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.
It is not surprising as Pharma has been actively transforming itself in diverse ways, depending on each firm's strategy. As above, the focus on safety now starts far earlier, reducing later "surprises" in PIII (and hopefully post-approval.) Other firms are unraveling the basis for disease through improved R&D "algorithms" and approaches that also may begin to show fruit. Such improvements may have caused an observed shift in improved innovation in approved drugs 3-4 years ago.
This progress is balanced against strong headwinds that persist, based on what society is willing to pay for life extension and enhancement.
Posted by: Terry McCormick | 01/09/2012 at 07:19 AM