At A Glance: COVID-19 Vaccines In EU And Great Britain
Same Four Vaccines Approved And Comirnaty Indication Extended In Both Jurisdictions
The EU and UK have approved the same COVID-19 vaccines but the review pathways have not always been the same.
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Thirteen of the 20 new active substances that were approved in the EU between January and April this year have also now received regulatory clearance in Great Britain, Pink Sheet analysis finds. New filing procedures have been in place there since 1 January.
Bristol Myers Squibb's marketing application for liso-cel is in the final stages of the review process at the European Medicines Agency. The agency’s drug evaluation committee, the CHMP, adopted in mid-April the list of concerns it has with the application.
Novartis is one of the latest companies to fail in its attempt to have a marketing authorization application fast-tracked at the European Medicines Agency. There was better news for BioMarin.