ARTICLE | Company News

Regulatory roundup: BioMarin poised to have first U.S., EU hemophilia gene therapy; plus Allergan, Eisai, FibroGen, ViiV and Vero

December 24, 2019 12:23 AM UTC
Updated on Jan 1, 2020 at 1:24 AM UTC

Monday's basket of regulatory news includes two landmark regulatory applications for BioMarin's hemophilia gene therapy in the U.S. and EU, and FDA approval of Allergan's migraine drug.

BioMarin Pharmaceutical Inc. (NASDAQ:BMRN) submitted a BLA to FDA for valoctocogene roxaparvovec for hemophilia A and announced EMA accepted an MAA for the adeno-associated virus subtype 5 (AAV5) vector delivering Factor VIII to treat severe hemophilia A...