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Latest From SIFI S.p.A.

Accelerated Assessment Requests Fall Flat At EMA

Very few companies asked the European Medicines Agency to fast track their drug marketing authorization applications in the first half of this year, and those that did were all turned down.

Review Pathway Europe

SIFI’s Parasitic Eye Infection Drug & Biosimilar Aflibercept Among Raft Of EU Filings

Polyhexanide, from SIFI, could become the first approved treatment for acanthamoeba keratitis, while aflibercept could become the first biosimilar version of Eylea in the EU.

Europe Drug Review

EU Accelerated Assessment: Lilly Requests Fast-Track Status, EMA Says No To SIFI And Janssen

Eli Lilly has asked the European Medicines Agency to grant accelerated assessment to its planned EU marketing application for pirtobrutinib. Meanwhile, the agency has rejected requests to fast-track SIFI’s Akantior and Janssen’s Zejula plus Zytiga combination therapy. 

European Performance Tracker Review Pathway

EU Accelerated Assessment Tracker

The EU filing for AstraZeneca’s nirsevimab is being reviewed under the accelerated pathway at the European Medicines Agency. Also, Janssen should know by now whether its planned filing for Zejula plus Zytiga will get the same treatment – as should SIFI for its planned Akantior filing.

Europe European Performance Tracker
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