FDAnews Drug Daily Bulletin

The final model guidelines for Medicare drug formularies represent a practical compromise that is focused on the needs of patients and practitioners, according to the head of U.S. Pharmacopeia (USP), which recently released the guidelines.

Pfizer was hit with another federal securities class action lawsuit for actions related to its painkiller Celebrex, which last month was linked to a federal study that showed the drug might cause adverse cardiovascular side effects.

Andrx is pursuing a corporate realignment that will involve the divestiture of its brand pharmaceutical operations, the company announced.

The FDA's Division of Drug Marketing, Advertising and Communications (DDMAC) has sent an untitled letter to Barr Pharmaceuticals informing the company it has conducted false and misleading advertising for Seasonale tablets, a daily birth control pill the company claims will help limit women's periods to just four a year.

Genzyme has completed the transaction to buy back the sales and marketing rights to Synvisc (hylan G-F 20) in the U.S. and five European countries from Wyeth. The cash transaction is accretive to Genzyme.

Canadian biotech company AEterna Zentaris is entering the U.S. market with its acquisition of Echelon Biosciences, a privately held company based in Salt Lake City, Utah, for up to $5.6 million.

GenData has announced a collaborative sponsored research and exclusive license agreement with Amgen for the discovery, development and commercialization of therapeutics and diagnostics aimed at an undisclosed disorder.

Nexia Biotechnologies has struck a deal to sell its lead product to a subsidiary of Maryland-based PharmAthene for cash and shares.

Schatz & Nobel has filed a lawsuit seeking class action against AtheroGenics alleging the company violated federal securities laws by issuing false or misleading public statements.

Paradigm Therapeutics has completed the acquisition of Amedis Pharmaceuticals, a medicinal chemistry and drug discovery company.

Albany Molecular Research has entered into a two-year research collaboration with Alcon Research to discover and develop ophthalmic pharmaceuticals.

Ligand Pharmaceuticals exercised the first option to buy down a portion of the royalties payable to Eli Lilly on sales of Ligand's U.S. marketed cancer drug, Ontak.

Nitto Denko and Nitto Denko Technical, a dedicated R&D facility in Oceanside, Calif., have announced development of a high-performance cross-linked polystyrene bead which can support a high-grade, high-yield synthesis of oligonucleotides, essential to DNA and RNA-based gene therapies, and provide solid support for the synthesis of antisense drugs.