A US Food and Drug Administration advisory committee meeting on Biogen, Inc.’s Alzheimer’s drug aducanumab will offer some insight into the amount of flexibility the agency and its external experts are willing to exercise for neurodegenerative diseases with high unmet need, particularly in the wake of a December 2019 guidance document on the quantum and … Continue reading “Biogen’s AdComm Meeting Will Test FDA’s “Substantial Evidence” Flexibility”
Author: Sue Sutter
Sue is a senior editor with Pink Sheet, where she writes primarily about drug, biologic and biosimilar regulation, FDA advisory committees and product approvals.
Gene Therapy Firms Seek Clarity on FDA Exclusivity, Orphan Designations
Gene therapy product developers are seeking more clarity from the US Food and Drug Administration on when viral vectors from the same class will be considered sufficiently different for purposes of awarding orphan drug designation or exclusivity. In addition, stakeholders want the FDA to better define, and provide examples of, the types of minor differences … Continue reading “Gene Therapy Firms Seek Clarity on FDA Exclusivity, Orphan Designations”