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Clinical Trial News

GSK Partners with Cloud Pharmaceuticals to Accelerate Drug Discovery Through AI Technology

  • GlaxoSmithKline has entered a strategic collaboration with Cloud Pharmaceuticals to leverage AI-driven technology for designing novel small-molecule agents, marking Cloud's first major pharma partnership.
  • Cloud Pharmaceuticals' proprietary AI platform claims to reduce traditional drug discovery timelines from over five years to just a few months, offering significant efficiency gains in lead molecule identification.
  • The partnership follows GSK's $33 million deal with ExScientia and represents the company's first major AI initiative under Chief Digital Officer Karenann Terrell's leadership.

CRISPR Gene Editing Restores Dystrophin Expression in Canine DMD Model

  • Systemic delivery of CRISPR gene editing components restored dystrophin expression in skeletal muscle of DMD dogs, ranging from 3 to 90% of normal levels.
  • Cardiac muscle dystrophin levels reached 92% of normal in the dog receiving the highest dose, demonstrating significant cardiac muscle restoration.
  • Treated dogs exhibited improved muscle histology, indicating a potential therapeutic benefit of gene editing for Duchenne muscular dystrophy.
  • This large-animal study supports the clinical potential of gene editing approaches for treating DMD, warranting further development and clinical translation.

NeuClone Announces Positive Preclinical Results for Stelara® Biosimilar Candidate

  • NeuClone's biosimilar candidate for Stelara® (ustekinumab) shows comparable 3D structure to the reference product through X-ray crystallography.
  • The structural confirmation supports NeuClone's 'Right from the Start®' approach, ensuring high similarity to the original biologic from early development stages.
  • Clinical trials for the Stelara® biosimilar, developed in partnership with Serum Institute of India, are planned to begin in 2019.
  • Stelara®, a monoclonal antibody targeting IL-12 and IL-23, had global sales of $4.0 billion in 2017 and is used to treat conditions like plaque psoriasis and Crohn's disease.

sTMS Shows Promise for Migraine Prevention in Open-Label Study

  • A multicenter, prospective, open-label study suggests that single-pulse transcranial magnetic stimulation (sTMS) may be an effective preventive treatment for migraine.
  • The study demonstrated a statistically significant reduction of 2.75 headache days per month compared to a performance goal (p < 0.0001).
  • 46% of participants experienced a 50% or greater reduction in headache days, alongside reduced acute medication use and improved HIT-6 scores.
  • sTMS was found to be safe and well-tolerated, with no serious adverse events reported during the study period.

eNeura SpringTMS Post-Market Observational US Study of Migraine

NCT02357381Completed
eNeura, Inc.
Posted 12/1/2014

Novartis' Sandoz Partners with Pear Therapeutics to Combat Substance Use Disorders with Digital Solutions

• Sandoz, a Novartis division, has partnered with Pear Therapeutics to commercialize reSET, the first FDA-approved mobile medical application for treating substance use disorders.
• The collaboration includes development of reSET-O, a specialized digital therapeutic for opioid use disorder patients undergoing buprenorphine treatment.
• This strategic partnership expands upon an existing collaboration between Novartis and Pear to develop digital therapeutics for schizophrenia and multiple sclerosis patients.

Alder BioPharmaceuticals to Present New Phase 3 Migraine Prevention Data for Eptinezumab

Alder BioPharmaceuticals announced it will present new Phase 3 data for eptinezumab, its lead investigational product for migraine prevention, at the 70th Annual American Academy of Neurology Meeting. The presentations will include data from the PROMISE 1 and PROMISE 2 clinical trials, highlighting eptinezumab's potential as a treatment option for migraine sufferers.

Blockchain Technology Poised to Transform Pharmaceutical Supply Chain Security and Traceability

• The pharmaceutical industry is turning to blockchain technology to address critical supply chain challenges including counterfeit drugs, product tracking, and temperature control issues.
• Blockchain implementation would enable real-time verification of drug authenticity and complete supply chain visibility through secure, transparent recording of transactions between verified stakeholders.
• Industry leaders are exploring cloud-based networks integrated with blockchain to enhance end-to-end visibility, improve product availability, and optimize inventory management across global pharmaceutical operations.

Survey Reveals Critical Gap in Patient Engagement Across Clinical Trial Industry

  • A comprehensive industry survey shows that 41% of pharmaceutical companies and CROs do not collect patient feedback at all, highlighting a significant gap in clinical trial engagement practices.
  • Despite growing evidence of benefits, patient engagement remains underfunded, with 26% of companies citing budget constraints as the primary barrier to implementing engagement initiatives.
  • Traditional face-to-face and phone interactions prove most effective for patient retention, while ROI from digital health technologies remains uncertain with 43% of respondents unsure of their value.

FDA Rejects Teva and Celltrion's Biosimilars for Rituxan and Herceptin Due to Manufacturing Issues

  • The FDA has rejected biosimilar versions of Rituxan and Herceptin developed by Teva and Celltrion following manufacturing concerns at Celltrion's South Korean facility.
  • Celltrion expects to resolve the manufacturing issues within months, aiming to align with patent expirations of Herceptin in June next year and Rituxan later this year.
  • The rejection impacts Teva's recovery plans, affecting potential revenue from the US market where Rituxan and Herceptin generated $4.3 billion and $2.8 billion respectively last year.

Nivolumab Plus Ipilimumab Shows Durable Benefit in MSI-H/dMMR Metastatic Colorectal Cancer

• Nivolumab plus low-dose ipilimumab demonstrates robust and durable clinical benefits in first-line treatment for MSI-H/dMMR metastatic colorectal cancer. • After a median follow-up of 29 months, the combination therapy shows deepening responses and promising progression-free and overall survival rates. • The objective response rate increased to 69%, with a complete response rate of 13%, indicating improved efficacy with longer follow-up. • The safety profile of the combination remains consistent, with manageable adverse events, supporting its potential as a new first-line option.

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