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Relabeling EPO: Closing the Books on a Safety Issue, Opening a New Chapter at FDA

This article was originally published in RPM Report

Executive Summary

The relabeling of Aransep and Procrit to address safety issues is taking longer than expected. There's nothing new about that. What is new is how FDA weighed in on the Congressional debate over coverage for the anemia therapies-and how the last step of the regulatory process is likely to play out.

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Cut to the Bone: Amgen Faces Further Aranesp Decline Ahead of Denosumab

When it comes to Amgen, all eyes are on denosumab. That's as it should be: Amgen's future rides on the potential blockbuster. But investors shouldn't lose sight of Amgen's past and present: how the company manages the continued threats to Aranesp have important lessons for the biopharma sector as a whole-and for denosumab too.

Cut to the Bone: Amgen Faces Further Aranesp Decline Ahead of Denosumab

When it comes to Amgen, all eyes are on denosumab. That's as it should be: Amgen's future rides on the potential blockbuster. But investors shouldn't lose sight of Amgen's past and present: how the company manages the continued threats to Aranesp have important lessons for the biopharma sector as a whole-and for denosumab too.

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