Best of the Blog: IN VIVO, February 2008
Best of the Blog is a monthly column highlighting the best of our online content at www.windhover.com/blog. In February, Windhover's staff posted 52 articles to the site, covering biopharma, device and diagnostics R&D, business development, regulatory, and commercial news.
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Lilly is in a race against the clock: it is counting on prasugrel to carve out a blockbuster position in the anti-clotting market before 2011. That is when Plavix generics will complicate the anti-clotting marketand Zyprexa generics will complicate Lilly's outlook. But will FDA go along with Lilly's schedule?
Approval letters are down, "approvable" and "non-approvable" letters are up. "Black box" warnings have seen a four-fold increase over the last five years. Biopharma executives are now drawing their own conclusions about the state of FDA regulation-based on the numbers.
Amgen's string of misfortunes has highlighted the group's need to find an alternative growth engine--one which will, necessarily, look very different from the current anemia franchise. The biotech is leaning too heavily on osteoporosis and cancer candidate denosumab.