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CBER chief’s conduct and Moderna RTF ignite FDA internal revolt
Reporting by The Wall Street Journal and follow‑up by STAT and Fierce documents internal complaints against Vinay Prasad, head of the FDA’s Center for Biologics Evaluation and Research (CBER), and...
AI hunts antibiotics in genomes and ancient sequences — Penn group scales search
César de la Fuente’s group at the University of Pennsylvania is using artificial intelligence to scour genomes, venoms and ancient sequences for antimicrobial peptides, reporting successive...
Drinkable gene‑therapy foam targets esophageal tumors: noninvasive local delivery
Researchers including Stephan, Cummings and Fitzgerald introduced a novel oral foam formulation intended to deliver gene therapy to constrictive esophageal carcinomas, aiming to overcome access...
Extracellular vesicles rise as nonviral delivery platform for genes and proteins
Researchers outlined strategies to harness extracellular vesicles (EVs) as safer, more precise carriers for gene and protein therapeutics, positioning EVs as an alternative to viral vectors in...
Clinical engineered‑cell therapies for autoimmunity: review flags early wins and gaps
Nature Biotechnology published a review by Payne and colleagues summarizing clinical progress of engineered cellular immunotherapies directed at autoimmune diseases. The review catalogs recent...
New broad‑spectrum prevention method blocks resistant bacteria and influenza
Researchers reported a novel infection‑prevention approach that demonstrated simultaneous blockade of drug‑resistant bacterial pathogens and influenza virus in preclinical tests. The study,...
CBER chief under fire: Moderna flu filing returned after internal pushback
Vinay Prasad, director of the FDA’s Center for Biologics Evaluation and Research (CBER), returned a refusal-to-file (RTF) for Moderna’s mRNA influenza candidate, sparking internal dissent and...
Fujifilm bets £400m: UK site becomes largest single-use CDMO
Fujifilm Biotechnologies opened an expanded Teesside campus in the UK backed by roughly £400 million ($545 million), unveiling what the company calls the UK’s largest single-use biopharma CDMO....
Engineered cell therapies for autoimmunity — Nature Biotechnology outlines clinical advances
Nature Biotechnology published a review summarizing clinical progress for engineered cellular immunotherapies targeting autoimmune diseases. Payne and colleagues synthesize emerging trial data...
Base barrier cells: new brain‑barrier compartmentalization discovered
Researchers reported discovery of specialized 'base barrier cells' that compartmentalize the choroid plexus, brain tissue and cerebrospinal fluid (CSF) in a Nature Neuroscience paper. The study...
Universal AI model raises MRI accuracy: cross‑site brain imaging generalizes
A team led by Tak, Garomsa, and Zapaishchykova published a universal foundation model in Nature Neuroscience that generalizes human brain MRI analysis across sites and protocols. The model...
Tumor microenvironment targeted — ferroptosis nanotherapy rewires CAFs; metabolism drives immunosuppression
Researchers introduced a ferroptosis‑based nanoparticle therapy that reprograms cancer‑associated fibroblasts (CAFs) in colorectal cancer, reversing pro‑tumor stroma phenotypes and sensitizing...
Two delivery routes advance gene therapy: drinkable foam and extracellular vesicles
Researchers presented a novel oral delivery approach—a drinkable gene‑therapy foam—to target constrictive esophageal carcinoma, aiming to overcome local-access barriers for gene transfer. The...
Regeneration insights: axolotl thymus rebuilds and apple snail regenerates eye
A Science Immunology study shows axolotls can fully regenerate a complex thymus within roughly 35 days, with functional integration after transplantation in follow‑up assays. More than 60% of...
Ultrasound and AI converge: acoustoelectric neural readout and real‑time acoustic trapping
Researchers reported in vivo acoustoelectric neural recording in mice using ultrasound‑induced frequency mixing, demonstrating a minimally invasive route to capture neural signals with spatial...
RNA methylation and neddylation emerge as oncology targets: RCC and CRC mechanisms
A new study shows CDK13 promotes clear cell renal cell carcinoma by enhancing METTL16‑dependent m6A modification of ACLY mRNA, stabilizing and increasing translation of a key metabolic enzyme. The...
CBER head faces internal revolt: Moderna flu filing returned
FDA’s Center for Biologics Evaluation and Research director Vinay Prasad returned Moderna’s mRNA-1010 influenza application and is facing internal complaints alleging interpersonal misconduct and...
Fujifilm doubles UK capacity – £400m CDMO opens
Fujifilm Biotechnologies inaugurated its expanded Teesside, UK campus after a roughly £400 million investment, unveiling what the company says is the largest single-use biopharmaceutical CDMO...
Ultrasound in the clinic: real-time microbubble control and in vivo neural reads
Researchers demonstrated two ultrasound-driven advances that extend acoustic tools into biomedical control and sensing: in vivo acoustoelectric neural recording in mice and AI-guided real-time...
New broad-spectrum defenses: hospital barriers and nicotine‑derived antivirals
Two independent advances target the twin challenges of drug-resistant bacteria and coronaviruses. One team reported a broad-spectrum infection‑prevention approach capable of blocking...