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Avandia and the Commercial Impact of FDA's Credibility Gap

Executive Summary

GlaxoSmithKline's diabetes drug Avandia survived a perilous FDA advisory committee review. The real question is whether the industry can survive the damage to FDA's credibility.

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Biopharma: Reviewing 2007 to Forecast 2008

If there's a theme to many of the top pharmaceutical stories of 2007 it's infrastructure: the crisis of owning too much infrastructure when R&D productivity is at its lowest level since 1983, and the economic power of leveraging someone else's. That's the connection, for example, between: Bristol-Myers "selective integration" strategy and its huge partnering deals with Pfizer and AstraZeneca; the rise of biopharma-focused private equity; the investment boom in China; the emerging strategies focused on reaping value from proof-of-concept development; even the now customary twin-tracking of the IPO/M&A process. Other key events for 2007 that will re-shape the playing field for 2008: the new role of CMS as a partner with FDA in the regulatory process; the continuing importance of large molecules and discovery platforms to Big Pharma; and the strategic restructuring of spec pharma.

FDA Fast Talk: Health Advisories with Unclear Advice

FDA is trying to get safety messages out to consumers more rapidly. A recent warning on Nexium and Prilosec shows how complicated these early warnings can be.

The Race for Avandia's Share: May the Safest Product Win

The safety problems with GlaxoSmithKline's Avandia have left a large chunk of the diabetes market open to competing products, and the outcome of an FDA advisory committee meeting could leave even more up for grabs. Who will be the big winner in the race for market share?

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