Biotechnology news

Novavax, Inc. (Nasdaq: NVAX) announced that enrollment has been completed in the first stage of a two-stage clinical study of its novel 2009 H1N1 virus-like-particle (VLP) pandemic influenza unadjuvanted vaccine in the country of Mexico.

Spherix Incorporated (NASDAQ CM: SPEX), an innovator in biotechnology for diabetes therapy, and a provider of technical and regulatory consulting services to food, supplement, biotechnology and pharmaceutical companies, announced positive interim Phase 3 clinical results for the planned review of the NEET (Naturlose (D-tagatose) Efficacy Evaluation Trial) trial of D-tagatose in drug naïve patient

Poniard Pharmaceuticals, Inc. (Nasdaq: PARD) announced that its pivotal Phase 3 SPEAR (Study of Picoplatin Efficacy After Relapse) trial of picoplatin in the second-line treatment of small cell lung cancer (SCLC) did not meet its primary endpoint of overall survival. The analysis, based on 320 evaluable events (patient deaths), showed a hazard ratio of 0.82 with a p value of 0.089.

Half Done On Health Reform The Washington Post Unless you find more realistic ways of paying for the promises included in the bill, you are simply setting up the public for more frustration -- and yourselves for a political backlash (David Broder, 11/13).

Cadence Pharmaceuticals, Inc. (Nasdaq: CADX) announced that the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) goal date for its Priority Review of the New Drug Application (NDA) for intravenous (IV) acetaminophen by three months. The extended PDUFA goal date is February 12, 2010.

Cadence Pharmaceuticals, Inc. (Nasdaq: CADX) announced that the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) goal date for its Priority Review of the New Drug Application (NDA) for intravenous (IV) acetaminophen by three months. The extended PDUFA goal date is February 12, 2010.

Esperion Therapeutics, a privately held biotechnology company working to discover, develop and commercialize treatments for cardiovascular and metabolic diseases, announced that the company has initiated a Phase I clinical study for ETC-1002, the company's novel small molecule compound designed to beneficially regulate the levels of plasma lipids and lipoproteins.

Getting regulatory agency approval for a new drug was once the end goal of pharmaceutical drug development, but in today's healthcare environment where governments increasingly determine price and the availability of drugs to patients through formulary designation, market access has become the "fourth hurdle" in successfully bringing a drug to market.

Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) announced that the company's investigational new drug, LX1031, a tryptophan hydroxylase (TPH) inhibitor, demonstrated positive results in clinically important parameters for the treatment of non-constipating irritable bowel syndrome (IBS).

Cequent Pharmaceuticals, a pioneer in the development of novel products to deliver RNAi-based treatments to prevent and treat human disease, has announced that it has filed its first IND (investigational new drug) application with the U.S. Food and Drug Administration (FDA).