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Clinical Trial News

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.

Clinical Database Delays Significantly Impact Trial Timelines, Tufts Study Reveals

  • New research by Tufts Center for the Study of Drug Development reveals that 85% of life sciences organizations release clinical study databases after first patient enrollment, causing significant downstream delays.
  • Database release delays double patient data entry time from 5 to 10 days and increase database lock time by 75%, highlighting critical inefficiencies in clinical trial management.
  • Protocol changes are cited as the primary cause of database-build delays by 45% of respondents, while 77% report challenges with data loading into EDC systems.

Protection of the Human Gut Microbiome From Antibiotics

A clinical trial demonstrated that DAV132, a product containing activated charcoal, significantly reduces the exposure of the human gut microbiome to the antibiotic moxifloxacin (MXF) without affecting its plasma pharmacokinetics. The study, involving healthy volunteers, showed that DAV132 could protect the intestinal microbiota's richness and composition from the adverse effects of MXF, suggesting its potential to mitigate the long-term consequences of antibiotic treatments.

Safety and Efficacy Study of DAV132 in Healthy Volunteers

NCT02176005CompletedPhase 1
Da Volterra
Posted 3/1/2014

Leading Pharma Companies and Regulators to Convene at 10th Annual Adaptive Clinical Trials Conference

  • Industry leaders from AstraZeneca, Novartis, and Roche will gather in London to discuss innovations in adaptive clinical trial designs and digital technology integration in drug development.
  • The conference will feature key regulatory perspectives from EMA and MHRA representatives, focusing on critical topics including umbrella trials and basket trial assessments.
  • Sessions will explore the application of adaptive designs in developing personalized medicines and the impact of digital technology on modern clinical trials.

GSK's BCMA-Targeting ADC, GSK2857916, Receives FDA Breakthrough Therapy Designation for Multiple Myeloma

  • GSK2857916, an investigational BCMA-targeting antibody-drug conjugate, has been granted Breakthrough Therapy Designation by the FDA for relapsed/refractory multiple myeloma.
  • The designation is for patients who have failed at least three prior lines of therapy, including an anti-CD38 antibody, and are refractory to proteasome inhibitors and immunomodulatory agents.
  • This decision was based on Phase 1 data, which demonstrated the potential of GSK2857916 as a monotherapy in heavily pre-treated multiple myeloma patients.
  • GSK plans to expedite clinical trials to further investigate the benefits of GSK2857916, both as a monotherapy and in combination with other treatments.

Dose Escalation Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics, Immunogenicity and Clinical Activity of GSK2857916

NCT02064387CompletedPhase 1
GlaxoSmithKline
Posted 7/29/2014

China's Pharmaceutical R&D Evolution: Regulatory Reforms Signal New Era for Drug Development

  • China's pharmaceutical landscape is transforming through major regulatory reforms, streamlining drug approvals and accepting international clinical trial data to accelerate new drug development.
  • Despite being the second-largest healthcare market globally, China faces significant challenges, including limited R&D investment and regulatory capacity compared to Western markets.
  • Novartis and other global pharma companies maintain strategic research presence in China, with CNIBR advancing 15 drug discovery projects and showing commitment to local innovation.

European Oncology Biosimilars Set to Generate €2 Billion in Healthcare Savings by 2021

  • IQVIA forecasts potential savings of €2 billion across European markets by 2021 through biosimilar versions of key oncology drugs including rituximab, trastuzumab, and bevacizumab.
  • Healthcare systems must focus on three critical factors for successful biosimilar adoption: evidence generation through real-world data, comprehensive stakeholder education, and aligned financial incentives.
  • While biosimilar savings represent 20% of biologics expenditure, strategic planning is needed to effectively allocate these funds for healthcare system sustainability.

FDA Approves Mylan's Generic Versions of Copaxone for Multiple Sclerosis Treatment

  • The FDA has approved Mylan's glatiramer acetate injections in two dosage forms (40 mg/mL three-times-weekly and 20 mg/mL once-daily) as therapeutically equivalent alternatives to Teva's Copaxone for relapsing forms of multiple sclerosis.
  • Mylan's generic versions demonstrated the same active ingredient, dosage form, route of administration, and strength as Copaxone, allowing them to be substituted with comparable safety and efficacy profiles.
  • Alongside the medication launch, Mylan introduced the comprehensive MS Advocate support program offering injection training, 24/7 patient support, co-pay assistance, and ongoing nurse support to help patients adhere to their treatment plans.

Advancing Traumatic Brain Injury Treatment Through the TED Initiative

The Traumatic Brain Injury Endpoints Development (TED) Initiative, funded by the Department of Defense, aims to improve clinical trials for TBI by developing precise diagnostic tools and effective treatments. Over its first 18 months, TED has made significant progress, including engaging with the FDA, creating a comprehensive metadataset, and advancing biomarker and clinical outcome assessment validation.

SpringWorks Therapeutics Launches with $103M to Advance Pfizer's Rare Disease Portfolio

• SpringWorks Therapeutics emerges as a Pfizer spin-off with $103 million in funding from multiple investors, including Pfizer, LifeArc, and Bain Capital, to develop four promising rare disease drug candidates.
• The company's pipeline includes nirogacestat for desmoid tumors and a MEK 1/2 inhibitor for neurofibromatosis, both advancing to phase 3 trials, along with treatments for hereditary xerocytosis and PTSD.
• Led by former Pfizer executive Lara Sullivan, SpringWorks represents a novel model for accelerating drug development by revitalizing lower-priority assets through focused development and strategic partnerships.

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