Here's one for the record books: 2007 finished with the worst record for new molecular entity approvals since 1983. (Remember 1983? The year Toto won for best album of the year? No?) If you're counting, and The In Vivo Blog is counting, the FDA approved 16 NMEs last year--18 if you include two new biologics OK'd by CDER. So while R&D budgets swelled from $3.2 billion to $43 billion, actual groundbreaking advances have slowed. Putting the bad news in another light, the FDA has approved 60 NMEs in the last three years. A little over ten years ago, the drug industry hit that post in one year. The silver lining? There were still more NME approvals last year than first-time generic launches.
- check out The In Vivo Blog report for more info
Related Articles:
New drug approval lags in 2007. Report
FDA quick to reject drugs as it gets more cautious. Report
Industry exec says FDA approval process too strict. Report