FDAnews Drug Daily Bulletin

The FDA has issued a warning letter to Lincare and its subsidiary, Reliant Pharmacy Services, informing them that their practice of manufacturing compounded drug products is in violation of the Compliance Policy Guide (CPG) of the Federal Food, Drug, and Cosmetic Act (FDCA).

Pharmaceutical executives are among the featured speakers at a series of upcoming town hall meetings on proposals to reform the U.S. patent system, including legislation that would allow firms to challenge the validity of patents at their issuance rather than in the courts.

The FDA has reopened the docket on the agency's premarket notification program for new dietary ingredients (NDIs) after receiving requests from trade associations representing dietary supplement makers.

A federal court has blocked a provision in a Washington, D.C., prescription drug law that would have imposed fiduciary duties on pharmaceutical benefit managers (PBMs) and required them to disclose proprietary financial information negotiated with drugmakers.

Noven Pharmaceuticals has earned a $3 million success fee for attaining a development milestone under its development collaboration with P&G Pharmaceuticals, a subsidiary of The Procter & Gamble Company.

Alnylam Pharmaceuticals, a leading therapeutic RNA interference (RNAi) company, has received a $7 million milestone payment from Merck in connection with the September 2003 strategic collaboration between the two companies to develop RNAi technology and therapeutics.

Bayer AG, the maker of Alka-Seltzer stomach remedies and inventor of aspirin, has completed its purchase of Roche Holding AG's non-prescription health-care unit for 3.6 billion Swiss francs ($3.1 billion.) European antitrust regulators approved Bayer's acquisition after the German drug company agreed to divest or license three pharmaceuticals in two countries.

Norak Biosciences has changed its corporate identity to Xsira Pharmaceuticals, effective immediately.

Shire Pharmaceuticals Group said it signed an agreement to globally develop and commercialize a new attention-deficit/hyperactivity disorder (ADHD) compound from New River Pharmaceuticals.

Genelabs Technologies has received a $1.25 million license payment from Affymetrix.

Ness Technologies, a global provider of information technology services, has been engaged by Wockhardt Pharmaceuticals of Mumbai, India to install, configure, customize, host and support Wockhardt Pharmaceuticals' U.S.-based financial IT infrastructure, including all financial modules, electronic data interchange, and interfaces to Wockhardt Pharmaceuticals' contract and procurement management systems.

While the Union Government issued Patents Ordinance fulfilling obligations and commitments under the TRIPS Agreement, which has opened the product patent regime in pharmaceuticals, food and agro-chemicals, the country's pharmaceutical industry including large, medium and small sectors is disappointed to find that some crucial points have either been left out or have been treated in a half hearted manner in the Ordinance.