AbbVie exercised an exclusive right to acquire TeneoOne, an affiliate of TeneoBio, and the company’s lead asset TNB-383B for relapsed or refractory multiple myeloma (R/R MM).
Q&A with Wendbush Securities analysts
Achondroplasia, Analysts, Annual Reports, Approvals, Biopharma/Biotech Annual Report, bluebird bio, Bristol Myers Squibb, Business, CAR-T Therapy, Clinical Trials, Issue Archives, June 2021, Med Ad News, Multiple myeloma, New Drug Approvals, Product Pipelines, R&D, TherapeuticsMed Ad News talked to Wendbush Securities analysts David Nierengarten, Laura Chico, and Liana Moussatos about various new drug approvals and other recent news updates in the industry.
The U.S. Food and Drug Administration accepted for priority review the Biologics License Application submitted by Janssen Biotech Inc. for ciltacabtagene autoleucel (cilta-cel). The investigational B-cell maturation antigen (BCMA)-directed chimeric antigen receptor T cell (CAR-T) therapy is intended for the treatment of patients with relapsed and/or refractory multiple myeloma (MM).
Less than a month after submitting an Investigational New Drug (IND) application, Anixa Biosciences ran into a snag with the U.S. Food and Drug Administration as the government agency asked for more information before approving a clinical study on the company’s Chimeric Antigen Receptor-T cell therapy (CAR-T).
The U.S. Food and Drug Administration approved Sarclisa (isatuximab-irfc) in combination with carfilzomib and dexamethasone, for the treatment of adult patients with relapsed or refractory multiple myeloma (RRMM) who have received one to three prior lines of therapy.
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.
The U.S. Food and Drug Administration approved Karyopharm Therapeutics Inc.’s Xpovio (selinexor) in combination with bortezomib and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy.
Can Janssen Cure Cancer? Company’s 80+ ASH Presentations Suggest It’s On Right Track
American Society of Hematology (ASH) Annual Meeting, B-cell maturation antigen (BCMA), Cancer, Clinical Data, Clinical Trials, Coronavirus Disease (COVID-19) Pandemic, Hematology, Janssen, Johnson & Johnson, R&D, Relapse/Refractory Multiple Myeloma, T-Cells, TherapeuticsThe Janssen Pharmaceutical Companies of Johnson & Johnson has a presence in more than 80 of the hematology studies presented at the 62nd American Society of Hematology (ASH) Annual Meeting & Exposition in December.
BioSpace reviewed the third-quarter 2020 financial announcements from some of the biopharma industry’s leading players.