Financial Analysts Roundtable Part II: Changes On Capitol Hill, FDA’s Risk Threshold And The Future Of The Cholesterol Market
• By The Pink Sheet
The following excerpts are from a conversation "The Pink Sheet" had with three large cap pharmaceutical analysts, Prudential's Tim Anderson, Goldman Sachs' Jim Kelly and Morgan Stanley's Jami Rubin, concerning the outlook for the drug industry in 2007. 1Kelly and 2Rubin provided "The Pink Sheet" with extensive disclosure statements, which can be accessed by visiting 3www.ThePinkSheet.com. The 4first part of the series, which covered Medicare Part D, big pharma diversification, and the outlook for M&A, appeared in the Feb. 5 issue of "The Pink Sheet."
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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.