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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The 31 May goal date for Moderna’s next-generation COVID-19 vaccine looms over the month, but the US FDA's decision lineup includes three more novel agents, including AbbVie's Teliso-V antibody-drug conjugate, as well as supplemental indications like GSK's bid for Nucala in COPD.
Efforts by the medicines regulator, the MHRA, to clear all backlogs relating to its statutory functions and maintaining predictable review timeframes have put pressure on its staff.
Pharmaceutical companies need to “pressure test” their clinical development strategies early for health technology assessment purposes, particularly in light of the new EU HTA Regulation, a life sciences consultant says.