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Latest From Kissei Pharmaceutical Co., Ltd

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

Finance Watch: Notable Neuroscience VC Deals Include Nura Bio’s $73m Launch

Private Company Edition: Several drug developers targeting neurological diseases raised venture capital recently. In addition to Nura Bio, Encoded Therapeutics revealed a $135m series D round. Also, Longwood closed a $170m fund and Flagship launched Omega Therapeutics with $85m.

Financing Neurology

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
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