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The Rebirth of A Niche Product: Three Silver Linings on the ESA REMS

The long-awaited Risk Evaluation & Mitigation Strategy for Aranesp and Procrit is here. For the oncology indication, it requires provider training program enrollment. It may not seem like the best outcome for Amgen and J&J, but there are some upsides.

Neither Amgen nor Johnson & Johnson could possibly have imagined three years ago that they would be registering oncologists in a program intended to curtail use of two blockbuster products, the erythropoiesis stimulating agents Aranesp (darbepoetin) and Procrit (epoetin).

But, after a long and difficult period of safety scrutiny, that is exactly what the companies are doing, thanks to...

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