MedPath

Clinical Trial News

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

NICE Rejects Cenegermin for Rare Eye Disease, Citing Cost Concerns

• NICE has issued a draft rejection for Dompé's cenegermin, a novel eye drop therapy for neurotrophic keratitis, deeming its £14,500 per course cost exceeding NHS value thresholds.
• Clinical trials showed promising results with low recurrence rates of 0-5% at 56 weeks in the European REPARO study, though NICE noted concerns about long-term efficacy data.
• Without access to cenegermin, patients may need to resort to tarsorrhaphy, a disfiguring procedure where eyelids are partially sewn together to protect the cornea.

Late-Stage Clinical Trials Advance with Oxabact, Imeglimin, and Favipiravir

  • Oxabact initiates a Phase III trial, marking a significant step in its development for treating bacterial infections, potentially addressing unmet needs in antibiotic therapy.
  • Imeglimin progresses to Phase III, offering a novel mechanism of action for type 2 diabetes management and a potential alternative for patients inadequately controlled by current treatments.
  • Favipiravir enters Phase III trials, aiming to provide an effective antiviral option for managing viral infections and potentially mitigating severe outcomes.

FDA Grants Breakthrough Device Status to 3i Diagnostics' Rapid Blood Infection Test

  • 3i Diagnostics' Biospectrix technology receives FDA Breakthrough Device Designation for its ability to identify bacteria directly from blood samples in under 60 minutes, compared to traditional 2-6 day culture methods.
  • The rapid diagnostic tool could significantly improve patient outcomes by enabling faster, targeted antibiotic treatment decisions, particularly crucial for preventing sepsis-related deaths.
  • The technology addresses a critical healthcare need, with potential to help reduce the 44,000 annual sepsis deaths in the UK alone, of which 14,000 are considered preventable.

Relaxed Trial Criteria Show Promise for AML and MDS Patients

  • A clinical trial demonstrated the feasibility of including acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS) patients with comorbidities typically excluded from standard trials.
  • Azacitidine, with or without vorinostat, showed acceptable toxicity and clinical benefit in patients with organ dysfunction or poor performance status.
  • The study suggests that relaxing exclusion criteria could broaden clinical trial access and offer potential therapies to a wider range of patients with dismal prognoses.
  • Findings indicate that stringent exclusion criteria may protect the drug being studied rather than the patients, limiting the extrapolation of trial outcomes to those with unfavorable clinical features.

Oncolytic Viruses Gain Momentum in Cancer Treatment Following Merck's $394M Viralytics Acquisition

  • Merck & Co's $394 million acquisition of Viralytics signals growing interest in oncolytic viruses as potential enhancers for cancer immunotherapy treatments.
  • With 10 oncolytic viruses in clinical development and 40 in labs, these agents show promise in 'priming' tumors for checkpoint inhibitor therapy, potentially improving response rates.
  • Targovax emerges as a leading independent biotech in the oncolytic virus space, developing TG01 for pancreatic cancer and ONCOS-102 for mesothelioma in partnership with AstraZeneca's MedImmune.

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.