The End of the REMS Era? Entyvio Approval Is Another Marker

This article was originally published in RPM Report

03 Jun 2014
Analysis

Laura Helbling @Laura_H laura.helbling@previsionpolicy.com

Executive Summary

FDA approved Takeda’s UC and Crohn’s disease therapy without a REMS – even though the product has a theoretical risk of causing PML, based on its similarity to Biogen’s Tysabri.

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BioPharmaceutical
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The End of the REMS Era? Entyvio Approval Is Another Marker

Analysis

Executive Summary

Related Content

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