The likelihood of Alfasigma subsidiary Intercept Pharmaceuticals withdrawing its primary biliary cholangitis treatment Ocaliva (obeticholic acid) got stronger following the US regulator’s fourth safety alert since an accelerated approval in 2016.
FDA’s Ocaliva Blow Spells Changes In Primary Biliary Cholangitis Landscape
Gilead’s Livdelzi, Ipsen’s Iqirvo To Gain
The landscape for primary biliary cholangitis or cirrhosis, PBC, is set to change if Intercept withdraws Ocaliva, which received its fourth safety alert from the US FDA and lost conditional marketing authorization in EU. Pink Sheet studies data from Citeline’s Pharmaprojects and separately Evaluate Pharma to reveal a promising clinical trials landscape and a sizeable market
More from Rare Diseases
More from Market Access
• By
England’s health technology assessment institute, NICE, is looking to “reimagine” its evaluation process with the help of AI, rather than just using this technology to speed up its existing processes.
• By
Calley Means defended reductions in force at the Health and Human Services Department that shocked and outraged federal workers and stakeholders.
• By
CMED, which sets medicine prices in Brazil, has published the maximum price adjustment index for 2025.