BioMarin Pulls EU Hemophilia Gene Therapy Filing, But Is Not Giving Up
Agios’s MAA For Tibsovo also withdrawn
BioMarin plans to resubmit its marketing application for Roctavian to the European Medicines Agency.
You may also be interested in...
This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the European Union, and updates on EU marketing authorization changes recommended by the CHMP.
Swiss company Santhera's lengthy and problem-laden journey to repurpose its already marketed idebenone for use in Duchenne Muscular Dystrophy has ended in failure. The company has withdrawn its EU filing for the product following its announcement that it was halting development.
The sponsors of 11 new treatments should learn this week whether the European Medicines Agency will recommend EU marketing approval for their products.