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Vertex Pharmaceuticals to present SVR data at the 60th Annual Meeting of the American Association

Vertex Pharmaceuticals Incorporated today announced that sustained virologic response (SVR) data from Study C208, which evaluated twice-daily dosing of Vertex’s investigational hepatitis C virus (HCV) protease inhibitor telaprevir, will be presented in an oral presidential plenary session at the 60th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) taking place Oct. 30 – Nov. 3, 2009 in Boston.

25 Sep 2009

ACP releases paper promoting increased funding for FDA

A new policy paper that calls for broader authority and increased funding for the Food and Drug Administration (FDA) was released today by the American College of Physicians (ACP). Improving FDA Regulation of Prescription Drugs offers a half-dozen recommendations about how to improve the agency's ability to approve and monitor new drugs.

25 Sep 2009

Phase III clinical trial of investigational HIV vaccine regimen complete

Global Solutions for Infectious Diseases (“GSID”) announced today that a Phase III clinical trial of an investigational HIV vaccine regimen has been shown to be safe and modestly effective in preventing HIV infection. The double-blind, placebo controlled study was conducted in Thailand among more than 16,000 volunteers.

25 Sep 2009

Qrxpharma forms an alliance with Liaoning Nuokang Medicines to commercialise its venomics assets

QRxPharma Limited,announced today a strategic alliance with Liaoning Nuokang Medicines Co. Ltd. ("Nuokang"), a Chinese biopharmaceutical company based in Shenyang, China, to develop and commercialise QRxPharma's venomics assets for the Chinese market.

25 Sep 2009

Seasonal and H1N1 flu vaccines from Priority Health

Priority Health has announced its coverage of both the seasonal flu and H1N1 flu vaccines. “Preventing the flu through immunization is the best way to keep yourself and your family healthy,” said John Fox, M.D., associate vice president of Medical Affairs at Priority Health. “We encourage our members to receive both vaccines to protect themselves against the two viruses.”

25 Sep 2009

Research study supports reovirus and cisplatin combination for cancer treatment

Oncolytics Biotech Inc. ('Oncolytics') reported today that research led by Prof. Hardev Pandha of the Royal Surrey County Hospital, U.K., was published September 22, 2009 in the online version of Clinical Cancer Research.

25 Sep 2009

Fomepizole Injection launched by Bioniche Pharma

Bioniche Pharma, a leading developer and manufacturer of injectable pharmaceuticals, and Synerx Pharma, LLC, announced today the launch of Fomepizole Injection, the generic equivalent of Antizol(R) from Paladin Labs, Inc.

25 Sep 2009

NDA submitted to the FDA for new osteoarthritis drug

NicOx S.A. today announced that a New Drug Application (NDA) for naproxcinod has been submitted to the United States Food and Drug Administration (FDA), seeking approval for an indication for the relief of the signs and symptoms of osteoarthritis (OA). The NDA file contains data from three large pivotal phase 3 studies, all of which met their co-primary efficacy endpoints. NicOx plans to submit a Marketing Authorization Application (MAA) for naproxcinod to the European Medicines Agency (EMEA) in Q4 2009.

25 Sep 2009

FDA grants priority review for Cephalon's sNDA

Cephalon, Inc. today announced the U.S. Food and Drug Administration (FDA) has granted a priority review for its supplemental New Drug Application (sNDA) for NUVIGIL(R) (armodafinil) Tablets [C-IV], which was filed in June of this year.

25 Sep 2009

Investigational vaccine shows modest potential for protecting against HIV infection

For the first time, scientists say an investigational vaccine has modest potential for protecting people against HIV infection, the Associated Press reports. "The vaccine — a combination of two previously unsuccessful vaccines — cut the risk of becoming infected with HIV by ... 31 percent in the world's largest [HIV] vaccine trial of more than 16,000 volunteers in Thailand, researchers announced Thursday in Bangkok," the news service writes (Marchione/Casey, 9/24).

25 Sep 2009

Combination drug to limit the dangerous side effects of morphine

University of Michigan scientists have developed a combination drug that promises a safer, more precise way for medics and fellow soldiers in battle situations to give a fallen soldier both morphine and a drug that limits morphine's dangerous side effects.

