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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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February 18, 2025

BSG 2025 Elections

The BSG 2025 Elections are opening on 7th March. There are a number of elections for BSG Sections that are open including Trainees and AGIP, Higher Committee representative roles, and Clinical Research Groups.

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February 13, 2025

BSG LIVE'25 Jobs Fair

As part of an ongoing commitment to support the gastroenterology and hepatology workforce, the BSG is launching a pilot ‘Jobs Fair’ at BSG LIVE conference in Glasgow, on Thursday 26th June 2025. Trusts will have the opportunity to showcase consultant and sub-specialty fellowship positions to delegates at the largest gastroenterology event in the UK.

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February 05, 2025

Apply for the Web Education Online Deputy Editor role

The BSG Education Committee is looking for a BSG member to join the BSG Education Online Editorial team as a Web Education Online Deputy Editor.