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Clinical Trial News

Dynamic Consent Platforms: Revolutionizing Clinical Trial Participation and Data Management

  • Dynamic consent technology enables personalized online platforms for managing informed consent in clinical trials, allowing participants to update their preferences and maintain ongoing dialogue with researchers.
  • A pioneering app developed at Radboud University Medical Centre empowers patients to create custom data-sharing policies and manage consent preferences through an intuitive mobile interface.
  • Implementation of dynamic consent platforms could significantly improve trial recruitment, participant retention, and data management efficiency while addressing current challenges in biomedical research participation.

Celltrion Pursues Novel Multi-Brand Strategy for Rituximab Biosimilar in EU Market

• Celltrion has received European regulatory approval to market its rituximab biosimilar under four different brand names - Truxima, Tuxella, Ritemvia, and Blitzima - in a unique market strategy.
• The company's approach aims to maximize market share through potential partnerships with multiple distributors, building on their successful dual-brand strategy with their infliximab biosimilar.
• Strategic differences in marketing authorizations include specific indications, with Ritemvia approved for chronic lymphocytic leukemia while Blitzima and Tuxella exclude this indication.

Tirzepatide Shows Superior Weight Loss Efficacy Over Semaglutide in Real-World Study

  • Real-world analysis of over 41,000 adults with overweight or obesity found tirzepatide users were significantly more likely to achieve clinically meaningful weight loss compared to semaglutide users.
  • Patients on tirzepatide achieved 15.2% average weight reduction at 12 months versus 7.9% with semaglutide, with 42.3% of tirzepatide users reaching ≥15% weight loss compared to only 19.3% of semaglutide users.
  • Both medications showed similar gastrointestinal adverse event profiles, with no significant differences in the incidence of side effects between treatment groups.

A Study of Tirzepatide (LY3298176) in Participants With Obesity or Overweight With Weight Related Comorbidities

NCT05822830CompletedPhase 3
Eli Lilly and Company
Posted 4/21/2023

FDA Approves Fourth ALK Inhibitor for Lung Cancer

The FDA has approved brigatinib (Alunbrig) for treating certain patients with metastatic non-small cell lung cancer (NSCLC) driven by ALK gene mutations, especially those not responding to crizotinib. This approval is based on the phase II ALTA clinical trial results, showing significant tumor shrinkage in patients.

FDA's Drug Trials Snapshots Highlight Sex Disparities in Cardiovascular Drug Trials

  • FDA's Drug Trials Snapshots program reveals demographic data and subgroup analysis for newly approved drugs, enhancing transparency.
  • Cardiovascular drug trials in 2015 showed disproportionately low enrollment of women, representing only 35% of participants.
  • While efficacy was generally similar between sexes, safety statements varied between Snapshots and Prescribing Information (PI), particularly regarding bleeding risks.
  • The FDA aims to collaborate with the cardiology community to address the underrepresentation of women in cardiovascular clinical trials.

Dendritic Cell Vaccine Shows Promise in Glioblastoma Phase I Trial

  • A phase one study of a dendritic cell vaccine combined with intensified temozolomide showed promising survival benefits in glioblastoma patients.
  • The combination therapy was well-tolerated, with no treatment-limiting adverse events related to the vaccine itself.
  • Four out of eleven patients survived more than five years, a notable outcome compared to the typical 15-month median survival with standard care.
  • Researchers are planning a larger study to compare the intensified regimen plus vaccine against standard temozolomide in glioblastoma.

BenevolentAI Partners with MRC Technology to Accelerate AI-Driven Drug Discovery

  • BenevolentAI and MRC Technology have formed a two-year collaboration to identify and validate novel small molecule and antibody drug candidates using artificial intelligence technology.
  • The partnership combines BenevolentAI's deep learning platform with MRCT's screening and drug development capabilities to streamline the discovery of new medicines.
  • BenevolentAI's advanced AI system, powered by NVIDIA DGX-1 supercomputer, positions the company as a leading competitor in the growing field of AI-driven pharmaceutical research.

Jim Mellon Backs Insilico Medicine's AI-Driven Anti-Aging Drug Discovery Platform

• British billionaire investor Jim Mellon has made a strategic investment in Insilico Medicine, a Baltimore-based AI company using deep learning for drug discovery and aging research.
• Insilico Medicine, founded in 2014 at Johns Hopkins University, is developing therapeutics for cancer, Parkinson's, Alzheimer's, and geroprotectors targeting the fundamental causes of aging.
• The company has demonstrated promising research outcomes, including a Nature Communications publication on gene expression analysis and a highly-cited blood test for predicting chronological age.

FDA Approves Bavencio: Merck KGaA and Pfizer's Breakthrough Immunotherapy for Rare Skin Cancer

• The FDA has granted accelerated approval to Bavencio (avelumab), the first approved therapy for metastatic Merkel cell carcinoma, developed through Merck KGaA and Pfizer's collaboration.
• Bavencio becomes the fourth checkpoint inhibitor to enter the market, joining established immunotherapies from Bristol-Myers Squibb, Merck & Co, and Roche in the oncology space.
• The drug's peak sales are projected to reach $4-6 billion, with development ongoing in multiple cancer indications including first-line lung cancer, gastric cancer, and ovarian cancer.

ALS Clinical Trials: Masitinib and Edaravone Offer Hope After 20 Years of Failure

  • A review of ALS clinical trials over the past 20 years reveals a high failure rate, with riluzole remaining the only approved treatment for many years.
  • Masitinib, a tyrosine kinase inhibitor, has shown promise in Phase 3 trials by reducing neuroinflammation and slowing disease progression in ALS patients.
  • Edaravone, an antioxidant, received marketing authorization in Japan after demonstrating clinical efficacy in a Phase 3 trial with a specific ALS patient subgroup.
  • Both masitinib and edaravone represent potential new treatment options for ALS, though further research is needed to compare their efficacy and safety.

Talampanel for Amyotrophic Lateral Sclerosis (ALS)

NCT00696332CompletedPhase 2
Teva Branded Pharmaceutical Products R&D, Inc.
Posted 9/1/2008

Masitinib in Combination With Riluzole for the Treatment of Patients Suffering From Amyotrophic Lateral Sclerosis (ALS)

NCT02588677CompletedPhase 2
AB Science
Posted 4/1/2013

Efficacy and Safety Study of MCI-186 for Treatment of Amyotrophic Lateral Sclerosis (ALS) Who Met Severity Classification III

NCT00415519CompletedPhase 3
Mitsubishi Tanabe Pharma Corporation
Posted 12/1/2006

Phase 3 Study of MCI-186 for Treatment of Amyotrophic Lateral Sclerosis

NCT01492686CompletedPhase 3
Mitsubishi Tanabe Pharma Corporation
Posted 12/1/2011

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