Office of Dietary Supplements urged to "continue and expand" research initiative on ephedra safety and efficacy under Senate appropriations bill passed Oct. 11. ODS, NCCAM have commissioned an AHRQ study on ephedra, which could be released as early as August 2002 (1"The Tan Sheet" Aug. 13, p. 10). Appropriations bill also urges ODS to "allocate sufficient funds to expand the number of botanical research centers," with hypericum, echinacea suggested subjects of study. Bill would allocate NCCAM $110 mil. for FY 2002 (2"The Tan Sheet" Oct. 15, 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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England’s Court of Appeal has upheld a Competition Appeal Tribunal’s 2023 finding that Advanz and its former owner Cinven abused their dominant position in the UK market for liothyronine tablets by charging prices that were many orders of magnitude higher than the benchmark for fair pricing.
Linerixibat, GSK's treatment for cholestatic pruritus in patients with primary biliary cholangitis, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.
US FDA critics have long decried the practice of using informal communications to convey regulatory expectations as podium policy. In the Makary era, the phrase may need to be updated because the agency now seems to be specializing in policy by podcast.