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Sage Therapeutics Inc.

Division of SAGE Therapeutics Inc.
www.sagerx.com

Latest From Sage Therapeutics Inc.

Janssen’s Esketamine Gets US FDA Panel Endorsement, But With Pricing, Access And Diversion Concerns

Committee overwhelmingly supports approval for treatment-resistant depression but warns that pricing and combination therapy indication could hinder patient access. Esketamine’s risks of sedation and dissociative effects, and its abuse potential, will necessitate a strict risk management strategy.

Advisory Committees Drug Review

Janssen’s Esketamine: US FDA Panel To Weigh Efficacy, REMS Restrictions For Treatment-Resistant Depression

FDA proposes requiring that healthcare facilities monitor patients for sedation and dissociative effects for two hours after self-administration; reliance on a randomized withdrawal trial as one of two adequate, well-controlled studies to support approval would be a first in the depression setting.

Advisory Committees Drug Review

Hazards Ahead For New Drugs At US FDA Amid Safety Concerns, Shutdown Disruption

The pipeline for new drug candidates remains healthy as 2019 begins, with almost 40 novel agents already under FDA review. But the chances of another record-breaking year are threatened by a confluence of safety issues that are putting risk management back in the spotlight – and by the widening ripple effects of the recent US government shutdown.

Drug Review Approvals

Q4 Earnings Preview: Pfizer, Amgen, Allergan, Biogen And Novartis

Pfizer's fourth-quarter call will be the first with new CEO Albert Bourla, while Amgen will provide reassurances after US Neulasta and Epogen biosimilar launches. Also, concerns swirl around the impending impact of generics on Allergan's blockbuster Restasis, Biogen investors await news on Alzheimer's programs and M&A, and Novartis will face scrutiny of recent launches.

Sales & Earnings Companies
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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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