Seven advanced therapies, eight chemical drugs, three biologics and one immunologic. Seventeen treatments for rare diseases. Accelerated assessment status often granted but also frequently withdrawn. And, in many cases, shorter regulatory review times than is standard.
PRIME: How The EU Scheme Is Delivering On Promise Of Faster Drug Approvals
Nineteen new products that were developed under PRIME, the European Medicines Agency’s priority medicines scheme, are now approved for use in the EU. Pink Sheet analysis finds that many were reviewed much faster than they would have been under standard review timelines.
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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.
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The Pink Sheet's list of EU centralized approvals of new active substances has been updated to include four new products, one of which is Tivdak, Pfizer/Genmab’s treatment for previously treated recurrent or metastatic cervical cancer.
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Eisai is working on securing reimbursement across the EU for Leqembi now that the Alzheimer’s disease treatment has secured marketing approval from the European Commission.
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The African Medicines Agency is to appoint a director general and become operational at the end of this month.