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.
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.
Growing Excitement Around Biomarkers in Clinical Trials
July 29th 2025In this video interview, Michael Miller, chief operating officer at Quanterix, discusses how the use of biomarkers is expanding beyond exploratory endpoints to inform efficacy and patient selection, driving improved outcomes and greater efficiency in clinical research.
How Research Institutions Can Future-Proof Compliance Programs
July 28th 2025In this video interview, Kate Gallin Heffernan, life sciences attorney at Epstein Becker Green, advises clinical research organizations to assess their portfolios, diversify funding sources, and strengthen industry-academic partnerships to maintain compliance and continuity amid shifting federal priorities.
Performing Risk Assessments Amid Shifting Federal Guidelines
July 25th 2025In this video interview, Kate Gallin Heffernan, life sciences attorney at Epstein Becker Green, advises clinical research teams to closely scrutinize federal fund certifications and document good-faith compliance efforts, even when policies stem from nonbinding executive orders.
Astegolimab Shows Mixed Results in COPD Trials, Meeting Endpoint in ALIENTO but Not in ARNASA
July 24th 2025Astegolimab met its primary endpoint in the Phase IIb ALIENTO trial with a 15.4% reduction in annualized exacerbation rate at 52 weeks, while the Phase III ARNASA study showed a 14.5% reduction and did not meet the primary endpoint.
Balancing DEI Reporting With Legal Risk
July 24th 2025In this video interview, Kate Gallin Heffernan, life sciences attorney at Epstein Becker Green, explains how clinical research teams can accurately report on diversity-related grant work while minimizing exposure to False Claims Act scrutiny, by focusing on precise language and framing.
The Quiet Risks of Ignoring Executive Orders in Research
July 23rd 2025In this video interview, Kate Gallin Heffernan, life sciences attorney at Epstein Becker Green, outlines how even unenforced executive orders can influence federal funding decisions, prompting sponsors and sites to alter public trial messaging to avoid informal scrutiny.
Understanding Executive Orders and Trial Compliance
July 22nd 2025In this video interview, Kate Gallin Heffernan, life sciences attorney at Epstein Becker Green, explains how recent executive orders are creating uncertainty around compliance for clinical research teams receiving federal funding, and why staying alert to agency interpretation is key.
The Future of Clinical Trials in Community-Based Settings
July 18th 2025In this video interview, Ramita Tandon, chief biopharma officer at Walgreens, outlines her five-year vision for community-based research, calling for deeper industry alignment, infrastructure expansion, and patient-first design principles.
Anselamimab Misses Primary Endpoint in Phase III CARES Trials for AL Amyloidosis
July 17th 2025In the Phase III CARES trials, anselamimab did not meet the primary endpoint for advanced-stage AL amyloidosis, but a prespecified subgroup analysis revealed meaningful improvements in survival and cardiovascular outcomes.
Advice for CROs and Sponsors Partnering With Retail Trial Sites
July 17th 2025In this video interview, Ramita Tandon, chief biopharma officer at Walgreens, offers practical insights for sponsors and CROs exploring partnerships with retail research sites, emphasizing collaboration, innovation, and shared accountability.
Advancing Inclusive Recruitment in Trials
July 16th 2025In this video interview, Ramita Tandon, chief biopharma officer at Walgreens, shares how the company is driving more inclusive enrollment by engaging diverse communities, developing culturally competent materials, and meeting patients where they are.
Building Clinical Trial Infrastructure Inside Pharmacies
July 15th 2025In this video interview, Ramita Tandon, chief biopharma officer at Walgreens, discusses the operational investments required to activate pharmacies as clinical trial sites, including staff training, regulatory coordination, and patient-facing technology.
Merck Launches Phase III Trials of Once-Monthly Oral HIV PrEP Candidate MK-8527
July 14th 2025In the new EXPrESSIVE clinical trial program, Merck will evaluate MK-8527, a once-monthly, oral PrEP therapy, in populations at high risk of HIV-1 infection, including adolescent girls and women in sub-Saharan Africa.