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Immunocore's Tebentafusp Sole Winner In EU Fast-Track Stakes In June

European Medicines Agency's CHMP Rejected Four Out Of Five Requests

Executive Summary

If Immuncore's tebentafusp is fast-tracked all the way through the centralized procedure at the EMA, it could be approved a few months earlier than it otherwise would be.

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Immunocore Working With EMA On Novel TCR Therapy Filing

While Immunocore is not giving details of what issues it still needs to address regarding its EU filing for tebentafusp, it said the drug is continuing to undergo an accelerated assessment by the CHMP. 

Immunocore Expects EU Verdict This Week On Novel TCR Immunotherapy

Pfizer’s oral COVID-19 antiviral drug and Celgene/Bristol Myers Squibb’s CAR-T for treating large B-cell lymphoma are among 11 new drugs on which the EMA is set to adopt recommendations on their possible EU-wide approval.

EU Accelerated Assessment Tracker

The Pink Sheet's EU accelerated assessment tracker has been updated to include developments relating to investigational products from Roche and CSL Behring/UniQure.

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