The long dry spell for new drug approvals has actually worsened a bit. In Vivo notes that the FDA approved six new molecular entities in the first half of the year, down one from the dreadful pace set in 2007. Last year only 16 NMEs made it through, the worst record in a generation at a time that pharma companies have been desperate to add new products to their lineup.
But don't panic yet. In Vivo also notes that there are at east 30 NMEs up for approval at the FDA with a PDUFA date falling prior to New Year's Day. And even though the FDA is increasingly likely to blow off its deadlines, there's still a good chance that 2008 will turn out better than 2007. Let the office pools begin.
- check out the report from In Vivo