Hexal Sues EMA Over Refusal To Accept Generic Aubagio Filing
Hexal is challenging a decision by the European Medicines Agency to reject its application for a generic version of Sanofi’s MS drug Aubagio, raising fresh questions about how a new active substance is defined. By contrast, a generic version from Glenmark was recently approved in the US.
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The EU’s top drug advisory committee was divided on how to interpret regulations on new active substance status when it came to Sanofi's oral MS drug Aubagio, which was only given NAS status by a majority vote after the French group appealed an initial refusal. The CHMP’s thinking on the issue will be useful to others wishing to develop new medicines closely related to already-marketed products.
A report from industry federation EFPIA and its Vaccines Europe arm says that R&D has produced safe and effective tools for tackling COVID-19 but that the EU needs to address a set of short- to medium-term priorities if it is to be in a position to tackle future health emergencies.
Announcements at the second Global COVID-19 Summit included a technology licensing agreement for vaccine and diagnostic products developed by the US NIH, a new partnership to boost the use of testing and antiviral treatments in less wealthy countries, and a flurry of new funding pledges from organizations and companies alike.