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Sage Therapeutics Inc.

www.sagerx.com

Latest From Sage Therapeutics Inc.

REMS Statutory Factors Weighed On Case-By-Case Basis, US FDA Says

US FDA rebuffs PhRMA’s request to clarify how the six statutory factors are weighed and to explain how it decides what a REMS should look like. All six factors are considered together to inform agency’s decision-making on the need for a Risk Evaluation and Mitigation Strategy, according to final version of guidance first issued in 2016.


Risk Management Drug Safety

Keeping Track: Thumbs Up For Zulresso And Sunosi, Thumbs Down For Zynquista And IV Meloxicam

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

Shionogi Stays The Course As It Lays Out R&D Priorities

Japan's Shionogi lays out its R&D priorities, with a continued strategic focus on anti-infectives and CNS drugs, saying it is looking for the approval of four molecules in the coming year.

Research and Development Strategies Japan

Why Biogen/Eisai's Aducanumab Failure Is Not The End Of Amyloid Hypothesis

Biogen and Eisai still have multiple programs testing amyloid-targeting therapies in the treatment of Alzheimer's disease, but pressure for Biogen to focus its efforts elsewhere are mounting after the partners discontinued Phase III studies for aducanumab.

Clinical Trials Neurology
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Company Information

  • Industry
  • Biotechnology
  • Pharmaceuticals
  • Therapeutic Areas
  • Neurology, Nervous System
  • Alias(es)
  • SAGE Therapeutics Inc.
  • Ownership
  • Public
  • Headquarters
  • Worldwide
    • North America
      • USA
  • Parent & Subsidiaries
  • Sage Therapeutics Inc.
  • Senior Management
  • Jeffrey M Jonas, MD, CEO
    Kimi Iguchi, CFO
    Albert J Robichaud, PhD, CSO
    Stephen Kanes, MD, PhD, CMO
    Amy Schacterle, PhD, SVP, Regulatory Affairs & Quality Assurance
    Jim Doherty, PhD, Chief Research Officer
    Mike Cloonan, Chief Bus. Officer
  • Contact Info
  • Sage Therapeutics Inc.
    Phone: (617) 299-8380
    215 First St.
    Cambridge, MA 02142
    USA
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