For NMEs, The Song Remains The Same: Specialty Markets Eye Further Growth For 2010, While Traditional Big Pharma, Primary Care NDAs Are Few
The outlook for novel drug and biologic approvals in 2010 is strikingly similar to the beginning of 2009: specialty markets continue to gain ground on new products for primary care, and specialty firms continue to gain in the ranks of sponsors while big pharma struggles to put up successful new candidates
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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.
Several blockbuster drugs will face generic competition for the first time in 2010, but overall the year marks a reprieve for brand drug makers, one last chance to grip the ledge before tumbling over the patent cliff in 2011
Novartis has gained the lead in the race to market for the first oral therapy for multiple sclerosis with the NDA submission for fingolimod, a feat made possible by FDA's refusal to file the earlier NDA for Merck Serono's oral MS candidate cladribine