Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

Latest From Catalent, Inc

Product Quality ‘Wild Card’? Sarepta’s Gene Therapy Manufacturing Process Change Means More Empty Capsids

SRP-9001 intended for commercialization is not analytically comparable to the product used in earlier clinical studies; FDA CMC reviewer said agency does not mandate the extent of empty or full capsids but, instead, looks at the totality of data to assess safety and efficacy.

Advisory Committees Gene Therapy

Gene Therapy: Four-Month Lag In Commercial Access Protects EMBARK Study, Sarepta Says

Company’s prediction that Duchenne muscular dystrophy patients likely would not be able to access SRP-9001 until four months after accelerated approval eased some US FDA panelists’ concerns about interference with the ongoing confirmatory trial.

Advisory Committees Gene Therapy

Gene Therapy: Four-Month Lag In Commercial Access Protects EMBARK Study, Sarepta Says

Company’s prediction that Duchenne muscular dystrophy patients likely would not be able to access SRP-9001 until four months after accelerated approval eased some US FDA panelists’ concerns about interference with the ongoing confirmatory trial.

Advisory Committees Gene Therapy

Sarepta Prepared For DMD Gene Therapy Launch Despite Regulatory Setbacks

Despite obstacles on the regulatory path for the firm’s Duchenne muscular dystrophy gene therapy, analysts and Sarepta itself seem confident about accelerated approval prospects, with plans already in place for launch.

Gene Therapy Sales & Earnings
See All

Company Information

  • Industry
  • Contract Research, Toxicology Testing-CRO
  • Services
  • Pharmaceuticals
    • OTC, Consumer
    • Drug Delivery
      • Controlled Release
      • Macromolecule
  • Biotechnology
    • Drug Discovery Tools
    • Large Molecule
    • Synthesis Technologies, Production Processes
  • Other Names / Subsidiaries
    • Accucaps Industries Limited
    • Catalent U.K. Swindon Zydis Limited
    • Cook Pharmica LLC
    • Juniper Pharmaceuticals
    • Molecular Profiles Ltd.
    • Columbia Laboratories, Inc.
UsernamePublicRestriction

Register