NME Candidates For 2012 Have Modest Ambitions; Standard Reviews And Small Molecules Dominate
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
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.
You may also be interested in...
Are The 90s Back? Oncologics Drove FDA’s 2012 Novel Approval Count To 15-Year High
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.
CDER Approvals In January Came Early And Often
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.
LEO Plays Up Rapid Action Of Picato For Actinic Keratosis
Newly approved plant-based gel works in just a few days of treatment, rather than the weeks required for some competitors.