Again Please: BioMarin Seeks Speedy EU Review For Hemophilia Gene Therapy
US BLA Submission For Roctavian Expected Next Year
BioMarin is planning to resubmit its EU marketing application for Roctavian soon and, as with the previously pulled application, it wants the regulators to fast-track the new filing.
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Novartis is one of the latest companies to fail in its attempt to have a marketing authorization application fast-tracked at the European Medicines Agency. There was better news for BioMarin.
BioMarin plans to file for approval of its investigational hemophilia A gene therapy in the EU in June this year but its US filing is not planned until Q2 2022. It will be the company's second attempt at success in both jurisdictions.
Daily round-up from the virtual J.P. Morgan Healthcare Conference: Business development is key topic for Amgen and Vertex; BioNTech talks COVID-19 vaccine supply while Merck KGAA's new CEO pledges to rise to meet the challenges posed by COVID-19.