to up to 4.5 hours after the onset of stroke doesn't result in any significant delays in treatment and appears to be a safe option for saving lives," according to a new paper in The Lancet Neurology. The "three-hour post-stroke time limit was set because of fears that use of the clot-dissolving drug beyond that period might cause dangerous bleeding or other complications," but after the "publication of two landmark studies, the American Heart Association, the American Stroke Association and the European Stroke Association revised their guidelines in October 2008 to recommend that tPA be used up to 4.5 hours after the onset of an ischemic stroke." Still, "experts have been worried."

So, researchers at the Karolinska Institute "analyzed data from 23,942 patients with ischemic stroke who were included in SITS-ISTR [the Safe Implementation of Treatment in Stroke-International Stroke Thrombolysis Registry] between December 2002 and February 2010," and reported that "although the rate of symptomatic hemorrhage and death was higher among those treated beyond three hours -- and the rate of functional independence was lower -- the benefits of treatment in that window outweighed the risks," the researchers explained. In fact, "safety and functional outcomes are less favorable after three hours, but the wider time window now offers an opportunity for treatment of those patients who cannot be treated earlier."

FDA Adds Boxed Warning To Plavix.
FDA "is adding its strongest warning to the label for Plavix [clopidogrel bisulfate], cautioning that some patients do not respond to the blockbuster blood thinner." The "warning indicates that the drug is dangerous only in the sense that it doesn't work in" certain "patients and thus may leave them unprotected against heart attacks and strokes."

Specifically, some patients have a difference in a liver enzyme known as CYP2C19, which helps to convert Plavix to a form that the body can use, Notably, FDA officials said CYP2C19 tests typically cost less than $500. Robert Temple, deputy director for clinical science at the FDA's Center for Drug Evaluation and Research, said, "What there hasn't been is a clear test of whether you can take people who are poor metabolizers, double their dose and do just as well.

Reovirus May Hold Promise As Nontoxic Prostate Cancer Treatment.
The respiratory, enteric, orphan virus, or 'reovirus' is widespread," but those who are exposed to it tend to "suffer, at most, mild flu-like respiratory symptoms or diarrhea." More interestingly, the "reovirus has 'oncolytic' potential," as there "is already some evidence of its effect against lymphoid, ovarian, breast, pancreatic, and high grade glioma brain cancers."

With that in mind, researchers in Canada "recruited six men with early-stage prostate cancer that had not yet started to spread. Each was given a single injection of the virus into their tumor, guided by ultrasound." After three weeks, "patients had their prostate glands removed as part of their normal treatment." Investigators were then able to see that the virus "triggered the cancer cells' self-destruct program. All around the injection site, the reovirus -- a product from Oncolytics Biotech Inc. called Reolysin -- made cancer cells go away" without harming normal cells. The only flaw was that "the virus did not spread throughout the prostate," meaning "cancer cells not in the immediate area of the injection were spared.

Canada Approves Seasonal Flu Nasal Vaccine.
Health Canada for the first time "granted approval for a nasal vaccine FluMist, designed to protect against seasonal flu." The nasal vaccine which is marketed by AstraZeneca Canada, is attractive to many who have a fear of needles. Another benefit of the nasal vaccine is that research finds it is "more effective in children age 2 to 17 than the traditional injectable flu vaccine."

Research Team Finds Q Fever Demands 18 Months Or More Of Treatment.
Researchers based in France have outlined treatment for Q fever, and "the findings have relevance because of the current -- and unusual -- outbreak of Q fever in the Netherlands, where 3,483 cases have been diagnosed since 2007 and six people have died." Dr. Didier Raoult, of the University of the Mediterranean and colleagues, published results of their study of 104 patients in the journal Lancet Infectious Diseases. The team said that "at least" 18 months of treatment are necessary to "cure an infection of the heart lining or valves resulting from Q fever, and an additional six months will most likely be required if the patient has a prosthetic valve."

Read more at-
http://www.latimes.com/news/health/la-heb-q-fever-20100714,0,2951263.story
http://www.theglobeandmail.com/life/health/nasal-vaccine-against-flu-gets-green-light-in-canada/article1640399/
http://consumer.healthday.com/Article.asp?AID=641489
http://www.medpagetoday.com/Cardiology/Strokes/21395

Disclaimer- The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

Http://www.drshrutibhat.com
Expert at leading Pharmaceutical R&D.
Translates innovative concepts to PROFITS.
YouTube Channel : Http://www.youtube.com/user/ShrutiBhat10

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New 'smart bomb' technology invented to target cancer cells.

2010-07-27T09:41:00.006-04:00

Dr.Shruti Bhat, Star formulator and Ace leader within pharmaceutical R&D, a specialist with hiTech formulations and quality-by-design.

Shruti brings to you some highlights from current pharma and clinical research news, views and data.

New 'smart bomb' tech used to target cancer cells.
A team of researchers from Australia and India are hard at work developing a new "smart bomb" to target tumors. The investigators are developing an antibody that binds to cancer stem cells, delivering a lipid particle containing an anti-cancer therapy coupled with RNAi gene silencing tech.

"While current treatments kill the bulk of the cancer cell, the cancer root escapes the therapy and can regenerate into a new cancer mass," says Wei Duan, an associate professor at Deakin University, who is collaborating with colleagues in India on the project. "The aim of our research is to develop a smart bomb that can penetrate the cell and release the drugs within the cells, rather than from the outside, and kills the whole tumor, root and all."

Indian Institute of Science in Bangalore, Barwon Health's Andrew Love Cancer Centre and ChemGenex Pharmaceuticals are all collaborating on the program, which has been funded in part by the Indian and Australian governments. And the scientists say the delivery technology isn't restricted to the cancer field. The same approach could also work for Alzheimer's, heart disease and diabetes.

"This system would also be very human compatible and human degradable meaning it would not be toxic to other cells in the body and would cause very limited side-effects," says Duan. The molecular drug delivery system would use a technique known as RNA interference, or gene silencing, which enables control over the genes inside cells.First, the scientists are developing a chemical antibody that will bind specifically to cancer cells. This "guided missile" will have a purpose-built lipid particle - carrying an anti-cancer drug as well as anti-cancer genes - as its payload. Combined, they create a treatment that will actively seek and penetrate the cells in a tumour, killing those vital for a cancer to spread.

