'Clean Label' For Intercept's Ocaliva In PBC Bodes Well For NASH Claim
By determining a safe dosing regimen for Child-Pugh B and C patients, FDA was able to provide a label almost completely without contraindications despite safety concerns about liver-related adverse reactions.
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With up to $100m from Abingworth and a recent $75m FOPO, CymaBay has runway to await pivotal data in primary biliary cholangitis in 2023 for seladelpar, after the candidate failed in NASH. It sees a significant market opportunity in the second-line setting cornered by Intercept.
The company pointed to cirrhosis benefit and less pruritis in a pooled analysis presented at EASL, which will help it will take on Intercept in primary biliary cholangitis on tolerability, cirrhosis benefit.
In its third venture funding round, Terns adds backing from Deerfield in addition to Lilly’s investment. It licensed three non-alcoholic steatohepatitis candidates from the big pharma in 2018.