Company Product Description Indication Status
Beigene Ltd., of Beijing Pamiparib PARP1/2 inhibitor Ovarian, fallopian tube or primary peritoneal cancer China’s NMPA accepted for review the NDA seeking approval to treat patients with deleterious or suspected deleterious germline BRCA-mutated advanced disease who have been treated with 2 or more lines of chemotherapy
Botanix Pharmaceuticals Ltd., of Philadelphia and Sydney BTX-1503 Transdermal gel Acne Completed end-of-phase II meeting with FDA, which provided feedback on development program and reached agreement on required co-primary endpoints for phase III studies
Bristol Myers Squibb Co., of New York Lisocabtagene maraleucel CD19-directed CAR T-cell therapy Relapsed or refractory diffuse large B-cell lymphoma, primary mediastinal B-cell lymphoma and follicular lymphoma grade 3B EMA validated the MAA seeking approval for use in adults after at least 2 prior therapies; centralized review process begins
Denovo Biopharma LLC, of San Diego DB-102 (enzastaurin) Small-molecule serine/threonine kinase inhibitor of PKC beta, PI3K and AKT pathways Newly diagnosed glioblastoma FDA granted fast track designation
Nabriva Therapeutics plc, of Dublin, and Sunovion Pharmaceuticals Canada Inc., of Mississauga, Ontario Xenleta (lefamulin) Semisynthetic pleuromutilin antibiotic Community-acquired pneumonia Oral and I.V. formulations approved by Health Canada
Specialised Therapeutics Asia Pte Ltd., of Singapore, and Puma Biotechnology Inc., of Los Angeles Nerlynx (neratinib) HER2-targeting therapy Breast cancer Approved in Malaysia for use in women who have had surgery, chemotherapy and prior trastuzumab-based therapy

Notes

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

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