The working of the ‘smart bomb’: According to the scientists, the mechanism is aimed at killing the root of the cells that play a vital role in generating the lethal cells in body.

The process involves a molecular drug delivery system which will pick out the active cells of the cancer before they can develop into a full blown lethal disease.

Researchers are designing a chemical antibody that will bind the cancer cells, which together with the technique known as 'RNA interference', or gene silencing, will penetrate and destroys mutated cells that cause the occurrence and reoccurrence of cancer.

Dr Duan stated, "Our precision-guided cancer therapy will afford reduced side-effects, decreased toxicity to normal cells. We will probably still be using existing drugs but the way we use them will be much more specific.

"We're not saying we will have a cure cancer in 10 years but at least these people will live longer and importantly enjoy a higher quality of life."

The researchers are optimistic that the clinical trials of the treatment will soon be on the way. Dr Duan said there was also potential to use the same technique to tackle neurodegenerative diseases such as Alzheimer's disease, heart disease and diabetes.

The project is a collaboration with the Indian Institute of Science in Bangalore, Barwon Health's Andrew Love Cancer Centre and ChemGenex Pharmaceuticals.It has received $400,000 funding over three years from the federal government's Australia-India Strategic Research Fund, with reciprocal support from the Indian government.

"This system would also be very human compatible and human degradable meaning it would not be toxic to other cells in the body and would cause very limited side-effects, that professes to slash the grim but inevitable effects of conventional treatment such as hair loss, vomiting, and irritated mucous membrane.

"The success of this project will bring us a step forward in significantly improving the survival rate and quality of life of cancer patients."

FDA Approves Three-In-One Blood Pressure Drug.
"Daiichi Sankyo Inc. stated that regulators have approved the sale of its three-in-one high blood pressure drug Tribenzor [hydrochlorothiazide, amlodipine, olmesartan medoxomil]."

The drug product is intended "to treat patients whose blood pressure is not controlled on angiotensin receptor blockers, calcium channel blockers, or diuretics." The FDA issued several warnings regarding the use of the drug, including that "pregnant patients should not take the new combination drug," and "those who become pregnant while on the polypill should discontinue therapy immediately." The drug also "may increase the risk of angina and myocardial infarction once calcium channel blocker therapy has started or after a dose increase, particularly in patients with severe obstructive coronary artery disease." The most common adverse reactions seen in clinical trials of the combo drug were dizziness, peripheral edema, headache, fatigue, nasopharyngitis, muscle spasms, nausea, upper-respiratory-tract infection, diarrhea, urinary-tract infection, and joint swelling."

AIDS Vaginal Gel Considered Promising, But More Work Remains.
"The best AIDS-prevention news in years was released...last week at a world conference on the disease: a vaginal gel, called a microbicide, that can be used without a man knowing it, gave women a 39 percent chance of avoiding infection with the deadly virus." The Times adds, "After more than a dozen microbicide failures," these findings were "a huge relief." Dr. Anthony S. Fauci, director of the NIH's NIAID, said, "There's a certain feeling of ease and pleasure for me as a scientist that any way you slice the data, it's statistically significant." Still, researchers must address many questions before the treatment can be submitted for regulatory approval.

Read more:

New 'smart bomb' tech used to target cancer cells - FierceDrugDelivery http://www.fiercedrugdelivery.com/story/new-smart-bomb-tech-used-target-cancer-cells/2010-07-06#ixzz0uFrrnwTq
http://news.smh.com.au/breaking-news-national/cancer-smart-bomb-being-developed-20100705-zwoe.html
http://www.themedguru.com/20100706/newsfeature/smart-bomb-effective-cancer-treatment-its-way-86136874.html
http://www.fiercedrugdelivery.com/story/new-smart-bomb-tech-used-target-cancer-cells/2010-07-06#ixzz0uFraccp4
http://finance.yahoo.com/news/Daiichi-Sankyo-says-FDA-apf-2700966247.html?x=0&.v=1
http://www.medpagetoday.com/Cardiology/Hypertension/21391
http://www.theheart.org/article/1105927.do
http://www.nytimes.com/2010/07/27/health/27aids.html?_r=2&ref=health

Disclaimer- The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

http://www.drshrutibhat.com/
Expert at leading Pharmaceutical R&D.
Translates innovative concepts to PROFITS.
YouTube Channel : Http://www.youtube.com/user/ShrutiBhat10

Do you have questions for the author?

Vaccine May Help Shrink The Most Deadly Cancers.

2010-07-20T13:20:00.004-04:00

Dr.Shruti Bhat, Star formulator and Ace leader within pharmaceutical R&D, a specialist with hiTech formulations and quality-by-design. Shruti brings to you some highlights from current pharma and clinical research news, views and data.

Experts Warn Absence Of Clinical Trials For Biosimilar Drugs Could Hurt Safety, Effectiveness.
Medical experts warned that the absence of mandatory clinical trials for biosimilar drugs could compromise their safety and effectiveness." That provision was "designed to get biosimilars – and the cost savings that accompany them – to the marketplace more quickly" by allowing FDA to base its approval, "in part, on the safety and efficacy record of the original breakthrough drug." The provision, however, is "vague," according to critics, and "leaves FDA with a great deal of leeway to okay those drugs – including the flexibility to decide whether clinical trials are necessary at all." The "difference in manufacturing processes" between companies "can alter the drugs 'in ways that technology can't detect.'"
http://thehill.com/blogs/healthwatch/health-reform-implementation/109647-experts-concerned-about-lack-of-clinical-trials-for-biosimilar-drugs

Number Of HIV-Positive Patients Receiving Antiretroviral Drugs Increased By More Than A Quarter In 2009.
The number of HIV-positive people receiving antiretroviral drugs for their infections jumped by more than a quarter in 2009, growing from four million to 5.2 million, the World Health Organization disclosed at the International AIDS Conference in Vienna." The organization's Dr. Hiroki Nakatani said, "This is the largest increase in people accessing treatment in a single year." But "unfortunately, that still leaves 10 million who need therapy."
http://www.latimes.com/news/health/boostershots/la-heb-aids-treatment-20100719,0,3111390.story

