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Asklepion Pharmaceuticals LLC

Latest From Asklepion Pharmaceuticals LLC

A Baker’s Dozen Of US FDA Efficacy Approvals Using Real World Evidence

Fresenius Kabi’s Omegaven is most recent of 13 approvals, including three with breakthrough therapy designations, where FDA has relied on real world evidence to make a regulatory decision about efficacy.
Drug Approval Standards Drug Review

Emflaza's 505(b)(2) Pathway Review: Rare, But With Precedent

US FDA has relied on 505(b)(2) pathway to approve a small group of 'orphaned orphan' drugs – products without patent protection being used on an informal 'gray market' of personal importation and compassionate use protocols.

Drug Review Profile Drug Approval Standards

KaloBios Can Get Priority Review Voucher With 505(b)(2) Chagas Application

US FDA’s recent guidance on the program notes that even tropical disease products approved under 505(b)(2) are eligible for a priority review voucher.

BioPharmaceutical Regulation

All Orphans Must Get 10-Year Exclusivity, Says Top EU Court

Ruling extends exclusivity even to those approved as "similar" to an existing orphan product, court says, rejecting an "evergreening" argument brought by Teva.

BioPharmaceutical Europe
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Company Information

  • Industry
  • Biotechnology
  • Pharmaceuticals
  • Therapeutic Areas
  • Cardiovascular
  • Hepatic (Liver)
  • Metabolic Disorders
  • Alias(es)
  • Ownership
  • Private
  • Headquarters
  • Worldwide
    • North America
      • USA
  • Parent & Subsidiaries
  • Asklepion Pharmaceuticals LLC
  • Senior Management
  • Gary Pasternack , CEO
  • Contact Info
  • Asklepion Pharmaceuticals LLC
    Phone: (410) 545-0494
    729 East Pratt St.
    Suite 360
    Baltimore, MD 21202