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Latest From Genfit SA

US FDA Picks Up The Pace Of Complete Response Letters Over June And July

The year began with an unusually low number of CRLs, but a recent burst of non-approval actions suggests a COVID-19 effect.

Complete Response Letters US FDA Performance Tracker

CymaBay’s Stalled Seladelpar Back In Play For PBC

Weeks after lifting of an FDA clinical hold, CymaBay says it will resume development of its PPAR agonist in primary biliary cholangitis. It will initiate a new Phase III trial but also use data from a terminated Phase III study.

Clinical Trials Drug Approval Standards

Genfit Not Fully Exiting NASH, Despite Terminating RESOLVE-IT

A fuller look at interim Phase III data shows no path forward to accelerated approval in NASH, company says. Genfit turns focus to developing elafibranor for PBC, as well as a NASH diagnostic.

Business Strategies Clinical Trials

ICER Determines OCA’s Benefit In NASH Might Support Limited Approval

The cost-effectiveness watchdog group sees the fibrosis benefit with Intercept’s obeticholic acid as supporting use in sicker NASH patients, but its overall risk-benefit ratio doesn’t merit broader use.

Cost Effectiveness Drug Safety
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