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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...
Ferroptosis and iron handling biology surfaces as drug target terrain
New lab findings are tightening the mechanistic link between iron metabolism and ferroptosis, increasing the number of actionable nodes for drug discovery. A study in Experimental & Molecular...
Phase 3 lymphoma safety signals roil Zynlonta’s path to full approval
ADC Therapeutics’ confirmatory Phase 3 LOTIS-5 dataset for Zynlonta (polatuzumab vedotin?—as described in the provided text: Zynlonta plus rituximab) has raised serious safety concerns and...
Germany austerity pressures big pharma manufacturing plans
Eli Lilly and Boehringer Ingelheim have rolled back large-scale investments in Germany in response to proposed health spending cuts. According to Handelsblatt reporting carried in the provided...
Russia? (Federal) 340B compliance squeeze tightens around Lilly
Eli Lilly has escalated enforcement of its 340B claims data policy, issuing an ultimatum to hospitals that have not complied with requests to share data intended to show they are not...
AI-for-RNA drug discovery cashes in: Alnylam and Inceptive expand to up-to-$2B
Alnylam has signed a multi-year AI-enabled RNA discovery collaboration with Inceptive Nucleics, with total potential value described as up to $2 billion. The deal structure includes $30 million...
Longevity biotech NewLimit bets big ahead of first-in-human liver age reprogramming trial
NewLimit has raised $435 million in a Series C financing to advance its first-in-human cell age reprogramming therapy targeting liver cells. The company’s stated plans are to start Phase I...
RNA exon editing gets a Lilly-sized vote of confidence in inherited kidney disease
Eli Lilly has entered a global research and licensing collaboration with Ascidian Therapeutics centered on RNA exon editing for monogenic inherited kidney diseases. Under the reported structure,...
Precision oncology platform partnerships move toward clinical implementation
Diagnostics and sequencing platforms are continuing to push deeper into clinical workflows, with partnerships aimed at making whole-genome sequencing and AI-driven cancer analysis more “default”...
Diagnostics and imaging advances: FDA nod for mold cfDNA and faster cardiac valve assessment
Diagnostic innovation moved on two fronts, with one regulatory milestone and one translational imaging advance. The FDA granted Zepto Life Technologies breakthrough device designation for its...
Longevity cell-age reprogramming
NewLimit, the aging-biotech backed by investors including Founders Fund, Thrive Capital, and Lilly Ventures, raised $435 million in a Series C to fund its first-in-human cell age reprogramming...