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Galmed Pharmaceuticals Ltd.

http://www.galmedpharma.com/

Latest From Galmed Pharmaceuticals Ltd.

No Read-Through Expected: NASH Field Unfazed By Intercept’s FDA Rejection

Execs from Madrigal, Cirius and Axcella say the FDA’s complete response letter is specific to shortcomings of Intercept’s OCA – and leaves the race to be first to market wide open again.

Business Strategies Drug Approval Standards

Intercept’s CRL Just Continues Upheaval In NASH

With approval timeline for OCA now thoroughly unclear and Genfit on the ropes, might the top spot in NASH end up with Galmed, AbbVie, Madrigal, Inventiva or Gilead instead?

Drug Approval Standards Business Strategies

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
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Company Information

  • Industry
  • Biotechnology
  • In Vitro Diagnostics
  • Pharmaceuticals
  • Other Names / Subsidiaries
    • Galmed Medical Research, Ltd.
    • Galmed International Ltd.
    • Galmed Research and Development Ltd.
    • Galtopa Therapeutics Ltd.
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