Company Product Description Indication Status
Bridge Biotherapeutics Inc., of Seongnam, South Korea BBT-401 Pellino-1 inhibitor Ulcerative colitis China’s Center for Drug Evaluation, part of the NMPA, cleared the IND application for a phase I study, expected to start in May 2020
Flexion Therapeutics Inc., of Burlington, Mass. Zilretta (triamcinolone acetonide extended-release) Glucocorticoid receptor agonist Pain FDA approved sNDA for label update regarding treatment of osteoarthritis knee pain, replacing language that drug was “not intended for repeat administration” with statement that “efficacy and safety of repeat administration of Zilretta have not been demonstrated"; updated label includes safety data from repeat administration trial
Immunomedics Inc., of Morris Plains, N.J. Sacituzumab govitecan Topoisomerase I inhibitor; Trop-2 calcium signal transducer inhibitor Metastatic triple-negative breast cancer FDA accepted resubmission of BLA seeking accelerated approval to treat individuals who received at least 2 prior therapies for metastatic disease, setting PDUFA date of June 2, 2020
OBI Pharma Inc., of Taipei, Taiwan OBI-999 Antibody-drug conjugate targeting glycolipid antigen Globo H Pancreatic cancer FDA granted orphan drug designation
Prevail Therapeutics Inc., of New York PR-001 GBA gene stimulator Gaucher disease FDA removed clinical hold and activated IND application for phase I/II study in neuronopathic form of disease, expected to initiate dosing during first half of 2020
Saniona AB, of Copenhagen Tesofensine Insulin sensitizer Obesity Partner Productos Medix SA de SV submitted new drug application to Mexico's Comisión Federal para la Protección contra Riesgos Sanitarios, or COFEPRIS
Sinovac Biotech Ltd., of Beijing Varicella vaccine Vaccine Prevention of varicella-zoster virus China’s NMPA approved and issued product license for use in children, ages 1-12
Spectrum Pharmaceuticals Inc., of Henderson, Nev. Rolontis (eflapegrastim) GCSF ligand; GCSF receptor agonist Chemotherapy-induced neutropenia FDA accepted BLA for review, setting PDUFA date of Oct. 24, 2020
Zai Lab Ltd., of Shanghai Zejula (niraparib) Dual PARP 1/2 inhibitor Ovarian, fallopian tube or peritoneal cancer China's NMPA approved NDA for maintenance therapy in adults with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to platinum-based chemotherapy
Zosano Pharma Corp., of Fremont, Calif. Qtrypta (zolmitriptan transdermal patch) Dual 5-HT 1b/1d receptor agonist Acute migraine NDA submitted to FDA through 505(b)(2) pathway

Notes

For more information about individual companies and/or products, see Cortellis.

No Comments