Four years after partnering with GammaDelta Therapeutics to develop therapies for solid tumors, Takeda Pharmaceutical pulled the trigger and exercised its option to acquire the London-based company.
The U.S. Food and Drug Administration greenlit the classification of California-based biotechnology firm Genentech’s Venclexta (venetoclax) and azicitidine combination as a Breakthrough Therapy Drug.
Shares of Magenta Therapeutics were down after the company announced the U.S. Food and Drug Administration placed a clinical hold on its clinical program for acute myeloid leukemia and myelodysplastic syndrome.
Shares of bluebird bio climbed in trading after the company announced on March 10 that analyses demonstrate the lentiviral vector BB305 was unlikely to be the cause of acute myeloid leukemia (AML) reported in an early-stage clinical study of LentiGlobin for sickle cell disease.
ASH 2020: CRISPR and Vertex’s Potential Cure for Sickle Cell Disease and More Glimmers of Hope
Acute Myeloid Leukemia (AML), American Society of Hematology (ASH) Annual Meeting, Analysts, Bristol Myers Squibb, Business, CAR-T Therapy, CD47 Inhibitors, Chronic Lymphocytic Leukemia (CLL), Clinical Studies, Clinical Trials, CRISPR, Data, Gene Therapy, Janssen, Johnson & Johnson, Large B-Cell Lymphoma, Monoclonal Antibodies, New England Journal of Medicine, R&D, Sickle Cell Disease, Therapeutics, Transfusion-Dependent Beta-Thalassemia (TDT)The American Society of Hematology (ASH) Annual Meeting & Exposition began December 5 with numerous presentations, abstracts and posters.
Roche’s Venclexta Granted Full Approval Under Project Orbis and Real-Time Review
Accelerated Approval, Acute Myeloid Leukemia (AML), Adults 75 or older, Approvals, B-cell lymphoma-2 (BCL-2) protein, Chemotherapy, Clinical Trials, FDA/Regulatory, Full Approval, Project Orbis, R&D, Real-Time Oncology Review (RTOR) PilotThe U.S. Food and Drug Administration granted Roche’s Venclexta (venetoclax) full approval in combination with azacytidine, or decitabine, or low-dose cytarabine for newly diagnosed acute myeloid leukemia in adults 75 years or older.
The U.S. Food and Drug Administration granted full approval of Genentech’s Venclexta (venetoclax) in combination with azacitidine, or decitabine or low-dose cytarabine for the treatment of newly diagnosed acute myeloid leukemia (AML) in adults 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy.
The U.S. Food and Drug Administration approved Bristol Myers Squibb’s Onureg (azacitidine 300 mg tablets, CC-486) for the continued treatment of adult patients with acute myeloid leukemia (AML) who achieved first complete remission or CR with incomplete blood count recovery following intensive induction chemotherapy and who are not able to complete intensive curative therapy.
Helsinn and MEI Discontinue AML Phase III Trial
Acute Myeloid Leukemia (AML), Business, Chemotherapy, Clinical Data, Clinical Trials, Data Monitoring Committee (DMC), Discontinued Clinical Trials, High-Risk Myelodysplastic Syndrome (MDS), Histone deacetylase inhibitors, Overall Survival (OS), R&D, TherapeuticsHelsinn Group, based in Lugano, Switzerland, and MEI Pharma, with headquarters in San Diego, announced they were discontinuing their Phase III trial of pracinostat with azacytidine in acute myeloid leukemia (AML).
Gilead to Acquire Immuno-Oncology Company Forty Seven for $4.9 Billion
Acquisitions, Acute Myeloid Leukemia (AML), Business, Cancer, Clinical Trials, Coronavirus Disease 2019 (COVID-19), Diffuse Large B-Cell Lymphoma (DLBCL), High-Risk Myelodysplastic Syndrome (MDS), Monoclonal Antibodies, R&D, TumorsGilead Sciences Inc. is buying Forty Seven Inc. for $95.50 per share, or a deal value of $4.9 billion. The deal was unanimously approved by both companies’ boards.