EU Gene Therapy Submissions, Approvals Expected To Pick Up In 2021
Coming year could feature first-time approvals in the EU for at least five gene therapies.
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The J.P. Morgan Healthcare Conference will be a virtual event but the industry's biggest business meeting will still lay the groundwork for the year ahead.
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.
The review of liso-cel, Celgene/Bristol Myers Squibb's potential new CAR T-cell therapy for R/R DLBCL, is facing regulatory setbacks in the EU as well as in the US.