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Takeda Test Drives EMA’s Parallel Review Route For EU And Non-EU Markets

Company Submits Two Sets Of Applications For Evaluation Of Its Dengue Vaccine To CHMP

Executive Summary

A new evaluation route that the European Medicines Agency launched last year came at the right time for Takeda’s dengue vaccine candidate. 

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Takeda says loss of accelerated assessment status at EMA for marketing authorization application for its dengue vaccine candidate TAK-003 “was anticipated as a potential outcome.”

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The EU marketing authorization application for Takeda's dengue vaccine candidate is no longer being fast-tracked. Also, four requests for accelerated assessment were decided on at the latest meeting of the European Medicines Agency's drug evaluation committee, the CHMP.

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