FDAnews Drug Daily Bulletin

The FDA's inability to evolve and keep pace with the rapidly advancing pharmaceutical industry has left it with a wide array of problems, particularly on the drug safety front, asserts Eve Slater, former assistant secretary for health at HHS.

The safety of antistroke drug Plavix -- one of the world's top-selling brands -- was called into question recently following the release of new clinical research that shows the drug might cause a high rate of recurrent ulcers.

German drugmaker Boehringer Ingelheim doesn't anticipate that a recent FDA health advisory for its HIV drug Viramune will have a major impact on the drug's sales or distribution.

Pfizer's top executives have denied reports that the company's fourth quarter earnings report contained references to additional clinical data that could be used to argue that its Cox-2 inhibitor Celebrex poses heart risks.

Alexion Pharmaceuticals in Cheshire, Conn., has completed the sale of $150 million principal amount of convertible senior notes due 2012 to unnamed institutional buyers.

LAM Pharmaceutical, a biomedical company focused on the development and commercialization of novel wound healing and transdermal drug delivery systems, has received a second order for IPM Wound Gel from Sinopharm Group, a subsidiary of one of China's largest pharmaceutical companies.

GlaxoSmithKline has said that its long-running, multibillion-dollar tax dispute with the Internal Revenue Service just got bigger.

A federal judge in Newark, N.J., gave preliminary approval for a $36 million nationwide settlement in an antitrust case involving the antidepressant Remeron.

GenData Research, a population genetics and biomarker discovery research company, is changing the company name and identity to LineaGen Research.

Eli Lilly has reported a surprise loss of $2.4 million in the fourth quarter, caused not by operational difficulties but by a big tax bite on billions of dollars it's bringing home from overseas and by a $36 million settlement-in-the-making with the Justice Department over improper product marketing.

Martek Biosciences has received $81.4 million in net proceeds from its recent stock offering, which it plans to use for capital expenditures, working capital and general corporate purposes.

On Jan. 24, 2005, the class action lawsuit was filed in the United States District Court of New Jersey against Pharmos.