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Latest From Alkermes plc

Intercept’s Ocaliva Falls At US FDA Panel; Is Accelerated Approval Withdrawal On The Horizon?

Obeticholic acid has not confirmed clinical benefit and the benefit-risk profile is not favorable in primary biliary cholangitis, the FDA advisory committee said. The agency must now decide whether to keep Ocaliva on the market with new study requirements or seek withdrawal.

Advisory Committees Liver & Hepatic

J&J’s Tremfya Gains First IBD Indication, Setting The Stage For A Big Pharma Showdown

The IL-23 inhibitor was approved by the US FDA for ulcerative colitis, joining AbbVie’s Skyrizi and Lilly’s Omvoh.

Approvals Regulation

Focus On Cardio-Oncology, Clinical Trends And AI At ESC 2024

Updated guidance on the risk of cardiotoxicity in patients following cancer treatment is expected soon. The first consensus guidelines were issued eight years ago. AI is being used for early risk identification, Philips said during the European Society of Cardiology congress 2024.

Innovation Cardiovascular

‘New Kenvue In Action Unleashed’ Isn’t The Business Consumers Remember From J&J

“We're significantly investing more in reaching more consumers, but we're doing it in a very different way,” says CGO Charmaine England. Brands may be “iconic,” but on their own they’re not driving sales growth, says CEO Thibaut Mongon.

Ad Campaigns Consumer
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