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BioMarin Pulls EU Hemophilia Gene Therapy Filing, But Is Not Giving Up

Agios’s MAA For Tibsovo also withdrawn

Executive Summary

BioMarin plans to resubmit its marketing application for Roctavian to the European Medicines Agency.

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BioMarin Secures Fast-Track Review For Hemophilia Gene Therapy In EU

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.

Again Please: BioMarin Seeks Speedy EU Review For Hemophilia Gene Therapy

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.

Plenty Of Action On EU Accelerated Assessment Front

A number of companies have sought to convince the European Medicine Agency that their drug merits a fast-track regulatory review.

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