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Sarepta Therapeutics Inc.

Latest From Sarepta Therapeutics Inc.

The Eteplirsen Precedent: No Denying It – So Let’s Define It

US FDA allowing Sarepta to seek accelerated approval for follow-on DMD agent – following 'precedent' set by eteplirsen. Now the new challenge is to define exactly what that precedent is.

Drug Approval Standards Drug Review

Refining A Controversial Endpoint: Sarepta Banking On Dystrophin Levels For Golodirsen Approval In DMD

While glodirsen did show higher levels of dystrophin production than eteplirsen did, increase is still unlikely to satisfy US FDA reviewers who disagreed with Janet Woodcock's decision to grant accelerated approval to eteplirsen.
Drug Approval Standards Drug Review

PTC’s Ataluren and Accelerated Approval: Is Eteplirsen A Precedent After All?

US FDA appears willing to consider accelerated approval for PTC's Duchenne Muscular Dystrophy therapy ataluren if company is able to provide compelling evidence of increased levels of dystrophin in boys with nonsense-mutation DMD. That is quite a reversal from the agency’s view heading into PTC’s appeal. 
Drug Approval Standards Rare Diseases

Outcomes-Based Contract By Harvard Pilgrim For Testing Could Be Model For Pharma

Prenatal testing services provider IIlumina commits to fund study on whether cost of expanding use of test is offset by reduction in spending on traditional screening practices.

Market Access Pricing Debate
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Company Information

  • Industry
  • Biotechnology
    • Antisense, Oligonucleotides
    • Large Molecule
  • Pharmaceuticals
    • Vaccines
  • Therapeutic Areas
  • Infectious & Viral Diseases
  • Musculoskeletal & Connective Tissue Disorders
  • Neurology, Nervous System
  • Alias(es)
  • AVI BioPharma Inc.
  • Ownership
  • Public
  • Headquarters
  • Worldwide
    • North America
      • USA
  • Parent & Subsidiaries
  • Sarepta Therapeutics Inc.
  • Senior Management
  • Douglas Ingram, Pres. & CEO
    Sandesh Mahatme, EVP, CFO & Chief Bus. Officer
    Bo Cumbo, SVP, Chief Commercial Officer
    Shamim Ruff, SVP, Reg. Affairs & Quality
    Catherine Stehman-Breen, MD, CMO
    Guriqbal Basi, PhD, SVP, CSO
  • Contact Info
  • Sarepta Therapeutics Inc.
    Phone: (617) 274-4000
    245 First St.
    Cambridge, MA 02142