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