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262,814 Results for "intercept pharmaceuticals".
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Regulatory
FDA Pushes Back PDUFA Dates for Amgen and Intercept
The regulator has delayed its respective decision dates on whether to grant full approval to Amgen’s Lumakras in metastatic colorectal cancer and Intercept Pharmaceuticals’ Ocaliva for primary biliary cholangitis.
October 18, 2024
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2 min read
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Tristan Manalac
Adcomms
Intercept’s Ocaliva in Jeopardy as FDA Questions Efficacy, Safety Ahead of Adcomm
With a Friday advisory committee meeting looming, the sole indication for Intercept Pharmaceuticals’ Ocaliva appears to be at risk as the regulator flags issues regarding its post-marketing results.
September 12, 2024
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2 min read
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Tristan Manalac
Postmarket research
Intercept’s Troubled Drug Ocaliva Linked to ‘Serious Liver Injury’: FDA
Ocaliva recently failed to secure the FDA’s traditional approval for primary biliary cholangitis due to safety concerns.
December 13, 2024
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2 min read
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Tristan Manalac
Drug Development
Intercept Announces New Data to be Presented at the European Association for the Study of the Liver (EASL) Congress 2024
Intercept Pharmaceuticals, Inc. announced nine abstracts related to primary biliary cholangitis and alcohol-related liver disease will be presented at EASL Congress 2024.
May 29, 2024
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12 min read
Deals
Alfasigma completes acquisition of Intercept Pharmaceuticals, Inc.
Alfasigma S.p.A. (“Alfasigma”) and Intercept Pharmaceuticals, Inc. (“Intercept”) announced today the completion of the acquisition of Intercept by Alfasigma through its wholly owned subsidiary Interstellar Acquisition Inc.
November 8, 2023
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12 min read
Press Releases
Intercept Provides Regulatory Update Regarding sNDA for OCALIVA
October 18, 2024
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8 min read
Pharm Country
Intercept Announces New PBC Data Analyses to be Presented at Digestive Disease Week® 2024 Conference
Intercept Pharmaceuticals, Inc., a biopharmaceutical company and wholly owned subsidiary of Alfasigma S.p.A. focused on the development and commercialization of novel therapeutics to treat rare and serious liver diseases, announced five abstracts on primary biliary cholangitis will be presented at Digestive Disease Week® 2024.
May 9, 2024
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4 min read
Pharm Country
Intercept Presents New Sub-Analyses of Phase 3 POISE Data Showcasing the Effect of OCA on Key Liver Biomarkers and Fibrosis in Patients with PBC at Digestive Disease Week® 2024
Intercept Pharmaceuticals, Inc. is presenting two new sub-analyses from its Phase 3 POISE study in primary biliary cholangitis (PBC), at Digestive Disease Week® (DDW) 2024 in Washington, D.C.
May 20, 2024
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13 min read
Drug Development
Intercept Presents New Sub-Analyses of Phase 3 POISE Data Showcasing the Effect of OCA on Key Liver Biomarkers in Patients with PBC at EASL Congress 2024
Intercept Pharmaceuticals, Inc. announced new sub-analyses from its Phase 3 POISE trial in primary biliary cholangitis showing the effect of obeticholic acid across a number of key biomarkers of liver health in people living with PBC will be presented at the European Association for the Study of the Liver Congress 2024 being held June 5-8, 2024, in Milan, Italy.
June 4, 2024
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12 min read
Pharm Country
Intercept Presents New Data on the Results of OCA-Bezafibrate Combination Therapy in PBC After Six Months of Treatment in Late-Breaking Poster Presentation at EASL Congress 2024
Intercept Pharmaceuticals, Inc. today announced new data from a planned six-month analysis of its ongoing Phase 2 study 747-213 evaluating the combination of obeticholic acid (OCA) and bezafibrate in patients with primary biliary cholangitis (PBC) at the European Association for the Study of the Liver (EASL) Congress 2024 being held June 5-8, 2024, in Milan, Italy.
June 5, 2024
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11 min read
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