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Sarepta Therapeutics Inc.

www.sarepta.com

Latest From Sarepta Therapeutics Inc.

EU Approval Set For Three New Orphans And Lilly’s Emgality; Exondys Appeal Fails

The CHMP has upheld its previous negative opinion on Sarepta’s DMD treatment Exondys, but has given a raft of positive opinions on other novel products, including Lilly’s new migraine prophylactic Emgality, Spark Therapeutics’ gene therapy Luxturna for retinal dystrophy, and Vabomere, The Medicines Co/Rempex Pharmaceuticals’ new antibiotic for severe infections.

Europe Drug Review

US FDA’s Streamlined Drug Approval Packages Shine Less Light On Sponsor Interactions

CDER is no longer proactively posting mid- and late-cycle meeting minutes and certain correspondence with sponsors for new drug and biologic approvals; drugs center says it is focused on ensuring the most scientifically meaningful information is prioritized and posted in a timely manner, but some observers say the change raises transparency concerns.

Drug Review Approvals

CHMP Preview: Lilly, Merck and Bayer Hopeful On Approvals; Sarepta’s Exondys Appeal Result Due

The European Medicines Agency’s key scientific committee, the CHMP, is deciding whether a raft of new products, including Eli Lilly’s galcanezumab, should be approved for sale across the EU. Sarepta’s appeal of the CHMP’s earlier rejection of its marketing application for Exondys is also slated for a decision.

Europe Drug Review

FDA Scientists Give Leadership High Marks; Some Worry About Industry Influence

Union of Concerned Scientists' survey finds 65% of 354 respondents feel their direct supervisors back them on politically contentious positions; Commissioner Gottlieb gets glowing reviews.

FDA BioPharmaceutical
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Company Information

  • Industry
  • Biotechnology
    • Antisense, Oligonucleotides
    • Gene Therapy, Cell Therapy
    • 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
    Gilmore O'Neill, CMO
    Guriqbal Basi, PhD, SVP, CSO
    Louise Rodino-Klapac, PhD, VP, Gene Therapy
  • Contact Info
  • Sarepta Therapeutics Inc.
    Phone: (617) 274-4000
    245 First St.
    Cambridge, MA 02142
    USA
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