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Clinical Trial News

IQVIA and Flagship Pioneering Form Strategic Alliance to Accelerate Biotech Innovation Through AI-Powered Drug Development

AI
  • IQVIA and Flagship Pioneering announced a strategic collaboration in August 2025 to accelerate breakthrough life sciences companies using AI-powered analytics and clinical trial expertise.
  • The partnership focuses on three core areas: drug development strategy and analytics, clinical development, and asset valuation and due diligence for Flagship's 40+ biotech portfolio companies.
  • IQVIA's deployment of over 50 NVIDIA-built AI agents trained on 1.2 billion health records aims to reduce patient recruitment bottlenecks and accelerate clinical trial timelines.
  • The collaboration leverages Flagship's $14 billion in assets under management and IQVIA's $32.1 billion R&D backlog to enhance commercial viability of emerging biotech ventures.

Teva Launches First Generic GLP-1 Weight Loss Drug as FDA Approves Generic Saxenda

Drug Approval
  • Teva Pharmaceuticals received FDA approval and launched the first-ever generic GLP-1 receptor agonist indicated for weight loss in the United States.
  • The generic liraglutide injection targets the $165 million annual Saxenda market and is approved for adults with obesity or overweight conditions and pediatric patients aged 12-17 years.
  • This marks Teva's fifth first-to-market generic entry in 2025, supporting the company's Pivot to Growth Strategy and complex generics portfolio expansion.
  • The drug carries significant safety warnings including potential thyroid tumors and cancer risks, requiring careful patient monitoring and contraindications for certain populations.

First-in-Class STAT3 Inhibitor Shows Promise in Feline Cancer Trial with Human Applications

  • Scientists at UC San Francisco and UC Davis completed the first clinical trial of a novel STAT3-targeting cancer drug in pet cats with oral squamous cell carcinoma, achieving disease control in 35% of treated animals.
  • The drug represents the first successful therapeutic approach to target STAT3, a protein that acts as a faulty switch driving cancer cell growth, which has been notoriously difficult to inhibit in the past.
  • Among the seven cats that responded to treatment, average survival post-treatment was 161 days, with minimal side effects observed, offering hope for both veterinary and human oncology applications.
  • The compound is being advanced for clinical trials in both pets and humans, with particular relevance for head and neck squamous cell carcinoma patients.

ImmuneOncia Partners with WuXi Biologics to Advance Anti-PD-L1/CD47 Bispecific Antibody IOH-001

  • ImmuneOncia Therapeutics, a clinical-stage immuno-oncology startup from South Korea, has signed a strategic partnership with WuXi Biologics for the development and manufacturing of IOH-001, a bispecific antibody targeting PD-L1 and CD47.
  • The collaboration provides ImmuneOncia access to WuXi Biologics' integrated services including cell line development, cell culture development, biologics manufacturing, and bioassay development for IOH-001's IND application.
  • WuXi Biologics will support the complete CMC studies required for IOH-001's Investigational New Drug application, leveraging their comprehensive bispecifics development and manufacturing capabilities.
  • The partnership aims to realize the therapeutic potential of IOH-001 for cancer patients in South Korea, with potential for future expansion to bring more innovative biologics to the market.

Eli Lilly Halts UK Mounjaro Shipments Ahead of 170% Price Increase

  • Eli Lilly has temporarily halted shipments of Mounjaro to UK wholesalers ahead of a planned 170% price increase in September, with the highest dose rising from £122 to £330.
  • The company warned against "inappropriate stockpiling of medicines" as customers rushed to purchase the diabetes and weight-loss drug before the price hike takes effect.
  • The price increase follows White House pressure to align European drug prices with other developed countries as part of a "most favored nation" policy aimed at reducing US drug costs.
  • UK orders will resume in September when the new pricing structure is implemented, with Lilly maintaining allocations for pharmacy orders to ensure patient access.

