2009 saw a record number of 505(b)(2) approvals. A total of thirty-three (33) 505(b)(2) NDA’s were approved by FDA in calendar 2009:
23 new formulations
1 New Molecular Entity
5 new combinations of existing drugs
4 drugs already marketed, but without an approved NDA
We track approvals on this blog as they occur (click here to see my entire list [...]
PhRMA Adds New Bio Companies
Published January 11th, 2010 in News Commentary. 0 CommentsThe trend in Big Pharma continues to shift from small molecules to biologics. PhRMA announced that it added seven (7) new members to its roster at the end of the year. The new PhRMA members are Cubist Pharmaceuticals, Inc., Lexington, MA; OSI Pharmaceuticals, Inc., Melville, NY; Alexion Pharmaceuticals, Inc., Cheshire, CT; Ferring Pharmaceuticals, Inc., [...]