Last year was one of the bleakest on record in terms of new drug approvals. Only 18 new molecular entities were approved by the FDA--the lowest number since 1983. The first half of 2008 was nothing to brag about either, as the industry seemed to be destined to repeat its lackluster performance the year before.
But In Vivo reports that this year promises to be slightly better. That's because the FDA has already approved 18 NMEs, and there are still six weeks left in the year. Ten more drug applications could be approved before the end of the year. If that happens, 2008 would be the best drug-approval year since 2004, when the agency approved 38 NMEs.
One good year won't solve the industry's problems. What's really needed is consecutive years of sustained new drug output. However, "the thought that FDA will end up approving more drugs this year than last offers a much-needed sign of hope for the biopharma industry. Maybe--just maybe--the new era in drug regulation ushered in by the FDA Amendments Act of 2007 won't be so bad after all," observes In Vivo's Michael McCaughan.
- see the blog post