FDAnews Drug Daily Bulletin

A federal district court judge has approved an amendment to the National Diet Drug Settlement, moving Wyeth one step closer to settling with the largest group of plaintiffs involved in a class action lawsuit over the company's fen-phen products.

lack of leadership combined with increasing pressure to approve new drugs quickly and the Bush administration's antiregulatory philosophy has left the FDA "timid and toothless," according to an editorial in The New England Journal of Medicine (NEJM).

India's continued emergence as one of the world's leading drug-manufacturing centers may be causing some U.S. firms to look over their shoulders, but Indian drugmakers say their goal is to partner with their American counterparts, not compete with them.

U.S. pharmaceutical companies looking to lower drug-development costs by contracting with Chinese drugmakers for active pharmaceutical ingredients (APIs) need to do so carefully, according to an industry expert, who warned that such partnerships are not always cost-effective.

Demegen, Inc., a biotechnology company specializing in the development of peptides for the treatment of infectious diseases, announced it had granted a license to Pacgen Biopharmaceuticals Corporation for certain Demegen peptides for prescription and over-the-counter pharmaceutical products to treat oral diseases.

Pharmacopeia Drug Discovery announced that the company has entered into a drug discovery and development collaboration with CV Therapeutics.

Curis has announced that it has achieved a development milestone in collaboration with one of its corporate partners, Wyeth Pharmaceuticals, a division of Wyeth.

Adherex Technologies said that it will employ the services of another Triangle drug company, Scynexis, as it tries to develop a way to administer drugs orally.

Cubist Pharmaceuticals announced that it has completed the issuance of $20 million worth of Cubist common stock to Eli Lilly and Company in connection with the previously announced royalty buy down transaction.

The U.S. federal pharmaceuticals regulator has taken a significant step toward the development of so-called personalized medicine, in which drugs would be tailored to individuals based on their genetic profiles.

Colorado, Florida and Kansas have settled a lawsuit against Sandoz Pharmaceuticals and Abbott Laboratories of Illinois.

Angiotech Pharmaceuticals said it has entered into an exclusive license agreement with CABG Medical to use the Canadian company's paclitaxel drug technology with coronary bypass surgery.