Belgium’s UCB is acquiring California-based Zogenix, a company focused on rare diseases, in a deal valued up to €1.7 billion ($1.9 billion).
U.S. FDA Approves Abecma for Relapsed or Refractory Multiple Myeloma
Approvals, B-cell maturation antigen (BCMA), Bristol Myers Squibb, CAR-T Therapy, Clinical Trials, Cytokine Release Syndrome (CRS), FDA/Regulatory, First-In-Class, Human Anti-CD38 Monoclonal Antibody, Immunomodulatory Agents, Proteasome Inhibitors, R&D, Relapse/Refractory Multiple Myeloma, TherapeuticsThe U.S. Food and Drug Administration approved Bristol Myers Squibb’s and bluebird bio’s Abecma (idecabtagene vicleucel) as the first anti-BCMA CAR T cell therapy for relapsed or refractory multiple myeloma.
FDA Approves Oncopeptides’ Pepaxto for Triple-Class Refractory Multiple Myeloma
Approvals, Brands, Clinical Trials, Dexamethasone, FDA, Human Anti-CD38 Monoclonal Antibody, Immunomodulatory Agents, Product Launches, Proteasome Inhibitors, R&D, Steroids, Therapeutics, Triple-Class Refractory Multiple MyelomaThe U.S. Food and Drug Administration approved Oncopeptides AB’s Pepaxto (melphalan flufenamide) in combination with dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and one CD38-directed monoclonal antibody.
Takeda Pharmaceutical released data from the Phase III TOURMALINE-MM2 clinical trial of adding Ninlaro (ixazomib) to lenalidomide and dexamethasone compared to lenalidomide and dexamethasone plus placebo in treating newly diagnosed multiple myeloma (MM) patients who were not eligible for autologous stem cell transplant.
Researchers tested a new drug combo that shows promise for the treatment of the childhood brain cancers diffuse midline gliomas.
The U.S. Food and Drug Administration gave Janssen Biotech and the Johnson & Johnson company’s research partner Genmab an approval for their Darzalex split-dosing regimen.
Companies Continue to Take Aim at Glioblastoma, a Cancer Highlighted by the Death of Sen. John McCain
Antigens, Brain Cancer, China Food and Drug Administration, Clinical Trials, Clinical Trials, Gene Therapy, Glioblastoma Multiforme (GBM), Immunotherapies, National Institute of Health, Proteasome Inhibitors, R&D, Rare Diseases, Small MoleculesCiting the National Institutes of Health (NIH), CNN reported there are 274 glioblastoma multiforme studies underway or recruiting across the United States.
DARZALEX (daratumumab) Approved by U.S. FDA: First Human Anti-CD38 Monoclonal Antibody Available for the Treatment of Multiple Myeloma
Accelerated Drug Approvals, Approvals, Biotech, Biotechnology, Blood Cancers, Breakthrough Designation, Breakthrough Therapy, Breakthrough Therapy Designation, Breakthrough Therapy Designation, Clinical Trials, FDA/Regulatory, First-In-Class, Health, Human Anti-CD38 Monoclonal Antibody, Immunomodulatory Agents, Immunotherapy, Launches, Monoclonal Antibodies, Monoclonal Antibodies, Multiple Myeloma, Multiple Myeloma, Multiple Myeloma, New Drug Approvals, Priority Review, Priority Review, Product Launches, Proteasome Inhibitors, R&DFirst-in-class immunotherapy approved for multiple myeloma patients who have received three or more prior lines of therapy, including a proteasome inhibitor (PI) and an immunomodulatory agent or who […]