While analysts were divided on whether there were broader implications for non-alcoholic steatohepatitis (NASH) R&D following the complete response letter that Intercept Pharmaceuticals Inc. revealed on 29 June, executives from three companies with mid-stage or later NASH candidates think the US Food and Drug Administration’s concerns are specific to Intercept and its drug, obeticholic acid (OCA).
No Read-Through Expected: NASH Field Unfazed By Intercept’s FDA Rejection
Execs from Madrigal, Cirius and Axcella say the FDA’s complete response letter is specific to shortcomings of Intercept’s OCA – and leaves the race to be first to market wide open again.
More from Strategy
• By
AstraZeneca remains committed to investing in R&D and alliances in China, where Susan Galbraith, the UK major’s head of oncology R&D, sees innovation eventually reaching parity with the US and Europe.
• By
The US FDA approved anti-CD19 antibody Uplizna, from Amgen’s $27.8bn purchase of Horizon in 2023, for IgG4-related disease – a larger market than its original NMOSD indication.
• By
BeiGene’s Phase III ociperlimab joins the list of failed TIGIT inhibitors, as candidates from Roche, Merck & Co. and others have failed late-stage studies.
• By
The German firm’s chairman, Hubertus von Baumbach, is adopting a ‘wait-and-see’ approach to the threat of pharma tariffs.
More from Business
• By
The German firm’s chairman, Hubertus von Baumbach, is adopting a ‘wait-and-see’ approach to the threat of pharma tariffs.
• By
Trump announced a 26% reciprocal tariff on India but a country-agnostic exemption of pharmaceuticals implies that the interests of Indian firms and the US consumer are protected for now. What is Indian pharma’s business exposure and what is domestic industry saying?
• By
Industry lobbied for pharmaceuticals to be exempt from Trump’s sweeping US tariffs and the effort appears to have paid off. J&J, Lilly and Merck & Co. even got shout outs.