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Clinical Trial News

TriSalus Launches Enhanced TriNav FLX Infusion System for Improved Tumor Drug Delivery

Oncology
  • TriSalus Life Sciences has launched the TriNav FLX Infusion System, featuring enhanced trackability with twice the length of flexible material at the distal end for easier navigation through tortuous vessels.
  • The new system demonstrates a 28% reduction in force during navigation compared to standard TriNav designs in benchtop models, particularly benefiting procedures requiring precise control in challenging peripheral vascular anatomy.
  • TriNav FLX is eligible for dual reimbursement coverage under HCPCS codes C8004 for simulation/mapping and C9797 for treatment procedures, allowing clinicians to use the system for both planning and delivery in radioembolization.
  • The system retains the same Pressure-Enabled Drug Delivery (PEDD) benefits as existing TriNav products while expanding treatment options for interventional radiologists treating solid tumors.

Fresenius Medical Care Advances U.S. Rollout of High-Volume Hemodiafiltration Following FDA Clearance

  • Fresenius Medical Care received FDA 510(k) clearance for its enhanced 5008X CAREsystem, enabling broader U.S. commercialization of high-volume hemodiafiltration therapy.
  • The CONVINCE study demonstrated a 23% reduction in mortality rates for patients receiving high-volume hemodiafiltration compared to traditional high-flux hemodialysis.
  • The company will begin offering the therapy in selected Fresenius Kidney Care clinics throughout 2025, with full commercial launch planned for 2026.
  • The updated system includes Fresenius Clinical Data Exchange technology for improved workflow and reduced equipment clutter at chairside.

Elucidata and Sapien Biosciences Form Strategic Partnership to Transform India's Largest Biobank into AI-Ready Data Platform

AIPrecision MedicineDrug Discovery
  • Elucidata and Sapien Biosciences announced a strategic partnership to convert Sapien's 300,000+ patient sample biobank into AI-ready, multimodal data products for drug discovery and diagnostic development.
  • The collaboration will focus initially on building AI models that infer genomic and transcriptomic insights from digital pathology images using NGS-annotated slides from Sapien's cancer biobank.
  • Sapien operates one of the top 10 biobanks globally with over 85,000 cancer patients and represents the largest integrated resource for Asian patient data across multiple disease areas.
  • The partnership aims to address underrepresentation in global omics datasets while accelerating precision medicine through synthetic clinicogenomic data generation.

Aitia Partners with Gustave Roussy to Develop AI-Powered Digital Twins for Cancer Research

AIDrug Discovery
  • Aitia and Gustave Roussy announced a collaboration to transform extensive cancer patient data into "Gemini Digital Twins" - computer-based models that reveal the underlying biological causes of cancer to drive new therapeutic discoveries.
  • The partnership targets cancers with high unmet medical needs, including brain, pancreatic, and ovarian cancers, using Aitia's causal AI engine REFS to analyze multiomic and patient outcome data.
  • Gustave Roussy, Europe's premier cancer research institute treating nearly 50,000 patients annually, will provide de-identified patient data to support the development of next-generation cancer treatments.
  • The collaboration aims to identify specific cancer-causing biological changes to create rational drug targets and optimize clinical trial patient populations across multiple cancer types.

New Research Reveals Complex Effects of Ozempic on Muscle Mass and Strength

Monoclonal Antibody
  • Clinical trials demonstrate that GLP-1 agonist drugs like semaglutide (Ozempic) can lead to a 13.9% loss of lean muscle mass, equivalent to approximately 20 years of age-related muscle decline.
  • A new preclinical study from University of Utah found that while Ozempic-induced weight loss decreased lean mass by 10% in mice, most loss came from organs like the liver rather than skeletal muscle.
  • Research indicates muscle strength can decline even when muscle size remains unchanged, raising concerns particularly for adults over 60 who face higher baseline risks for muscle loss.
  • Prevention strategies include regular resistance training, adequate protein intake, and aerobic exercise, though researchers emphasize the need for more human clinical studies to validate findings.

Daiichi Sankyo's New CEO Charts Course for ADC Expansion Beyond Enhertu Success

OncologyDrug Approval
  • Hiroyuki Okuzawa assumed leadership of Daiichi Sankyo two months ago, inheriting a company strengthened by three major pharmaceutical licensing deals worth up to $27 billion based on ADC technology.
  • Enhertu demonstrated potential as frontline therapy for advanced breast cancer at ASCO 2025, continuing the drug's track record of clinical success since 2022.
  • The company plans to have five ADCs approved across more than 30 tumor types by 2030, targeting treatment of nearly 400,000 cancer patients annually.
  • Okuzawa faces the challenge of identifying next-generation growth drivers while navigating development setbacks and potential trade policy impacts on global supply chains.

Federal Circuit Upholds Moderna Victory in COVID-19 Vaccine Patent Dispute with Alnylam

  • The U.S. Court of Appeals for the Federal Circuit affirmed a district court ruling in favor of Moderna, rejecting Alnylam Pharmaceuticals' patent infringement claims over mRNA-based COVID-19 vaccine technology.
  • The court held that Alnylam's narrow definition of "branched alkyl" in its patent specifications precluded infringement allegations against Moderna's SPIKEVAX vaccine containing the SM-102 lipid.
  • The precedential decision reinforces that patent holders face a demanding standard to establish exceptions to explicit claim term definitions, even when those definitions might exclude disclosed embodiments.

Biotech Funding Plummets 57% to $2.7 Billion as Trump Administration Policies Shake Investor Confidence

  • Biotech funding dropped 57% to $2.7 billion in May 2025, marking one of the worst funding periods in three years according to Jefferies investment bank analysis.
  • Trump administration policies including FDA mass layoffs, proposed NIH budget cuts, and unclear drug pricing plans have created significant uncertainty among biotech investors.
  • Public biotech companies raised only $1.1 billion in May while burning through approximately $4.5 billion monthly on average, creating a dangerous cash flow gap.
  • Several biotech companies including iTeos and Third Harmonic Bio have announced plans to liquidate assets and shut down operations due to the challenging funding environment.

Sanofi and GSK Pursue Aggressive M&A Strategies While mRNA Technology Faces Economic Headwinds

  • Sanofi and GSK have recently made significant moves in mergers and acquisitions, marking a notable shift in the pharmaceutical industry as both companies pursue aggressive expansion strategies.
  • The companies are focusing on growth and innovation through M&A activities to strengthen their positions in the competitive pharmaceutical market.
  • mRNA technology, which gained prominence during the COVID-19 pandemic, is now encountering economic hurdles due to evolving tariff adjustments and shifts in funding priorities.
  • These economic factors could significantly impact future advancements in mRNA applications and have broader implications for pharmaceutical development across the biotechnology sector.

THIO Plus Cemiplimab Demonstrates Promising Activity in ICI-Resistant Advanced NSCLC

  • The combination of THIO (ateganosine) plus cemiplimab showed clinical activity with a 77% disease control rate in patients with advanced NSCLC resistant to immune checkpoint inhibitors.
  • Median overall survival reached 17.8 months in the third-line setting, with partial responses observed in 10 patients across second- and third-line treatments.
  • The treatment was generally well tolerated with most adverse events being grades 1-2, and biomarker analyses suggested response occurred independent of PD-L1 status.
  • Elevated interleukin-6 levels may serve as a predictive biomarker for treatment efficacy, with the 180 mg THIO dose showing optimal safety and efficacy profile.

THIO Sequenced With Cemiplimab in Advanced NSCLC

NCT05208944RecruitingPhase 2
Maia Biotechnology
Posted 6/8/2022

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