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FDA approval for BeOne’s BCL2 inhibitor in mantle cell lymphoma
BeOne Medicines received US FDA accelerated approval for sonrotoclax, now marketed as Beqalzi, for patients with relapsed or refractory mantle cell lymphoma after treatment with a BTK inhibitor....
Regenxbio’s Duchenne gene therapy clears pivotal bar for FDA submission path
Regenxbio said its Duchenne muscular dystrophy gene therapy met the bar in a pivotal study, setting up an FDA submission expected in 2027. The company reported the therapy produced sufficiently...
Cell therapy manufacturing automation for progenitor T-cell therapy
Cellares and ProTgen announced a partnership to automate manufacturing and quality control for ProT-096, a personalized progenitor T-cell therapy aimed at refractory leukemia and other hematologic...
BeOne/Biopharma compliance and reimbursement pressures shaping diagnostics and lab economics
MDxHealth reported Q1 revenue rose 13% year over year while the company discontinued its Resolve UTI test and lab operations in Plano, Texas. The company cited a reimbursement landscape it...
EU diagnostic regulation milestone: Cepheid multiplex GI panel gains IVDR CE marking
Cepheid received CE marking under the EU IVDR framework for its Xpert GI Panel, a multiplex PCR test intended to identify 11 gastrointestinal pathogens from a single stool sample in about 74...
AI-backed liquid biopsy diagnostics for immunotherapy-response prediction
LiquidCell Dx said it is developing LiquidTME, a cfDNA-based methylation profiling liquid biopsy assay designed to predict response to immune checkpoint inhibition by identifying tumor...
Gene therapy safety question in Dravet: steroids may blunt efficacy in Encoded trial data
A study from Encoded Therapeutics suggested that a medicine commonly used to reduce gene-therapy immune responses could also reduce effectiveness. In a Dravet syndrome gene-therapy trial, most of...
Rebuild at the FDA after commissioner resignation and leadership handoff
Marty Makary resigned as FDA commissioner, ending a politically turbulent tenure as Kyle Diamantas, previously the agency’s top food regulator, moved in as acting commissioner. The transition...
FDA approval for next-gen BCL2 inhibitor
BeOne Medicines’ sonrotoclax (sonrotoclax/Beqalzi) won US accelerated approval for relapsed or refractory mantle cell lymphoma after a BTK inhibitor, giving the company a first US BCL2-labeled...
FDA blessing for BCL2 inhibitor in US and oncology sequencing impact
BeOne’s next-generation BCL2 inhibitor sonrotoclax (branded Beqalzi) received FDA accelerated approval in mantle cell lymphoma following treatment with a BTK inhibitor. The label creates a new US...
FDA leadership shake-up after Makary exit
Marty Makary resigned as FDA commissioner, with Kyle Diamantas, previously the agency’s top food regulator, stepping in as acting commissioner. The transition comes amid ongoing concerns from...
Alzheimer’s tau drug misses Phase 2 endpoint at Biogen
Biogen reported that diranersen (BIIB080), a tau-targeting Alzheimer’s therapy, missed its primary dose-response efficacy endpoint in a Phase 2 study. The company said lower tau levels in spinal...
Duchenne gene therapy clears pivotal bar toward FDA submission
Regenxbio said its Duchenne muscular dystrophy gene therapy met the pivotal trial bar by producing sufficiently high levels of a miniaturized muscle protein, setting up an FDA submission path. The...
New in vivo CAR-T funding and pipeline expansion
CREATE Medicines, formerly Myeloid Therapeutics, raised $122 million to advance its first in vivo CAR-T candidates targeting autoimmune disease into human trials. The funding round expands the...
CREATE Medicines adds $122M funding momentum for in vivo CAR-T
The in vivo CAR-T buildout continued as CREATE Medicines (previously Myeloid Therapeutics) secured a $122 million Series B to fund early development of autoimmune and cancer candidates. The round,...
BCL2 inhibitor approval in lymphoma race
BeOne’s lymphoma momentum accelerated with US accelerated approval for sonrotoclax (Beqalzi) in mantle cell lymphoma after BTK inhibitor therapy. The FDA’s decision gives BeOne a new commercial...
BMS and Hengrui expand global oncology collaboration
Bristol Myers Squibb and Hengrui Pharma agreed to a collaboration spanning 13 early-stage programs across oncology, hematology, and immunology, with potential value of more than $15.2 billion. BMS...
Volixibat/volixibat-like pipeline and PSC NDA push at Mirum
Mirum Pharmaceuticals advanced its primary sclerosing cholangitis (PSC) program after reporting phase IIb data from the Vistas trial of the oral IBAT inhibitor volixibat (and related follow-on...
Hengrui and BMS ink large global oncology research pact
Bristol Myers Squibb (BMS) and Jiangsu Hengrui Pharmaceuticals announced a collaboration spanning 13 early-stage programs across oncology, hematology and immunology. BMS will pay Hengrui up to...
Isomorphic Labs closes $2B Series B for AI drug design
Isomorphic Labs, the Alphabet-backed AI drug discovery company, closed a $2.1 billion Series B round led by Thrive Capital, with participation from Alphabet and Google’s GV, plus other global...