At A Glance: COVID-19 Vaccines In EU And Great Britain
Same Four Vaccines Approved And Comirnaty Indication Extended In Both Jurisdictions
Executive Summary
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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Companies Take Their Products To GB Market Post-Brexit
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.
EU Accelerated Assessment Tracker
Marinus’s ganaxolone has lost its accelerated assessment status mid-review at the European Medicines Agency while Roche’s glofitamab will be fast-tracked once a filing has been made.
EU Accelerated Assessment Tracker
The EU filing for AstraZeneca’s nirsevimab is being reviewed under the accelerated pathway at the European Medicines Agency. Also, Janssen should know by now whether its planned filing for Zejula plus Zytiga will get the same treatment – as should SIFI for its planned Akantior filing.