EMA Endorses Use Of Dexamethasone In COVID-19
The Move Should Speed Up EU National Approvals
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.
You may also be interested in...
The agility, flexibility and transparency that the European Medicines Agency has adopted during the development and assessment of COVID-19 products will have to continue after treatments and vaccines are on the market, says the soon-to-be new head of the agency, Emer Cooke.
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.
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.