Bosentan May Not Improve Exercise Capacity In Patients With Systemic Sclerosis.
"Treatment with the endothelin receptor antagonist bosentan (Tracleer) failed to improve exercise capacity in patients with systemic sclerosis, a randomized trial found." James R. Seibold, MD, of the University of Connecticut in Farmington, and colleagues said that after one year of treatment, "there was a nonsignificant mean change in the six-minute walk test in the bosentan-treated patients (−12 meters) compared with the change in the placebo group (9 meters)." In addition, the study found bosentan "had no effect on time to death or worsening pulmonary function test scores."
http://www.medpagetoday.com/Rheumatology/GeneralRheumatology/21082

Clinical Trials To Continue For Potential Hemophilia Drug.
"Biogen Idec Inc. and Swedish Orphan Biovitrum stated they will continue clinical testing of a potential hemophilia drug based on promising results from an early trial." The companies "are testing a form of a protein called factor VIII," which "is involved in the formation of blood clots, and people with hemophilia A have little or none of it." Biogen and Biovitrum also "said that in an early study on 16 patients, their drug was safe and had 'a prolonged half-life' compared an older drug, Advate."
http://www.businessweek.com/ap/financialnews/D9GRJQP00.htm

Vaccine May Help Shrink The Most Deadly Cancers.
"An injection to help kill off the most deadly cancers...has been created by scientists" in the UK. The "Middlesex University vaccine capitalizes on the finding that some of the most vicious tumors produce a hormone normally only found in pregnancy," that is, human chorionic gonadotropin. In fact, "a form of hCG is...made by around half of bladder and pancreatic cancers," and "some breast, bowel, ovarian, and cervical tumors also pump it out." The vaccine, however, "which is being developed in conjunction with US firm Celldex Therapeutics, revs up the immune system, directing it to destroy hCG." This "shrinks tumors -- and, crucially, stops them from spreading, or metastasizing."
http://www.dailymail.co.uk/health/article-1293927/Jab-halt-deadly-forms-cancer.html

Large Drugmakers Placing New Emphasis On Targeted Cancer Treatments.
Increasingly, large pharmaceutical companies are restructuring their business models so that they can collaborate with small biotech firms to develop medications which target small groups, rather than large populations. This move is influenced in part by a new emphasis on personalized medicine and the need for targeted therapies. For instance, Pfizer has partnered with Abbott Molecular to develop a treatment called crizotinib, which would only benefit four percent of lung cancer patients. Meanwhile, AstraZeneca is seeking FDA approval so that its drug Iressa [gefitinib] can be used to treat EGFR-positive lung cancer patients.
http://www.ft.com/cms/s/2/72803d54-9046-11df-ad26-00144feab49a,dwp_uuid=e8477cc4-c820-11db-b0dc-000b5df10621.html

Dengue Returns To US; Sanofi Sees Phase 3 Trials For Vaccine By 2010 End.

2010-07-12T06:36:00.002-04:00

Dr.Shruti Bhat, Star formulator and Ace leader within pharmaceutical R&D, a specialist with hiTech formulations and quality-by-design. Shruti brings to you some highlights from current pharma and clinical research news, views and data.

Dengue Returns To US; Sanofi Sees Phase 3 Trials For Vaccine By 2010 End.
The New York Times reported that "for the first time in more than 65 years, dengue has returned the continental US," according to an advisory the Centers for Disease Control and Prevention issued in late May. Since last August, the US has diagnosed 28 people with dengue, and all were infected in Florida.

Experts say "more than half the world's population" will be at risk by 2085, because of increased global travel and climate change, and as a result of "resurgence of the mosquito." There are no drugs for the disease, and experts looking for an "effective and affordable vaccine." Sanofi Pasteur is working on a vaccine, and expects to have "phase 3 trials on an industrial scale by the end of the year." Pharma companies may hence consider this an important lead for drugs of future...initate development research in time to ensure patients get appropriate medicines whenever needed.
http://www.nytimes.com/gwire/2010/06/28/28greenwire-dengue-re-emerges-in-us-spurring-race-for-vacc-14067.html

Lawmakers Call For Avandia To Be Pulled From Market.
Healthwatch blog reported that "Sen. Chuck Grassley (R-Iowa) and Rep. Rosa DeLauro (D-Conn.) called for the diabetes drug Avandia to be pulled from the market in the wake of two new medical studies." In a joint statement, Sen. Grassley said, "The serious issues delineated in these two new, independent reports put additional onus on advisory committee members when they meet in July."
http://thehill.com/blogs/healthwatch/prescription-drug-policy/105999-grassley-delauro-press-for-fda-to-pull-avandia-from-the-market-following-critical-jama-studies
http://www.bloomberg.com/news/2010-06-28/fda-avandia-panel-likely-to-vote-on-withdrawal-deputy-commissioner-says.html

Potential Drug To Treat Pain Associated With Diabetes Fails In Mid-Stage Study.
"Forest Laboratories Inc. said that its potential treatment for pain associated with diabetes," called Radiprodil (RGH-896), "failed to meet key midstage study goals." The company and its partner, Gedeon Richter PLC, said the drug failed to reduce pain when compared with a placebo. Therefore, they "will review the complete study database over the coming weeks to determine the appropriate next steps regarding development of the drug candidate."
http://www.forbes.com/feeds/ap/2010/06/28/business-health-care-us-forest-laboratories-study_7726783.html

Tea Tree Oil May Help Treat Some Skin Cancers.
"Tea tree oil may provide a fast, cheap and effective treatments for some skin cancers, according to researchers." A team of researchers from the University of Western Australia found that the common remedy was able "to shrink non-melanoma skin cancers in mice in just one day and wiped them out within three days." Study leader Dr. Sara Greay said, "We are very excited about these results and are hoping to find funding for a small clinical trial of about 50 people with pre-cancerous lesions, with the aim of preventing the development of skin cancers."
Non-melanoma skin cancer is one of the most common types of cancer in the UK, with around 100,000 new cases diagnosed every year. Scientists believe a tea tree oil formulation could be an effective treatment

Read more: http://www.dailymail.co.uk/health/article-1292074/Tea-tree-oil-offers-hope-new-effective-treatment-skin-cancer.html#ixzz0t2gOdtiK
http://www.dailymail.co.uk/health/article-1292074/Tea-tree-oil-offers-hope-new-effective-treatment-skin-cancer.html

Diet drug linked to heart problems.
Preliminary analysis of data from a placebo-controlled study of sibutramine (Meridia) suggested an excess risk of cardiovascular events including myocardial infarction and cardiac death among patients taking the diet drug, according to the FDA." These "findings come from a trial of 10,000 high-risk patients who were randomized to sibutramine or placebo." The agency "said there was a 1% absolute difference in the rate of heart attack, stroke, resuscitated cardiac arrest, or death, with 11% of the sibutramine patients reaching that endpoint versus 10% of the placebo patients."

