Company Product Description Indication Status
Daiichi Sankyo Co. Ltd., of Tokyo Enhertu (trastuzumab deruxtecan) Antibody-drug conjugate targeting HER2  HER2-positive unresectable or recurrent breast cancer after prior chemotherapy  Japanese Ministry of Health, Labor and Welfare approved the drug under the conditional early approval system
EMD Serono, part of Merck KGaA, of Darmstadt, Germany Tepmetko (tepotinib) MET inhibitor Unresectable, advanced or recurrent non-small-cell lung cancer with MET exon 14 skipping alterations Japanese Ministry of Health, Labor and Welfare approved the drug
Exelixis Inc., of Alameda, Calif., and Takeda Pharmaceutical Co. Ltd., of Osaka, Japan Cabometyx (cabozantinib) Kinase inhibitor Curatively unresectable or metastatic renal cell carcinoma Japanese Ministry of Health, Labor and Welfare approved the drug
Gilead Sciences Inc., of Foster City, Calif. Remdesivir RNA polymerase modulator COVID-19 Gilead submitted request to FDA to rescind orphan designation and said it is waiving all benefits that accompany such designation
Infinity Pharmaceuticals Inc., of Cambridge, Mass. IPI-549  PI3K-gamma inhibitor Advanced urothelial cancer FDA granted fast track designation in combination with Opdivo (nivolumab, Bristol Myers Squibb Co.)
Intrabio Inc., of Oxford, U.K. IB-1001  Modified amino-acid analogues/esters  GM2 gangliosidosis FDA granted fast track designation
Intrabio Inc., of Oxford, U.K. IB-1001  Modified amino-acid analogues/esters  Niemann-Pick disease type C  FDA granted fast track designation
Sumitomo Dainippon Pharma Co. Ltd., of Osaka, Japan Latuda (lurasidone hydrochloride) Atypical antipsychotic Schizophrenia and bipolar depression Japanese Ministry of Health, Labor and Welfare approved the drug for both diseases
Sumitomo Dainippon Pharma Co. Ltd., of Osaka, Japan Rethio (thiotepa) Alkylating agent Malignant lymphoma Japan’s Ministry of Health, Labor, and Welfare approved the partial change in the marketing approval to include conditioning treatment prior to autologous hematopoietic stem cell transplantation for malignant lymphoma
Valneva SE, of Saint-Herblain, France VLA-1533 Monovalent, single-dose, live-attenuated vaccine Chikungunya Completed end-of-phase II meeting with FDA and agreed on development plan based on immunology surrogate (accelerated approval pathway); company is preparing for phase III initiation as soon as the COVID-19 situation permits, currently assuming initiation in the fourth quarter of 2020

Notes

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

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