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Gentium SPA

Division of Jazz Pharmaceuticals PLC

Latest From Gentium SPA

Sarepta Smacked By FDA's Curiously Timed Compassionate Use Revisions

Sarepta Therapeutics Inc. investors panicked over the FDA's June 2 release of revised expanded access guidances – worried the action was in preparation for the agency to reject the company's Duchenne muscular dystrophy drug eteplirsen, whose verdict was curiously delayed last week.

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Keeping Track: FDA On A Complete Response Spree?

The latest drug development news and highlights from our FDA Performance Tracker.

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Keeping Track: Sanofi Submits Lixisenatide NDA (Again); Sandoz Files Second Biosimilar Application

The latest drug development news and highlights from our FDA Performance Tracker.

BioPharmaceutical United States

Jazz Jumps On Defibrotide Priority Review

Shares of Jazz Pharmaceuticals plc jumped 8% in morning trading on Sept. 30 on word the FDA had granted a priority review of the company's new drug application (NDA) for its anticoagulant defibrotide as a treatment for patients with hepatic veno-occlusive disease (VOD) with evidence of multi-organ dysfunction (MOD) following hematopoietic stem-cell transplantation (HSCT).

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Company Information

  • Industry
  • Biotechnology
    • Antisense, Oligonucleotides
    • Drug Discovery Tools
      • Molecular Diversity
        • Natural Products
    • Large Molecule
  • Pharmaceuticals
  • Therapeutic Areas
  • Blood & Coagulation Disorders & Products
  • Cardiovascular
  • Gastrointestinal
  • Hepatic (Liver)
  • Alias(es)
  • Pharma Research SRL
  • Ownership
  • Private
  • Headquarters
  • Worldwide
    • Europe
      • Western Europe
        • Italy
  • Parent & Subsidiaries
  • Jazz Pharmaceuticals PLC
  • Senior Management
  • Finton Keegan, Chmn. & CEO
    Salvatore Calabrese, SVP, Fin., CFO & COO
    Adrian Haigh, SVP, Commercial Operations
    Giorgio Mosconi, MD, PhD, SVP & Scientific Dir.
  • Contact Info
  • Gentium SPA
    Phone: (39) 031-5373 200
    Piazza XX Settembre, 2
    Villa Guardia, 22079