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Madrigal Pharmaceuticals Inc.

www.madrigalpharma.com

Latest From Madrigal Pharmaceuticals Inc.

Gilead’s Bad Luck In NASH Continues With ATLAS Failure

None of the two-drug combinations tested by Gilead met statistical significance in the multi-arm non-alcoholic steatohepatitis trial. This follows the Phase III failure of selonsertib monotherapy earlier in 2019.

Clinical Trials Business Strategies

Zydus Cadila Strides Ahead With NASH Filing In India

Cadila has filed for approval of saroglitazar for NASH in India. The drug, which could emerge as the first medicine for the indication if approved, is already being used by a million Indian patients for diabetic dyslipidemia and hypertriglyceridemia.

 

Policy & Regulation Liver & Hepatic

Intercept’s NASH NDA Positions OCA For May 2020 Approval, Then Launch

Intercept hopes to be first to market in NASH with an indication to treat fibrosis. It also is enrolling a study to show a benefit in NASH patients with cirrhosis.

Drug Approval Standards Clinical Trials

Intercept Could Face Tougher Road To NASH Approval In EU Than US

Recently filed NDA for obeticholic acid relies on US FDA's specified endpoints for treatment of fibrosis, but European standards are less clear cut, the company acknowledges.

Drug Approval Standards Clinical Trials
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