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Pi Health Partners with GSK to Accelerate Phase 2 Oncology Trial Using AI-Powered Platform

AIOncology
  • Pi Health has entered a Master Clinical Services Outsourcing Agreement with GSK to provide fully outsourced clinical research services for a global Phase 2 oncology clinical trial.
  • The collaboration leverages Pi Health's proprietary FICS platform, which integrates artificial intelligence capabilities to make study conduct 50% faster while maintaining audit-ready data quality.
  • Pi Health will manage all aspects of the trial including site selection, patient enrollment, real-time monitoring, and regulatory submissions through its technology-driven service model.
  • The partnership aims to accelerate development of cancer treatments by removing inefficiencies that can slow clinical trial progress.

FYR Bio Secures $8 Million to Advance Blood-Based Biomarkers for Brain Cancer and Neurodegeneration

Precision MedicineAI
  • FYR Bio closed an $8 million funding round led by The Sontag Innovation Fund and Yuvaan Tiwari Foundation to advance blood-based biomarker development for oncology and neuroscience applications.
  • The company's EVO platform demonstrated 100% specificity and 89% sensitivity in distinguishing adult malignant gliomas from healthy controls using brain-derived extracellular vesicles.
  • Funding will accelerate expansion into neuro-oncology and neurodegeneration programs, including Parkinson's disease biomarker development for patient stratification.
  • The platform leverages proprietary SPARCs technology to enrich extracellular vesicles from diseased cells using simple blood draws for precision medicine applications.

UCLA Launches First Large-Scale U.S. Trial Testing AI in Breast Cancer Screening

AI
  • UCLA and UC Davis will co-lead the PRISM Trial, a $16 million randomized controlled study evaluating artificial intelligence support for mammogram interpretation across seven academic medical centers.
  • The study represents the first large-scale randomized trial of AI in breast cancer screening in the United States, involving hundreds of thousands of mammograms across California, Florida, Massachusetts, Washington, and Wisconsin.
  • Researchers aim to determine whether AI tools help radiologists detect more cancers or simply increase false positives, addressing a critical evidence gap as AI-assisted mammograms become increasingly common in clinical practice.
  • The patient-centered trial will maintain routine screening procedures while randomly assigning mammograms to be interpreted either by radiologists alone or with FDA-cleared AI assistance from Transpara by ScreenPoint Medical.

Duke Engineers Develop AI-Powered Platform to Optimize Nanoparticle Drug Delivery

AI
  • Duke University biomedical engineers have created TuNa-AI, an artificial intelligence platform that combines automated wet lab techniques to design optimized nanoparticles for drug delivery applications.
  • The platform achieved a 42.9% increase in successful nanoparticle formation compared to standard approaches and successfully improved venetoclax encapsulation for leukemia treatment.
  • TuNa-AI demonstrated the ability to reduce potentially carcinogenic excipients by 75% in chemotherapy formulations while maintaining drug efficacy and improving biodistribution in mouse models.
  • The research addresses a critical gap in drug development by optimizing both material selection and ingredient ratios, which existing AI platforms cannot handle simultaneously.

Prellis Biologics Partners with Eli Lilly to Accelerate Antibody Discovery Using Novel Biological AI Platform

AIMonoclonal AntibodyDrug Discovery
  • Prellis Biologics announced a multi-target drug discovery collaboration with Eli Lilly combining Prellis' EXIS™ organoid platform with Lilly's development expertise.
  • The partnership leverages Prellis' proprietary lymph node organoid technology that generates diverse, high-affinity antibodies in 3-4 weeks using fully human artificial immune systems.
  • Prellis' biological AI platform represents the first system to design drugs by combining living human lymph node organoids with generative AI refinements.
  • The collaboration aims to accelerate discovery of fully human antibodies for multiple disease targets including GPCRs with enhanced therapeutic efficacy and manufacturability.

