FDAnews Drug Daily Bulletin

French drugmaker sanofi-aventis is facing yet another patent challenge -- this time in Europe -- to its top-selling antistroke drug Plavix.

Barr has elected to withdraw its pending abbreviated new drug application (ANDA) from the FDA for a generic version of Wyeth's Premarin, after a federal appeals court ruled that Barr's development partner misappropriated information from Wyeth.

The Good Automated Manufacturing Practice (GAMP) Forum, a division of the International Society for Pharmaceutical Engineering (ISPE), will release its "GAMP Good Practice Guide: Risk Management Approach to Electronic Records and Signatures," on Feb. 18 at an ISPE conference in Tampa, Fla.

The FDA has granted its first tentative approval for an HIV drug regimen manufactured by a generic pharmaceutical company outside of the U.S., the agency said.

Meridian Bioscience has completed the acquisition of all of the outstanding capital stock of O.E.M. Concepts for $6 million in cash and a performance based earnout opportunity over four years of $2.3 million.

ActivX Biosciences, a biotechnology company developing advanced proteomic technologies for drug discovery and development, has announced the formal completion of its acquisition by Tokyo-based Kyorin Pharmaceutical.

Pfizer and Schering AG have signed a license agreement granting Pfizer a worldwide license to Schering AG's ADP receptor antagonist program.

Northwest Biotherapeutics said in an SEC filing that KPMG LLP has resigned as Northwest's independent auditor because the company has no audit committee.

As new technologies are innovated in the pharmaceutical and biotechnology sectors, the number of fresh patents and related regulations is also on the rise.

Biotechnology firm Protein Design Labs has said it increased the price it will pay for ESP Pharma after the Edison, N.J.-based drugmaker acquired rights to a heart attack treatment.

Gov. Christine Gregoire, in her first major initiative to boost Washington's economy, is pushing to create a $350 million Life Sciences Discovery Fund to bankroll biomedical research in the state.

Valeant Pharmaceuticals has signed a definitive agreement to acquire Xcel Pharmaceuticals, a privately held specialty pharmaceutical company focused on neurology products in the U.S.

The health department will on March 15 argue that the Constitutional Court should hear its appeal against a Supreme Court of Appeals ruling scrapping government's controversial medicine pricing regulations because the lower court did not have jurisdiction to decide on the matter.