An NME Surge After The Patent Cliff? Reinvention Of R&D Starts Paying Off In 2013 New Product Candidates
With almost 40 novel agents already pending at FDA, 2013 looks like a good bet to repeat the strong NME and novel biologic approval counts of 2012 and 2011. Big pharma and big markets dominate the 2013 slate so far, especially with diabetes, respiratory and central nervous system candidates.
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A senior Pfizer executive pushes the theme of large collaborations by stakeholders globally to spur innovation and productivity.
Takeda’s type 2 diabetes drug alogliptin – on its third pass through FDA – was cleared Jan. 25 as a single agent as Nesina, in combination with metformin as Kazano and in combination with pioglitazone as Oseni.
With 45 new molecular entities and novel biologics cleared in 2012, FDA approvals have reached a level not seen since the mid-90s, the golden age of modern medicine. The group reflects a boom in oncology; other drug development trends like orphan diseases and personalized medicine held steady. Big pharma contributed just over a third of the 2012 class, with Pfizer regaining the lead with five novel approvals.