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Shionogi & Co. Ltd.

www.shionogi.co.jp

Latest From Shionogi & Co. Ltd.

Keeping Track: A Novel Approval For Fluorodopa F 18, A Tentative Approval For Vumerity, And A Missed Goal Date For Zilretta

The latest drug development news and highlights from our US FDA Performance Tracker.

US FDA Performance Tracker Approvals

Cefiderocol Approval Likely After Panel Vote, But Future Still Clouded

Shionogi's cUTI drug clears US FDA advisory committee by 14-2, though a black box warning is possible after one of the clinical studies showed a potential mortality imbalance disfavoring cefiderocol in other diseases.

Advisory Committees Infectious Diseases

Possible Mortality Imbalance For Shionogi's Cefiderocol On US FDA Panel Agenda

Although cefiderocol demonstrated safety and efficacy in a pivotal trial for complicated urinary tract infections, there was a mortality imbalance between the study drug and comparator arms in a separate descriptive trial; the US FDA is unsure whether the imbalance was a "chance finding."
Advisory Committees Infectious Diseases

PureTech’s Problem-Solving Skills Target The BIG Picture

PureTech Health has amassed niche expertise and built a unique structure that allows it to develop technologies for unmet needs, in the separate but related areas of brain-immune-gut. And now, with the experienced ex-Sanofi CEO Chris Viehbacher as interim chair, PureTech can target a smooth path to its next growth stages in the “BIG Axis.” Senior executives Eric Elenko and Joep Muijrers reveal more about the focus and aims of the Boston, US group.

C-Suite Speaks Business Strategies
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Company Information

  • Industry
  • Pharmaceuticals
  • Therapeutic Areas
  • Blood & Coagulation Disorders & Products
  • Cancer
  • Gynecological, Urological
  • Immune Disorders
  • Infectious & Viral Diseases
  • Metabolic Disorders
  • Neurology, Nervous System
  • Respiratory, Pulmonary
  • Alias(es)
  • Ownership
  • Public
  • Headquarters
  • Worldwide
    • Asia
      • Pacific Rim
        • Japan
  • Company Type
  • Top Japanese Pharma
  • Parent & Subsidiaries
  • Shionogi & Co. Ltd.
  • Senior Management
  • Isao Teshirogi, PhD, Pres. & CEO
  • Contact Info
  • Shionogi & Co. Ltd.
    Phone: (81) 6 6202 2161
    1-8, Doshomachi 3-chome
    Chuo-ku
    Osaka, 541 0045
    Japan
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