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Clinical Trial News

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.

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.

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.

Final 5-Year Results of the Phase 2 PACE Trial for CML and Ph+ ALL Patients

The PACE trial's final 5-year results demonstrate ponatinib's efficacy and safety in treating chronic myeloid leukemia (CML) and Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) patients who have undergone prior therapies. The study highlights significant response rates, durability of responses, and the impact of dose adjustments on maintaining efficacy while managing adverse events.

Ponatinib in Participants With Resistant Chronic Phase Chronic Myeloid Leukemia (CP-CML) to Characterize the Efficacy and Safety of a Range of Doses

NCT02467270CompletedPhase 2
Takeda
Posted 6/30/2015

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