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Clinical Trial News

Global Pricing Dilemma: The Complex Challenge of Valuing COVID-19 Vaccines

  • Pharmaceutical companies face unprecedented challenges in pricing COVID-19 vaccines, balancing global access needs with innovation rewards and sustainable development costs.
  • Early pricing discussions for COVID-19 treatments like remdesivir suggest potential vaccine prices could range from $2,000-$5,000 per course in developed markets, raising concerns about global accessibility.
  • Multiple factors including clinical efficacy, supply capabilities, competition, and government funding will influence final vaccine pricing, while maintaining public trust remains crucial for manufacturers.

Karyopharm Initiates Phase 1/2 Trial of Selinexor in Glioblastoma

  • Karyopharm Therapeutics has begun a Phase 1/2 clinical trial evaluating oral selinexor combined with standard care for newly diagnosed or recurrent glioblastoma (GBM).
  • The study aims to enroll approximately 400 patients across sites in the U.S., Europe, and Israel to assess the safety and efficacy of selinexor-based regimens.
  • The trial will explore selinexor in combination with radiation therapy, temozolomide, or lomustine, with progression-free survival and overall survival as primary endpoints.
  • Previous studies have indicated that selinexor crosses the blood-brain barrier and exhibits anti-GBM activity, supporting its further clinical development.

A Study of Selinexor in Combination With Standard of Care Therapy for Newly Diagnosed or Recurrent Glioblastoma

NCT04421378TerminatedPhase 1
Karyopharm Therapeutics Inc
Posted 6/8/2020

Study Evaluating the Efficacy and Safety of Selinexor (KPT-330) in Participants With Recurrent Gliomas

NCT01986348TerminatedPhase 2
Karyopharm Therapeutics Inc
Posted 3/3/2014

Advancements in Neurology: From Hunter Syndrome to Alzheimer's Disease

Recent studies and trials in neurology have shown promising results across a range of conditions, including Hunter syndrome, Alzheimer's disease, and Dravet syndrome. Innovations in treatment and diagnostic tools are paving the way for more effective management of these complex conditions.

FTC Clears AbbVie's $63 Billion Allergan Acquisition with Asset Divestiture Requirements

  • The Federal Trade Commission has approved AbbVie's $63 billion acquisition of Allergan after requiring the divestiture of key assets to preserve competition in specific therapeutic markets.
  • AbbVie and Allergan must divest Allergan's EPI treatment drugs Zenpep and Viokace to Nestlé, as the companies currently control 95% of the exocrine pancreatic insufficiency drug market.
  • The companies are also required to transfer brazikumab, an investigational IL-23 inhibitor for Crohn's disease and ulcerative colitis, to AstraZeneca to maintain future competition in inflammatory bowel disease treatments.
  • The FTC's ten-month investigation involved reviewing over 430,000 documents and conducting more than 40 interviews to assess potential competitive harm to consumers.

Subthreshold Electrical Stimulation Shows Promise in LHON Treatment

  • A prospective study reveals that subthreshold electrical stimulation (SES) can lead to statistically significant improvements in visual acuity in LHON patients.
  • The study demonstrated that younger patients at disease onset may experience more pronounced benefits from SES treatment, irrespective of the time between disease onset and SES initiation.
  • Visual field analysis showed significant improvements in summed actual sensitivity in half of the patients, suggesting potential for broader visual function enhancement.
  • While critical flicker frequency did not show significant changes, some patients exhibited notable increases, indicating variable responses to SES.

FDA Accepts NDA for Oral Semaglutide 25 mg for Weight Management and Cardiovascular Risk Reduction

  • The FDA has accepted the New Drug Application for oral semaglutide 25 mg, positioning it as a potential daily treatment option for both weight management and cardiovascular risk reduction.
  • If approved, oral semaglutide 25 mg would represent a significant advancement in GLP-1 receptor agonist therapy, offering patients a non-injectable alternative for obesity treatment.
  • The acceptance comes amid growing clinical interest in GLP-1 therapies, with this higher dose formulation potentially addressing the increasing demand for effective weight management solutions.

Global Clinical Trial Landscape Adapts to Post-Pandemic Research Challenges

• Clinical trial operations worldwide have undergone significant transformations in response to lessons learned from the COVID-19 pandemic, emphasizing remote monitoring and decentralized approaches.
• The evolution of CAR-T cell therapies, including HCAR-19 and PBCAR-19B, represents a new frontier in personalized medicine with promising developments in clinical research.
• Regulatory bodies and research institutions are implementing enhanced protocols for trial conduct, focusing on patient safety and data integrity in the modern clinical research environment.

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