Get the Daily Brief
Latest Biotech News
Bristol Myers Squibb pipeline: Phase 3 momentum for fibrosis and RayzeBio
Bristol Myers Squibb reported a pair of Phase 3 wins tied to its fibrosis and RayzeBio programs, underscoring renewed clinical momentum for the company’s oncology and organ-disease pipeline. The...
FDA and regulatory approvals: Herpes drug cleared after acquisition
Asahi Kasei’s Hovilpri (approved for treating lesions caused by herpes simplex virus) received FDA approval, validating a key milestone following the company’s $919 million acquisition of AiCuris...
Cancer immunotherapy endurance: KEYNOTE-966 3-year durability in biliary tract cancer
Three-year follow-up from the Phase 3 KEYNOTE-966 trial confirms that adding pembrolizumab to gemcitabine plus cisplatin maintains a durable overall survival benefit in advanced biliary tract...
Turnaround in super-early diagnostics: Urine test gets FDA clearance for invasive aspergillosis
Johns Hopkins Medicine researchers provided clinical validation supporting the first FDA-cleared rapid urine test to aid diagnosis of invasive aspergillosis. The clearance moves fungal diagnostics...
Telemedicine impact: virtual urgent care keeps most patients out of ED
A consultant-led virtual urgent care clinic at Cork University Hospital managed 73.1% of 2,584 referred patients without any emergency department attendance during its first six months, with no...
Regulatory-facing oncology care: multiple groups validate biomarker strategies
Two new diagnostic-focused readouts point to expanding pathways for biomarker-guided care. In one study, pooled stool DNA screening kit return behavior in a national cohort was associated with a...
CAR-T escalation after transplant failure: donor-derived CD19 responses
A Chinese clinical study reported that donor-derived anti-CD19 CAR-T cells achieved complete remissions in 13 of 14 leukemia patients who relapsed after stem-cell transplantation, including most...
Drug dosing optimization for difficult infections: high-dose sulbactam exposure targets
A Thai pharmacokinetic study in 55 critically ill patients established a two-compartment dosing model suggesting that 12 grams of sulbactam per day—adjusted for kidney function—can achieve...
Cell and gene therapy industry: Aspen Neuroscience files for IPO
Aspen Neuroscience, a Parkinson’s cell-therapy developer, filed to go public and is seeking Nasdaq listing with funds earmarked for its lead program. The approach aims to turn a patient’s own...
Clinical imaging shift: liquid biopsy and CT-based predictions expand triage tools
New evidence suggests a widening toolbox for predicting disease state using imaging and liquid biopsy signals. A meta-analysis of circulating tumor DNA shows post-neoadjuvant ctDNA detectability...
Regulatory and evidence updates for diagnostics and tumor-agnostic oncology
Two new companion-diagnostic validations support broader pembrolizumab eligibility in dMMR/MSI-H solid tumors, with post-marketing bridging data confirming that two commercially available...
Phase 3 and higher evidence reshaping cancer and radiation strategies
In advanced hepatocellular carcinoma, proton therapy failed to deliver a survival benefit in the Phase III NRG-GI003 trial, which was stopped early for futility. The results reinforce that...
Immuno-oncology biomarkers and translational ex vivo testing
A Lund University-led ex vivo model suggests that precision-cut bladder tumor slices can preserve immune cells and remain functional for up to six days, enabling drug testing that reproduced...
Molecular drivers of therapy resistance and immune evasion in cancer
New mechanistic work ties gene regulation and immune escape to real resistance phenotypes. A study reports that DNA methylation silences components of the TRAIL apoptosis pathway—DR5, DcR2 and...
Drug safety, toxicity, and precision risk signals across clinical care
A new analysis in pharmacovigilance reports that liver injury after CAR T-cell therapy often tracks with cytokine release syndrome timing, with an early-onset signal dominating. The dataset also...
Evidence on imaging and AI-driven patient selection for oncology
Machine learning continues to move from retrospective performance toward tools that can influence patient pathways. A multicenter study reports that CT-based radiomics can noninvasively predict...
NICU care practices: revisiting rooming strategies
A randomized trial of 85 very preterm infants found no difference in death or neurodevelopmental impairment at 36 months between single-family room and open-bay NICU care. Despite the lack of...
Pediatric and maternal care: precision dosing and clinical trial evidence
A Vietnamese cohort study suggests a simplified fixed-dose follitropin delta regimen can match standard approaches for live birth in IVF freeze-all cycles, with shorter stimulation durations and...
Technology transfer and formulation science moving toward the clinic
The Journal of Pharmaceutical Investigation announced a January 2027 special issue focused on translational advances in pharmaceutical dosage form development, emphasizing particle engineering,...
Major funding and corporate deal activity in biotech
Viatris will acquire Pacira BioSciences in a $1.65 billion transaction, agreeing to buy all outstanding Pacira shares for $36.50 each in cash. The deal brings a pain-care portfolio platform into...