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FDA’s Ocaliva Blow Spells Changes In Primary Biliary Cholangitis Landscape

Gilead’s Livdelzi, Ipsen’s Iqirvo To Gain

 
• By Vibha Ravi

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

Human Liver Model

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.

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Miguel Forte, CEO of Kiji Therapeutics, tells the Pink Sheet why he is confident in the future of gene therapies, despite the global “turmoil” that is impacting investment in the industry and changes to the EU and US regulatory landscapes.

Companies Advised To Assess Potential Impacts Of Landmark Global Pandemic Treaty

 
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