The U.S. Food and Drug Administration placed a partial clinical hold on studies conducted by Gilead Sciences assessing the combination of magrolimab plus azacitidine due to concerns of unexpected serious adverse events between study arms.
FDA Action Alert: Bristol Myers Squibb/Juno, Seattle Genetics, BioMarin and Tricida
Adeno-Associated Virus (AAV), B Cell Lymphomas, Biologics License Application (BLA), Brain Metastases, CAR-T Therapy, Chronic Kidney Disease, Diffuse large B-cell lymphoma (DLBCL), FDA, FDA/Regulatory, Hemophilia A, HER2-positive breast cancer, Immunotherapy, New Drug Applicationa, Project Orbis, Quarterly results, T-CellsThe U.S. Food and Drug Administration’s approval-review schedule for August includes the Biologics License Application for Bristol Myers Squibb and Juno Therapeutics’ lisocabtagene maraleucel (liso-cel) for relapsed or refractory large B-cell lymphoma after at least two previous therapies.
Health authorities in England rejected a pricey CAR-T cell therapy from Novartis for adults with blood cancer, two weeks after endorsing Kymriah’s use in children and young people.
AbbVie’s shares dropped after releasing an update on the company’s Phase III B-cell lymphoma trial.
Novartis’s new gene-modifying cancer therapy’s $475,000-per-patient sticker price has drawn fire from advocate groups calling for cheaper drugs, but analysts said the Swiss drugmaker could initially struggle to break even.
Tazemetostat – an experimental Phase II treatment for lymphomas – showed a 29 percent overall response rate in patients with DLBCL, below investors’ expectations.
Gazyva combined with chemotherapy failed to meet its primary endpoints in a Phase III trial for patients with previously untreated diffuse large B-cell lymphoma.
Novartis: Lymphoma study shows CART on track for 2017 U.S. submission
Analysts, B Cell Lymphomas, B Cells, Blood Cancers, Cells, Chimeric Antigen Receptor T Cell Therapy (CART), Diffuse large B-cell lymphoma (DLBCL), FDA, FDA/Regulatory, Follicular Lymphoma, Gene Therapy, Health, Immune System, Immune Systems, Leukemia, Leukemia, New Drug Application (NDA), Oncology, Pricing, Studies, T-CellsSwiss drugmaker Novartis said the latest findings from a study on its newest therapy for two kinds of blood cancer track earlier results, bolstering its confidence in a 2017 U.S. regulatory submission. Novartis is testing CTL019, its investigational chimeric antigen receptor T cell therapy, or CART, on 15 adult patients with the most-common non-Hodgkins […]
Amgen And Merck Announce Cancer Immunotherapy Collaboration For Patients With Non-Hodgkin Lymphoma
Anti-colony-stimulating factor 1 receptor (CSF1R) antibodies, B Cell Lymphomas, Beta Blockers, Biology, Biotech, Bispecific CD19-directed CD3 T cell engager (BiTE) antibodies, Business, Clinical Trials, Collaboration, Collaborations, Colorectal Cancer, Diabetes, Diabetic Ketoacidosis, Diffuse large B-cell lymphoma (DLBCL), Health, Hyperthyroidism, Hypophysitis, Immune System, Immune Systems, Immunotherapies, Immunotherapy, Lymphomas, Monoclonal Antibodies, Monoclonal Antibodies, Non-Hodgkin Lymphoma, Non-Small Cell Lung Cancer, Non-Small Cell Lung Cancer (NSCLC), Oncology, Pneumonitis, R&D, Studies, Therapeutics, Tumors, Type 1 DiabetesTHOUSAND OAKS, Calif. and KENILWORTH, N.J., Dec. 4, 2015 /PRNewswire/ — Amgen (NASDAQ: AMGN) and Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced a cancer immunotherapy collaboration to support a Phase 1b/3 study investigating BLINCYTO® (blinatumomab) in combination with KEYTRUDA® (pembrolizumab) in patients with diffuse large B-cell lymphoma (DLBCL), which […]