Archive: October 19 2020

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Evolving use of real-world evidence in the regulatory process: a focus on immuno...

This article reviews current literature on the use of RWE for regulatory submissions, with a focus on novel anticancer immunotherapies, and discusses the utility and current limitations of RWE in the context of drug development and regulatory approvals.

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Tecartus Recommended for EU Approval as CAR T-cell Therapy for Mantle Cell Lymph...

A committee of the European Medicines Agency (EMA) has recommended the conditional approval of Tecartus (brexucabtagene autoleucel) for the treatment of adults with relapsed or refractory mantle cell lymphoma (MCL).

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