NME Candidates For 2012 Have Modest Ambitions; Standard Reviews And Small Molecules Dominate
This article was originally published in Pharmaceutical Approvals Monthly
With the same range of novel product submissions as in 2011, the year ahead could reach an equally healthy tally of new molecular and novel biological entity approvals. But a look at upcoming applications suggests that the makeup of those classes could be very different.
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With 45 new molecular entities and novel biologics cleared in 2012, FDA approvals have reached a level not seen since the mid-1990s, 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.
FDA started 2012 with a bang: five novel approvals in January, including two of the fastest approval times in modern agency history (and the fastest therapeutic approval outside of oncology), plus two big decisions on anti-diabetics.
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