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Eisai Inc.

Division of Eisai Co. Ltd.
us.eisai.com

Latest From Eisai Inc.

Importation, Pricing Policies Raised Concerns For US FDA's Project Orbis

Allowing multi-regulator collaboration on oncology application assessment may run into pricing issues if Canada and Australia gain access to novel drugs before European countries, US FDA's Pazdur says.

Pricing Debate Drug Review

'Project Orbis' Oncology Pilot Eventually Will Target 'Major Impact' Applications

But US FDA is starting small, OCE Director Pazdur says. Program will hand-select approve high-priority oncology treatments that have to potential to change the standard of care.

Cancer Drug Review

US FDA’s Project Orbis Could Streamline Global Clinical Trials In Cancer

Richard Pazdur tells the Pink Sheet that program for concurrent submission of oncology applications and collaborative review by global regulators also could speed approval in smaller countries; first applications under Project Orbis were for use of Lenvima/Keytruda combination for endometrial cancer in US, Canada, and Australia.

Drug Review Review Pathway

Keeping Track Of Non-Oncology Review and Approval News: Erectile Dysfunction, Parkinson's, Cholesterol

The latest non-oncology drug development news and highlights from our US FDA Performance Tracker.
Drug Review Regulation
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Company Information

  • Industry
  • Pharmaceuticals
  • Therapeutic Areas
  • Cancer
  • Gastrointestinal
  • Neurology, Nervous System
  • Alias(es)
  • Ownership
  • Private
  • Headquarters
  • Worldwide
    • North America
      • USA
  • Parent & Subsidiaries
  • Eisai Co. Ltd.
  • Senior Management
  • Ivan Cheung, Chmn. & CEO
    Patrick Coyle, VP, CFO
    Shaji Procida, Pres. & COO
  • Contact Info
  • Eisai Inc.
    Phone: (201) 692-1100
    100 Tice Blvd.
    Woodcliff Lake, NJ 07677
    USA
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