It was reported yesterday that the US Food and Drug Administration (USFDA) has granted orphan drug designation to United States-based Onspira Therapeutics for its investigational product, OSP-101, intended for treating Bronchiolitis Obliterans.
The designation offers the potential for seven years of market exclusivity upon US Food and Drug Administration approval, along with prescription drug user fee waivers and tax credits for qualified clinical trials.
Onspira Therapeutics president and CEO, Brian Lortie, said, 'We are very pleased that FDA granted Orphan Drug Designation to OSP-101 for the treatment of Bronchiolitis Obliterans (BO). This is a significant milestone for Onspira, and we look forward to advancing the clinical program in coordination with the FDA and our advisors. BO is a relentless, progressive disease which causes significant mortality in affected patients, and our team is highly focused on providing an effective therapy to improve their lives.'
BeOne Medicines' sonrotoclax receives FDA Breakthrough Therapy Designation for MCL
Ascletis selects once-monthly SQ GLP-1R/GIPR dual peptide agonist, ASC35, for clinical development
Celltrion's biosimilar EYDENZELT (aflibercept-boav) approved by US FDA
Rigel Pharmaceuticals begins dose expansion phase of R289 study in lower-risk MDS
Precision NeuroMed's glioblastoma multiforme treatment granted FDA Orphan Drug Designation
Merck completes acquisition of Verona Pharma to expand cardio-pulmonary portfolio
Oxford Biomedica expands US operations with acquisition of viral vector facility in North Carolina
DarioHealth and OneStep partner to integrate fall risk technology into digital health platform
Ananda Pharma achieves key Phase 1 milestone for MRX1 CBD program
Alvotech and Advanz Pharma announce EMA acceptance of AVT23 marketing application
Polarean expands Ascend Imaging partnership to boost US market reach