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European Performance Tracker
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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.
New EU Approvals
Ten new products including Spark Therapeutics' gene therapy for treating patients with an inherited retinal disease, Luxturna, have been added to the Pink Sheet’s 2018 list of EU centralized approvals of new active substances. The list includes brand name, generic name, company, therapeutic category/indication, date of marketing authorization and product type (e.g., medicine, vaccine, biologic).
EU Biosimilar Filings, Opinions And Approvals
A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.
New Filings At The EMA
EU Accelerated Assessment Tracker: Second Half Trumps First By Far
The first half of the year was pretty bleak for companies seeking fast-track review of their products in the EU. There has been much better news in the second half. The Pink Sheet tracks the winners and losers.
New EU Approvals
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