Metformin Use May Reduce Mortality Among Patients With Type 2 Diabetes.
MedPage Today reported that "metformin use may reduce mortality among patients with type 2 diabetes who are at risk for cardiovascular events," according to research presented at the American Diabetes Association (ADA) meeting. Investigators reported that "a large, multicenter trial found a 24% reduced risk of all-cause mortality among patients on the drug, compared with those not taking it." HeartWire reported that "even patients thought to have contraindications to metformin, such as those with moderate renal failure, congestive heart failure, or advanced age up to 80 years, showed benefit."
http://www.medpagetoday.com/MeetingCoverage/ADA/20971
http://www.theheart.org/article/1093929.do

Glaxo changes R&D model: Group Aims To Develop Drugs Like Small Biotech Companies.
The Wall Street Journal reported that GlaxoSmithKline has turned its research and development group into a number of specialized teams that aim to discover drugs in a similar way to biotechnology companies. The teams, known as discovery performance units, or DPUs, are about halfway through the three-year budgets they were given in 2008, and the company has notified them that if they don't produce, there will be layoffs. The company has also reduced its R&D staff by about 20% since 2006, and increased its investment in outside research firms.
http://online.wsj.com/article/SB10001424052748704569204575328580921136768.html.html

Europeans Said To Be Skeptical Of Flu Vaccines.
The Financial Times reported that Europeans are skeptical of flu vaccines. Thus, drug companies predict, there will be no increase in demand for the vaccines across the European Union. But drugmakers are expecting increased sales in the US. The Times also notes that EU citizens may have greater protection from the seasonal flu than those in the US because the EU uses adjuvanted vaccines.
http://www.ft.com/cms/s/c6a7e850-82d6-11df-b7ad-00144feabdc0,Authorised=false.html?_i_location=http%3A%2F%2Fwww.ft.com%2Fcms%2Fs%2F0%2Fc6a7e850-82d6-11df-b7ad-00144feabdc0.html&_i_referer=http%3A%2F%2Fsn129w.snt129.mail.live.com%2Fmail%2FInboxLight.aspx%3FFolderID%3D00000000-0000-0000-0000-000000000001%26InboxSortAscending%3DFalse%26InboxSortBy%3DDate%26n%3D2080073193

Disclaimer- The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

Http://www.drshrutibhat.com
Expert at leading Pharmaceutical R&D.
Translates innovative concepts to PROFITS.
YouTube Channel : Http://www.youtube.com/user/ShrutiBhat10

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EU Approves Chewable Form Of Lipitor For Children.

2010-07-10T06:21:00.005-04:00

Dr.Shruti Bhat, Star formulator and Ace leader within pharmaceutical R&D, a specialist with hiTech formulations and quality-by-design. Shruti brings to you some highlights from current pharma and clinical research news, views and data.

EU Approves Chewable Form Of Lipitor For Children.
The European Union has approved a new chewable form of cholesterol blockbuster Lipitor for children 10 and up with high levels of bad cholesterol and triglycerides...Pfizer said Tuesday.This "approval includes children whose high blood fats are due to...familial hypercholesterolemia.
http://www.google.com/hostednews/ap/article/ALeqM5j7lgaYrKYwRcQCtKT0Y2jSQstyNQD9GPLL480

Doctors Identify Two Therapies That May Slow Progress Of Diabetic Retinopathy.
The Los Angeles Times blog reported that, according to data published June 29 in the New England Journal of Medicine and presented at the American Diabetes Association meeting, "doctors said they have identified two therapies that may slow the progress of" diabetic retinopathy. After examining data on a subset of 2,856 people from the ACCORD study, researchers found that "people with type 2 diabetes who adhere to intensive blood sugar control, compared with standard blood sugar control, have reduced progression of retinopathy. In addition, patients treated with a combination of a cholesterol-lowering statin and fibrate drugs also had a lower rate of progression compared with patients taking statins alone."
http://latimesblogs.latimes.com/booster_shots/2010/06/diabetes-retinopathy-glucose-control.html
http://content.nejm.org/cgi/content/full/NEJMoa1001288
http://www.nhlbi.nih.gov/health/prof/heart/other/accord/index.htm

Weight-Loss Supplement Contains Potentially Dangerous, Undeclared Drug Ingredients, FDA Warns.
MedPage Today reported, "The FDA warned customers about several potentially dangerous and undeclared drug ingredients in Que She, a pill sold as an herbal weight-loss supplement." Specifically, the "supplement contains fenfluramine, a stimulant drug withdrawn from the market because it may cause serious heart valve damage; propranolol, a prescription beta-blocker that may be hazardous to patients with bronchial asthma or certain heart conditions; sibutramine, a controlled, prescription weight-loss drug that studies have shown may increase heart attack and stroke risk; and ephedrine, a stimulant that is sold over-the-counter for temporary asthma relief but may have adverse cardiovascular effects.
http://www.medpagetoday.com/ProductAlert/OTC/21087

Two Studies Suggest Diabetes Drug Avandia Increases Risk Of Heart Problems.
ABC World News reported, "Two major studies have found the medicine called Avandia [rosiglitazone] could create a significant new risk of heart attack and other serious problems."

