Company Product Description Indication Status
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

Notes

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