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Janssen Wins EU Fast-Track Status For CAR-T Therapy Cilta-Cel

Filing Of Potential Multiple Myeloma Treatment Planned For H1

Executive Summary

Three requests for the accelerated assessment of planned EU marketing applications were considered by the European Medicines Agency last month.

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EU Accelerated Assessment Tracker

Novartis is trying its luck with capmatinib on the accelerated assessment front at the European Medicines Agency. Gilead and Astellas/Seagen have secured fast-track review for their respective potential new products while Sesen Bio and Amryt Pharma are dealing with rejection.

EU Accelerated Assessment Tracker

One out of seven requests for the accelerated assessment of planned EU marketing authorization applications is known to have been granted this year to date.

EMA PRIME Wins For Bispecific Antibodies & Another Gene Therapy

Just three of the 13 applications that the European Medicines Agency most recently reviewed for entry onto its priority medicines scheme made the grade.

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