Best of the Blog: IN VIVO, April 2008
"Best of the Blog" is a monthly column highlighting the best of our free online content at www.windhover.com/blog. In April: Televancin Delayed by Grassley's Ketek Data Integrity Rule; Diabetes Drug Development and Regulatory Risk: Why the Guidance May Be Good News; and Mircera: Bad for Patents, Good for Patients?
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How serious is the follow-on biological challenge from Roche's CERA to Amgen Inc.'s $6 billion erythropoietin (Epogen) franchise? Serious enough to move Amgen from a growth favorite to a biotech bargain. Serious enough to threaten the ability of Amgen and Procrit manufacturer Johnson & Johnson Inc. to find new dollars in the EPO world market in 2009 and beyond.
Drug and biotech companies will face an emerging trend of outside interference on pending drug reviews at FDA. The events surrounding the final outcome of FDA's review of Bristol-Myers Squibb and Merck's diabetes drug muraglitazar (Pargluva) signal that outside medical centers and prominent researchers will voluntarily play a larger role in drug safety oversight in the future.
FDA concluded that original formulation of brain hemorrhage treatment was not discontinued for safety or effectiveness reasons, saying Arbor had other options to reduce risk of confusion between the new and original formulations. But the sponsor argues that withdrawal was part of FDA-approved risk mitigation plan.