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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...
Rapid Ebola preparedness and antiviral/vaccine development
SwRI and Texas Biomed are collaborating to test AI-identified antiviral compounds against Ebola virus, targeting the Bundibugyo species as the strain resurfaces in the Democratic Republic of...
Neonatal sepsis detection using AI in NICUs
Researchers unveiled an AI system intended to provide just-in-time, risk-stratified evaluations for neonatal sepsis in neonatal intensive care units. The goal is earlier detection during the...
Clinical trial and diagnostics expansion in women’s health biomarkers
Aspira Women’s Health signed a deal with Cleveland Clinic to expand access to patient samples and accelerate the clinical validation of multiomic diagnostics in women’s health. The collaboration...
Biotech regulation: COINS Act expansion discussion and China IIT rules
Two policy developments are reshaping the regulatory and compliance backdrop for biotech dealmaking tied to China. A separate report said calls for expanding the COINS Act are growing, with...
FDA approval milestone in mantle cell lymphoma
The FDA approved Beqalzi (sonrotoclax), described as the first BCL2 inhibitor specifically approved for relapsed or refractory mantle cell lymphoma after at least two prior lines of systemic...
Cancer immunotherapy and tumor recognition via antibody conjugates
A research report highlighted how platinum-antibody conjugates are designed to enhance tumor recognition and immune system engagement, aiming to broaden benefit from immune checkpoint inhibitors....
Medtronic expands neuromodulation with SPR Therapeutics acquisition
Medtronic agreed to buy SPR Therapeutics for $650 million, strengthening its pain management portfolio by adding a peripheral nerve stimulation system designed for sustained pain relief. The deal...
Antibody distribution partnership in molecular oncology diagnostics
Eurobio Scientific struck a distribution agreement with Canhelp Genomics for two molecular oncology assays across the UK, EU, and Benelux. The partnership covers the Canhelp-Uca urine assay for...
Gene-editing for LDL lowering moves through early clinical readouts
Eli Lilly reported early Phase 1 results for its VERVE-102 base-editing program, saying a single infusion reduced LDL cholesterol by as much as 62% and sustained the effect for up to 18 months....
Lilly accelerates infectious-disease dealmaking with three vaccine acquisitions
Eli Lilly announced agreements to acquire three private vaccine developers—Vaccine Co., Curevo, and LimmaTech Biologics—expanding its infectious-disease pipeline through a series of transactions...