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ESAs in Renal Disease: Amgen Braves an Advisory Committee Storm With Another Regulator in Mind

This article was originally published in RPM Report

Executive Summary

An FDA panel was convened to re-evaluate the cardiovascular risks associated with Amgen’s Aranesp and the ESAs after a third clinical trial showed CV endpoints going in a negative direction. The company was able to emerge from the meeting with a near-best case scenario. That’s critical with a CMS coverage decision looming.

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Amgen's Denosumab: Quick Takes from FDA's Advisory Committee Meeting

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Amgen's D-mab: The New EPO

D-mab is the new EPO. At least, that's what Amgen is hoping as it awaits FDA approval for its next growth engine, denosumab (D-mab). Assuming the drug gets to market--and Amgen is very confident it will--the drug's success will depend largely on pricing.

Amgen's Biotech Shopping Spree

It was always a question of when, not if. Amgen needed to do something to provide for its post-EPO future; now the action has started. The big biotech went on a $720 million cash shopping spree in the early part of June, buying first Ilypsa Inc. for $420 million, then swallowing up Alantos Pharmaceuticals for $300 million a couple of days later.

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