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Clinical Trial News

Syngene International's Bengaluru Facility Receives Clean FDA Inspection with NAI Status

  • Syngene International's Bengaluru-based manufacturing facility successfully passed a US FDA inspection with zero observations and no Form 483 issued.
  • The facility received "no action indicated" (NAI) status, demonstrating full compliance with FDA regulations for pharmaceutical manufacturing operations.
  • The company reported mixed Q4 2025 financial results with net sales rising 11.03% to Rs 1018 crore while net profit declined 2.81% to Rs 183.30 crore.
  • Syngene serves multiple sectors including pharmaceutical, biotechnology, nutrition, animal health, consumer goods, and specialty chemicals through integrated R&D and manufacturing services.

Twin Health Raises $53 Million to Scale AI-Powered Digital Twin Platform for Metabolic Disease Management

AI
  • Twin Health secured $53 million in funding led by Maj Invest to expand its AI digital twin platform for metabolic health management into Fortune 500 enterprises and health plans.
  • The company's platform creates personalized metabolic models using biomarker data and has demonstrated significant clinical outcomes, with over 90% of diabetic subjects achieving type 2 diabetes reversal in clinical trials.
  • Twin Health operates on a performance-based care model where clients only pay when members achieve measurable clinical results such as improved A1C levels or weight loss.
  • The technology addresses the growing use of GLP-1 medications by providing personalized pathways to reduce long-term dependence on costly diabetes drugs.

Ethniq Launches Patented Natural Antifungal Treatment Showing 90% Efficacy in Clinical Trials

  • Ethniq has launched Skin Revive, a patented steroid-free treatment for chronic fungal skin infections that demonstrated over 90% efficacy in clinical trials registered with CTRI.
  • The natural formulation combines almond extract, coconut oil, eucalyptus oil, and chamomile processed through special extraction methods and has received patents in India and internationally.
  • The treatment addresses a significant medical need as fungal infections affect up to 61% of the population in some Indian states, with conventional steroid-based treatments facing growing drug resistance concerns.
  • Developed by Dr. Sunita Kumari and AYUSH-certified, the product aims to eliminate root causes of fungal overgrowth rather than masking symptoms like standard antifungals.

Sun Pharma Names Kirti Ganorkar as Managing Director in Major Leadership Transition

  • Kirti Ganorkar, a 29-year Sun Pharma veteran, will become Managing Director on September 1, 2025, succeeding founder Dilip Shanghvi who transitions to Executive Chairman.
  • The appointment marks the culmination of Sun Pharma's structured succession planning process as the company reported ₹52,041 crore in sales for FY2025, with 9% growth and specialty products contributing $1.21 billion.
  • Ganorkar has led Sun Pharma's India Business since 2019 and played key roles in the company's specialty drug expansion, including securing rights for innovative products like Ilumya.
  • The leadership change comes as Sun Pharma operates across challenging global markets including the US and Europe while maintaining its position as India's largest drugmaker.

Multimodal AI System Demonstrates Superior Survival Prediction for Hepatocellular Carcinoma Immunotherapy

AI
  • A novel multimodal fusion (MMF) system combining CT imaging-based deep learning with clinical features achieved C-index values of 0.74 for overall survival and 0.69 for progression-free survival in predicting outcomes for unresectable hepatocellular carcinoma patients receiving immune checkpoint inhibitors.
  • The MMF system outperformed traditional assessment methods by 29.8% for overall survival prediction compared to mRECIST criteria and demonstrated consistent risk stratification across diverse clinical subgroups in a multicenter validation study of 859 patients.
  • Biological analysis revealed the system's predictions correlate with key molecular pathways including PI3K-Akt signaling and tumor suppressor genes like GCK, providing mechanistic insights into immunotherapy response patterns in hepatocellular carcinoma.

