FDAnews Drug Daily Bulletin

The FDA is encouraging drugmakers to voluntarily submit pharmacogenomic data as part of an initiative to speed the development of personalized therapies based on patients' genetic profiles, according to a new final guidance.

The FDA was able to shave a significant amount of time off the drug-approval process in 2004, despite approving 65 percent more new product applications than in 2003, according to new figures released by the agency.

The recent flood of negative news about drug safety concerns has hurt the image of drugmakers in the eyes of both consumers and physicians, but doctors also say media attention has been blown out of proportion, a new poll finds.

Onyx Pharmaceuticals and Bayer Pharmaceuticals plan to file a new drug application (NDA) for cancer drug candidate BAY 43-9006, based on the results of a Phase III study that showed the drug delayed the progress of the disease in patients with advanced kidney cancer, Onyx said.

Allergan has entered into an exclusive licensing agreement with Sanwa Kagaku Kenkyusho (Sanwa) to develop and commercialize POSURDEX for the ophthalmic specialty market in Japan.

Tanox has inked a deal with Miramar, Fla.-based Sunol Molecular Corp. to acquire Sunol's tissue factor antagonist program for $6 million and Tanox stock shares.

Tanabe Seiyaku announced that the company has decided to establish a production company as of October 1.

Seattle law firm Keller Rohrback LLP has filed a securities fraud case in U.S. District Court in Seattle against Cell Therapeutics Inc., a Seattle-based biotech company.

Glenmark Pharmaceuticals Ltd. said it will jointly develop and sell 12 generic drugs in the United States with Shasun Chemicals & Drugs Ltd.

Dainippon Pharmaceutical and Kowa announced that they have concluded an agreement on the upcoming transfer of Dainippon's over-the-counter (OTC) drug business to Kowa.

Klein-Becker USA, exclusive licensee of StriVectin-SD, the stretch-mark-cream-turned-anti-wrinkle-phenomenon, has filed suit against Home Shopping Network, (HSN), Flageoli and Serious Skin Care alleging they use false cost comparisons between a product called RuLinea-FX and StriVectin-SD.