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.
The monkeypox cases reported this month are evidence of chains of transmission of the virus, according to the European Centre for Disease Prevention and Control, which says that vaccination of high-risk close contacts should be considered after a benefit-risk assessment.
Coronavirus Notebook: WHO Says Extra Vaccine Boosters Confer Some Limited Benefits, Emergex & Zosano Link Up On T Cell Vaccine Patch
International regulators have issued an updated statement on the benefits and safety of COVID-19 vaccines for use by health professionals, while the UK BioIndustry Association has welcomed a MAb licensing deal between AstraZeneca and UK-based biotech firm RQ Bio.