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EMA Endorses Use Of Dexamethasone In COVID-19

The Move Should Speed Up EU National Approvals

Executive Summary

Companies marketing dexamethasone in Europe have been told they can use a CHMP endorsement to request the addition of COVID-19 to their product license.

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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 Regulatory Network 'Competing With Google' For Tech & AI Experts

The European medicines network needs to quickly build up its capabilities in the area of data analysis and digital transformation, but finding the necessary staff is difficult in the face of stiff competition from both the pharmaceutical industry and the likes of Google and Facebook, according to the head of the Danish regulator. 

Rasi To Ombudsman: No Risk Of Bias In EMA’s COVID-19 Drug Evaluations

European Medicines Agency chief Guido Rasi has responded to questions by the European Ombudsman about its COVID-19 Pandemic Task Force.

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