The FDA approvals for full year 2011 can now be formally tallied. The agency did approve more drugs this year than it has for any of the past seven. Some points include 30 new drugs approved, including many novel applications that were approved in the US first. Both J&J and GSK each achieved 3 new approvals.
Analysts attribute the higher approval numbers to such things as pharma's improved data packages being submitted with drug applications, specifically with more safety data. Pharma companies also appear to be picking better candidates that represent more novel treatments as drug they preferential push toward approval.
The agency for its part says it is trying to streamline the approval process -- a process that heretofore has been under heavy criticism by pharma company's, industry analysts and investment groups. It remains to be seen if 2012 will be as rosy -- but we can start 2012 optimistically can't we? See Fierce Biotech.
Posted by Bruce Lehr Jan 6th 2012.