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

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

BioLineRx Reports Engraftment Data of BL-8040 in P-III GENESIS Trial for Patients with Multiple Myeloma

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


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Shiwani Sharma

Shiwani Sharma was Senior Editor at PharmaShots. She has in-depth knowledge of the life sciences industry including the Pharma and Biotech sectors. Any articles written by her can be contacted at connect@pharmashots.com.

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