Seventeen And Counting – Bumper Crop Of New EU Filings
Orphan drugs and COVID-19 products are among the latest filings under review by the European Medicines Agency for potential pan-EU approval.
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Tabelecleucel, Atara Biotherapeutics’ advanced therapy for the treatment of Epstein-Barr virus-positive post-transplant lymphoproliferative disease, is among the latest new medicines that have been submitted for review for potential pan-EU approval.
The Pink Sheet's EU accelerated assessment tracker has been updated to include developments relating to investigational products from Roche and CSL Behring/UniQure.
There have been some recent successes on the accelerated assessment front in the EU but more requests are rejected than granted.