(IN BRIEF) AstraZeneca and Daiichi Sankyo’s supplemental Biologics License Application for Enhertu plus pertuzumab has been accepted for Priority Review by the FDA for the first-line treatment of HER2-positive metastatic breast cancer. The application is supported by data from the … Read the full press release
Posted in Business, Healthcare, News, Pharma & Biotech, Science, Technology, United Kingdom
Tagged ADC, antibody-drug conjugate, AstraZeneca, breakthrough therapy designation, cancer treatment innovation, Daiichi Sankyo, DESTINY-Breast09, Enhertu, Enhertu plus pertuzumab moves closer to first-line approval in HER2-positive metastatic breast cancer after FDA Priority Review acceptance, FDA, FDA grants Priority Review to Enhertu plus pertuzumab for 1st-line HER2-positive metastatic breast cancer following DESTINY-Breast09 success, HER2-positive breast cancer, Ken Takeshita, metastatic breast cancer, oncology, pertuzumab, Priority Review, progression-free survival, Real-Time Oncology Review, Susan Galbraith, THP regimen, trastuzumab deruxtecan
(IN BRIEF) GSK has received approval from Japan’s Ministry of Health, Labour and Welfare (MHLW) for Blenrep combinations to treat adults with relapsed or refractory multiple myeloma. The approval follows positive results from the DREAMM-7 and DREAMM-8 phase III trials, … Read the full press release
Posted in Business, Environment, Financial, Government, Healthcare, Industrial, Investment, Management, News, Pharma & Biotech, Science, Security & Safety, Technology, United Kingdom
Tagged anti-BCMA, antibody-drug conjugate, Blenrep, bortezomib, chemotherapy, clinical efficacy, clinical trials, DREAMM-7, DREAMM-8, global markets, GSK, Japan approval, Multiple Myeloma, oncology, orphan drug designation, overall survival, partnership, PDUFA, pomalidomide, progression-free survival, regulatory approval, sustainability, treatment options
(IN BRIEF) AstraZeneca and Daiichi Sankyo’s Biologics License Application (BLA) for datopotamab deruxtecan has been accepted by the U.S. FDA for treating advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC) in patients who have previously received systemic therapies. The … Read the full press release
Posted in Business, Financial, Healthcare, Industrial, Investment, Management, News, Pharma & Biotech, Science, Security & Safety, Technology, United Kingdom
Tagged advanced NSCLC, antibody-drug conjugate, AstraZeneca, Biologics License Application, BLA, breakthrough therapy designation, Daiichi Sankyo, datopotamab deruxtecan, drug approval, EGFR-mutated, EGFR-tyrosine kinase inhibitors, FDA, metastatic NSCLC, non-small cell lung cancer, NSCLC, objective response rate, oncology, partnership, Phase III Trials, Priority Review, safety profile, systemic therapies, TROP2-directed, TROPION-Lung01, TROPION-Lung05, TROPION-Lung14, TROPION-Lung15
(IN BRIEF) BioNTech and Duality Biologics have received Breakthrough Therapy designation from the FDA for their antibody-drug conjugate (ADC) candidate, BNT323/DB-1303. The designation is for the treatment of advanced endometrial cancer in patients who have progressed following immune checkpoint inhibitor … Read the full press release
Posted in Germany, Healthcare, Pharma & Biotech, Technology
Tagged advanced endometrial cancer, antibody-drug conjugate, BioNTech SE, BNT323, Breakthrough Therapy, DB-1303, Duality Biologics, DualityBio, endometrial cancer, FDA, HER2, Human Epidermal Growth Factor Receptor 2, Prof. Özlem Türeci M.D., uterine cancer, Vivian Gu M.D.
(IN BRIEF) Merck, a prominent science and technology company, has entered into a strategic partnership with Jiangsu Hengrui Pharmaceuticals. This collaboration includes an exclusive global license (excluding China) to develop and commercialize Hengrui’s advanced PARP1 inhibitor, HRS-1167. Additionally, there is … Read the full press release
Posted in Germany, Healthcare, Pharma & Biotech
Tagged ADC, antibody-drug conjugate, ATM, ATR, Cancer, CEACAM5-targeting ADC, Claudin-18.2, Danny Bar-Zohar, DDR cascade, DNA-PK, Frank Jiang, Hengrui, HRS-1167, inhibitor, Jiangsu Hengrui Pharmaceuticals Co. Ltd., M9140, Merck, metastatic colorectal cancer, oncology, PARP, PARP1, poly (ADP-ribose) polymerase 1, SHR-A1904
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