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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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July 30, 2025

Call for UEG Elections 2025

We’re inviting expressions of interest for the upcoming UEG Council Elections, taking place during UEG Week in Berlin on Saturday, October 4, 2025.

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July 15, 2025

Opportunity to contribute to "Gut Highlights" as an ambassador

The BSG publishes a monthly 'Gut Highlights' covering interesting articles from the journal each month in IBD, Hepatology, Endoscopy, HPB and Nutrition. We are looking for new contributors to this successful series.

news and updates Liver News
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July 09, 2025

BSG Travelling Fellowship – AASLD and visit to the National Institute of Health in Baltimore

This fellowship aims to offer an opportunity for a trainee who has a strong interest in Hepatology to attend AASLD’s Liver Meeting in Washington DC, USA in November 2025 to see the latest research and clinical updates in Hepatology.