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To Market Or Not To Market? Roche Fights Amgen Patent Litigation

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

While FDA's review of the Mircera BLA offers a focal point for the agency's battle to keep ESA labeling abreast of ESA science, the Mircera molecule itself may not see the U.S. market.

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Redeeming a priority review voucher obtained by developing a drug for a tropical disease will cost companies $6.1 million in fiscal 2011

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