Breaking Down Data Silos to Enable Real-Time Trial Oversight
August 7th 2025In this video interview, Luke Wilson, senior director, biotech, pharma services at Thermo Fisher Scientific, outlines the key barriers to real-time oversight in clinical trials and explains how integrated systems, built-in analytics, and live dashboards can empower clinops leaders to make faster, better-informed decisions.
FDA Supports Continued Development of Eftilagimod Alfa in PD-L1–Negative Head and Neck Cancer
August 6th 2025Following positive Phase IIb TACTI-003 data, the FDA has endorsed further evaluation of Immutep’s efti-Keytruda combination in first-line recurrent/metastatic HNSCC patients with PD-L1 CPS <1, a population with few chemotherapy-free treatment options.
Using Digital Twins to Improve Efficiency and Accuracy in Clinical Research
August 6th 2025Jon Walsh, founder, chief scientific officer, Unlearn, explains how AI-designed therapies and digital twin technology are accelerating clinical trials, improving data precision, and reshaping early-phase drug development.
How Integrated Systems Help Biotechs Stay Inspection-Ready
August 6th 2025In this video interview, Luke Wilson, senior director, biotech, pharma services at Thermo Fisher Scientific, discusses how integrated systems and data transparency enable sponsors to meet evolving regulatory expectations and streamline FDA inspections through enhanced operational readiness.
How Remote Monitoring Enhances Trial Efficiency and Patient Safety
August 5th 2025In this video interview, Luke Wilson, senior director, biotech, pharma services at Thermo Fisher Scientific, explains how clinical operations teams can use remote monitoring and connected technologies to reduce site burden, respond faster to emerging data, and improve both patient safety and trial outcomes.
FDA Grants Priority Review to Breyanzi for Relapsed Marginal Zone Lymphoma
August 5th 2025Based on positive Phase II TRANSCEND FL data showing a 95.5% overall response rate, the FDA has accepted Bristol Myers Squibb’s sBLA for Breyanzi in relapsed or refractory MZL with a PDUFA date set for December 5, 2025.
Why Real-Time Data Visibility Is Essential for Biotech Clinical Trials
August 4th 2025In this video interview, Luke Wilson, senior director, biotech, pharma services at Thermo Fisher Scientific, discusses how real-time data access is helping biotechs accelerate trial timelines, ensure patient safety, and gain greater oversight—especially through integrated CDMO and CRO partnerships.
Monthly Ivermectin Cuts Malaria Infection by 26% in Kenyan Phase III BOHEMIA Trial
August 1st 2025In the BOHEMIA study, once-monthly ivermectin over 3 months significantly reduced malaria incidence versus albendazole in children aged 5 to 15 years, supporting its role as a novel vector-control tool amid rising insecticide resistance.
Obicetrapib Shows Alzheimer’s Biomarker Reduction in Phase III BROADWAY Trial
August 1st 2025In a pre-specified sub-study of the BROADWAY trial, obicetrapib 10 mg significantly reduced plasma p-tau217 levels in patients with ASCVD, including ApoE4 carriers, suggesting dual potential to lower LDL-C and impact Alzheimer’s disease progression.
Adapting to a Changing Research Funding Landscape
August 1st 2025In this video interview, Michael Miller, chief operating officer at Quanterix, discusses how biopharma companies—especially smaller biotechs—can leverage platform trials and biomarker-driven accelerated approvals to remain efficient and competitive amid shifting public-private funding dynamics.
Cardiff Reports 49% Response Rate With Onvansertib in RAS-Mutated Colorectal Cancer
July 31st 2025In the ongoing Phase II CRDF-004 trial, onvansertib plus standard-of-care showed a 49% confirmed ORR and early PFS benefit in first-line RAS-mutated metastatic colorectal cancer, with a favorable safety profile and dose-dependent efficacy across endpoints.
ACT Brief Episode 1: Placebos, Politics, and the Ethics of Vaccine Trials
July 31st 2025In this pilot episode of the Applied Clinical Trials Brief, we examine the renewed push for placebo-controlled vaccine trials in the US, why experts warn it violates core ethical standards, and how these proposals could jeopardize both participant safety and future innovation.
What Clinical Ops Teams Must Know About Biomarkers in Trials
July 31st 2025In this video interview, Michael Miller, chief operating officer at Quanterix, outlines key technical and regulatory considerations for clinical operations professionals integrating biomarkers into studies, stressing the importance of clarity on biomarker purpose and working with qualified assay partners.
VYNE Ends Phase IIb Vitiligo Trial of Repibresib After Missing Primary Endpoint
July 30th 2025VYNE Therapeutics will terminate its Phase IIb trial of topical Repibresib gel in nonsegmental vitiligo after failing to meet F-VASI50 and F-VASI75 endpoints at week 24, despite nominally significant improvements in other secondary and exploratory measures.
How Biomarkers Are Transforming Neurology and Oncology Trials
July 30th 2025In this video interview, Michael Miller, chief operating officer at Quanterix, highlights neurology and oncology as two therapeutic areas experiencing major advances from biomarker integration, from blood-based diagnostics in Alzheimer’s to multiomic strategies in cancer research.
AbbVie Submits sNDA to FDA for Venclexta-Acalabrutinib Combo in Frontline CLL
July 29th 2025The application is backed by Phase III AMPLIFY trial results showing the oral combination significantly improved progression-free survival versus chemoimmunotherapy in previously untreated chronic lymphocytic leukemia.