Bluebird Seeks EU Fast-Track Review For Lenti-D Gene Therapy
Bluebird bio is planning to file its EU marketing application for Lenti-D this year, before it files for approval in the US in mid-2021.
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Two products that were under fast-track review at the European Medicines Agency have reverted to standard review timelines – Eiger's lonafarnib and GSK's dostarlimab. The Pink Sheet tracker logs these and other developments relating to the agency's accelerated assessment mechanism.
At least another four investigational therapies will join the few that are already being fast-tracked at the European Medicines Agency.
While Accord HealthCare has convinced the European Medicines Agency that its rivaroxaban generic should be approved in the EU, Bayer has warned that patent protection for Xarelto continues until at least late 2023. The EMA this week also recommend approval for a number of other new drugs.