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A coalition of drug wholesalers will soon seek an injunction in federal court to delay the implementation of the FDA's long-awaited drug tracking program, contending the new requirement will devastate their businesses.
A study showing that patients taking Gleevec could be at increased risk for certain cardiovascular problems has resulted in Novartis changing the labeling for the blockbuster cancer drug.
Pfizer will seek to cut operating costs amid lower revenue projections for 2007 and 2008, the pharmaceutical giant said in its third quarter financial report.
Bristol-Myers Squibb's (BMS) problems continue as the company lost substantial revenue from generic competition to its blood thinner Plavix and now faces potentially broader criminal charges related to the drug.
The FDA intends to issue a proposed rule on current good manufacturing practices (cGMPs) for combination products next spring, a senior FDA official said at a recent industry conference.
CBER is increasing the use of electronic applications for new biologics in order to ensure more efficient, effective and consistent reviews, an agency official said.
IMS Health projections predict a lower growth rate for the global pharmaceutical market in 2007, with the U.S. in particular contributing less due to generic competition and an increase in niche products.
The FDA believes its funding will increase in 2008 through negotiations over the Prescription Drug User Fee Act (PDUFA) but remains concerned that flat funding levels in 2007 will undermine a number of agency programs.
Eli Lilly will buy Washington-based ICOS for an estimated $2.1 billion in cash, giving the Indiana-based drugmaker full control over the highly profitable erectile dysfunction drug Cialis.
A recent direct-to-consumer (DTC) ad may indicate that the new active ingredient in many nasal decongestants is no more effective than a placebo, highlighting the need for an FDA investigation, Rep. Henry Waxman (D-Calif.) says.