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Abeona Therapeutics Inc.

www.abeonatherapeutics.com

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Industry and academic representatives shared viewpoints at Biotech Week Boston in September 2018, including what is unique about deal-making in the cell and gene field.

Regenerative Medicine Deals

RMAT Designation Requests May Rise Or Fall On Manufacturing Changes, Clinical Data Breadth

Product characterization questions and partial or inconsistent clinical data are among the more common reasons why the US FDA denies, or seeks additional information about, a request for regenerative medicine advanced therapy designation, FDA’s Bryan says; sponsors should consider why they are seeking designation when deciding whether to apply for RMAT, breakthrough therapy or both.


Regenerative Medicine Review Pathway

Pipeline Watch: Phase III Progress With Bempedoic Acid, Lefamulin, And Ibrutinib Combo

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

 

Pipeline Watch Approvals

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Company Information

  • Industry
  • Biotechnology
    • Gene Therapy, Cell Therapy
    • Large Molecule
    • Nanotechnology, Chips, etc.
    • Synthesis Technologies, Production Processes
  • Medical Devices
  • Pharmaceuticals
    • Drug Delivery
      • Controlled Release
      • Macromolecule
      • Site Specific
      • Topical Delivery
  • Therapeutic Areas
  • Blood & Coagulation Disorders & Products
  • Dermatology
  • Metabolic Disorders
  • Alias(es)
  • PlasmaTech Biopharmaceuticals Inc.
  • Access Pharmaceuticals Inc.
  • Ownership
  • Public
  • Headquarters
  • Worldwide
    • North America
      • USA
  • Parent & Subsidiaries
  • Abeona Therapeutics Inc.
  • Senior Management
  • Carsten Thiel, PhD, CEO
    Timothy J Miller, PhD, Pres. & CSO
    Jeffrey B Davis, COO
    João Siffert, MD, Head, R&D & CMO
    Max Colao, Chief Commercial Officer
    Christine Silverstein, SVP, Fin.
  • Contact Info
  • Abeona Therapeutics Inc.
    Phone: (214) 665-9495
    3333 Lee Parkway
    Ste. 600
    Dallas, TX 75219
    USA
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