The CBS Evening News reported, "FDA experts meet in two weeks to decide whether or not to pull Avandia off the market." NBC Nightly News reported, however, that the drug's maker, GlaxoSmithKline, "said today the drug is effective and safe."

The Washington Post reported that one study, "involving more than 35,500 people, found that Avandia significantly raises the chances of a heart attack." A separate study "of more than 227,500 Medicare patients -- the largest such study to date -- found that the drug boosts the risk for strokes, heart failure, and death." The Los Angeles Times reported that the first study "found Avandia raised the risk of heart attacks by 28% to 39% as compared with other diabetes medications. The study was published online in the Archives of Internal Medicine."

Bloomberg News quoted "I think we've got more than enough evidence to say this drug should not be used." USA Today reported that in the second study, published in the Journal of the American Medical Association, "scientists from the Center for Drug Evaluation and Research at the Food and Drug Administration evaluated data from 227,571 Medicare beneficiaries taking either Avandia or Actos [pioglitazone hydrochloride]." The investigators found "no differences in the risk for heart attack between the two drugs, but the study found that compared with Actos, Avandia was associated with a 25% increased risk of heart failure, a 27% increased risk of stroke and a 14% increased risk of death." The Boston Globe quoted the study's coauthor Dr. David Graham, the FDA's associate director for science and medicine, as saying, "Look at our study, and then ask yourself, 'Why would you want to take Avandia?'"

The New York Times reported that "the studies were made public in hopes of influencing an expert panel to offer advice to the Food and Drug Administration about whether Avandia should be removed from the market." According to Dr. Joshua M. Sharfstein, the FDA's principal deputy commissioner, the studies "will be part of the discussion that FDA has as we consider the important question of Avandia's safety." The AP reports that "at the FDA's request, Glaxo began a big study last year comparing heart and stroke risks in patients on Avandia or Actos, made by Japan's Takeda Pharmaceuticals. It aims to enroll thousands of patients, but an editorial in JAMA about the Medicare study says it would be unethical to let the study continue."

The NPR blog reported that "Glaxo, for its part, defended the medicine, saying in a statement that randomized clinical trials have shown 'Avandia does not increase the overall risk of heart attack, stroke or death.'".

http://www.washingtonpost.com/wp-dyn/content/article/2010/06/28/AR2010062802089.html?hpid=moreheadlines
http://www.latimes.com/news/science/la-sci-diabetes-avandia-20100629,0,6076476.story?track=rss
http://archinte.ama-assn.org/cgi/content/abstract/2010.207v1?maxtoshow=&hits=10&RESULTFORMAT=&fulltext=Avandia&searchid=1&FIRSTINDEX=0&resourcetype=HWCIT

http://www.bloomberg.com/news/2010-06-28/glaxo-diabetes-drug-avandia-harms-patients-should-be-pulled-doctors-say.html
http://www.usatoday.com/news/health/2010-06-28-Avandiaheartrisks-diabetes_N.
http://jama.ama-assn.org/cgi/content/full/jama.2010.
http://www.boston.com/business/healthcare/articles/2010/06/29/new_studies_add_to_avandia_concerns/ http://www.nytimes.com/2010/06/29/health/research/29drug.html?_r=1&ref=health
http://www.forbes.com/feeds/ap/2010/06/28/business-health-care-us-med-diabetes-drugs_7726225.html
http://jama.ama-assn.org/cgi/content/full/jama.2010.954
http://www.npr.org/blogs/health/2010/06/28/128161946/diabetes-avandia-heart-risks
http://www.medpagetoday.com/MeetingCoverage/ADA/20933
http://www.washingtontimes.com/news/2010/jun/28/study-finds-diabetes-drug-risky-health/
http://online.wsj.com/article/SB10001424052748703964104575334570859778764.html?mod=googlenews_wsj
http://www.washingtontimes.com/news/2010/jun/28/study-finds-diabetes-drug-risky-health/
http://www.reuters.com/article/idUSN2826887120100628
http://www.google.com/hostednews/afp/article/ALeqM5gk-BsMFSQxxxAoQBhSkWMTivx9fA
http://consumer.healthday.com/Article.asp?AID=640571
http://diabetes.webmd.com/news/20100628/new-study-avandia-riskier-than-actos

Disclaimer- The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

http://www.drshrutibhat.com/
Expert at leading Pharmaceutical R&D.
Translates innovative concepts to PROFITS.
YouTube Channel : Http://www.youtube.com/user/ShrutiBhat10

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FDA Approves First Implantable Miniature Telescope to Improve Sight of AMD patients.

2010-07-07T16:24:00.003-04:00

Dr.Shruti Bhat, Star formulator and Ace leader within pharmaceutical R&D. Shruti is a specialist with hiTech formulations and quality-by-design. Shruti brings to you some highlights from current pharma and clinical research news, views and data.

The U.S. Food and Drug Administration yesterday announced it has approved the Implantable Miniature Telescope (IMT) to improve vision in some patients with end-stage age-related macular degeneration (AMD).

Surgically implanted in one eye, the IMT is a small telescope that replaces the natural lens and provides an image that has been magnified more than two times. AMD, a condition that mainly affects older people, damages the center of the retina (macula) and results in a loss of vision in the center of the visual field. About 8 million people in the United States have AMD and nearly 2 million of them already have significant vision loss, according to the National Eye Institute. AMD can make it difficult or impossible to recognize faces or perform daily tasks such as reading or watching television.

"This innovation has the potential to provide many people with an improved quality of life," said Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health.

The IMT is available in two models: one that provides 2.2 times magnification and another 2.7 times magnification. The IMT is designed to magnify and project images onto a healthy portion of the retina. The IMT is intended to be implanted in only one eye; the non-implanted eye is used for peripheral vision.

The IMT is used in patients ages 75 years and older with stable severe to profound vision impairment (when vision impairment has not changed over time) caused by blind spots (bilateral central scotoma) associated with end-stage AMD. These patients also have evidence of a visually significant cataract.

Patients agree to undergo training with an external telescope with a low vision specialist prior to implantation to determine whether adequate improvement in vision with the external telescope can be obtained and to verify if the patient has adequate peripheral vision in the eye that would not be implanted. Patients also agree to participate in a post-operative visual training program.

