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.
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Amryt Pharmaceuticals is set to appear before the European Medicines Agency to explain why its treatment for patients with epidermolysis bullosa merits EU-wide approval. The drug was recently rejected in the US.
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.
Several new drugs are now on track for an EU marketing authorization after getting the EMA’s thumbs up this week.