multiple myeloma
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Pfizer Expands to Multiple Myeloma With FDA Approval for New Antibody Drug
Oncology is already a big piece of Pfizer’s drug lineup. The portfolio is expanding to multiple myeloma with FDA approval of Elrexfio, a bispecific antibody that targets the cancer protein BCMA.
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J&J Broadens Scope in Multiple Myeloma, Winning FDA Approval for New Drug
Johnson & Johnson’s stable of multiple myeloma drugs has grown to five products with the FDA approval of Talvey. The bispecific antibody is the first in a new class of new drugs designed to go after the novel multiple myeloma target GPRC5D.
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Payer’s Place: Dawn Maroney
Dawn Maroney, President, Markets of Alignment Health and CEO of Alignment Health Plan, to discuss how they are using technology to provide better service and care to consumers.
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FDA Places Arcellx Cell Therapy Under a Clinical Hold After Patient Death
Arcellx attributes the death to limitations of the treatments that patients receive while their cell therapies are being manufactured. The company is working to expand these so-called bridging therapy options for patients.
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ASCO Recap: Multiple Myeloma Moves, ADC Advances & Brain Cancer Progress
During the annual meeting of the American Society of Clinical Oncology, a cell therapy posted clinical data that could broaden its use in multiple myeloma. In other developments, the class of drugs called ADCs continue to make progress and a novel brain cancer drug has Phase 3 data that support its use as a new treatment option.
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J&J Aims to Expand in Multiple Myeloma With First Drug for Novel Target
Johnson & Johnson is seeking FDA approval of a multiple myeloma drug that could become the first one addressing a novel target called GPRC5D. Data from the Phase 1/2 study supporting the biologics license application were presented in New Orleans during the annual meeting of the American Society of Hematology.
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Thermo Fisher bets big on blood cancer, immune diagnostics with $2.6B Binding Site buyout
Thermo Fisher Scientific’s acquisition of The Binding Site brings a company that specializes in diagnostic tests for blood cancers and immune system disorders. It’s Thermo Fisher’s biggest acquisition since its 2021 buyout of contract research organization PPD.
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J&J multiple myeloma drug gets FDA nod, bringing patients an easier dosing option
FDA approval of Tecvayli, from Johnson & Johnson subsidiary Janssen Biotech, makes it the newest therapy that treats multiple myeloma by targeting the cancer protein BCMA. Though this off-the-shelf drug offers patients a more convenient dosing option, it comes with similar complication risks as other biologics approved for this type of blood cancer.
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BMS reports data that could give its cell therapy an edge over rival J&J product
Bristol Myers Squibb has data showing that its multiple myeloma treatment Abecma beat the standard of care, preliminary Phase 3 results that could support moving the FDA-approved CAR T-cell therapy into an earlier line of treatment—ahead of a rival cell therapy. In other BMS cell therapy news, the pharma giant started an R&D alliance focused on inflammatory bowel disease.
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J&J, Legend win FDA nod for cell therapy challenger to BMS in multiple myeloma
Approval of the Johnson & Johnson and Legend Biotech cell therapy, Carvykti, marks the second CAR T-cell therapy to clear the regulatory bar for multiple myeloma. The FDA approved Bristol Myers Squibb’s cell therapy Abecma last year.
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Applying Remote Patient Monitoring to Surgery Prep and Recovery, Oncology and Women’s Health
Join us to learn about the latest trends in remote monitoring and how to extend its benefits beyond chronic conditions to more patients – all while using fewer staff resources.
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AbbVie acquires TeneoOne to keep pace in chase for new multiple myeloma drugs
AbbVie is acquiring a Teneobio subsidiary developing a drug that targets BCMA, a popular protein target for multiple myeloma drugs. There are two FDA-approved BCMA-targeting therapies and more on the way, but AbbVie believes the newest addition to its pipeline could offer some advantages.
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Bristol Myers Squibb wins first CAR-T therapy approval in multiple myeloma
The FDA has approved a Bristol Myers Squibb cell therapy made by engineering a patient’s immune cells to target a cancer protein called BCMA. The regulatory decision for Abecma in multiple myeloma gives BMS its second approved CAR-T therapy.
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BMS, bluebird get sped-up review for multiple myeloma CAR-T cell therapy
The companies said Tuesday that the FDA had accepted their application for idecabtagene vicleucel, which they resubmitted in July after the agency initially refused to file it in May. The action date is in March of next year.
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GSK nabs FDA approval for first-in-class multiple myeloma drug
Blenrep, an antibody-drug conjugate, is the first drug approved for multiple myeloma that targets the antigen BCMA. Several other companies are also developing BCMA-targeting therapies for the blood cancer, including CAR-T cells and bispecific antibodies.
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BMS, bluebird refile FDA approval application for CAR-T therapy in myeloma
The companies’ resubmission of their application Wednesday seeking approval for idecabtagene vicleucel was in line with the timeline they provided in May, when the FDA sent a refuse-to-file letter in response to their initial submission.
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FDA AdCom votes unanimously in favor of GSK myeloma drug, despite earlier agency skepticism
The Oncologic Drugs Advisory Committee voted 12-0 that the benefit-risk profile of belantamab mafodotin supported the drug. The vote came despite concerns expressed by the FDA in briefing documents ahead of the ODAC meeting, particularly with regard to ocular toxicity.
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Payer’s Place: Dr. Anil Singh
Dr. Anil Singh shares his insights into the strategies employed by the organization to identify the most effective digital solutions for their members.
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Discover the Next-Gen Platform for Integrated Collaborative Care
Beyond EHRs and digital front doors, reducing the gaps in patient care journeys.
