|Arch Biopartners Inc., of Toronto||Metablok||LSALT peptide||COVID-19 infection||Istanbul University Ethics Committee cleared initiation of phase II trial to treat acute lung and kidney injury caused by inflammation in people with severe infection; regulatory review by Turkish Ministry of Health expected to finish by mid-September 2020|
|Genmab A/S, of Copenhagen, and Halozyme Therapeutics Inc., of San Diego||Darzalex Faspro (daratumumab + hyaluronidase-fihj)||ADP ribosyl cyclase-1 inhibitor||Light-chain amyloidosis||Partner Janssen Biotech Inc. submitted sBLA to FDA for use in combination with bortezomib, cyclophosphamide and dexamethasone; agency to review under Real-Time Oncology Review pilot program|
|Glaxosmithkline plc, of London||Trelegy Ellipta (fluticasone furoate + umeclidinium + vilanterol)||Beta 2 adrenoceptor agonist; muscarinic receptor antagonist||Asthma||FDA approved sNDA to treat indication in adults 18 and older|
|Sarepta Therapeutics Inc., of Cambridge, Mass.||SRP-9001||DMD gene stimulator||Duchenne muscular dystrophy||Completed type C meeting with Office of Tissues and Advanced Therapies at FDA's CBER seeking concurrence on initiation of next trial using commercial process material, including additional potency assay for material release|
|Terns Pharmaceuticals Inc., of Foster City, Calif.||TERN-201||Vascular adhesion protein-1 inhibitor||Nonalcoholic steatohepatitis||FDA granted fast track designation|
|Zai Lab Ltd., of Shanghai||Zejula (niraparib)||PARP inhibitor||Ovarian cancer||NMPA approved sNDA for first-line maintenance treatment of advanced epithelial ovarian, fallopian tube or primary peritoneal cancer in adults with complete or partial response to first-line platinum-based chemotherapy|
For more information about individual companies and/or products, see Cortellis.