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Latest From Fresenius SE & Co. KGaA

US FDA Formal Dispute Resolution Guides Evolution Of Trials For CKD Complications, Pain

Ardelyx will add to FDA’s growing dispute resolution queue with plan to appeal tenapanor complete response letter; Avenue Therapeutics’ IV tramadol dispute resolution tops out with FDA plea for advisory committee advice.

Review Pathway Drug Review

Vifor/Angion Collaboration On Rocky Ground As ANG-3777 Phase III Trial Fails In Kidney Transplant Patients

Vifor and Angion’s ANG-3777 has failed in a Phase III trial for kidney transplant patients at risk of delayed graft function less than a year after the companies sealed a $80m licencing deal for the product. As focus shifts to another rare nephrological indication, analysts express skepticism.

Clinical Trials Companies

Metacrine’s Shift Means Further Attrition In FXR Agonist Class For NASH

Metacrine halts development of its FXR agonist compounds in NASH and turn its focus to inflammatory bowel disease. Firm plans Phase II ulcerative colitis study in 2022 with MET642.

Business Strategies Drug Approval Standards

Amicus Spins Out Rare Disease Gene Therapy Pipeline, Raises $200m

While Amicus will transfer the gene therapy portfolio’s R&D risk to Caritas, it retains a financial interest in many of the spinout’s programs. Pompe candidate AT-GAA accepted for FDA review.

Business Strategies Deals
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Company Information

  • Industry
  • Distributors
  • In Vitro Diagnostics
  • Medical Devices
  • Pharmaceuticals
  • Services
  • Other Names / Subsidiaries
    • APP Pharmaceuticals, Inc.
    • Asia Renal Care Ltd.
    • Fresenius Kabi Pharmaceuticals Holding, Inc.
    • Fresenius Medical Care
    • Fresenius Medical Group AG
    • Vifor-Fresenius Medical Care Renal Pharma Ltd. (VFMCRP)
    • Xenios AG
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