Best of the Blog: IN VIVO, November 2008
Best of the Blog is a monthly column highlighting the best of our free online content at www.windhover.com/blog. In November, Windhover's editorial staff posted 28 articles to the site, covering biopharma, device and diagnostics R&D, business development, regulatory and commercial news. Highlights included advice from our mothers on how to defrost a Thanksgiving turkey as well as our coverage of the US Presidential election and how it might impact our industry.
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FDA has used its new authority to impose a Risk Evaluation and Mitigation Strategy on one-third of all new molecular entities approved since the REMS provisions of the FDA Amendments Act took effect at the end of March
You have to go back to 1983 to find a year as bad as 2007 for R&D output. It was a terrible year by any measure. The key question for industry: does it need to learn to subsist on a trickle of new drugs coming to market each year, or is the current drought in fact a sign of a transition to a new, more innovative R&D model? The sparse class of 2007 does offer some glimmers of hope.
American Injectables plans to build up its US-based manufacturing after securing a commitment for $10m of ‘Series A’ financing from New Rhein Healthcare Investors, which it will use to scale up production and launch several generic parenteral products.