FDAnews Drug Daily Bulletin
March 22, 2005 | Vol. 2 No. 57
The number of adverse event reports submitted to the FDA's Center for Drug Evaluation and Research (CDER) increased nearly 14 percent in 2004, according to a preliminary estimate from the agency.
The U.S. economy operates in a complex global environment that for the first time has seen the emergence of low-cost, high-value innovators worldwide -- a situation that could affect the U.S. pharmaceutical industry's pre-eminence in research and innovation, experts say.
The FDA's Division of Drug Marketing, Advertising, and Communications (DDMAC) has issued AstraZeneca its second untitled letter in four months regarding promotional activities for the company's cholesterol-lowering drug Crestor.
Indian drugmaker Ranbaxy Laboratories has reconfigured its R&D program -- a move sparked by the departure of its top research executive.
Medicis Pharmaceutical Corp. agreed to buy Inamed Corp., the company seeking to return silicone-gel breast implants to the U.S. market for the first time in more than a decade, for $2.8 billion in stock and cash. Inamed investors will get 1.4205 shares of Medicis, a Scottsdale, Ariz.-based maker of skin treatments, and $30 in cash for each share they own, the companies said in a Business Wire statement today.
A Maryland biotech has raised $22 million to bring its AIDS-fighting drug a step closer to market.
Notice is hereby given that a class action lawsuit was filed in the United States District Court for the District of New Jersey against Bradley Pharmaceuticals Inc. on behalf of purchasers of Bradley securities between Oct. 8, 2003 and Feb. 25, 2005, inclusive.
Predix Pharmaceuticals Holdings and Cystic Fibrosis Foundation Therapeutics have signed a research, development and commercialization agreement for two cystic fibrosis drug development programs. The award funds two research programs.
Nigeria's food and drug safety agency NAFDAC said that it had blacklisted 11 Indian and one Pakistani firm for allegedly supplying fake and counterfeit drugs.
Corautus Genetics Inc. significantly reduced its net loss while it increased its revenue in 2004. The Atlanta-based biopharmaceutical company reported a net loss of $10.4 million on $83.3 million in revenue last year, compared with a net loss of $30.4 million on $34.7 million in revenue in 2003.
NascaCell IP GmbH and Discovery Partners International Inc. announced that they have entered into a co-marketing agreement.
New England Compounding Pharmacy Inc. reported that it has filed counterclaims against DUSA Pharmaceuticals Inc. of Wilmington, Mass., alleging, among other things, defamation, violations of the Lanham Act 15 U.S.C.A. Section 1051 et seq., Massachusetts General Laws c. 93A, Section 11, and the tortious interference with advantageous business relationship.
Pharmaceutical company aaiPharma is considering filing for Chapter 11 bankruptcy protection in order to stay in business while it repays $350 million in bond and credit debt.
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