Clearer Purpose And Direction Needed For EU Agency Heads Network
Thomas Senderovitz will chair the management group of the EU Heads of Medicines Agencies for at least the next two years. The Danish regulator tells the Pink Sheet of his big plans for the network.
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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.
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.
There could be a regulatory decision on AstraZeneca and Sanofi's nirsevimab in the EU in H2 as a result of the European Medicines Agency speeding up its review of the marketing application for the potential new immunization against RSV in all infants.