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Intercept Pharmaceuticals, Inc.

http://www.interceptpharma.com

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Intercept Offloads Ex-US Business To Advanz, May Be Doubling Down On NASH In US

Still working to refile its NASH fibrosis NDA 22 months after an FDA complete response letter, Intercept gets $405m up front for its ex-US business, including commercial rights to Ocaliva in PBC.

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Excuses, Excuses: How ‘Delayed’ Confirmatory Trials Are Explained By FDA

US FDA currently reports about two dozen Accelerated Approval having ‘delays’ in the confirmatory trials. COVID is one factor in some – and the agency also appears to be clearing out some of the others.

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Keeping Track: US FDA Approves Carvykti, Vonjo, But Turns Down Lenacapavir, Filsuvez And GC1507

The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.

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Ipsen Seeks Success Outside Big Pharma's Hunting Grounds

David Loew has assembled a strong business development team which secured seven licensing pacts in 2021 and the Ipsen CEO tells Scrip that this year should see more of the same.

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