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Gemzar Ovarian Cancer Negative Review Shows Discomfort With Ex-U.S. Data

Executive Summary

The Oncologic Drugs Advisory Committee's negative review of Lilly's Gemzar for treatment of ovarian cancer illustrates the difficulty of receiving approval for submissions based on solely ex-U.S. trials lacking FDA input on design

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Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011

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