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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Chaos wrought by the ongoing coronavirus pandemic. A heavy workload and continuing resource constraints at the European Medicines Agency. Nonetheless, a record number of novel drugs and vaccines were cleared for marketing in the EU last year.
The filing for Origin Biosciences’ fosdenopterin (Nulibry) is being fast-tracked at the European Medicines Agency. The outcomes of accelerated assessment requests from Janssen and Sanofi for teclistamab and nirsevimab respectively appear not yet to be in the public domain.
Further analysis is under way, but first impressions by EU R&D industry group EFPIA of policy proposals for tackling drug shortages are not good.