Sunday, November 6, 2011

Pharmaceutical R&D is turning around - FDA grants a record 35 NME approvals in 2011 after a long slack

The FDA approved 35 new molecular entities (NMEs) in 2011 and marks an end to a long drought.  70 percent of those have been approved have preceded other major regulatory approval, while 2/3rd have been approved in first cycle review. 35 NME approval is a sign that pharmaceutical R&D is turning around and should silence critics that R&D in pharma industry is a non - viable.
These are early signs of a turnaround in R&D product flow and expect the end of a painful decade.  The new product flow should accelerate from now onwards, as increasing critical mass of the “New Science” and a more balanced regulatory outlook under a strong FDA leadership are converging. 
 


2007
2008
2009
2010




       26
Total Approvals
18
25
28          
Share of Global Pharma in total number of approvals
55%
36%
46%
45%
Total  Approvals for BLA’s
2
5
10
17
Total Approvals for BLA’s for Global Pharma companies
1
1
7
9