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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

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.

The Value of Knowing: CMS Rejects Coverage of Lilly’s Amyvid – Except As Tool For Further Research

CMS is proposing to deny coverage of Lilly’s Alzheimer’s “rule-out” diagnostic Amyvid. The decision is important for biopharma manufacturers for several reasons, both as a demonstration that the agency really will refuse to pay for FDA approved drugs—and for how CMS thinks it can actually use its authority to encourage research on effective AD therapies.

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