Company Product Description Indication Status
3DBio Therapeutics, a unit of 3D Bio Holdings Inc., of New York Aurinovo 3D-bioprinted implant seeded with autologous auricular cartilage cells Microtia FDA granted orphan drug designation to combination candidate
Achillion Pharmaceuticals Inc., of Blue Bell, Pa. Danicopan Complement factor D inhibitor Paroxysmal nocturnal hemoglobinuria EMA granted PRIME designation to treat individuals with PNH not adequately responding to C5 inhibitor
Alkermes plc, of Dublin ALKS-3831 (olanzapine/samidorphan) 5-HT 2 receptor antagonist; dopamine D1/D2/D4 receptor antagonist Schizophrenia; bipolar I disorder Submitted NDA to FDA
Genmab A/S, of Copenhagen, Denmark Darzalex (daratumumab) CD38-targeting monoclonal antibody Multiple myeloma European Commission approved use in combination with lenalidomide and dexamethasone in adults with newly diagnosed disease who are ineligible for autologous stem cell transplant
Medexus Pharmaceuticals Inc., of Montreal Gliolan  5-aminolevulinic acid hydrochloride Glioma imaging agent Health Canada granted priority review for new drug submission to guide maximal surgical resection of high-grade disease in adults
Newron Pharmaceuticals SpA, of Milan Sarizotan 5-HT 1a receptor agonist; dopamine D2 receptor agonist; dopamine D3/D4 receptor antagonist Rett syndrome FDA granted rare pediatric disease designation
Orphazyme A/S, of Copenhagen, Denmark Arimoclomol Hsp70 stimulator Niemann-Pick disease type C FDA granted breakthrough therapy designation
Samsung Bioepis Co. Ltd., of Incheon, South Korea SB-8 (bevacizumab biosimilar) VEGF ligand inhibitor Non-small-cell lung cancer FDA accepted BLA for review under 351(k) pathway to treat metastatic or recurrent nonsquamous NSCLC
Sangamo Therapeutics Inc., of Brisbane, Calif. TX-200 Chimeric antigen receptor regulatory T-cell therapy Organ transplant rejection U.K.'s MHRA authorized first-in-human trial to prevent immune-mediated rejection following HLA-A2 mismatched kidney transplantation in end-stage renal disease

Notes

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

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