HHS lacks authority to approve Vermont Pharmacy Discount Program demonstration project extending Medicaid drug rebate structure to 70,000 beneficiaries without drug coverage, D.C. federal appeals court rules June 8. The opinion reverses Jan. 18 D.C. federal court decision denying the Pharmaceutical Research & Manufacturers of America's request for a preliminary injunction against the program (1"The Pink Sheet" Jan. 29, p. 7). "Because Congress imposed the rebate requirement in order to reduce the cost of the Medicaid program, and because no Medicaid funds are expended under the Vermont demonstration project and thus no Medicaid savings produced by the required rebates, we conclude that the department lacked the authority to approve the project," the appeals court says
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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.’
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.
