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Positive Evidence Stacks Up For Takeda's Dengue Vaccine

Phase II Support For Durability, Dosing

Executive Summary

New long-term clinical data with Takeda’s dengue vaccine contender show a durable response against all four serotypes and support the dosing regimen in an ongoing pivotal study.

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EU Accelerated Assessment Tracker

Sanofi failed in its attempt to have its EU marketing authorization application for avalglucosidase alfa fast-tracked through the centralized review process at the European Medicines Agency. This and other developments relating to the agency's accelerated assessment mechanism are logged in this latest update to the Pink Sheet's EU accelerated assessment tracker.

EU Accelerated Assessment Tracker

Another three marketing authorization applications will be fast-tracked through the centralized review process at the European Medicines Agency. The Pink Sheet tracker logs these and other developments relating to the agency's accelerated assessment mechanism.

EU Fast-Track Review In Store For Takeda’s Dengue Vaccine

Takeda will soon seek EU approval of its dengue vaccine candidate. The marketing application will be fast-tracked, as will the applications for Regeneron's evinacumab and bluebird bio's eli-cel Lenti-D gene therapy.

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