Notizia - Recent Pharma, Healthcare and Biotech Happenings

Intercept Pharmaceuticals receives a clear rejection from the FDA for its NASH drug, Obeticholic acid (OCA) Intercept Pharmaceuticals announced the issuance of a Complete Response Letter (CRL) by the FDA regarding the New Drug Application (NDA) for Obeticholic acid (OCA) for the treatment of fibrosis due to Non-alcoholic steatohepatitis (NASH). The drug already in the market as Ocaliva to treat primary biliary cholangitis was under clinical trials for treating NASH. After facing so many snags and delays, the outright rejection from the US FDA proved to be another setback.  The NDA submission of the drug was based on data from 35 clinical trials with ...