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Galmed Pharmaceuticals Ltd.

www.galmedpharma.com

Latest From Galmed Pharmaceuticals Ltd.

Provention Announces First Clinical Trial Delay, Others Follow As COVID-19 Concerns Persist

Rather than expose patients and others to SARS-CoV-2, Provention opted to pause a Phase III type 1 diabetes trial. Addex and Iveric have since delayed trial initiations and more studies are likely to be impacted as coronavirus concerns mount.

Clinical Trials Coronavirus COVID-19

Will A US FDA Advisory Committee Be In Intercept's Future?

There are strong reasons to justify an advisory committee meeting for the NASH application, but also an outlet for the US FDA to skip it.

Advisory Committees Drug Review

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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Company Information

  • Industry
  • Biotechnology
  • In Vitro Diagnostics
  • Pharmaceuticals
  • Therapeutic Areas
  • Hepatic (Liver)
  • Metabolic Disorders
  • Alias(es)
  • Galmed International Ltd.
  • Ownership
  • Public
  • Headquarters
  • Worldwide
    • Middle East
      • Israel
  • Parent & Subsidiaries
  • Galmed Pharmaceuticals Ltd.
  • Senior Management
  • Allen Baharaff, Pres. & CEO
    Yohai Stenzler, CFO
    Liat Hayardeny, PhD, CSO
    Tali Gorfine, MD, CMO
    Guy Nehemya, VP, Operations
  • Contact Info
  • Galmed Pharmaceuticals Ltd.
    Phone: (972) 3 693 8448
    16 Tiomkin St.
    Tel Aviv, 6578317
    Israel
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