In a 219-patient, multi-center clinical study of the IMT, 90 percent of patients achieved at least a 2-line gain in either their distance or best-corrected visual acuity, and 75 percent of patients improved their level of vision from severe or profound impairment to moderate impairment.

Because the IMT is a large device, implantation can lead to extensive loss of corneal endothelial cells (ECD), the layer of cells essential for maintaining the clarity of the cornea, and chronic endothelial cell loss. The chronic rate of endothelial cell loss is about 5 percent per year. Significant losses in ECD may lead to corneal edema, corneal decompensation, and the need for corneal transplant. In the study, 10 eyes had unresolved corneal edema, with five resulting in corneal transplants. The calculated five-year risk for unresolved corneal edema, corneal decompensation, and corneal transplant are 9.2 percent, 6.8 percent and 4.1 percent, respectively.

To ensure that the risks of IMT implantation are sufficiently and consistently communicated to patients, the FDA and the manufacturer created detailed labeling, including an Acceptance of Risk and Informed Decision Agreement, which patients must complete prior to IMT implantation. The agreement provides a guide for patients and their physicians to discuss the risks associated with IMT implantation. Patients should be given adequate time to review all of the information regarding the IMT.

As a condition of FDA approval, the manufacturer, VisionCare Ophthalmic Technologies Inc. of Saratoga, Calif., must conduct two post-approval studies. In one study, VisionCare must continue follow-up on the subjects from its long-term follow-up cohort for an additional two years. Another study of 770 newly enrolled subjects will include an evaluation of the endothelial cell density and related adverse events for five years after implantation.

Disclaimer- The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

Http://www.drshrutibhat.com
Expert at leading Pharmaceutical R&D.
Translates innovative concepts to PROFITS.
YouTube Channel : Http://www.youtube.com/user/ShrutiBhat10

Introducing ! A new blog- Http://www.PharmaceuticalCareerDevelopment.blogspot.com which contains articles on motivation, career counselling and coaching, job search strategies, personal branding etc. especially for pharma professionals.

Resveratrol seems to be the promising drug of future- Yet another use might be to help Prevent Age-Related Deterioration Of Eyesight.

2010-06-26T12:21:00.007-04:00

Dr.Shruti Bhat, Leader Pharmaceutical R&D and Expert in hiTech formulation development for over 35 different therapeutic class of drugs moeities, brings to you some highlights from current pharma and clinical research news, views and data.

Resveratrol May Help Prevent Age-Related Deterioration Of Eyesight.
Resveratrol, found in particularly high levels in grape skin (and consequently red wine)," may help prevent age-related deterioration of eyesight, according to a study published in the American Journal of Pathology. "The substance...is believed to work because it protects against abnormal angiogenesis -- the formation of damaged or mutated blood vessels," a condition which "is linked to cancer, heart disease, and eye diseases, such as age-related macular degeneration."
http://www.telegraph.co.uk/health/healthnews/7851772/Drinking-wine-could-protect-your-eyes.html

Pfizer Suspends Clinical Trials Of Tanezumab As Potential Osteoarthritis Treatment.
Pfizer Inc. Spokesperson said Wednesday it has suspended clinical trials of its drug tanezumab as a potential osteoarthritis treatment, after some patients' conditions worsened." The drugmaker "said it halted the worldwide program following a request by the Food and Drug Administration after reports of a 'small number' of patients experiencing more severe osteoarthritis that led to joint replacement."

FDA has also asked the company to show data on potential effects in clinical studies of the drug among patients with cancer pain, interstitial cystitis, chronic low back pain and painful diabetic peripheral neuropathy, Pfizer said." The FDA "will then decide whether to halt Pfizer's remaining trials of tanezumab after reviewing company data." However, "trials for other conditions haven't reported similar adverse events, MacKay Jimeson, a Pfizer spokesman, said."

The drugmaker recently reported that patients using the drug for knee pain related to osteoarthritis had positive responses.
http://www.forbes.com/feeds/ap/2010/06/23/business-health-care-us-pfizer-halts-study_7714952.html
http://www.bloomberg.com/news/2010-06-23/pfizer-suspends-trial-of-tanezumab-for-osteoarthritis-pain-at-u-s-request.html
http://online.wsj.com/article/SB10001424052748703900004575325320800502744.html

Glucosamine, Chondroitin Sales Remain Strong Despite Evidence They May Be Ineffective.
Despite a 2006 study published in the New England Journal of Medicine that suggested that "for most people, glucosamine and chondroitin do not soothe knee pain much better than a placebo," Americans nevertheless "spent $838 million on glucosamine and chondroitin in 2008," according to the Nutrition Business Journal. Rheumatologist Sean Whelton, MD, who "attended the American College of Rheumatology meeting where" results of the NEJM study were presented, tells his osteoarthritis patients that the products are safe, but also points out that they may not be "particularly effective."

SSRI Antidepressant Use Associated With Cataracts.
According to a study published online in the journal Ophthalmology, "SSRI antidepressants raise the risk of cataracts by about 15% -- enough to cause 22,000 extra cataract cases in the US each year." After analyzing "data collected from 18,784 cataract patients and 187,840 comparison patients between 1995 and 2004," researchers found that risk for cataracts was associated with the antidepressants Luvox (fluvoxamine, 39%), Effexor (venlafaxine, 33%), and Paxil (paroxetine, 23%), while overall "use of any SSRI antidepressant raised cataract risk by 15%." The authors theorized that SSRI antidepressants may cause more serotonin to be deposited into receptors in the lens of eye, over time making the lens more opaque.

Disclaimer- The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

Http://www.drshrutibhat.com
Expert at leading Pharmaceutical R&D.
Translates innovative concepts to PROFITS.
YouTube Channel : Http://www.youtube.com/user/ShrutiBhat10

Introducing ! A new blog- Http://www.PharmaceuticalCareerDevelopment.blogspot.com which contains articles on motivation, career counselling and coaching, job search strategies, personal branding etc. especially for pharma professionals.

Do you have questions for the author?