Study to Determine the Safety, Tolerability, Pharmacokinetics and Recommended Phase 2 Dose (RP2D) of Livmoniplimab (ABBV-151) as a Single Agent and in Combination With Budigalimab (ABBV-181) in Participants With Locally Advanced or Metastatic Solid Tumors

NCT03821935Active, Not RecruitingPhase 1
AbbVie
Posted 2/21/2019

A Study of Atezolizumab Plus Bevacizumab Versus Active Surveillance as Adjuvant Therapy in Patients With Hepatocellular Carcinoma at High Risk of Recurrence After Surgical Resection or Ablation

NCT04102098Active, Not RecruitingPhase 3
Hoffmann-La Roche
Posted 12/31/2019

NICE Rejects First Alzheimer's Disease-Modifying Drugs for NHS Use Due to Cost-Effectiveness Concerns

Monoclonal Antibody
  • The National Institute for Health and Care Excellence (NICE) has refused to recommend lecanemab and donanemab for NHS use, denying access to over 70,000 eligible patients in England unless they can afford private treatment costing £60,000-80,000 annually.
  • Both drugs demonstrated clinical efficacy in trials, with lecanemab slowing cognitive decline by 27% over 18 months and donanemab reducing decline by 4-7 months by clearing toxic amyloid protein from the brain.
  • NICE determined the cost-effectiveness estimates are five to six times above acceptable thresholds for NHS resources, despite the drugs representing the first treatments proven to slow Alzheimer's disease progression.
  • The decision has drawn criticism from Alzheimer's Research UK, which warns it sends a damaging signal to the life sciences sector and undermines the UK's position as a leader in dementia research and innovation.

NATCO Pharma's Mekaguda API Facility Receives FDA Establishment Inspection Report Following Successful Remediation

  • NATCO Pharma Limited received an Establishment Inspection Report (EIR) from the U.S. FDA for its Active Pharmaceutical Ingredient facility in Mekaguda, Hyderabad on July 24, 2025.
  • The FDA inspection conducted from June 9-13, 2025 resulted in one observation classified as "Voluntary Action Indicated" (VAI), which the company characterized as procedural in nature.
  • The successful resolution demonstrates NATCO's commitment to maintaining cGMP compliance and ensuring high-quality API manufacturing for global pharmaceutical supply chains.

InspireMD Receives FDA Approval for CGuard Prime Carotid Stent System with Record-Low Stroke Rates

FDA Approval
  • InspireMD's CGuard Prime Carotid Stent System received FDA premarket approval based on the C-GUARDIANS pivotal trial showing the lowest 30-day (0.95%) and 1-year (1.93%) major adverse event rates of any carotid intervention study.
  • The device features proprietary MicroNet mesh technology that combines the largest open-cell frame with the smallest mesh pore size to prevent plaque protrusion and provide sustained embolic protection beyond five years.
  • The approval triggers a $17.9 million warrant tranche from InspireMD's $113.6 million financing agreement and enables immediate commercial launch in the United States following prior CE Mark approval in Europe.
  • The C-GUARDIANS trial enrolled 316 patients across 24 sites in the US and Europe, with 25% being symptomatic patients at high risk for carotid endarterectomy surgery.

CAR-T Cell Therapies Show Promise for Severe Autoimmune Diseases at EULAR 2025

CAR-T
  • Multiple CAR-T cell therapies targeting CD19-positive B cells demonstrated clinical efficacy across severe autoimmune diseases including systemic lupus erythematosus, systemic sclerosis, and rheumatoid arthritis at EULAR 2025.
  • Resecabtagene autoleucel achieved deep B cell depletion and clinical responses in patients with systemic sclerosis, idiopathic inflammatory myopathy, and lupus, with patients remaining free of immunosuppressive therapy.
  • Novel approaches including dual CD19/BCMA targeting CAR-T cells and off-the-shelf iPSC-derived CAR-T therapies showed favorable safety profiles with no severe cytokine release syndrome or neurotoxicity.
  • Early data suggest CAR-T therapy can reset the immune system in multiple rheumatic and musculoskeletal diseases, allowing patients to achieve sustained remission without ongoing immunosuppression.

Benchling Partners with Merck to Streamline Vaccine Bioanalysis Through Integrated Digital Platform

  • Benchling and Merck have announced a collaboration to implement a unified software framework that integrates pre-clinical and clinical bioanalytical workflows onto a single platform.
  • The partnership focuses on three key areas: enhancing speed and throughput through automated data capture, streamlining workflows with unified data management, and maintaining compliance standards in regulated environments.
  • The collaboration aims to improve efficiency throughout the vaccine development lifecycle by enabling scientists to better access, analyze, and harness data insights during the development process.
  • Over 200,000 scientists currently rely on Benchling's R&D Cloud platform, which serves cutting-edge startups and more than half of the top 50 global biopharma companies.

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