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European Medicines Association (EMA) statement on Obeticholic acid (Ocaliva) for the treatment of primary biliary cholangitis (PBC)


The European Medicines Association (EMA) issued a statement on Obeticholic acid (Ocaliva) for the treatment of primary biliary cholangitis (PBC) on 28 06 2024. 

The EMA has recommended that the marketing authorisation for Ocaliva be revoked in the European Union following results of the COBALT trial, 747-302 .  In the UK EMA recommendations do not apply, as we are regulated by the Medicines and Healthcare products Regulatory Agency (MHRA). At present, there are no changes to the recommendations on use of Obeticholic acid in PBC from the MHRA or the National Institute for Health and Care Excellence (NICE) and so current prescribing practices should NOT change.

We shall update the UK liver community if there are any changes to the recommendations on the use of Obeticholic acid.

View the full statement here.

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November 11, 2025

Applications open for BSG Mentoring Lead

Applications are now open for the role of BSG Mentoring Lead from December 2025.

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November 10, 2025

BSG Member Professor Alan Lobo Shortlisted for National Leadership Award

Professor Alan Lobo, Consultant Gastroenterologist at Sheffield Teaching Hospitals NHS Foundation Trust, Professor of Gastroenterology at the University of Sheffield, and a longstanding member of the British Society of Gastroenterology (BSG), has been named a finalist for Clinical Leader of the Year at the 2025 Health Service Journal (HSJ) Awards.

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November 05, 2025

We are inviting expressions of interest to join a Clinical Endoscopists Working Group

We are keen to give our clinical endoscopist members a louder voice within the BSG. Could you represent regional colleagues on issues important to you, including workforce, training, education and research?