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What's "New" at FDA?

This article was originally published in RPM Report

Executive Summary

Amarin, biosimilars and why FDA’s low point was even lower than you thought.

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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.

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-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.

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