MedPath

Clinical Trial News

Clinical Trial Outsourcing Set to Reach 72% by 2020 as Industry Embraces CRO Partnerships

  • The pharmaceutical industry is witnessing a dramatic shift towards outsourcing clinical trials, with projections showing an increase from 23% in 2012 to 72% by 2020.
  • Strategic partnerships between sponsors and Contract Research Organizations (CROs) demonstrate potential for reducing costs, improving trial efficiency, and enhancing data quality.
  • Successful collaboration between sponsors and CROs requires transparent communication, shared decision-making, and aligned performance metrics to overcome operational challenges.

Roche's Ocrevus to Match Novartis's Gilenya Pricing in UK MS Market

• Roche announces pricing strategy for Ocrevus in the UK multiple sclerosis market, aligning costs with Novartis's Gilenya at approximately £19,169 per patient annually.
• Ocrevus becomes the first approved treatment for primary progressive MS (PPMS), though NICE approval for this indication may face longer review timelines.
• The drug has demonstrated strong efficacy in relapsing MS with no direct links to PML, positioning it favorably against competitors like Biogen's Tysabri and Tecfidera.

Janssen to Address Key Challenges in Drug-Device Combination Product Development at Pre-Filled Syringes Conference

  • Janssen's Head of Combination Products Center of Excellence, Susan Neadle, will deliver a keynote presentation on drug-device combination product development challenges at the Pre-Filled Syringes East Coast Conference in Boston.
  • The conference will feature critical discussions on manufacturing processes, including high-concentration monoclonal antibody formulation filling and technical updates from industry leaders GSK and ZEON.
  • Interactive workshops focusing on design considerations and human factors for connected drug delivery systems will be led by experts from Battelle and Cambridge Consultants Ltd.

FDA Grants Breakthrough Therapy Designation to Lenvima-Keytruda Combination for Advanced Renal Cell Carcinoma

  • The FDA has granted Breakthrough Therapy Designation to Eisai's Lenvima (lenvatinib) combined with Merck's Keytruda (pembrolizumab) for treating patients with advanced and/or metastatic renal cell carcinoma.
  • The designation was based on results from Study 111, a multicenter Phase 1b/2 clinical trial evaluating the combination therapy in selected solid tumors including renal cell carcinoma.
  • This marks the second Breakthrough Therapy Designation for Lenvima and the twelfth for Keytruda, providing expedited development pathways and regulatory benefits.
  • The combination therapy is being jointly developed by Eisai and Merck as part of a broader strategic collaboration worth up to $5.76 billion.

Landiolol Demonstrates Rapid Rate Control in Atrial Fibrillation Patients

  • Landiolol, an ultra-short acting beta-blocker, effectively reduces heart rate in patients with tachycardic atrial fibrillation without significant blood pressure drop.
  • Studies show landiolol has higher cardioselectivity and potency compared to esmolol, requiring lower doses for effective heart rate control.
  • Clinical trials in both Asian and Caucasian populations confirm landiolol's rapid pharmacokinetic profile and similar efficacy in controlling supraventricular tachycardia.
  • Landiolol is well-tolerated, with dose-ranging studies determining optimal regimens for managing heart rate in emergency department settings.

Futura Medical's MED2005 Shows Promise as Rapid-Acting Topical Treatment for Erectile Dysfunction

  • Phase II trial of MED2005, a novel topical gel containing glyceryl trinitrate, demonstrates significant improvement in erectile function scores with onset within 10 minutes for 70% of participants.
  • The treatment showed an excellent safety profile with no serious adverse events reported, positioning it as a potential first-line therapy for erectile dysfunction.
  • Futura Medical plans to advance MED2005 to Phase III trials in 2018, exploring higher doses to enhance efficacy in moderate to severe erectile dysfunction cases.

PMV Pharma's Rezatapopt: First p53(Y220C) Stabilizer Shows Promise in Solid Tumors

  • PMV Pharma's rezatapopt is the first p53(Y220C) mutant stabilizer to enter clinical trials, targeting a common cancer mutation.
  • The drug is designed to bind to and stabilize the p53(Y220C) mutant, restoring its tumor-suppressing function in various solid tumors.
  • Early clinical results indicate potential efficacy across a range of solid tumors, marking a significant advancement in oncology.
  • Rezatapopt represents a novel approach to cancer therapy by directly addressing p53 mutations, present in over 50% of malignancies.

UK Survey Reveals Complex Landscape of Pharmaceutical Market Access Challenges

  • A comprehensive survey by UK PM Society's Market Access Interest Group reveals significant diversity in understanding market access across pharmaceutical industry and agencies.
  • Survey findings highlight major challenges including budget constraints, pricing pressures, and difficulties accessing key decision-makers within healthcare systems.
  • Results demonstrate a shifting emphasis toward process management in response to evolving NHS organizational structures and agendas.

MedPath

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

© 2025 MedPath, Inc. All rights reserved.