Company Product Description Indication Status
Bristol Myers Squibb Co., of New York Zeposia (ozanimod) S1P receptor modulator Relapsing remitting multiple sclerosis EMA’s Committee for Medicinal Products for Human Use recommended approval for use in adults with active disease as defined by clinical or imaging features
Cstone Pharmaceuticals Co. Ltd., of Suzhou, China Avapritinib Inhibitor of KIT and PDGFRA mutant kinases Gastrointestinal stromal tumor NDA submitted
Cytodyn Inc., of Vancouver, Wash. Leronlimab CCR5 antagonist HIV infection Filed another round of modifications to its IND and protocol for a phase II trial 
Eisai Co. Ltd., of Tokyo Denileukin diftitox (genetic recombinant) Fusion protein of the receptor-binding portion of interleukin-2 and diphtheria toxin that binds to the IL-2 receptor Relapsed or refractory cutaneous T-cell lymphoma and peripheral T-cell lymphoma Submitted a marketing authorization application in Japan
Genentech, of South San Francisco, a member of the Roche Group Xofluza Baloxavir marboxil Acute uncomplicated influenza; post-exposure prophylaxis of influenza FDA accepted an NDA for a new formulation as 1-dose granules for oral suspension; the FDA also accepted 2 sNDAs: for acute uncomplicated influenza in children and for post-exposure prophylaxis of influenza in people 1 and older
Humanigen Inc., of Burlingame, Calif. Lenzilumab GM-CSF ligand inhibitor COVID-19 Submitted an initial protocol synopsis to the FDA in support of its plans to initiate a multicenter, phase III study in the U.S.
Intelgenx Technologies Corp., of Saint Laurent, Quebec Rizaport Versafilm Oral thin-film formulation of 5-HT1 receptor agonist rizatriptan Acute migraine FDA issued complete response letter for resubmitted 505(b)(2) NDA, stating the agency cannot approve the application in its present form and requesting additional information, though no new bioequivalence study was requested
Mylan NV, of Hertfordshire, U.K., and Lupin Ltd., of Mumbai, India Nepexto Etanercept biosimilar Rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, axial spondyloarthritis, plaque psoriasis and pediatric plaque psoriasis The EMA's Committee for Medicinal Products for Human Use adopted a positive opinion recommending approval 
Novartis AG, of Basel, Switzerland Cosentyx Secukinumab; IL-17A inhibitor  Non-radiographic axial spondyloarthritis Gained positive opinion from EMA's Committee for Medicinal Products for Human Use for a new indication in the axial spondyloarthritis spectrum
Novartis AG, of Basel, Switzerland, and its Avexis unit Zolgensma (onasemnogene abeparvovec) Gene therapy Spinal muscular atrophy EMA's Committee for Medicinal Products for Human Use adopted a positive opinion recommending conditional marketing authorization 
Pharming Group NV, of Leiden, the Netherlands Ruconest (conestat alfa) Recombinant analogue of human C1 esterase inhibitor Hereditary angioedema EMA’s Committee for Medicinal Products for Human Use recommended approval for treating acute angioedema attacks in children, expanding the age range to children 2 and older 
Rockwell Medical Inc., of Wixom, Mich. Triferic AVNU (ferric pyrophosphate citrate) Iron maintenance therapy Hemodialysis-dependent chronic kidney disease FDA approved NDA for I.V. formulation to replace iron and maintain hemoglobin in adults 
Sanofi SA, of Paris Sarclisa Isatuximab Relapsed and refractory multiple myeloma EMA's Committee for Medicinal Products for Human Use adopted a positive opinion
Translate Bio Inc., of Lexington, Mass. MRT-5005 mRNA therapeutic Cystic fibrosis  FDA granted rare pediatric disease designation

Notes

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

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