FDAnews Drug Daily Bulletin
March 21, 2005 | Vol. 2 No. 56
Sanofi-aventis is facing a new patent challenge to blood-thinning agent Lovenox -- this time in Canada.
The FDA has pushed back its timetable for a major restructuring of the Office of New Drugs (OND), but some activities already are moving forward at the OND, including in the office that reviews cancer products.
An FDA advisory committee voted unanimously to recommend approval of Bristol-Myers Squibb's (BMS) Baraclude, an investigational oral antiviral agent under development for the treatment of chronic hepatitis B.
In a victory for pharmaceutical firms, a federal appeals court has overruled an FTC mandate that attempted to prevent drug patent holders from paying generic manufacturers to keep less-expensive versions of branded products off the market.
Dutch biotechnology company Crucell N.V. announced that it has extended its Cooperative Research and Development Agreement (CRADA) with the Vaccine Research Center (VRC), part of the National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health (NIH), for the development of vaccines to protect against Ebola, Marburg and Lassa infections.
Argonaut Technologies announced it has amended its definitive agreement with Biotage AB of Uppsala, Sweden to increase the purchase price to $21.2 million in cash and to include the sale of certain assets (excluding receivables) and the assumption of specified liabilities, including warranty service and maintenance, and accounts payable of up to $350,000 associated with its remaining Process Development Products and Services.
Eisai announced on March 18 that the company has concluded an agreement with TorreyPines Therapeutics to collaborate in new drug development.
Noven Pharmaceuticals announced that the United States District Court for the Southern District of Florida has issued an order dismissing without prejudice a lawsuit filed against Noven and certain individual defendants styled In re Noven Pharmaceuticals Securities Litigation.
Oscient Pharmaceuticals has completed the expansion of its primary care sales force with the hiring of 150 new sales representatives.
Cardiome Pharma announced that it entered into an agreement with a syndicate of underwriters in connection with its previously announced public offering of 8,500,000 common shares.
German biotechnology company Brahms AG has reached a cooperation agreement with a leading Japanese pharmaceuticals firm in the field of medical technology, a top executive disclosed.
A proposal to tighten state restrictions on drug company sales representatives was met with little support at a public hearing Thursday.
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