Litigation In Brief
Antioxidant claims basis for FDA suit: In his third lawsuit filed against FDA in less than a month, attorney Jonathan Emord alleges FDA "created a rigid construct that categorically rejects a large quantum of peer-reviewed science," namely qualified health claims linking antioxidant vitamins C and E with reduced risk of site-specific cancers. Emord's 1complaint, filed Aug. 14 in the U.S. District Court for the District of Columbia, says FDA violated First Amendment-based precedent in denying the claims for which he petitioned in 2008. As with the similar recent suit Emord filed against FDA for rejecting selenium QHCs, the Clifton, Va.-based attorney represents the Alliance for Natural Health U.S., the Coalition to End FDA and FTC Censorship, and businesspeople Durk Pearson and Sandy Shaw (2"The Tan Sheet" Aug. 3, 2009, In Brief)
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Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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A new pilot aims to take Brazil closer to ‘digital transformation.’
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While treatments for scleroderma are in development, none are approved for the condition that is associated with high morbidity and mortality. The European Medicines Agency says guidance on how to design development programs for the disorder is needed.
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Highlights from Day Four of the BIO International Convention include policy concerns helping constrain dealmaking, Novartis discussing its approach to partnering, and Generate looking for funding to move into Phase III.