Vanda Pharmaceuticals Receives FDA Orphan Drug Designation for Novel JAK2-Selective Antisense Therapy VGT-1849B in Polycythemia Vera

Rare Disease
  • The FDA has granted Orphan Drug Designation to VGT-1849B, a selective peptide nucleic acid-based JAK2 inhibitor developed by Vanda Pharmaceuticals for treating polycythemia vera.
  • VGT-1849B utilizes novel OliPass Peptide Nucleic Acid (OPNA) chemistry to selectively target JAK2 mRNA, potentially offering improved safety compared to existing JAK inhibitors that affect multiple kinases.
  • The antisense oligonucleotide specifically addresses the JAK2 V617F mutation found in over 95% of polycythemia vera patients, with the disease affecting 44-57 per 100,000 people in the United States.
  • Unlike current JAK inhibitors such as Jakafi, Inrebic, Ojjaara, and Vonjo, VGT-1849B aims to avoid off-target kinase effects that can lead to increased toxicity and adverse side effects.

Texas House Passes Bill Allowing Over-the-Counter Ivermectin Sales Without Prescription

  • The Texas House approved House Bill 25, which would allow pharmacies to sell ivermectin without a prescription, making Texas the fifth state to grant such access if signed into law.
  • Republican supporters argue for universal access to the Nobel Prize-winning anti-parasite drug, while Democrats warn that unsupervised use could lead to preventable deaths.
  • Medical associations do not recommend over-the-counter ivermectin sales, with opponents citing concerns about misinformation and patients avoiding proper medical care.
  • The bill now advances to the Republican-controlled Texas Senate, where passage appears likely before reaching Governor Greg Abbott's desk.

GC Biopharma Advances Two-Dose Varicella Vaccine BARYCELA to Phase 3 Trial in Thailand

  • GC Biopharma has submitted an IND application to Thailand's FDA to initiate a Phase 3 clinical trial for BARYCELA, becoming the first South Korean company to advance a two-dose varicella vaccine to this stage.
  • The trial will enroll 474 healthy children aged 12 months to 12 years and include a head-to-head comparison with MSD's Varivax, the global market leader.
  • The two-dose varicella vaccine regimen is the established standard of care, officially recommended in 28 countries including the US, Canada, Japan, and several European nations.
  • GC Biopharma aims to complete the Phase 3 trial by the second half of 2027 and pursue regulatory approval in Southeast Asian markets.

Biophytis Receives EMA and Belgian Regulatory Approval for Phase 3 Sarcopenia Trial

  • Biophytis SA has received both EMA Part I scientific approval and Belgian Part II ethical approval to initiate a Phase 3 clinical trial for sarcopenia treatment.
  • The regulatory clearances allow patient enrollment to begin in Belgium with plans for collaboration across additional European Member States under the harmonized framework.
  • The trial will evaluate BIO101 (20-hydroxyecdysone), the company's lead small molecule drug candidate, marking a significant milestone in developing therapies for age-related muscle loss.
  • The approvals confirm the study meets rigorous clinical and scientific standards while ensuring compliance with ethical requirements and participant safety protocols.

ACROBiosystems and DAAN Biotherapeutics Form Strategic Alliance to Accelerate Precision Immuno-Oncology Development

Precision Medicine
  • ACROBiosystems and DAAN Biotherapeutics signed a strategic MOU to establish a multi-faceted collaboration framework for developing precision immunotherapies targeting drug-resistant cancers.
  • The partnership combines ACROBiosystems' GMP-grade bioreagent expertise with DAAN's proprietary immune-modulation platform that selectively activates T cells within tumor microenvironments.
  • DAAN's lead TCR-T cell therapy pipeline has completed preclinical development and is preparing for global clinical trials, with platform applications expanding to autoimmune and rare diseases.
  • The collaboration aims to overcome current immunotherapy limitations including toxicity and therapeutic resistance through enhanced precision targeting and improved manufacturing capabilities.

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