October 15th 2024
The need to boost education, shift culture, and embrace new technologies.
October 15th 2024
September 23rd 2024
September 19th 2024
Data from the RAINBOWFISH trial shows early treatment with Evrysdi (risdiplam) in pre-symptomatic infants with spinal muscular atrophy (SMA) leads to significant motor milestone achievements, such as standing and walking, as well as cognitive development typical of non-SMA children, without the need for permanent ventilation.
Potential Challenges with FDA’s Multiregional Clinical Trials Guidance
October 14th 2024In this video interview with ACT editor Andy Studna, Mwango Kashoki, SVP, global head of regulatory strategy, Parexel, touches on challenges that may be created by the guidance such as meeting multiple regulatory requirements.
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.