Rural Americans have difficulty accessing a promising cancer treatment
After settling in rural New Mexico, a cancer patient had to move 750 miles east and live in a trailer to access CAR-T treatment at the MD Anderson Cancer Center.
BMS cancer drug’s expanded approval gives it an edge over a Gilead cell therapy
The new FDA approval for Breyanzi moves the Bristol Myers Squibb cancer cell therapy into an earlier line of treatment for an aggressive type of blood cancer. The decision also gives the pharmaceutical giant access to an additional pool of patients untapped by a rival cell therapy from Gilead Sciences.
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BMS shows what’s NEX-T for CAR T, plus its strategy for next-gen cancer cell therapy
As an oncologist, Kristen Hege first encountered cancer cell therapy research in the mid-1990s. Now as a Bristol Myers Squibb executive, she oversees efforts to improve the pharma giant’s first generation of cell therapies while also building a pipeline of next-generation treatments with better features and properties.
WMIF panel: How cell and gene therapy can overcome limitations of CAR T
CAR T cell therapies for cancer still pose challenges in manufacturing, safety, and the ability to address solid tumors. A panel at the World Medical Innovation Forum discussed efforts to improve CAR T as well as new approaches for the next generation of cell therapies.
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.
Arcellx’s IPO raises $124M to fuel chase of better CAR T-cell therapy for cancer
Clinical-stage Arcellx raised $123.8 million from its IPO, which the company will use to advance to a pivotal test for its lead program, a CAR T-cell therapy for multiple myeloma. Though Arcellx trails its large pharmaceutical rivals, the biotech contends its technology produces cell therapies with key advantages.
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ImmPACT Bio reels in $111M to prevent tumor escape with novel cell therapies
Despite the targeted approach of some cancer treatments, tumors can find ways to escape, leading patients to relapse. ImmPACT Bio will apply its Series B financing toward the development of cell therapies designed to prevent tumor escape.
MD Anderson researchers find mechanisms behind CAR-T cells’ efficacy, toxicity
The findings may make it possible to identify a subset of patients who experience poorer outcomes or more serious side effects, especially neurotoxicity.
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.
Gilead’s Kite submits FDA approval application for CAR-T in slow-growing lymphomas
The company said Friday that it had submitted for approval of Yescarta in follicular and marginal zone lymphoma, based on data from the ZUMA-5 study that were presented at the 2020 ASCO meeting in May.
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Triumvira Immunologics raises $55M in Series A funding round for new form of cancer cell therapy
The company hopes to use the money to bring its T-cell antigen coupler cell therapy technology - currently in preclinical development - into human clinical trials. German drugmaker Bayer's venture capital arm led the round.
Novartis plans to seek approval for CAR-T in slow-growing lymphoma after Phase II success
The company said the study of Kymriah in follicular lymphoma met its primary endpoint, though it did not disclose the trial data. It plans to submit approval applications to the FDA and EMA next year.
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.
Gilead’s Kite Pharma gets FDA nod for second CAR-T cell therapy
The agency approved Tecartus, previously developed under the name KTE-X19, as the first CAR-T therapy for mantle cell lymphoma. The company had previously won approval for another CAR-T, Yescarta. Tecartus is a similar product, but with a different manufacturing process.
FDA slaps hold on Cellectis’ off-the-shelf myeloma CAR-T trial after patient death
The patient, who had been enrolled in the Phase I study at the higher dose level of UCARTCS1A, suffered a cardiac arrest, the causes of which are under investigation, the company said.