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European CHMP recommends marketing approval for Sanofi-aventis' Multaq

Sanofi-aventis announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) has adopted a positive opinion recommending to grant a marketing authorization in the European Union for Multaq(R) (dronedarone - 400mg Tablets).

26 Sep 2009

Teva to market generic version of AstraZeneca's antipsychotic agent Seroquel tablets

Teva Pharmaceutical Industries Ltd. announced today that the U.S. Court of Appeals for the Federal Circuit has affirmed a July 1, 2008 decision by the District Court to grant AstraZeneca’s motion for summary judgment of no inequitable conduct related to U.S. Patent No. 4,879,288.

26 Sep 2009

GenVec to receive $2.3M from NIAID for HIV vaccine candidate production

GenVec, Inc. announced today that the National Institute of Allergy and Infectious Disease (NIAID), part of the National Institutes of Health (NIH), has executed its third option period (year four) under a previously announced, five-year contract with GenVec valued at up to $52 million for the production of HIV vaccines.

26 Sep 2009

Stelara approved by the FDA for treating psoriasis

The U.S. Food and Drug Administration today approved Stelara (ustekinumab), a biologic product for adults who have a moderate to severe form of psoriasis.

25 Sep 2009

WHO lowers expectation of H1N1 vaccine output, appeals for donations to fight pandemic

International drug makers are expected to produce three billion doses of the H1N1 (swine flu) vaccine, "enough for just under half the world's population," a WHO official said Thursday, Canwest News Service/Ottawa Citizen reports. "The agency was hoping pharmaceutical companies would be able to make about five billion doses a year, but data collected over the summer led to the revised estimate," the news service writes (Fitzpatrick, 9/24).

25 Sep 2009

Folotyn approved for the treatment of Peripheral T-Cell Lymphoma

The U.S. Food and Drug Administration has approved Folotyn (pralatrexate), the first treatment for a form of cancer known as Peripheral T-cell Lymphoma (PTCL), an often aggressive type of non-Hodgkins lymphoma.

25 Sep 2009

Health officials anticipate 6 million H1N1 vaccine doses by early October

U.S. health officials announced Thursday that "[m]ore than six million doses of swine flu vaccine will be available by the first week in October, more that twice as many as had been recently expected," The New York Times reports.

25 Sep 2009

Investigational New Drug application for Uricase-PEG 20 approved

EnzymeRx, LLC, a clinical-stage biotechnology company, announced that its Investigational New Drug (IND) application for Uricase-PEG 20, filed with the U.S. Food and Drug Administration (FDA) last month, has become effective.

25 Sep 2009

Wound Management Technologies inks marketing agreement with Pharma Technology International

Wound Management Technologies, Inc., (OTC Bulletin Board: WNDM) a rapidly growing provider of specialty medical products, announced today an agreement with Pharma Technology International, LLC (Pharma Tech) to market, distribute and sell the company's wound care products in the Middle East. Pharma Tech is a joint venture between A&Z Pharmaceutical and BioPharma Management Technologies, Inc., a company recently acquired by Wound Management Technologies.

25 Sep 2009

Phase III PLATO study proves that ticagrelor is more effective than clopidogrel

New data from the phase III PLATO study showed that ticagrelor (BRILINTA((TM))) provided greater reduction of cardiovascular (CV) events (composite of CV death, heart attack and stroke) than clopidogrel (9.02% vs. 10.65%,>

25 Sep 2009

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