Get the Daily Brief
Latest Biotech News
Early-detection tools advance: Mayo predictive model and gentler methylation sequencing
Mayo Clinic researchers unveiled a predictive model that estimates Alzheimer’s risk years before clinical symptoms using decades of clinic data; the model appears to stratify individuals for...
Gene therapy for bladder cancer delivers: Engene posts pivotal data, eyes 2026 filing
Engene/EnGene disclosed additional pivotal‑cohort data for its nonviral gene therapy detalimogene voraplasmid in high‑risk, BCG‑unresponsive non‑muscle invasive bladder cancer with carcinoma in...
Stanford links EBV to lupus: virus shown to reprogram immune B cells
Researchers at Stanford published evidence connecting Epstein‑Barr virus infection to the development of systemic lupus erythematosus. The study demonstrated that EBV can reprogram B cells to...
Novartis’ GanLum passes Phase 3 — poised to tackle artemisinin resistance
Novartis reported Phase 3 results showing GanLum (ganaplacide + lumefantrine) achieved non‑inferiority to current standard therapy and cleared World Health Organization efficacy thresholds in...
FDA taps Richard Pazdur: Oncology veteran named CDER director
The FDA named Richard Pazdur to lead the Center for Drug Evaluation and Research (CDER), moving its long‑time oncology chief into the agency’s top drug regulator role. Pazdur’s appointment follows...
FDA unveils plausible‑mechanism path... bespoke gene edits could speed approvals
Top FDA officials and agency commentators outlined a new regulatory roadmap—often called the “plausible‑mechanism” pathway—intended to accelerate approvals for bespoke, patient‑specific therapies....
GLP‑1s go mainstream: Medicare, sales reshape obesity market
Analyses indicate GLP‑1 receptor agonists are shifting from specialty to mass‑market drugs. Medicare policy changes and potential coverage expansions are expected to reduce patient prices while...
CRISPR’s split week — clinical death and technical wins roil field
The CRISPR sector faced contrasting developments: Intellia reported a fatality and an FDA clinical‑hold risk in its MAGNITUDE Phase III program after a patient developed severe liver injury,...
Neuro‑immunology gets a $101M lift: startups build neural‑immune modality stacks
Nilo Therapeutics launched with a $101 million Series A to translate neuro‑immunology discoveries into therapies that modulate brain‑body circuits to restore immune homeostasis. Backers include...
VISTA emerges as checkpoint target: TRIM25 link boosts immunotherapy
Multiple preclinical studies strengthened VISTA’s candidacy as an immune‑checkpoint target. One paper shows that loss of TRIM25 enhances anti‑tumor immunity by modulating VISTA pathways in T...
Ultra‑mild methylation sequencing... cancer epigenetics gets gentler, deeper tools
The University of Chicago introduced Ultra‑Mild Bisulfite Sequencing (UMBS‑seq), a new method that preserves DNA while delivering accurate, genome‑wide methylation profiles—addressing major...
Gene therapy for bladder cancer surges — Engene posts pivotal Phase II
Engene released additional pivotal‑cohort data for detalimogene voraplasmid, a nonviral gene therapy for high‑risk, BCG‑unresponsive non‑muscle‑invasive bladder cancer with carcinoma‑in‑situ. The...
AI meets tissue biology: BostonGene‑Kyoto deal and Dyno’s AI capsids
BostonGene agreed with Kyoto University to apply its AI‑powered molecular platform to identify biomarkers and immune pathways in esophageal squamous cell carcinoma, combining genomic and...
Novartis to file for approval after Phase 3 win – ganaplacide combo meets WHO cure target
Novartis reported Phase 3 results showing its ganaplacide-based combination therapy (GanLum) achieved cure rates that exceed the World Health Organization’s 95% threshold in trials across...
Single-dose malaria cocktail: Four‑drug shot matches standard multi‑day regimen in Gabon
A Phase 3 trial in Gabon presented at ASTMH found that a single‑dose regimen combining four existing antimalarials matched the effectiveness of conventional multi‑day therapy. Investigators...
FDA unveils new regulatory pathway: faster routes for personalized rare‑disease therapies
Top FDA officials sketched a new regulatory approach designed to expedite bespoke therapies for patients with ultra‑rare conditions. Agency leaders outlined a 'plausible mechanism' pathway that...
Nilo launches with $101M — aims to harness neural circuits to reset immunity
Nilo Therapeutics launched out of academic labs with a $101 million Series A to translate neuro‑immunology discoveries into therapies for autoimmune and inflammatory diseases. The New York‑based...
CRISPR’s mixed week: breakthrough cholesterol data shadowed by trial death
The CRISPR field saw divergent news: a promising in‑vivo cholesterol editing readout was published days after Intellia reported a fatality in its MAGNITUDE Phase III program and an FDA...
GLP‑1 drugs linked to halved mortality in colon cancer cohort
A multi‑site UC Health analysis of more than 6,800 colon cancer patients found those prescribed GLP‑1 receptor agonists had substantially lower five‑year mortality versus non‑users, with adjusted...
UniQure gene therapy shows large slowing of Huntington’s in early trial
UniQure reported that its intracranial AAV‑delivered microRNA therapy AMT‑130 produced a 75% slowing of Huntington’s disease progression versus historical controls at three years in a Phase 1/2...