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Nephrology outcomes: finerenone in non-diabetic CKD
Finerenone cleared another major efficacy bar in chronic kidney disease without diabetes after results from the Phase III FIND-CKD trial showed slower kidney function decline and reduced...
Regulatory pressure: FDA Commissioner’s National Priority Voucher backlash
Drug companies, patient groups, and academic stakeholders pressed the FDA to pause its Commissioner’s National Priority Voucher (CNPV) program during a public listening session, citing “deep...
Regulatory decision: Otsuka’s Voyxact Phase 3 performance
Otsuka said its monoclonal antibody Voyxact (in IgA nephropathy) slowed kidney function decline in a one-year Phase 3 period, but the benefit was less than expected versus historical expectations...
Oncology setbacks: Zynlonta confirmatory trial safety
ADC Therapeutics disclosed top-line results from the Phase III LOTIS-5 confirmatory trial of Zynlonta (loncastuximab tesirine) plus rituximab in relapsed or refractory diffuse large B-cell...
ADC pipeline: Ona Therapeutics Series B and clinical push
Ona Therapeutics secured $86.6 million in an oversubscribed Series B round to advance two antibody-drug conjugate programs into human testing. The financing is aimed primarily at ONA-255 in breast...
Biosecurity policy: mandatory screening for synthetic DNA orders
A coalition of life sciences leaders and security experts urged the U.S. to require mandatory screening and recordkeeping for orders of synthetic nucleic acids. The open letter calls on lawmakers...
CAR T access: Cencora and Kite distribution deal
Cencora signed an agreement with Kite, a Gilead company, to distribute Kite’s FDA-approved CAR T therapies Yescarta and Tecartus across the U.S. The partnership is designed to expand access at...
Nephrology outcomes: low-dose rivaroxaban in advanced CKD
A new JAMA clinical investigation examined whether low-dose rivaroxaban reduces cardiovascular events in patients with advanced chronic kidney disease and elevated cardiovascular risk. The study...
AI platform deal: Alnylam teams with Inceptive Nucleics
Alnylam expanded its AI strategy by striking a partnership with Inceptive Nucleics to apply AI foundation models to RNA interference therapeutic design. The three-year strategic collaboration...
Adjuvants and universal vaccines for future outbreak readiness
University of Cambridge researchers and their spin-out DIOSynVax completed the first human clinical trial of a universal vaccine aimed at Sarbeco coronaviruses, including SARS-CoV-2-related...
Nephrology outcomes: finerenone and semaglutide extend renal benefit signals
The Phase III FIND-CKD trial reported that finerenone significantly slowed kidney function decline and reduced cardiovascular risk in adults with non-diabetic chronic kidney disease. As a...
Otsuka’s Voyxact faces approval pressure as late-stage results disappoint
Otsuka reported that Voyxact (a monoclonal antibody for IgA nephropathy) slowed kidney function decline after one year, but the benefit landed below expectations in a Phase 3 study. eGFR-based...
Oncology: new ADC funding and target competition heats up
Barcelona-based Ona Therapeutics closed an oversubscribed Series B totaling $86.6 million to advance next-generation antibody-drug conjugates. The financing supports clinical development for...
ADC confirmatory setback: death imbalance complicates Zynlonta full-approval bid
ADC Therapeutics disclosed Phase 3 confirmatory data from LOTIS-5 for Zynlonta plus rituximab in relapsed or refractory diffuse large B-cell lymphoma. The regimen met the progression-free survival...
Immunology discovery: TRIM21 drives antibody-directed xenophagy
Researchers at the MRC Laboratory of Molecular Biology identified a previously undescribed intracellular antimicrobial route called antibody-directed xenophagy (ADX). The work, co-led by Leo James...
Biobank-scale genomics meets clinical care: WGS as default in leukemia and routine precision oncology
Genomic Medicine Sweden and the Hartwig Medical Foundation announced a strategic partnership to implement whole-genome sequencing and precision oncology in routine cancer care. The agreement...
Cell therapy manufacturing scale-up: automated TCR-T production evaluation
Cellares and TScan Therapeutics agreed to evaluate automated manufacturing of TSC-101, TScan’s lead TCR-T therapy candidate for AML and MDS patients at risk of relapse following allogeneic...
RNA exon editing dealmaking: Lilly expands into inherited kidney disease genetics
Eli Lilly entered a research and licensing collaboration with Ascidian Therapeutics for RNA exon editors targeting inherited kidney diseases. The deal, valued up to $1.9 billion in upfront fees,...
Funding and market signal: NewLimit raises $435M for first-in-human liver age reprogramming
Longevity biotech NewLimit raised $435 million in a Series C to fund its first human clinical trial of a cell age reprogramming therapy focused on liver aging. The company’s path to clinic...
Nephrology: finerenone benefits expanded to non-diabetic CKD
A major Phase 3 effort, the FIND-CKD trial, reported that finerenone—a non-steroidal mineralocorticoid receptor antagonist—slowed kidney function decline and reduced cardiovascular risk in adults...