Best of the Blog: IN VIVO, April 2008
Executive Summary
"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?
You may also be interested in...
A CERA-ous Challenge to Amgen's EPO Franchise?
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.
Shadow FDA? Researchers Are Taking Approval Matters into their Own Hands
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.
FTC’s New Commissioner, Alvaro Bedoya, May Bolster Tougher Stance On Pharma Oversight
Democrats gain majority on Federal Trade Commission with Bedoya’s swearing in. His positions on technology and digital privacy suggest he will align with commissioners who have advocated stricter review of pharma mergers.