'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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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.
With an FDA clinical hold lifted, CymaBay plans to initiate a new Phase III in primary biliary cholangitis early in 2021. It also hopes to partner the drug in NASH with a company developing a metabolic drug for the disease.