EU CHMP Opinions and MAA Updates
Executive Summary
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.
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ERC Not Giving Up On Glioma Immunotherapy In EU
ERC Belgium has pledged to collect more data to convince the European Medicines Agency that Sitoiganap merits approval. Meanwhile, UGA Biopharma said it would address the agency’s objections over its biosimilar version of eptacog alfa.
PTC’s ‘Life-Changing’ Gene Therapy Among Nine Drugs To Win EU Thumbs Up
The European Medicines Agency has delivered its verdict on the latest medicines it believes should be approved for marketing in the EU. By contrast, it has given the thumbs down to one biosimilar anticancer drug and its duplicate.
Marketing Firsts Due As Amryt’s Filsuvez And Roche’s Lunsumio Win EU Nod
Amryt’s epidermolysis bullosa gel and Roche’s CD20xCD3 bispecific antibody for follicular lymphoma are among four drugs that have received the thumbs up from the European Medicines Agency.