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Cardiovascular: Alzheimer’s, diagnostic expansion and blood biomarker adoption
Roche and Eli Lilly have received FDA clearance for a new blood test, Elecsys pTau217, designed to help clinicians rule in and rule out Alzheimer’s disease. The assay measures phosphorylated tau...
Biotech deals: big licensing and platform expansion in cell and protein tools
Monod Bio and SignalChem Biotech, a wholly owned subsidiary of Sino Biological, announced a non-exclusive licensing agreement covering Monod Bio’s LuxSit de novo luciferase technology and...
Clinical trial readouts and pipeline pivots: rheumatoid arthritis TL1A antibody setback and course changes
Spyre Therapeutics said it is deprioritizing its rheumatoid arthritis anti-TL1A antibody program after modest Phase 2 data for its SPY072 candidate. The company indicated the monotherapy results...
Clinical development risk: Regeneron ends CD3 antibody eye therapy trial after safety event
Regeneron terminated its early Phase I/IIa TITAN trial evaluating REGN7041, a T cell-targeting monoclonal antibody for noninfectious uveitis. The study stopped after a safety event triggered an...
Biomanufacturing scale-up: sterilization constraints and alternatives gaining attention
Biosphere’s COO Arye Lipman argued that biomanufacturing’s next scaling bottleneck may be sterilization, especially for industrial-scale capacity built around steam-in-place and aseptic...
Viral vector characterization: flow virometry tool targets lentiviral analytics for in vivo CAR-T
Kite Pharma, a Gilead company, introduced a new cytometry-based technique for analyzing individual lentiviral vector particles. The approach is intended to improve characterization of future in...
Workforce and capacity building: Canada funds life sciences biomanufacturing training
Canada’s Government committed up to $8.7 million to the Canadian Alliance for Skills and Training in Life Sciences (CASTL) to expand biomanufacturing workforce training. The funding is delivered...
Genomics diagnostics and implementation: citywide rapid WGS in Dubai for critically ill children
A citywide rapid whole-genome sequencing (rWGS) program in Dubai reported a high diagnostic yield among critically ill infants and toddlers, with particular enrichment among cases from...
Biotech restructuring and funding signals: Aurora Therapeutics pauses bespoke CRISPR program
Aurora Therapeutics, the first startup focused on bespoke CRISPR therapies, laid off staff and stopped its lead program. The company’s work centered on CRISPR base editing to correct mutations,...
FDA approvals and label expansions for next-wave oncology and diagnostics
The FDA expanded Jazz Pharmaceuticals’ Ziihera (zanidatamab) into a new frontline regimen for HER2-positive gastrointestinal cancers, creating a broader commercial runway beyond its earlier...
Company deals: large licensing and M&A that move clinical-stage assets
Genentech struck a major metabolic pact with Hanmi Pharmaceutical to advance HM-17321, a long-acting urocortin-2 analog, in obesity and related conditions. The transaction includes a $190 million...
Clinical setbacks and regulatory holds that reshape development plans
Regenxbio’s Hunter syndrome gene therapy (RGX-121) ran into another FDA stop as the company reported a clinical hold after discovering asymptomatic spine MRI findings in five patients during the...
Immunotherapy effectiveness and trial readouts in blood cancers
Janssen’s teclistamab delivered a major Phase I/IIa win in refractory multiple myeloma, with MajesTEC-9 meeting its primary endpoint and improving progression-free and overall survival. Reporting...
Viral vector and synthetic DNA manufacturing partnerships
4basebio and Genezen announced a collaboration aimed at viral vector manufacturing using 4basebio’s hairpin DNA (hpDNA) technology. Under the deal, Genezen will provide hpDNA-based constructs...
Clinical evidence for prostate cancer radiotherapy strategy
A large randomized Phase III NRG-GU005 trial compared stereotactic body radiation therapy (SBRT) with moderately hypofractionated intensity-modulated radiation therapy (MH-IMRT) in localized...
Immune mechanism research: CD8+ T cells and T-cell mediated protection in Zika vaccines
Two independent Zika vaccine research threads emphasized CD8+ T cells as a key protective arm. Researchers at the La Jolla Institute for Immunology reported that an engineered Zika vaccine...
Data infrastructure and real-world evidence pipelines for oncology testing
Guardant Health continues to build real-world validation for its Shield multi-cancer detection (MCD) test, using intended-use data to refine performance ahead of potential regulatory submission....
RNA and whole-genome clinical implementation: scaling rWGS in pediatrics
A citywide rapid whole-genome sequencing (rWGS) program in Dubai reported high diagnostic yield for critically ill infants and toddlers, particularly among cases from consanguineous families. The...
Biomanufacturing and platform enablement: synthetic biology tools for CHO production
SynGenSys introduced an expanded CHO.SET synthetic promoter library aimed at boosting protein production in CHO cell lines. The CHO.SET CHO-specific promoter pools combine computational design...
FDA clears Alzheimer’s blood testing – market ramps up
The FDA cleared Roche and Eli Lilly’s Elecsys pTau217 plasma blood test for assessing both the likelihood of Alzheimer’s disease and the presence of amyloid pathology in patients with cognitive...