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Amgen, the world’s largest biotechnology company, will acquire drug development partner Abgenix for $2.2 billion, allowing Amgen to acquire a promising experimental cancer drug that may spell trouble for Bristol-Myers Squibb’s (BMS) and ImClone’s competing drug Erbitux.
Sen. Richard Burr (R-N.C.) is pledging to make major changes to his bioterrorism legislation within the next few days because the bill will likely fail on the Senate floor, various sources say.
The FDA’s current policy on follow-on biologics amounts to a “monopoly” situation for brand firms, according to two prominent lawmakers who helped shape the current generic drug industry.
Generic heavyweight Sandoz has filed a lawsuit against the FDA accusing the agency of unlawfully delaying a decision on the firm’s application to market generic human growth hormone — a move that ramps up pressure on the FDA to issue guidelines for follow-on biologics.
Sandoz has filed a lawsuit against the FDA accusing the agency of unlawfully delaying a decision on the firm’s application to market generic human growth hormone — a move that ramps up pressure on the FDA to issue guidelines for follow-on biologics.
Momenta Pharmaceuticals has formally started the ball rolling on its effort to market a generic version of sanofi-aventis' blood thinner Lovenox, a move which could ultimately pave the way for generic biologic drugs.
Competition to launch the first generic version of sanofi-aventis’ profitable blood thinner Lovenox has heated up after Momenta Pharmaceuticals said it was able to duplicate biologic drugs by characterizing complex sugars.
The FDA has extended an emergency-use-authorization (EUA) for the military use of the anthrax vaccine by individuals who face a heightened risk of exposure to the toxin.
The U.S. will not likely establish an abbreviated approval pathway for follow-on biologics until at least 2007, according to experts who note the European Union will have such a framework in place by November.