Bionest

The Orphan Drug Act: Successes and Challenges

By Alain J. Gilbert, Co-Chair, Bionest Partners   Rare and orphan diseases have grown dramatically as a focus of drug development since the passage of the Orphan Drug Act and the institution of other regulatory and financial incentives in both the United States and Europe aimed at spurring development for such conditions.  Franҫois Beaubien, Ph.D....

Bionest

FDA Grants Priority Review for KEYTRUDA® IN MSI-H Cancers

On November 28, the U.S. Food and Drug Administration granted Priority Review to Merck’s Supplemental Biologics License Application (sBLA) for KEYTRUDA® (pembrolizumab) in the new indication of microsatellite instability-high (MSI-H) cancer. MSI-H is a biomarker caused by a deficiency in a cell’s ability to repair errors in DNA sequences that occur during cell division. The...