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European Performance Tracker
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New Filings At The EMA
New medicines under evaluation at the European Medicines Agency.
New EU Approvals
The Pink Sheet’s list of EU centralized approvals of new active substances now includes a new product, Alexion Pharmaceuticals' Ultomiris, for the treatment of adult patients with paroxysmal nocturnal hemoglobinuria. The list, which contains information dating back to January 2018, includes brand name, generic name, company, therapeutic indication, date of marketing authorization and product type (eg, medicine, vaccine, biologic).
European CHMP Opinions and MAA Updates
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.
EU Biosimilar Filings, Opinions And Approvals
A list of new EU biosimilar product filings, CHMP opinions and marketing authorizations issued by the European Commission. The updated list includes the filing of the first biosimilar version of insulin aspart and the approval of the EU’s sixth biosimilar pegfilgrastim product.
EU Accelerated Assessment Tracker
Will Chugai's European marketing authorization application for satralizumab be fast-tracked when the company files for approval? The European Medicines Agency's drug evaluation committee, the CHMP, will decide this week.
European CHMP Opinions and MAA Updates
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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