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European Performance Tracker

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New EU Approvals

The Pink Sheet’s list of EU centralized approvals of new active substances has been updated with two new products including Merck Sharp & Dohme's Ebola vaccine, Ervebo. 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).

Approvals Europe

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.

Drug Review Europe

EU Accelerated Assessment Tracker

Janssen’s two investigational Ebola vaccines are among four new products recently granted fast-track review by the European Medicines Agency. GlaxoSmithKline and Viiv Healthcare are not disclosing the outcomes of accelerated assessment requests they have made.

Europe Drug Review

New Filings At The EMA

New medicines under evaluation at the European Medicines Agency.

Europe Drug Review

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.

European Performance Tracker Approvals

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.

Europe European Performance Tracker
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