FDAnews Drug Daily Bulletin

The Justice Department is investigating GlaxoSmithKline's (GSK) use of nominal pricing arrangements to determine whether the pricing strategy violates Medicaid price-reporting rules.

The FDA has issued a warning letter to custom chemical company DanChem for failing to meet current good manufacturing practices (cGMPs) in its production of active pharmaceutical ingredients (APIs).

Biovail Laboratories has filed a lawsuit in federal court against generic firm Impax over its bid to launch a generic version of Biovail's Wellbutrin XL, an antidepressant marketed by GlaxoSmithKline.

Former HHS Secretary Tommy Thompson has accepted two positions in the private sector - one with law firm Akin Gump Strauss and another with consulting firm Deloitte & Touche, the companies recently announced.

Sigma-Aldrich Corp. will serve as a scientific collaborator and distribution partner of the RNAi Consortium under an agreement with the Massachusetts Institute of Technology.

Sonus Pharmaceuticals said it has backed out of a proposal to buy Synt:em SA, a French drug discovery and development company.

Geneva Pharmaceuticals, which changed its name to Sandoz in 2003, and Abbott Laboratories have settled a lawsuit with the attorneys general of Colorado, Florida and Kansas, the Colorado Attorney General's office said Monday.

KaloBios Pharmaceuticals, a privately-held emerging therapeutic antibody company, announced the completion of its Series B financing round of $20 million.

Predix Pharmaceuticals Holdings Inc., a drug discovery and development company, and Cystic Fibrosis Foundation Therapeutics (CFFT), the drug discovery and development affiliate of the Cystic Fibrosis Foundation, announced that they have signed a research, development and commercialization agreement.

Novavax, a specialty biopharmaceutical company, and Ranbaxy Laboratories, have entered into an agreement to evaluate a new transdermal product (this is a new product and is not related to ESTRASORB).

Cyclacel Group, the cell cycle-based biopharmaceutical company, announced execution of a research collaboration agreement with ALTANA Pharma AG, the pharmaceutical division of ALTANA AG, in which Cyclacel will use its expertise in mitosis or cell division to identify the molecular targets of specific ALTANA Pharma experimental drugs.

OncoGenex Technologies and Isis Pharmaceuticals announced they have broadened their antisense drug development partnership to allow for the development of two additional second-generation antisense anticancer drug candidates.