Best of the Blog: IN VIVO, January 2009
Best of the Blog is a monthly column highlighting the best of our free online content at www.windhover.com/blog. In January, Windhover's editorial staff posted 48 articles to the site, covering biopharma, device and diagnostics R&D, business development, regulatory and commercial news. Highlights included our ongoing coverage of Pfizer's acquisition of Wyeth as well as dispatches from the JP Morgan meeting in San Francisco. And we awarded IN VIVO Blog's Deal of the Year. Here are a few of our favorite blog posts and excerpts for stories not covered elsewhere in this month's IN VIVO.
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Not satisfied with its R&D experiments to date, GSK has taken its most radical step yet toward re-creating biotech within its walls: even smaller units complete with investment boards occupied by external VCs and CEOs and milestone-based funding and external VCs.
US FDA looks to post-marketing studies to address elements of the NDA that were not central to its initial swift approval as the first COVID-19 therapy, including pediatric use and the interaction of hepatotoxicity and dose duration.
But advisory committee members caution against including pediatric population in COVID-19 vaccine trials, and one member expresses concern that Pfizer is testing those as young as 12 years of age. Agency is in discussions with product sponsors about enrollment of adolescents.