European CHMP Opinions and MAA Updates
Executive Summary
This is a monthly 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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Roche Takes Orphan Satralizumab To EMA
There are six new entries on the latest list of products under review at the European Medicines Agency – products with orphan status from Roche and Novo Nordisk and four generic or biosimilars.
EMA OKs Seven New Drugs But Delivers Another Blow To Emmaus
Seven new drugs have this week moved closer to gaining EU approval following positive recommendations from the European Medicines Agency, but Emmaus’ glutamine product has fared less well and the company is considering another route for getting the drug to sickle cell disease patients in Europe
New EU Approvals
The Pink Sheet's list of EU centralized approvals of new active substances has been updated to add two new products, including Ryzneuta, Evive Biotechnology's treatment for chemotherapy-induced neutropenia.