Company Product Description Indication Status
Astrazeneca plc, of Cambridge, U.K. Lokelma (sodium zirconium cyclosilicate) Potassium binder Hyperkalemia FDA approved label update to treat hyperkalemia in patients with end-stage renal disease on chronic hemodialysis
Carmell Therapeutics Inc., of Pittsburgh BHA Bone healing accelerant Bone fractures FDA granted fast track status
Carsgen Therapeutics Co. Ltd., of Shanghai CT-053 Anti-BCMA CAR T-cell therapy Multiple myeloma EMA’s Committee for Orphan Medicinal Products adopted positive opinion for orphan designation
Cytodyn Inc., of Vancouver, Washington Leronlimab (PRO-140) CCR5 antagonist HIV Submitted clinical and CMC portions of BLA to FDA, seeking approval for use as combination with HAART for highly treatment-experienced HIV patients
Diffusion Pharmaceuticals Inc., of Charlottesville, Va. TSC Trans sodium crocetinate COVID-19 Pre-IND submission to FDA for a planned clinical program in patients displaying severe respiratory symptoms and low oxygen levels
Eiger Biopharmaceuticals Inc., of Palo Alto, Calif. Lonafarnib Orally active inhibitor of farnesyltransferase Hutchinson-Gilford progeria syndrome and progeroid laminopathies EMA validated MAA
Halozyme Therapeutics Inc., of San Diego, and Janssen Pharmaceutical KK, a unit of New Brunswick, N.J.-based Johnson & Johnson Daratumumab  CD38-targeting antibody Multiple myeloma Janssen submitted NDA to Japan’s Ministry of Health, Labour and Welfare for approval of subcutaneous formulation using Halozyme’s Enhanze technology
Mateon Therapeutics Inc., of Agoura Hills, Calif. OT-101 Inhibitor of SAR-CoV2 replication COVID-19  Submitted IND to FDA for phase II study in adults hospitalized with COVID-19 and pneumonia
Neurocrine Biosciences Inc., of San Diego Ongentys (opicapone) Oral, selective catechol-O-methyltransferase inhibitor Parkinson’s disease FDA approved as add-on treatment to levodopa/carbidopa in patients experiencing “off” episodes
Polyneuron Pharmaceuticals AG, of Basel, Switzerland PN-1007 Mimics natural HNK-1 carbohydrate epitope found on myelin of peripheral nerves and binds to circulating disease-causing antibodies Anti-MAG neuropathy Regulatory authorities in France, the Netherlands and the U.K. approved CTA for a phase I/IIa study
Shanghai Green Valley Pharmaceuticals Co. Ltd., of Shanghai GV-971 Oral mixture of acidic linear oligosaccharides derived from marine brown algae Alzheimer’s disease FDA cleared IND for a phase III study
Takeda Pharmaceutical Co. Ltd., of Osaka, Japan Mobocertinib (TAK-788) Tyrosine kinase inhibitor targeting EGFR and HER2 exon 20 insertion mutations Metastatic non-small-cell lung cancer FDA granted breakthrough therapy designation for use in patients with EGFR exon 20 insertion mutations whose disease has progressed on or after platinum-based chemotherapy 

Notes

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

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