European CHMP Opinions and MAA Updates
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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New treatments for advanced endometrial cancer and hereditary angioedema are among six drugs that have just been recommended for EU-wide approval. Harmonized EU advice has also been issued in relation to an investigational antibody combination for treating COVID-19.
Alexion is collecting more evidence to convince NICE that its anticoagulant reversal agent is also cost-effective for intracranial hemorrhage.
The Pink Sheet's list of EU centralized approvals of new active substances has been updated to include six new products, including Evrysdi, Roche/PTC Therapeutics' treatment for spinal muscular atrophy. The list, which contains information dating back to January 2018, comprises brand name, generic name, company, therapeutic indication, date of marketing authorization announcement and product type (eg, medicine, vaccine, biologic).