Get the Daily Brief
Latest Biotech News
Regulatory and clinical trial: Otsuka’s Voyxact underlines mixed late-stage outcome
Otsuka disclosed late-stage trial evidence for Voyxact (ocrelizumab was not; Voyxact is a monoclonal antibody) as it pursues full approval in IgA nephropathy. Separate reporting highlighted a...
ADC pipeline: Innovent eyes CLDN18.2 filing after phase 3 win
Innovent Biologics reported interim success for its Claudin18.2-targeted antibody-drug conjugate arcotatug tavatecan (IBI-343, TAK-921) in the international Phase 3 G-Hope-001 trial in advanced...
Oncology investment: Ona Therapeutics raises to push two ADCs into humans
Ona Therapeutics secured an oversubscribed $86.6 million Series B to advance two antibody-drug conjugates toward clinical proof of concept. The funding is set to accelerate ONA-255 in breast...
Cell therapy distribution: Cencora expands access to Kite’s FDA-approved CAR T
Cencora agreed to distribute Kite’s FDA-approved CAR T-cell therapies Yescarta (axicabtagene ciloleucel) and Tecartus (brexucabtagene autoleucel) across the U.S., aligning distribution with Kite’s...
Genetic medicines: Lilly pays up to $1.9B for Ascidian’s RNA exon editors
Eli Lilly struck a global research and licensing collaboration with Ascidian Therapeutics for RNA exon editing aimed at inherited kidney diseases. Under the deal, Lilly could pay up to $1.9...
Diagnostics: Photocure to acquire Vesica Health for urine molecular bladder cancer testing
Photocure agreed to acquire Vesica Health for $30.5 million in cash and stock, adding AssureMDx—Vesica’s urine-based molecular test for early bladder cancer detection—to its portfolio. The...
Clinical trial shock: ADC Therapeutics faces confirmatory setback in DLBCL
ADC Therapeutics disclosed top-line results from the Phase 3 LOTIS-5 confirmatory trial of Zynlonta (loncastuximab tesirine) plus rituximab in relapsed or refractory diffuse large B-cell lymphoma...
Funding and innovation: NewLimit’s $435M Series C targets first-in-human cell age reprogramming
Longevity biotech NewLimit raised $435 million in a Series C to fund its first human trial of a cell age reprogramming therapy, after faster-than-expected scientific progress. The company says it...
AI and biomanufacturing safeguards: synthetic DNA screening gains new momentum
A coalition of tech and life sciences leaders and AI companies called for mandatory screening and recordkeeping for synthetic nucleic acid orders, arguing that current safeguards are insufficient...
Oral targeted oncology candidate enters first-in-human testing
E7386 has moved into the clinic after an international team reported first-in-human results from a Phase 1, open-label, multicentre trial in advanced cancer. The orally administered regimen is...
ctDNA monitoring advances in metastatic breast cancer
Researchers reported a methylation-based circulating tumor DNA (ctDNA) strategy to track metastatic breast cancer therapy response and disease progression. The approach focuses on methylation...
Diagnostics expansion: Photocure to buy Vesica Health for urine-based bladder cancer detection
Photocure agreed to acquire Vesica Health for $30.5 million to expand its bladder cancer diagnostics portfolio. The deal adds AssureMDx, a urine-based molecular test built on methylation-specific...
FDA policy fight: Industry and patient groups urge pause of commissioner voucher program
Leaders from drug companies and patient groups urged the FDA to pause the Commissioner’s National Priority Voucher program during a White Oak listening session. The meeting followed criticism that...
Phase 3 kidney drug signal undershoots expectations in IgA nephropathy
Otsuka reported that Voyxact (a CAM/capsid-modulating strategy is not implied here; the article describes kidney-function effects) slowed the loss of kidney function in IgA nephropathy, but the...
Cell therapy distribution: Cencora partners with Kite for US CAR T rollout
Cencora entered an agreement with Kite (a Gilead company) to support distribution of Kite’s FDA-approved CAR T therapies Yescarta and Tecartus across the United States. The partnership targets...
Oncology biotech financing: Ona raises $86.6M to push ADCs into human trials
Ona Therapeutics closed an oversubscribed $86.6 million Series B to advance two antibody-drug conjugates toward clinical testing. The capital is primarily earmarked for ONA-255 in advanced...
NDA filing in China: Innovent submits CLDN18.2 ADC application for gastric cancer
Innovent Biologics submitted an NDA to China’s NMPA for its CLDN18.2-targeted ADC arcotatug tavatecan (IBI-343, TAK-921) after positive interim results in the international multicenter Phase 3...
Ongoing lymphoma safety dispute: ADC Therapeutics faces confirmatory trial death imbalance
ADC Therapeutics disclosed top-line results from the Phase 3 LOTIS-5 confirmatory trial of Zynlonta (loncastuximab tesirine) plus rituximab in relapsed or refractory DLBCL, showing no overall...
Major clinical breakthrough in pancreatic cancer: daraxonrasib extends survival in Phase 3
Revolution Medicines’ pan-RAS inhibitor daraxonrasib delivered a survival gain in the Phase 3 RASolute 302 study for advanced pancreatic ductal adenocarcinoma. In a trial of 500 patients...
Alzheimer’s genetics and mechanistic timing of neurodegeneration
A pair of new studies are reshaping how researchers think about Alzheimer’s disease risk and progression timing, using large-scale human genetics and disease-focused molecular mapping. A GWAS...