Magenta Therapeutics is reducing the company’s workforce by 14 percent in a revised operating plan to prioritize research and development.
Gilead Sciences Inc. said on April 11 the U.S. Food and Drug Administration had lifted the partial clinical hold placed on the company’s trials testing a blood cancer drug combination.
Gilead Combo Therapy Hit with FDA Hold Over Serious Adverse EventsAcute Myeloid Leukemia (AML), CD47 Protein, Clinical Trials, Combination Therapies, Diffuse large B-cell lymphoma (DLBCL), FDA/Regulatory, Gilead, Head & Neck Squamous Cell Carcinoma (HNSCC), Malignancies, Myelodysplastic Syndromes, Partial Clinical Hold, R&D, Triple Negative Breast Cancer (TNBC)
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.
The U.S. Food and Drug Administration lifted the partial hold on Kura Oncology’s clinical trial on a potential treatment for acute myeloid leukemia (AML).
Johnson & Johnson decided to terminate a $1.6 billion partnership with Argenx to develop the anti-CD70 antibody cusatuzumab to treat amyotrophic lateral sclerosis (AML) and myelodysplastic syndromes (MDS).
Now, a few years down the road,
Bristol Myers Squibb announced that the Phase III IDHENTIFY trial of Idhifa (enasidenib) plus best supportive care compared to conventional care did not meet the primary endpoint of overall survival in relapsed or refractory acute myeloid leukemia with an isocitrate dehydrogenase-2 mutation.
U.S. FDA Approves Rubraca as Monotherapy Treatment for mCRPCAccelerated Approval, Acute Myeloid Leukemia (AML), Androgen Receptor-Directed Therapy, Approvals, BRCA Mutation-Associated Metastatic Castration-Resistant Prostate Cancer (mCRPC), Chemotherapy, FDA, FDA/Regulatory, Myelodysplastic Syndromes, New Indications, PARP Inhibitors, Supplemental New Drug Application (sNDA), Taxane-Based Chemotherapy
The U.S. Food and Drug Administration approved Clovis Oncology Inc.’s Rubraca (rucaparib) tablets for the treatment of adult patients with a deleterious BRCA mutation (germline and/or somatic)-associated metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor-directed therapy and a taxane-based chemotherapy.
ASH Roundup: Bristol-Myers Squibb, bluebird bio, Oryzon and MoreAcute Myeloid Leukemia (AML), American Society of Hematology (ASH) Annual Meeting, Chronic Lymphocytic Leukemia (CLL), Clinical Data, Clinical Trials, Diffuse Large B-Cell Lymphoma (DLBCL), Epigenetic, LSD1, Myelodysplastic Syndromes, Progression-Free Survival (PFS), R&D, Relapse/Refractory Multiple Myeloma, Small Lymphocytic Lymphoma (SLL), Small Molecules
Hundreds of studies and results were presented at the 61st American Society of Hematology (ASH) Annual Meeting.
ImmunoGen shares fell after the company announced the slashing of 220 employees as part of an effort to reduce ongoing expenses while recovering from an FDA rejection of an ovarian cancer drug.
Independent experts on an advisory panel to the U.S. Food and Drug Administration voted against Daiichi Sankyo Co. Ltd.’s treatment for adults with a type of acute myeloid leukemia.