25 Sep 2009

Drug Discovery and Development to focus on pharmaceutical trends

NanoViricides, Inc., announced today that the Company’s CEO, Eugene Seymour, MD, MPH has been invited as a panelist at the 2nd Annual Livingston Healthcare Summit on September 24th, 2009 in New York City.

24 Sep 2009

Patents listed in FDA's Orange Book for Eli Lilly’s Evista invalidated

Teva Pharmaceutical Industries Ltd. announced today that the U.S. District Court for the Southern District of Indiana has issued a decision invalidating two patents listed in the FDA’s Orange Book for Eli Lilly’s Evista® (raloxifene hydrochloride) Tablets in litigation concerning Teva’s abbreviated new drug application to market a generic version. The court found these patents to be invalid for lack of written description.

24 Sep 2009

Rio Grande Dermatology offers eyelash drugs for $99

Many women desire to have thicker and longer eyelashes. Previously this could only be accomplished with the use of fake lashes. However, due to the discovery of a desirable side effect of a glaucoma drug, Latisse was born. Rio Grande Dermatology, providers of comprehensive dermatology treatments for the Albuquerque metropolitan area, is proud to offer this highly anticipated "eyelash drug" for an introductory price of $99 dollars.

24 Sep 2009

Flood-affected customers in Georgia can obtain early refills of their prescriptions

UnitedHealth Group and its family of companies are authorizing plan participants who are affected by the floods in Georgia and enrolled in its fully insured health plans and pharmacy benefit management (PBM) services to obtain early refills of their prescription medications. In addition, a free help line is available for people who are coping with the emotional consequences of the floods.

24 Sep 2009

Walgreens ensures that all its pharmacies can provide Tamiflu

Less than a month after launching the largest flu prevention initiative in the company’s 108-year history, Walgreens is taking proactive measures to ensure its nearly 7,000 pharmacies can provide the suspension - or liquid - form of seasonal flu-fighting drug Tamiflu this season. Following Tamiflu manufacturer Roche’s notification that Tamiflu Oral Suspension is in short supply, Walgreens pharmacies in all 50 states are prepared to compound Tamiflu capsules into the liquid form to produce an Oral Suspension prescription. Tamiflu capsules remain in adequate supply.

24 Sep 2009

Octapharma AG submits Biological License Application for its octagam(R) 10% to FDA

Octapharma AG recently submitted its Biological License Application for octagam(R) 10% (human normal intravenous immunoglobulin, liquid) to the U.S. Food and Drug Administration (FDA) with the goal of expanding the biopharmaceutical company's U.S. immune globulin therapy portfolio by early 2010. The application was submitted for the treatment of Idiopathic Thrombocytopenic Purpura (ITP), a blood-clotting disorder that can result in excessive bruising and bleeding.

24 Sep 2009

Biotech company Pharming Group receives confirmation of validation for Rhucin

Biotech company Pharming Group NV ("Pharming" or "the Company") today received confirmation of validation from EMEA of its Marketing Authorization Application (MAA) for Rhucin.

24 Sep 2009

Controlled release pills and capsules with dose dumping tendency should be tested

Controlled release pills and capsules that show a tendency in the standard laboratory test toward "dose dumping" - releasing their medicine in a faster and potentially unsafe manner in patients who have consumed alcohol - should be withheld from the market until proven safe with testing in people. That's the conclusion of a review of existing studies in the September-October issue of ACS' Molecular Pharmaceutics, a bi-monthly journal.

24 Sep 2009

PCMA releases statement regarding the Senate Finance Committee’s ongoing deliberations on health-care reform

“As the Senate Finance Committee continues to craft legislation, the next 48 hours will be critical in determining whether health reform delivers on the promise of making prescription drugs more affordable for all Americans. With nearly $245 billion spent annually on prescription drugs, Americans want the peace of mind that comes from knowing that reform makes common-sense improvements that lower the cost of prescriptions for everyone.

24 Sep 2009