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FDA expands point-of-care testing for group A strep
FDA cleared and CLIA-waived Diasorin’s Liaison Nes multiplex group A streptococcus rapid molecular test on the firm’s point-of-care PCR instrument. Diasorin said the assay returns results in about...
Cancer immunotherapy long-term safety signal quantified
A systematic review and meta-analysis has estimated the frequency of second primary malignant neoplasms (SPMs) occurring after treatment with T-cell-engaging bispecific antibodies across B-cell...
Biased opioid agonist advances to early human safety data
SHR8554 has entered Phase I with reported safety, pharmacokinetics, and pharmacodynamics for the investigational biased µ-opioid receptor agonist. The reported profile positions the compound as...
Novel AI model targets protein–protein interaction prediction
Researchers unveiled a generative AI model capable of atomic-scale prediction of protein–protein interactions, aiming to improve how scientists identify and engineer biologically relevant binding...
Cancer biology identifies new invasion and oncogenic control mechanisms
Two new cancer-focused findings highlight distinct mechanisms that could expand therapeutic entry points. First, researchers reported that novel molecular drivers shape the invasive margins of...
Early puberty biology linked to obesity inflammation and metabolism
A study published in Pediatric Research reported mechanisms tying obesity-related metabolic, hormonal, and inflammatory pathways to early pubertal onset. Researchers led by Wang, Yan, and Liu...
Mitochondrial mutation disrupts human brain organoid neurons
Researchers reported that mitochondrial DNA heteroplasmy in human brain organoids causes cortical neuronal disturbances, centering on the common m.3243A>G mutation. The study frames the results as...
Clinical evidence gap for kidney transplant listing
A national study from NYU Langone Health highlights how few kidney transplant candidates reach the waitlist after referral. The report found that only about 19% of American patients diagnosed with...
Point-of-care and genomics leadership moves
Executives and leadership changes across genomic diagnostics and spatial biology signal continued emphasis on commercialization and platform scaling. GeneDx appointed Mark Gardner as president,...
US trade pressure over Europe’s drug pricing
The U.S. Trade Representative has launched a Section 301 investigation into Germany’s drug pricing policies, arguing the country’s approach leaves the U.S. bearing a disproportionate share of...
US voucher policy scrutiny at the FDA
A key FDA expedited-review instrument is coming under pressure as stakeholders call for clearer guardrails—or a pause—around the Commissioner’s National Priority Review Voucher program. Experts...
Lilly acquisition expands non-opioid pain pipeline
Eli Lilly has agreed to buy 4E Therapeutics, extending its push for pain treatments that avoid the brain-side effects associated with opioids. The Austin-based company’s lead candidate, 4ET1103,...
Diasorin expands point-of-care strep testing
Diasorin’s Luminex subsidiary received FDA 510(k) clearance and CLIA waiver for a multiplex group A streptococcus test on the Liaison Nes point-of-care PCR instrument. The company says the assay...
US funding to scale near point-of-care TB diagnostics
The Global Fund is coordinating the rollout of PlusLife MiniDock Ultra near point-of-care TB test systems across 13 countries, supported by $50 million from the Children’s Investment Fund...
Metaplasticity framing for brain-health interventions
New research argues that incorporating “metaplasticity” principles—how the brain regulates its own synaptic plasticity—could improve the effectiveness of brain-health strategies across the...
Protein engineering: generative AI predicts protein–protein interactions
A newly reported generative AI model is designed to predict protein–protein interactions at a scale intended to accelerate therapeutic discovery and protein engineering. The work is positioned...
Wilson’s disease: Prime Medicine editor enters clinical testing
Prime Medicine has cleared a clinical trial application with New Zealand’s Medsafe for PM-577a, a Prime Editor program intended for Wilson’s disease. The company’s advance moves the...
Translational platforms: EndoDNA, exosome isolation, and spatial reagents go commercial
Three enabling tools moved closer to commercial adoption in genomics and translational biology. EndoDNA launched BIOS, a clinical decision-support platform that integrates curated variant-level...
AI-designed DNA vaccine data for AML target
Evaxion reported characterization results for EVX-04, an AI-designed DNA vaccine encoding antigenic fragments derived from 1β endogenous retroviruses. The goal is to drive broad antigen-specific...
Regulatory/policy: U.S. trade probe targets Germany drug pricing
The U.S. Trade Representative has launched a Section 301 investigation into Germany’s drug pricing policies, arguing the U.S. carries an outsized share of global biopharma R&D costs. The probe was...