Get the Daily Brief
Latest Biotech News
Cardiovascular risk drug failure
A phase 3 HORIZON trial has failed to show that pelacarsen reduces cardiovascular death or events compared with placebo in patients enrolled for lipoprotein(a)-lowering, according to Novartis. The...
Gene therapy manufacturing partnership
NewBiologix and Synastra Biotechnology have signed an agreement to develop a stable producer cell line for Synastra’s investigational Duchenne muscular dystrophy (DMD) gene therapy program....
ADARx IPO plans
ADARx Pharmaceuticals has filed for an initial public offering with three drugs in the clinic, seeking to capitalize on renewed IPO momentum in biotech. The RNA interference company positions its...
Late-breaking CAR-T safety signal and program pause
Novartis has halted immunology and neuroscience studies after deaths were reported from its experimental CAR-T therapy, according to the latest industry reporting. The action reflects how patient...
Biotech funding for first-in-clinic strategy
Superluminal has raised $60 million in a Series B round to drive its first clinical study, according to finance reporting. The funding is positioned to support the transition from preclinical...
Immunotherapy mechanism—exosome-mRNA vaccine
Case Western Reserve University researchers have reported a mechanistic roadmap for multimodal cancer vaccines that combine personalized mRNA payloads with engineered exosomes to convert “cold”...
Pharma dealmaking—Menarini obesity push
Gan & Lee’s cross-border deal is supporting Menarini’s move into obesity, tied to data for a twice-monthly GLP-1 receptor agonist that was reported as competitive versus market leaders Zepbound...
Regulatory landscape for pipeline approvals
BioCentury’s data-bytes round-up highlights six first-in-class approvals in August, including Ionis’ Zanvastro for Alexander disease and AZ’s Etcamah for breast cancer. The list also signals how...
CAR-T manufacturing optimization
A Chinese research team has reported a microfluidic approach to boost CD19 CAR-T cell transduction at low viral doses, aiming to reduce manufacturing bottlenecks for CAR-T programs. The work...
Regulatory approvals in rare neurology
The FDA approved Ionis Pharmaceuticals’ antisense therapy zilganersen (Zanvastro) for Alexander disease, delivering the first disease-modifying option for the ultra-rare, progressive neurologic...
Clinical trial failure challenges cardiovascular target validation
Novartis’ pelacarsen failed to reduce cardiovascular events in the Phase 3 HORIZON trial, after earlier studies showed it could drastically lower Lp(a). The result directly challenges the drug’s...
Biologics/engagement upgrades for multiple myeloma
AbbVie reported that etentamig met the main goal of its Phase 3 trial in multiple myeloma, improving progression-free outcomes versus standard regimens at an interim checkpoint. The bispecific...
Immuno-oncology: engineered antibody boosts CD4 T cell–dendritic cell cooperation
Researchers published in Nature Cancer report an Fc-optimized engineered GITR antibody that enhances antitumor immunity by strengthening communication between CD4 T cells and dendritic cells. The...
Cancer metabolism vulnerability in triple-negative breast cancer
A research team identified a pathway linking MINK1 activity to glucose metabolism reprogramming in triple-negative breast cancer, exposing a metabolic vulnerability. The study, led by scientists...
Early diagnostics: AI radiomics for lung cancer invasiveness
A computational radiomics model reported by Tianjin Chest Hospital aims to distinguish whether pure ground-glass lung adenocarcinoma lesions are pre-cancerous or early invasive based on...
Therapeutic manufacturing: stable rAAV producer cell line collaboration
NewBiologix and Synastra Biotechnology signed an agreement to develop a stable producer cell line for Synastra’s investigational Duchenne muscular dystrophy rAAV gene therapy program. NewBiologix...
Biotech finance: Series B funding to move brain-health drugs into clinics
NeuShen Therapeutics, a Shanghai and Boston biotech, raised more than $80 million in a Series B round to advance three clinical-stage brain-health drugs. The funding underscores continued investor...
Public-private health: UK end-of-life benefit access shift re-scored
A UK study in BMC Medicine reports that extending the prognostic window from six to twelve months changed who received fast-tracked access to end-of-life benefits under the Special Rules for End...
Institutional review: digital twins guide ventilation protocol transitions
Clinicians and researchers at the University of Warwick, University Hospital North Midlands NHS Trust, and Imperial College London used digital twin technology to evaluate a newly proposed...
Alexander disease therapy approval expands Ionis’s CNS franchise
The FDA approved Ionis Pharmaceuticals’ antisense therapy Zanvastro (zilganersen) for Alexander disease in pediatric and adult patients, establishing the first disease-modifying treatment for this...