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Pfizer provides update on Prevnar 13

Pfizer Inc. announced today that the U.S. Food and Drug Administration (FDA) has not yet completed its review of the Biologics License Application (BLA) for Prevnar 13™, (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]), the Company’s candidate 13-valent pneumococcal conjugate vaccine.

31 Dec 2009

Research suggests high-dose Vitamin E supplements may do more harm than good

Vitamin-fortified foods and dietary health supplements can ease health worries. But what kinds of vitamins are right for you? And how much of them should you take, and how often?

31 Dec 2009

CVS Caremark to provide H1N1 flu vaccinations at selected locations

CVS Caremark announced today that it will provide H1N1 flu vaccinations at select CVS/pharmacy locations in the States of Alabama, Illinois, Kansas, Missouri, Pennsylvania and New York as well at MinuteClinic locations in Massachusetts and Connecticut beginning Thursday, December 31.

30 Dec 2009

FDA accepts NDA review for new anticonvulsant drug

The U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) seeking marketing approval for Retigabine. In addition, the European Medicines Agency (EMEA) confirmed on November 17, 2009 that the MAA (Marketing Authorization Application) was successfully validated thus enabling the MAA review to commence.

30 Dec 2009

Biodel submits NDA to FDA for clearance to market VIAject

Biodel, Inc. announced today that it has submitted a new drug application (NDA) to the U.S. Food and Drug Administration for clearance to market VIAject® as a treatment for diabetes.

30 Dec 2009

J&JPRD receives FDA Complete Response Letter for ceftobiprole

Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD) today announced it received a Complete Response letter from the U.S. Food and Drug Administration (FDA) for ceftobiprole. The New Drug Application (NDA) was originally submitted to the FDA in May 2007 for the treatment of complicated skin and skin structure infections (cSSSI), including diabetic foot infections.

30 Dec 2009

Meda expands collaboration with Etypharm for Axorid

Meda expands the collaboration with the French development company Etypharm for the patented product Axorid. New territories, such as East Europe with Russia and Turkey, are now included in the collaboration. Previously, Meda held commercialization rights in Central and West Europe.

30 Dec 2009

Liraglutide FDA feedback expected within weeks, says Novo Nordisk

Novo Nordisk today announced that formal feedback from the United States Food and Drug Administration (FDA) regarding liraglutide, a once-daily human GLP-1 analogue, is expected within weeks.

30 Dec 2009

Significant limitations in new Ginkgo biloba study published in JAMA, says ABC

New research findings published this week on a standardized Ginkgo biloba extract are very limited and the public should focus on the well-documented cognitive and cardiovascular benefits of ginkgo, said the American Botanical Council (ABC), an independent nonprofit research and education organization.

30 Dec 2009

CRN stands by Ginkgo biloba's effectiveness in improving cognitive function

"It is important to put this study into context and to remember that there is a large body of previously published evidence, which suggests that Ginkgo biloba may help improve cognitive impairment in older adults. There are also additional ongoing clinical trials, the results of which may address some of the limitations of the current study. The results of this single study add to the overall data on Ginkgo biloba, including valuable evidence in support of Ginkgo's safety profile, but should not be viewed as the final word.

30 Dec 2009

Ginkgo biloba does not slow rate of cognitive decline in older adults

Older adults who used the herbal supplement Ginkgo biloba for several years did not have a slower rate of cognitive decline compared to adults who received placebo, according to a study in the December 23/30 issue of JAMA.

30 Dec 2009

Pharmacists can reduce treatment costs and improve outcomes if given the chance

The role of pharmacists hasn't received much attention in the debate on the cost of health care. But national and regional studies show that when pharmacists directly participate in patient care, they significantly reduce treatment costs and improve outcomes.

30 Dec 2009

U.S. PTO grants reissue patent concerning OSI Pharmaceuticals’ Tarceva

OSI Pharmaceuticals, Inc. today announced that the U.S. Patent & Trademark Office (PTO) has granted reissue patent RE41,065, replacing Tarceva’s® (erlotinib) composition of matter patent (formerly No.5,747,498). The Company had applied for the reissue patent in February 2008, and on September 17, 2009 the Company had announced that the PTO had issued a “Notice of Allowance” accepting the Company’s application to correct certain errors relating to the claiming of compounds, other than Tarceva, which had fallen outside of the scope of the main claim of the patent.

30 Dec 2009

Projects investigating placebo effects in Parkinson's disease receive funds

The Michael J. Fox Foundation for Parkinson's Research announced funding for two projects investigating the placebo effect in Parkinson's disease.

30 Dec 2009

FDA impersonators threaten and extort victims who purchase drugs over the Internet

The U.S. Food and Drug Administration is warning the public about criminals posing as FDA special agents and other law enforcement personnel as part of an international extortion scam.

30 Dec 2009

Walgreens offers H1N1 vaccinations at all of its pharmacies throughout Massachusetts

Walgreens, the nation’s largest drugstore chain and industry leader with more than 17,000 certified or licensed immunizers, is now offering H1N1 vaccinations at all of its pharmacies throughout Massachusetts.

30 Dec 2009

VIVUS submits a NDA to the FDA for obesity drug Qnexa

VIVUS, Inc., a biopharmaceutical company developing innovative, next-generation medical therapies to address unmet needs in obesity, diabetes and sexual health, announced today that a New Drug Application (NDA) has been submitted to the U.S. Food and Drug Administration (FDA) seeking approval of Qnexa, its investigational drug for the treatment of obesity, including weight loss and maintenance of weight loss, in patients who are obese or overweight with co-morbidities such as hypertension, type 2 diabetes, dyslipidemia or central adiposity.

30 Dec 2009

Xin Aoxing Oleanolic Acid Capsules for treatment of Hepatitis B to be launched

Biostar Pharmaceuticals, Inc. ("Biostar" or "the Company"), a Xianyang-based developer, manufacturer and supplier of pharmaceutical products and medical nutrients addressing a variety of diseases and conditions, today announced it has completed preparation to launch its flagship Xin Aoxing Oleanolic Acid ("Xin Aoxing") Capsules for the treatment of Hepatitis B in Beijing and Shanghai in early January 2010.

29 Dec 2009

H1N1 vaccine currently available at all seven Target Clinic locations in Maryland

Target® announces today that the H1N1 vaccine is currently available at all seven Target Clinic locations in Maryland, while supplies last.

29 Dec 2009

Results from Bionovo's study on BN107 published

Bionovo, Inc. announced today the publication of results from its study on the anti-tumor mechanism of BN107. The results of the study, published in the International Journal of Cancer, describe the potential molecular mechanisms mediating the selective pro-apoptotic (cell death) effect induced by BN107 on estrogen receptor negative (ER-) breast cancer cells.

29 Dec 2009