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Best of the IN VIVO Blog, October 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 October, Windhover's editorial staff posted 36 articles to the site, covering biopharma, device and diagnostics R&D, business development, regulatory and commercial news. A few of our favorite blog posts include: Lilly's Prasugrel Delay; Glaxo has Seen the Future and the Future is Mouthwash; and FDA Has a New Guard Dog and He's a Wolfe.

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Vitae's Debt Financing: Crucial Lifeline in a Tightening Financial Market

Roughly one week after GlaxoSmithKline gave Vitae Pharmaceuticals back rights to its renin inhibitor, the biotech signed a $13 million loan deal with Silicon Valley Bank and Oxford Finance, providing a cash runway at least into 2010. The cash lifeline was relatively small in dollar value but significant for even happening in the first place. The hard economic times have all but shut down the venture capital supply, leaving serious questions about money strategies for other biotechs.

Pharma's Strategic Divide: Focus or Diversify

It looks like the biggest strategic gulf in the industry: focus or diversify? If the CEO thinks he can't rely on R&D to grow his way out of the industry's revenue hole, get ready to live alongside generics and OTC businesses--though he'll downplay to investors the risks of managing different businesses by stressing the commonalities with the core branded efforts and probably won't move into wholly non-pharma businesses. If he's still committed to R&D--get ready for diversification of other sorts, and some pretty clever financial tactics.

Running Late: FDA Review Timelines Lengthen For New Product Applications

FDA is missing more new drug review deadlines: at least seven in the first eight months of this year. The experiences of those delayed applications indicate some interesting ways to interpret what it means when a user fee date comes and goes without an FDA decision. One clear observation: the longer a sponsor has to wait after the user fee deadline, the worse the likely result.

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