HeartFlow Receives FDA Clearance for Next-Generation AI Plaque Analysis Platform with Enhanced Detection Capabilities

AI
  • HeartFlow received FDA 510(k) clearance for its Next Generation Plaque Analysis platform, featuring an updated algorithm that shows 21% improvement in plaque detection compared to the first-generation version.
  • The AI-powered platform demonstrates 95% agreement with the gold standard IVUS and leverages data from approximately 273,000 patients, representing a dataset 9x larger than current plaque quantification studies.
  • Cigna announced nationwide coverage for HeartFlow Plaque Analysis across all business lines beginning in October, becoming the second national insurer to adopt coverage following UnitedHealthcare.
  • The DECIDE Registry data showed that HeartFlow Plaque Analysis led to medical management changes in over 50% of patients beyond coronary CTA alone, resulting in an expected 15% event reduction.

DaltonTx Emerges from Stealth with £4M Seed Funding to Transform Drug Discovery with Adaptive AI Platform

AIDrug Discovery
  • DaltonTx, a UK-based technology company, has completed a £4 million seed financing round to develop adaptive AI-enabled discovery platforms that reshape R&D economics and timelines.
  • The company's disease- and technology-agnostic platform integrates directly into pharma, biotech, and CRO workflows, providing immediate access to AI-enabled discovery capabilities.
  • Founded by experts from AstraZeneca, Exscientia, and Oxford University, DaltonTx offers a reasoning engine that learns from every scientist, model, and experiment to continuously improve outcomes.
  • The platform supports both small molecules and biologics discovery, enabling collaborative intelligence between human expertise and machine learning systems.

Healx Partners with Vuja De Sciences to Advance AI-Driven Therapy for Metastatic Osteosarcoma Recurrence

AIRare DiseaseDrug Discovery
  • Healx has entered into a strategic transaction with Vuja De Sciences to combine AI-powered drug discovery with clinical expertise in cancer recurrence prevention.
  • The partnership advances HLX-4310, a promising therapy for preventing recurrence of metastatic osteosarcoma that has received FDA IND clearance for clinical trials.
  • Metastatic osteosarcoma affects mostly young patients with a devastating five-year survival rate of less than 20%, representing a critical unmet medical need.
  • The collaboration strengthens Healx's rare and pediatric oncology portfolio, now advancing two clinical-stage assets in this therapeutic area.

Merck and Siemens Expand Partnership to Accelerate AI-Driven Drug Discovery and Manufacturing

AIDrug Discovery
  • Merck and Siemens signed a new Memorandum of Understanding to deliver integrated digital workflows connecting drug discovery, development, and manufacturing through AI and automation technologies.
  • The partnership will integrate Merck's software-as-a-service products with Siemens' digital ecosystem, including the first joint use of technology from Siemens' recent Dotmatics acquisition completed in July 2025.
  • Initial pilot projects focus on making Merck's AI tools available in Siemens' Luma platform, providing scientists with a unified environment for faster, data-driven decision making.
  • The collaboration aims to address the escalating costs of drug development, which double every few years, by leveraging digitalization and AI to streamline processes from laboratory to patient.

Median Technologies Secures €61.4M Financing, Extends Cash Runway Through 2026 as AI Cancer Diagnostic Tool Awaits FDA Clearance

AI
  • Median Technologies completed a €61.4 million refinancing in July and August 2025, extending its cash runway through Q4 2026 and potentially beyond with warrant exercises.
  • The company's AI-powered eyonis® LCS lung cancer screening device is progressing toward FDA 510(k) clearance, with a decision now expected in early Q1 2026 due to regulatory delays.
  • Commercial launch preparations for eyonis® LCS are underway in the U.S., with advanced negotiations for distribution partnerships and comprehensive mapping of medical institutions completed.
  • The iCRO division secured €3.4 million in new orders from a top Chinese pharmaceutical company and launched specialized imaging services for radiopharmaceutical therapies.

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