'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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Life After NASH For CymaBay: An Interview With CEO Sujal Shah
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.
CymaBay Builds Seladelpar Case In PBC, But Door Not Closed On NASH
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.
Terns Raises $87m More For NASH R&D, Including Lilly Equity Purchase
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.