08 abril 2020

Regulatory Actions For April 2, 2020 .

Regulatory actions for April 2, 2020

CompanyProductDescriptionIndicationStatus
Affimed NV, of Heidelberg, GermanyAFM-13CD30- and CD16A-binding innate cell engagerT-cell lymphomaFDA granted orphan drug designation
Applied Therapeutics Inc., of New YorkAT-001Aldose reductase inhibitorCOVID-19IND opened with FDA for multiple investigator-initiated studies
Celularity Inc., of Warren, N.J.CYNK-001Placenta-derived natural killer cell therapyCOVID-19FDA cleared the IND for a phase I/II trial
Fera Pharmaceuticals LLC, of New York, and Nicox SA, of Sophia Antipolis, FranceNaproxcinodCyclooxygenase-inhibiting, nitric oxide-donating naproxenSickle cell diseaseApplied for orphan drug designation with the FDA
Pfizer Inc., of New YorkRuxience (rituximab)Biosimilar to MabtheraNon-Hodgkin lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis, granulomatosis with polyangiitis and microscopic polyangiitis, and pemphigus vulgarisApproved by the European Commission
Pharmamar SA, of MadridAplidin (plitidepsin)CyclodepsipeptideCOVID-19 pneumoniaSubmitted trial protocol for the Aplicov study to the Spanish Medicines and Healthcare Products Agency
Seattle Genetics Inc., of Bothell, Wash.Padcev (enfortumab vedotin-ejfv)Antibody-drug conjugate targeting Nectin-4