Investigational Implantable Sensor May Reduce Risk Of Hospitalizations For Heart Failure- Pharmaceutical R&D updates

2010-06-24T21:45:00.006-04:00

Dr.Shruti Bhat, Leader Pharmaceutical R&D and Expert in hiTech formulation development for over 35 different therapeutic class of drugs moeities, brings to you some highlights from current pharma and clinical research news, views and data.

Antiretroviral Therapy Treatment May Reduce Perinatal AIDS Transmission.
According to studies published June 17 in the New England Journal of Medicine, "AIDS transmission to babies was blocked in 99 percent of cases when breastfeeding mothers infected with the HIV virus took triple-drug combinations." In fact, one study in Botswana of 730 pregnant women with HIV found that "virus transmission fell to 1.1 percent when mothers were assigned to one of three combination regimens initiated before birth and continued through six months of pregnancy." But, "without the drugs, the infection rate would be at least 25 percent."

The second study, which took place in Malawi, "found that giving babies an antiretroviral drug once a day during their first six months of life reduced the transmission rate to 1.7 percent." Researchers came to that conclusion after giving 2,369 "HIV-positive mothers...either antiretrovirals after delivery and while breast-feeding, or" instructing them "to give their babies a single vial of the drug nevirapine daily." Meanwhile, "infants in a third control group received a single dose of nevirapine and seven days of two other antiretroviral drugs."

According to accompanying editorial "debate over which regimen is best 'should not be used to justify inaction.'" Rather, "the choice of regimen is secondary to identifying, caring for, and treating HIV-positive women and their infants."
http://www.bloomberg.com/apps/news?pid=newsarchive&sid=aTKRE8oVsUVg
http://consumer.healthday.com/Article.asp?AID=640176
http://content.nejm.org/cgi/content/full/362/24/2271
http://www.medpagetoday.com/HIVAIDS/HIVAIDS/20717

Experimental Colon Cancer Treatment Fails To Meet Goal In Midstage Study.
A potential colon cancer treatment failed to meet its goal in a midstage study." The research "was conducted by Curis' partner Roche and that company's Genentech unit." A drug, a so-called hedgehog-pathway inhibitor, combined with the Avastin [bevacizumab] tumor drug and chemotherapy didn't keep the disease at bay or extend lives of patients compared with those given standard treatment." This "study of 199 patients was the biggest yet for the hedgehog treatment," known as GDC-0449.
http://www.bloomberg.com/apps/news?pid=20601202&sid=aJxiB1BIwgUM
http://www.forbes.com/feeds/ap/2010/06/16/business-health-care-us-curis-mover_7694092.html
http://www.reuters.com/article/idUSSGE65F0G020100616

After 12 Months, Aspirin OK Without Plavix For Patients With Stents.
Giving aspirin alone to patients who have had stents implanted seems just as good as giving aspirin along with the blood thinner Plavix [clopidogrel]," according to a study presented at the American College of Cardiology annual meeting. Researchers discovered that, after an initial year receiving the dual anti-clotting therapy, patients who went off Plavix and just took aspirin had the same rate of heart attacks and death as those patients continuing on the two drugs together. Dr. Gurpreet Sandhu, an interventional cardiologist with the Mayo Clinic, cited ACC guidelines, saying, "In general, this fits with current guidelines, so it's not going to be practice-changing, per se."

Investigational Implantable Sensor May Reduce Risk Of Hospitalizations For Heart Failure.
A study being called the start of a revolution in the management of heart failure." Among heart failure patients with moderate to severe disease, six months of monitoring with an investigational implantable sensor that measures pulmonary artery pressure was associated with a 30% relative risk reduction in hospitalizations for heart failure," according to the research, presented at the Heart Failure Congress. Investigators found that, "after six months there were 83 hospitalizations for heart failure among the 270 patients randomized to treatment guided by hemodynamic measurements from the CardioMems Heart Sensor, compared with 120 heart failure hospitalizations in the 280-patient control arm." One of the researchers "said the data suggests that using the pulmonary monitoring device to guide treatment in just eight heart failure patients for six months would result in one less hospitalization for heart failure."

FDA Seeks More Information On Inhaled Insulin Drug.
MannKind Corp.allegedly "failed to win approval from US regulators to market its inhaled insulin drug, Afrezza, for people with diabetes." The FDA "asked for more information about the medication and the inhaler patients will use, MannKind said today in a statement," and although the agency "didn't cite any safety concerns, they requested updated safety data." The FDA questioned whether the inhaler used in clinical trials was similar to another one the company created and wants to market with Afrezza.

Related links-
http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm215515.htm
http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm216214.htm
http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm216218.htm
http://www.medscape.com/viewarticle/723988

Disclaimer- The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

http://www.drshrutibhat.com/
Expert at leading Pharmaceutical R&D.
Translates innovative concepts to PROFITS.
YouTube Channel : Http://www.youtube.com/user/ShrutiBhat10

Introducing a new blog http://www.pharmaceuticalcareerdevelopment.blogspot.com/ which contains articles on motivation, career counselling and coaching, job search strategies, personal branding etc. especially for pharma professionals.

Do you have questions for the author?

Pharma industry updates: Biovail And Valeant Pharmaceuticals Agree To Merge In $3.2 Billion Deal.

2010-06-22T09:10:00.007-04:00

Dr.Shruti Bhat, Leader Pharmaceutical R&D and Expert in hiTech formulation development for over 35 different therapeutic class of drugs moieties, brings to you some highlights from current pharma and clinical business news, views and data.

"Two drug makers with sometimes stormy pasts, Biovail and Valeant Pharmaceuticals International, said Monday that they had agreed to merge in a $3.2 billion deal." The new company "will retain the Valeant name," and "will focus on four areas, including treatments for the skin and for neurology, and is expected to have more than $175 million in savings by the second year."

Up "to 20 percent of the workers of the combined company will lose their jobs." The AP also adds that Biovail's "most advanced" drug "is Staccato loxapine, which is designed to treat agitation in patients with schizophrenia and bipolar disorder. The Food and Drug Administration is scheduled to make a ruling on the drug in the fall."

The new company, which will be based in Mississauga, Ontario, also will focus on specialty drugs for the central nervous system and dermatology, in addition to branded generics in Canada and in emerging markets. Biovail CEO Bill Wells told that the deal solidified the company's position in specialty neurology, adding, "We've achieved with this deal what I only hoped we'd be able to do in 10 years."

