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
Click here to read full press release/ article | Ref: PRNewswire | Image: Pharma