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BioLineRX's BL-8040 Receives FDA's Orphan Drug Designation (ODD) for Pancreatic Cancer

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BioLineRX's BL-8040 Receives FDA's Orphan Drug Designation (ODD) for Pancreatic Cancer

Shots:

  • The FDA’s ODD to BL-8040 is granted for pancreatic cancer- with an addition to previously granted for AML and stem-cell mobilization in 2015
  • The US FDA’s ODD is granted to the drugs offering treatment for rare diseases and disorders affecting fewer than 200-000 people or >200-000 persons with seven yrs. of market exclusivity- significant development incentives- including tax credits related to clinical trial expenses- an exemption from the FDA-user fee- and FDA assistance in clinical trial design
  • BL-8040 is an antagonist for CXCR4 targeted for hematological malignancies- solid tumors and stem cell mobilization and is a licensed product of BioLineRx from Biokine Therapeutics


   Ref: PRNewswire | Image: Pharma


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