FDAnews Drug Daily Bulletin

As lawmakers and the FDA mull over proposals to address recent drug safety concerns, pharmaceutical firms are hoping that any potential fix will not focus on the premarket side of the equation, according to a top FDA official.

Recent FDA warnings about the use of antidepressants in children appear to be having a significant effect on the number of pediatric prescriptions for the drugs, according to an analysis by one of the nation's largest pharmaceutical benefit managers.

AstraZeneca's cancer treatment Iressa will be a main topic of discussion at next month's meeting of the FDA's Oncologic Drugs Advisory Committee, which will examine a recent clinical trial that raised questions about the drug's effectiveness.

The FDA has issued a public call for information on the use of color on pharmaceutical labeling and packaging to determine if the practice is one that warrants further action from the agency.

Invitrogen has signed a definitive agreement to acquire privately held molecular separation and purification technology pioneer Dynal Biotech from majority owner Nordic Capital and a co-investor for approximately NOK 2.5 billion.

Albany Molecular Research has renewed its drug discovery research agreement with Eli Lilly.

Maxim Pharmaceuticals has implemented a plan realigning its resources and corporate objectives, resulting in 12 layoffs.

Two men have been charged in a multimillion dollar scheme to sell counterfeit and illegally imported Lipitor. Three others have already been convicted in the plot.

New York's JDS Pharmaceuticals and the North Carolina-based arm of Synthon Pharmaceuticals have entered into a co-promotion agreement for Lithobid, a leading brand of twice-daily lithium carbonate for the treatment of bipolar disorder.

Wockhardt has set up two business joint ventures in Mexico and South Africa to enter the biopharmaceutical markets in these countries.

Sinovac Biotech Ltd. has announced that as of Feb. 4 it has completed the acquisition of an additional 20.56 percent of its Beijing-based operating subsidiary, Sinovac Biotech Co. Ltd. (Sinovac (Beijing)) for approximately US$3,310,000.

Rx Processing has acquired Lab Pass Associates LLC. The deal is valued at approximately $120,000.

EpiTan has in-licensed the Australian and New Zealand rights to OraDisc A from Access Pharmaceuticals (Dallas, Texas) as part of its strategy to establish a specialty pharmaceutical business focused on ethical dermatology.