Month: May 2024

Image Credit: © iDoPixBox – stock.adobe.com A study recently published in JAMA Network Open compared response- and progression-based end points in clinical trials and clinical practice settings for patients with stage IV…

ACT: If companies choose not to adopt risk-based approaches, what are some of the largest risks they leave themselves susceptible to? Young: I’ll start. Certainly, I guess an obvious one is regulatory…

David Alsadius, MD, PhD, Senior Medical Director, Oncology Center of Excellence, IQVIA Sergio Sánchez-Gambetta Director, Design Analytics, IQVIA Matt Simmons Senior Director, Oncology Strategy, IQVIA Biotech Investment into cancer drugs is reportedly…

Image credit: 9dreamstudio | stock.adobe.com Roche’s dual GLP-1/GIP receptor agonist CT-388 produced positive findings treating obesity and type 2 diabetes in Phase Ib clinical trial.1 The company announced results from the trial…

Panna Sharma, CEO, Lantern Pharma ACT: While reaching the first-in-human stage is a significant achievement, what specific endpoints or biomarkers will you be looking at in the Phase I trial to assess…

ACT: What do you think the RBQM space will look like in five years? Will we see any drastic changes in adoption either way? Getz: As an academic researcher, we fully expect…

Image credit: Ban | stock.adobe.com Four-year data from the long-term extension (LTE) of the POETYK PSO clinical trial program found that more than seven in 10 adults with moderate-to-severe plaque psoriasis administered…

Applied Clinical Trials May 2024 Issue (PDF) A Promising Future for Oncology R&D Where Innovation and Patients Meet to Improve Cancer Care A Fun and Insightful Exploration of Behavioral Science Accelerating the…

Mike Hennessy Jr, president and CEO, MJH Life Sciences® Oncology clinical trials have always been a unique area in the R&D landscape. One of their greatest and longest-standing challenges has been enrollment….

Image credit: Dr_Microbe | stock.adobe.com Eisai and Biogen Inc. have initiated a rolling FDA submission for a subcutaneous (SC) version of Leqembi (lecanemab-irmb) to treat Alzheimer disease (AD) in patients with mild…

Brian S. McGowan, PhD, FACEHP, Chief Learning Officer and Co-Founder, ArcheMedX, Inc. This installment of my column is a little different than most we’ve published over the last year, but one that…

Hannah Jones, PhD, Senior Vice President, PBPK Consultancy Services, Certara Masoud Jamei, PhD, Senior Vice President, Research and Development, Certara More than 50 kinase inhibitors (KIs) have been approved by the FDA to…

Discover effective strategies for outsourcing clinical trial operations to ensure trials run smoothly and within budget. Join us for a two day event filled with case studies, panel discussion and face to…

Image Credit: © iDoPixBox – stock.adobe.com In an update on the Phase III CheckMate -73L trial, Bristol Myers Squibb announced it did not meet its primary endpoint of progression-free survival (PFS) in…

Image credit: Ocskay Mark | stock.adobe.com Merck is discontinuing the coformulation arm of the Phase III KeyVibe-010 trial (NCT05665595) analyzing the combination of vibostolimab (MK-7684) and Keytruda (pembrolizumab) in the adjuvant treatment…

Andreas Dreps, Senior VP and Global Head Drug Development Unit, ICON plc Over the years, extensive research and clinical trials have led to the development of highly potent and specific antibody–drug conjugates…

Image credit: Jafree | stock.adobe.com Diarrheal diseases place a significant burden on public health in India, particularly among children and vulnerable populations. Unfortunately, diarrhea often goes untreated in our country. Diarrhea kills…

Image Credit: © putilov_denis – stock.adobe.com Patient enrollment has been a persistent challenge in clinical trials over the years across almost all therapeutic areas. However, it is particularly concerning in cancer clinical…

ACT: Ken, could you give us an overview of the risk-based quality management (RBQM) study conducted by Tufts? Getz: Yes, absolutely. And let me position it by just saying that this study…

Image credit: JHVEPhoto | stock.adobe.com The FDA has notified Moderna that it will be unable to finish reviewing its Biologics License Application (BLA) for the company’s investigational respiratory syncytial virus (RSV) vaccine…

Image Credit: © NicoElNino – stock.adobe.com The Tufts Center for the Study of Drug Development (Tufts CSDD) is conducting an important new empirical study looking at the time and cost of the…