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Living in a Bipolar World: Implications of the EPO Safety Debate (Part 1)

This article was originally published in RPM Report

Executive Summary

CMS’ coverage policy on erythropoietin has huge commercial implications for Amgen and J&J. It is also a wake-up call for the rest of the industry: there are now two regulators who control the keys to success in the pharmaceutical industry.

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Times Have Changed: FDA Ends ESA REMS Ahead Of First Biosimilars

FDA is ending one of the landmark drug safety programs from the REMS era, announcing it has released Amgen from its mandatory obligations for the erythropoiesis-stimulating agent (ESA) class. The decision comes just ahead of the likely approval of the first biosimilar application in the class.

Times Have Changed: FDA Ends ESA REMS Ahead Of First Biosimilars

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