Get the Daily Brief
Latest Biotech News
Regulatory: FDA signals possible turnaround on reformulated Avastin for wet AMD
Outlook Therapeutics said the FDA reversed course on its reformulated Avastin version for wet age-related macular degeneration (AMD) after three prior rejections dating back to 2023. The company...
Immuno-oncology/regulatory approval: Beqalzi becomes first BCL2 inhibitor for mantle cell lymphoma
The FDA granted accelerated approval to Beqalzi (sonrotoclax), the first BCL2 inhibitor specifically for relapsed or refractory mantle cell lymphoma (MCL) after at least two prior lines of...
Clinical science: AI-assisted prediction of neonatal sepsis risk in NICUs
Researchers unveiled an AI system intended to deliver “just-in-time,” risk-stratified evaluations of sepsis in neonatal intensive care units (NICUs). The approach is designed to support earlier...
Diagnostics/biomarkers: Urine-based screening for early autism indicators
Arizona State University researchers developed a urine-based diagnostic screening tool designed to identify autism spectrum disorder (ASD) biochemical signatures in children as young as two years...
Clinical trial research: Vitamin D receptor modulation targets pancreatic cancer defenses
A clinical trial led by researchers at Dana-Farber Cancer Institute tested a vitamin D receptor (VDR) modulation strategy intended to alter the tumor microenvironment in pancreatic cancer. The...
Gene regulation and prediction: MutationProjector links tumor mutational co-dependencies to therapy response
University of California San Diego researchers unveiled MutationProjector, an AI-enabled tumor genome foundation model designed to map mutational co-dependencies and predict therapy response. The...
Diagnostics distribution: Eurobio expands UK/EU access to Canhelp molecular oncology assays
Eurobio Scientific signed a distribution partnership to commercialize two Canhelp Genomics molecular oncology assays across the UK, France, Germany, Austria, Switzerland, and the Benelux. The...
Biotech startups and funding: Protuoso secures $9.5M seed for hub-and-spoke antibody development
Protuoso Biosciences raised $9.5 million in a seed round to build a hub-and-spoke antibody developer model. The funding positions the company to support antibody discovery and development by...
Lilly expands infectious-disease footprint via major vaccine acquisitions
Eli Lilly has agreed to buy three vaccine developers in coordinated deals totaling up to nearly $4 billion, extending the company’s push to prevent disease rather than just treat downstream...
PCSK9 base editing moves toward mid-stage testing after early LDL reduction
Eli Lilly reported early trial data for VERVE-102, its PCSK9 base-editing program acquired via the Verve Therapeutics buyout, showing a single infusion can reduce LDL cholesterol by as much as 62%...
FDA decision-making: wet AMD Avastin iteration reversal reported
Regulatory oversight appears to be shifting for an ophthalmology program: Outlook Therapeutics said FDA reversed course on its reformulated version of Avastin for wet age-related macular...
Regulatory acceleration for next-generation BCL2 inhibition in mantle cell lymphoma
The FDA granted accelerated approval to Beqalzi (sonrotoclax) for adults with relapsed or refractory mantle cell lymphoma after at least two prior systemic therapies, including a BTK inhibitor....
Wearable fetal monitoring moves closer to continuous high-risk surveillance
Researchers unveiled a wearable ultrasound patch designed for continuous, autonomous fetal monitoring in high-risk pregnancies, aiming to overcome the limitations of intermittent ultrasound exams...
AI model maps tumor mutational co-dependencies to predict therapy response
A University of California San Diego team published a new AI foundation-style model, MutationProjector, in Cancer Discovery that compresses mutational patterns into a low-dimensional...
Cardiometabolic gene therapy gains additional evidence in early-stage planning
Lilly’s gene-editing strategy continues to move forward as it discloses additional Phase 1b results tied to its VERVE-102 program. The company said new data further support safety and...
Cancer biology: immune-cell maps differentiate tumor killers from tumor helpers
Cancer researchers published new immune-cell mapping work aimed at separating the roles of tumor-infiltrating cells that attack versus those that support malignancy. The study focuses on how...
Neuroscience: cryopreservable dopaminergic progenitors restore function in Parkinsonian rats
A team reported cryopreservable dopaminergic progenitors derived from human iPSCs that can be stored and later transplanted, demonstrating early functional restoration in Parkinsonian rat models....
Oncology diagnostics: blood test aims to detect early breast-cancer recurrence
Lund University researchers developed a blood test intended to identify early indicators of breast-cancer recurrence by detecting circulating fragments of tumor-derived DNA. The approach is...
Gene editing for LDL and cardiovascular prevention
Eli Lilly reported early clinical data for its PCSK9 base-editing program VERVE-102, showing the one-time gene-editing therapy reduced LDL cholesterol by up to 62% in a Phase 1 open-label,...
Lilly’s infectious disease buyouts to build prevention pipeline
Eli Lilly agreed to acquire three vaccine developers—Curevo, LimmaTech Biologics, and Vaccine Company—for up to nearly $4 billion total, aiming to expand an infectious disease portfolio centered...