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
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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The EU marketing authorization application for Takeda's dengue vaccine candidate is no longer being fast-tracked. Also, five requests for accelerated assessment were decided on at the latest meeting of the European Medicines Agency's drug evaluation committee, the CHMP.
New long-term Phase III data for Takeda's candidate dengue vaccine show continued protection against illness and hospitalization, regardless of previous exposure, out to the three-year mark following the two-dose jab.
CDC drafting recommendation for Sanofi’s Dengvaxia, setting parameters for required pre-vaccination screening in the absence of tests approved by the US FDA.