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FDA oversight and COVID-era regulatory wind-down
HHS moved to end COVID-era Emergency Use Authorization (EUA) declarations for medical devices starting a 180-day countdown, with similar terminations for drugs and biologics beginning 12 months...
FDA cell and gene therapy leadership transition
Vijay Kumar is stepping down as acting director of the FDA’s Office of Therapeutic Products within CBER, STAT reported. The change follows a broader leadership shuffle in the gene and cell therapy...
Investigational CAR-T trial moves forward with FDA IDE for MRD assay
FDA granted an investigational device exemption (IDE) for the use of Adaptive Biotechnologies’ ClonoSeq assay in a clinical trial sponsored by Imviva Biotech. The TENACITY-01 study evaluates...
Big pharma dealmaking and late-stage portfolio bets
Ipsen agreed to acquire Kartos Therapeutics in a deal valued at $1.75 billion total, including $450 million upfront, to bring navtemadlin—an investigational oral MDM2 inhibitor—into its late-stage...
Trial integrity shock: Tavneos pivotal data retracted
Academic authors retracted a pivotal phase 3 paper for Amgen’s Tavneos (avacopan) from The New England Journal of Medicine after the primary endpoint assessments for nine patients were reportedly...
Next-generation CAR-T manufacturing capacity expansion
Korea’s KRICT reported a novel viral vector technology aimed at improving CAR immune cell production. The approach centers on a newly identified SRV2 envelope protein to enhance CAR immune cell...
Immunology startup funding: Beeline doubles down on BMS-origin lupus asset
Beeline Medicines secured a $126.3 million Series A extension, bringing total funding to $426.3 million, as it advances afimetoran for lupus and expands development of additional immune...
Clinical microbiology diagnostics update: BioMérieux submits updated GI PCR panels
BioMérieux submitted updated gastrointestinal FilmArray PCR panels to FDA for 510(k) review, aiming to strengthen norovirus detection and improve specificity. The company filed both the FilmArray...
Sequencing platform competition heats up with Roche’s Axelios 1 launch
Roche started shipping its Axelios 1 next-generation sequencing platform commercially, positioning the system as a potential alternative to entrenched Illumina workflows. The company said it will...
Biotech financing: Proteomics firm Pictor raises bridge capital
Proteomics company Pictor closed a $7.5 million bridge funding round to expand commercial partnerships and scale both its platform development and manufacturing capabilities. The company said the...
FDA / regulatory leadership shakeups in cell and gene therapy
Vijay Kumar is stepping down as acting director of the FDA’s Office of Therapeutic Products within CBER, according to STAT and an FDA-related statement reviewed by the agency’s leadership team....
FDA Precheck pilot accelerates manufacturing review planning
The FDA moved the Precheck program from planning to execution by clearing the first flight of a manufacturing pilot with seven biopharma companies participating. The initiative is designed to...
Clinical evidence integrity: NEJM retracts Tavneos pivotal trial data
The New England Journal of Medicine retracted the pivotal phase 3 Tavneos (avacopan) study article after primary endpoint assessments for nine patients were reportedly “re-adjudicated” following...
Company transaction: Zymeworks buys Theravance in $929M deal
Zymeworks agreed to acquire Theravance Biopharma in a $929 million transaction, combining Theravance’s commercial and royalty-stream assets with Zymeworks’ balance-sheet and portfolio strategy....
Late-stage oncology deal: Ipsen acquires Kartos and navtemadlin in myelofibrosis
Ipsen agreed to buy Kartos Therapeutics in a deal valued at $450 million upfront, with potential milestone payments up to $1.75 billion, to add navtemadlin—an MDM2 inhibitor in Phase 3—to its...
Immuno-oncology clinical progress: Epkinly combo win in DLBCL Phase 3
AbbVie and Genmab reported Phase 3 success for Epkinly (t-cell engager) in diffuse large B-cell lymphoma, with the Epkinly plus lenalidomide regimen reducing the risk of progression or death by...
Cell and gene therapy diagnostics enabling clinical trial enrollment: ClonoSeq IDE for Imviva
FDA granted an investigational device exemption for Adaptive Biotechnologies’ ClonoSeq MRD assay in a clinical trial sponsored by Imviva Biotech. The IDE covers use of ClonoSeq to support the...
Biotech funding: Proteomics platform Pictor closes $7.5M bridge round
Pictor, a proteomics-focused company, closed a $7.5 million bridge funding round to expand commercial partnerships, scale its platform development, and support translational studies. The company...
Platform innovation: AI-accelerated liquid biopsy with Fragmentia-AI for ctDNA fragmentomic signals
Geneseeq advanced its fragmentomic cell-free DNA approach with Fragmentia-AI, an AI model designed to read DNA fragment patterns as a language rather than relying only on mutation lists and...
Preclinical cell models: iPSC-derived retinal endothelial cells integrate and restore vascular function
Duke University researchers reported iPSC-derived retinal endothelial cells (iRECs) that integrate into damaged retinal tissue in mouse models and form functional vascular structures in vitro. The...