Tufts CSDD Reports Increased Collaboration to Reduce Development Risk
According to Tufts CSDD R&D Management Report, more than half of all new drugs approved in the United States between 2000 and 2011 were developed by companies that collaborated in one form or another with other entities.
According to Tufts CSDD R&D Management Report, more than half of all new drugs approved in the United States between 2000 and 2011 were developed by companies that collaborated in one form or another with other entities. The report is based on insights gathered at an executive roundtable of biopharma R&D leaders. Other points included that risk-sharing partnerships are most likely to succeed when governed by a charter that ensures executive engagement, clearly delineates roles and tasks for each organization and key individuals, and defines success metrics and quality measures
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Final ENLIVEN Trial Results Confirm Long-Term Benefit of Turalio in Tenosynovial Giant Cell Tumor
July 9th 2025In final data from the Phase III ENLIVEN study, Turalio (pexidartinib) demonstrated durable tumor responses and a consistent safety profile in patients with symptomatic TGCT not amenable to surgery.
Unifying Industry to Better Understand GCP Guidance
May 7th 2025In this episode of the Applied Clinical Trials Podcast, David Nickerson, head of clinical quality management at EMD Serono; and Arlene Lee, director of product management, data quality & risk management solutions at Medidata, discuss the newest ICH E6(R3) GCP guidelines as well as how TransCelerate and ACRO have partnered to help stakeholders better acclimate to these guidelines.
FDA Expands Farapulse PFA Approval to Persistent AF After Strong ADVANTAGE AF Trial Results
July 7th 2025Boston Scientific’s Farapulse Pulsed Field Ablation System is now approved for treating persistent atrial fibrillation, following 12-month data from the ADVANTAGE AF trial showing strong safety, high freedom from AF, and no major complications.
Effect of AI/ML, Real World Evidence and Master Protocols on Trial Success
July 7th 2025How the application of artificial intelligence, broader use of real-world evidence, decentralized clinical trials, master protocols, and risk-based quality monitoring, together with strong ethical oversight and increased collaboration, are contributing to better healthcare delivery and strengthening the role of clinical research in driving global health progress.