References-
http://www.nytimes.com/2010/06/22/business/22drug.html?src=busln
http://www.forbes.com/feeds/ap/2010/06/21/business-health-care-providers-us-biovail-valeant_7706755.html
http://www.bloomberg.com/news/2010-06-21/valeant-pharma-canada-s-biovail-corp-agree-to-merge-in-stock-transaction.html
http://online.wsj.com/article/BT-CO-20100621-709413.html?mod=WSJ_World_MIDDLEHeadlinesAmericas

Rosiglitazone, Metformin Low-Dose Combination May Reduce Progression To Type 2 Diabetes.

2010-06-16T21:57:00.002-04:00

Dr.Shruti Bhat, Leader Pharmaceutical R&D and Expert in hiTech formulation development for over 35 different therapeutic class of drugs moeities, brings to you some highlights from current pharma and clinical research news, views and data.

Presented below are updates in Pharmaceutical and clinical research-

Teva Announces Positive Results from a Study Assessing a New Formulation of Copaxone(R). Significantly less pain and fewer injection site reactions were reported by patients receiving the new lower volume injection.
Teva Pharmaceutical Industries Ltd. announced positive results from a study assessing a new lower-volume injection of Copaxone(R) (glatiramer acetate) containing the currently approved dose in half the injection volume.

The SONG study ('Study of New Glatiramer Acetate Formulation') explored the safety and tolerability of a 20mg/0.5mL injection of Copaxone(R) versus the current formulation of 20 mg/1.0mL. These findings were presented at the 24th Annual meeting of the Consortium of Multiple Sclerosis Centers (CMSC) in San Antonio, Texas.

"Copaxone(R) has proven long-term efficacy, safety and tolerability with more than one million patient years of treatment," said Dr. Ronald Murray, FAAN, a lead study investigator and Director of the MS Clinic of Colorado. "We are encouraged by these data as they suggest that a 0.5mL dose of glatiramer acetate may enhance patients' experience with the most frequently prescribed MS therapy."

http://www.marketwatch.com/story/teva-announces-positive-results-from-a-study-assessing-a-new-formulation-of-copaxoner-2010-06-04?reflink=MW_news_stmp

Starpharma Plans Effectiveness Studies On Herpes-Killing Gel For Women.
Bloomberg News reported, "The world's first herpes-killing vaginal gel may go on sale within two years, said its developer Starpharma Holdings Ltd., which plans to start patient studies on its effectiveness." Starpharma CEO Jackie Fairley said her company is discussing the trials of VivaGel with "a number of groups," noting that it's the only microbicide designed to stop herpes from spreading. The company also "plans to study the product's effectiveness against bacterial vaginosis, the most common vaginal infection in women of childbearing age, later this year, it said" in March.
http://www.bloomberg.com/apps/news?pid=20601202&sid=aqEEau5hBC6Q

Bevacizumab May Improve Some Outcomes In Advanced Gastric Cancers.
MedPage Today reported that "bevacizumab (Avastin) may improve some outcomes in advanced gastric cancers, but it did not benefit overall survival, according to a major international clinical trial reported" at the American Society of Clinical Oncology annual meeting. Researchers found, "in the phase III AVAGAST clinical trial, conducted among more than 770 patients," that "adding the monoclonal antibody bevacizumab to standard chemotherapy tended to be associated with a 13% reduction in risk of death from any cause, but the two-month survival advantage was not significant compared with chemotherapy alone." But, "bevacizumab produced significant benefits in progression-free survival and response rates," the researchers reported.
http://www.medpagetoday.com/MeetingCoverage/ASCO/20582

Erlotinib May Prolong Survival In Older Women With Advanced Non-Small Cell Lung Cancer.
MedPage Today reported that "the targeted agent erlotinib (Tarceva) prolonged survival by 26% in older women with advanced non-small cell lung cancer, but did not benefit men with the disease," according to research presented at the American Society of Clinical Oncology annual meeting. Investigators found, "in the randomized clinical trial, conducted among 670 patients (median age 77)," that "erlotinib also markedly extended the time before relapse in women." However, "men in the study saw no benefit either in overall survival or progression-free survival."
http://www.medpagetoday.com/MeetingCoverage/ASCO/20581

Mapatumumab Fails In Midstage Study.
"Human Genome Sciences's potential cancer drug mapatumumab failed in a midstage study. The company found "no difference in disease response or progression-free survival rates between patients receiving the drug for multiple myeloma and the control group. The drug was studied in combination with bortezomib for the study.
http://www.forbes.com/feeds/ap/2010/06/09/business-health-care-us-human-genome-sciences-study_7672784.html
http://www.reuters.com/article/idUSSGE6580FL20100609

Rosiglitazone, Metformin Low-Dose Combination May Reduce Progression To Type 2 Diabetes.
The Los Angeles Times reported, "A combination of low doses of the diabetes drugs Avandia [rosiglitazone] and metformin can reduce the progression to type 2 diabetes by two-thirds in people who are at high risk of developing the disease," according to a study published online in The Lancet. In fact, "the benefit is greater than with either of the drugs used alone, and the combination has fewer side effects." For the study, researchers at the University of Toronto "enrolled 207 patients with impaired glucose tolerance, randomly assigning half to take the combination and half to take a placebo," then followed them for almost four years.

HealthDay reported that not only did the study find "that the risk of developing type 2 diabetes was reduced by two-thirds in those taking the drug combo compared to those on placebo," but also that "using half of the maximum dose was extremely effective for preventing type 2 diabetes." Moreover, "the drug combination appeared to counteract the weight gain that's common with Avandia therapy alone," and with relatively few side effects.

"The dosages used in the study were 2 milligrams of Avandia plus 500 milligrams of metformin. There is no evidence whatsoever that lower doses of [Avandia] are 'safe’. Any suggestion that serious cardiovascular toxicity can be avoided by using a small dose represents pure speculation at best." According to MedPage Today , an accompanying editorial also "cautioned that the 'larger issues that have cast doubt on use of drugs to prevent diabetes are not addressed by the'" study.

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