October 14th 2024
A data-fueled framework for sponsors and CROs in navigating this shifting terrain.
September 23rd 2024
September 19th 2024
Tremfya Shows Superior Endoscopic Remission Rates in Crohn Disease, Ulcerative Colitis
Tremfya (guselkumab) demonstrated superior endoscopic remission rates in both Crohn disease and ulcerative colitis, including biologic-naïve and biologic-refractory patients, according to Phase III clinical trial data.
Ensuring Greater Access and Diverse Patient Populations
October 10th 2024In this video interview with ACT editor Andy Studna, Mwango Kashoki, SVP, global head of regulatory strategy, Parexel, highlights how FDA’s multiregional clinical trials in oncology guidance encourages more diverse site locations and patient populations.
Talzenna (talazoparib) with Xtandi (enzalutamide) produced a statistically significant improvement in overall survival among patients with metastatic castration-resistant prostate cancer, regardless of mutation status, making it the first combination of a PARP inhibitor and ARPI to achieve these results.
KEYNOTE-689 trial shows Keytruda (pembrolizumab) produced significantly improved event-free survival and major pathological response in patients with resected, locally advanced head and neck squamous cell carcinoma, marking the first Phase III trial to show meaningful results with an anti-PD-1 therapy in both the neoadjuvant and adjuvant settings.
In the Phase II PATH-HHT trial, pomalidomide significantly reduced the severity of epistaxis and improved quality of life in patients with hereditary hemorrhagic telangiectasia, offering a potential treatment for the bleeding disorder, which currently lacks FDA-approved therapies.
Parexel’s FSP: Evolving With Your Needs Now and in the Future
Jenny Denney, EVP, Head of FSP Clinical and Biometrics at Parexel, discusses current transformations in the industry in addition to how Parexel, as the landscape shifts, supports clients with proper models and infrastructure from a functional service provider (FSP) perspective.
New Survey Uncovers Distrust as Key Factor in Enrollment Declines Among Black Patients
October 2nd 2024Findings from two Baltimore medical centers presented at the American Society for Radiation Oncology Annual Meeting suggest spiritual themes and distrust may be behind the decline in trial participation.
Tulisokibart Shows Superior Efficacy in Achieving Clinical Remission for Ulcerative Colitis Patients
Proof-of-concept Phase II ARTEMIS-UC trial shows efficacy of investigational humanized monoclonal antibody tulisokibart in treating inflammatory bowel disease compared with placebo.