FDAnews Drug Daily Bulletin

U.S. drug industry representatives are applauding the approval of strict new patent rules in India, but the action has been met with mixed reactions elsewhere, including from international advocacy groups and within India's own drug industry.

PhRMA member companies invested a record $38.8 billion in pharmaceutical R&D in 2004, an increase of nearly 13 percent from the previous year, according to the association's annual membership survey.

The FDA's Division of Drug Marketing, Advertising, and Communications (DDMAC) has cited Boehringer Ingelheim Pharmaceuticals for running a journal advertisement containing unsubstantiated superiority claims about its stroke drug Aggrenox.

Sanofi-aventis has fended off the first of several patent challenges against its blockbuster stroke medication Plavix, winning a patent suit in Canada, the company said.

Baxter Healthcare Corporation and Cangene Corporation announced that, effective immediately, Baxter has assumed exclusive rights to market and distribute Cangene's WinRho SDF [Rho(D) Immune Globulin Intravenous (Human)] in the United States. WinRho SDF is used to treat a critical bleeding disorder called immune thrombocytopenic purpura (ITP).

Maxygen announced that it has earned a significant milestone in its collaboration with Roche to develop improved interferon alpha protein therapeutics to treat hepatitis C virus (HCV) and hepatitis B virus (HBV) infections.

Hokuyaku announced that the company has mutually entered into a business alliance with six drug distributors.

Organic Soils.com announced that it has signed a definitive agreement to acquire all of the issued and outstanding common stock of Inhibetex Therapeutics, Inc. (Inhibetex) in a tax-free exchange.

Agennix, a closely held developer of protein and peptide-based drugs, announced completion of private placement financing of $22 million.

La Jolla Pharmaceutical said it plans to cut its work force by about 40 percent, to a staff of 95, in order to cut costs.

Cephalon completed the move of its corporate headquarters to Frazer, Pa., from West Chester, Pa., on Tuesday.

In an environment where big drug companies are furiously courting biotechnology companies for licensing deals, Ron Cohen is a hot date.