July 18th 2025
Despite the setback with the Oncologic Drugs Advisory Committee vote, GSK emphasizes the unmet need in multiple myeloma and highlights global momentum behind Blenrep combination approvals.
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.
How Parexel Supports Cross Functional Trials for Emerging GLP-1 Therapies
July 17th 2025Shipra Patel, global therapeutic area section head, endocrinology, global head, pediatrics, Parexel, explains how therapeutic alignment and cross-functional collaboration enable the company to support GLP-1 trials across multiple disease areas.
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.
Inside the GLP-1 Strategy Driving Competitive Edge in Obesity Clinical Research
July 16th 2025Shipra Patel, global therapeutic area section head, endocrinology, global head, pediatrics, Parexel, explains how a focused GLP-1 task force and deep market insights are helping sponsors stand out in an increasingly competitive obesity drug landscape
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.
CAHtalyst Trial Shows Crenessity Sustains Efficacy in Classic Congenital Adrenal Hyperplasia
July 14th 2025Results from the Phase III CAHtalyst show that patients treated with Crenessity for classic congenital adrenal hyperplasia achieved and maintained lower, more physiologic glucocorticoid doses while keeping key adrenal biomarkers at or below baseline levels.
Baxdrostat Shows Significant Blood Pressure Reduction in Phase III BaxHTN Trial
July 14th 2025In the BaxHTN Phase III study, AstraZeneca’s baxdrostat demonstrated statistically significant and clinically meaningful reductions in systolic blood pressure in patients with uncontrolled or treatment-resistant hypertension.
Walgreens’ Clinical Trials Journey: Three Years In
July 14th 2025In this video interview, Ramita Tandon, chief biopharma officer at Walgreens, reflects on the company’s three-year evolution as a clinical trials partner, highlighting its pharmacy-led model and community-driven approach to trial access and participation.
New FDA Initiative Reveals Common Reasons for Drug Application Rejection
July 11th 2025By publishing more than 200 complete response letters, the FDA is offering new visibility into the issues that most often delay drug approvals, including safety concerns, trial design flaws, and manufacturing gaps.
Arcus’ Quemliclustat Earns Orphan Drug Designation as Phase III Pancreatic Cancer Trial Advances
July 11th 2025The FDA has granted orphan status to Arcus Biosciences’ CD73 inhibitor quemliclustat for metastatic pancreatic cancer, as the global PRISM-1 Phase III trial nears full enrollment following promising survival data from ARC-8.
Designing Trials Around the Full Patient Journey
July 11th 2025In this video interview, Heather Horville, solutions consultant at Greenphire, emphasizes the growing need for clinical operations to embed patient-centric services—from consent through final visit—to improve retention and overall trial success.
Moderna’s mRNA-1010 Flu Vaccine Meets Efficacy Goals in Phase III Trial of Adults 50+
July 10th 2025In the P304 Phase III study, Moderna’s mRNA-1010 demonstrated a 26.6% relative efficacy over a standard-dose flu vaccine in adults aged 50+, showing consistent protection across strains and age groups.
QWINT-1 Trial: Once-Weekly Efsitora Matches Daily Glargine in Type 2 Diabetes Management
July 10th 2025Results from the Phase III QWINT-1 trial show that Eli Lilly’s once-weekly insulin efsitora is noninferior to once-daily glargine in reducing HbA1c among insulin-naïve adults with type 2 diabetes, offering a simplified fixed-dose regimen with fewer hypoglycemic events and less treatment burden.
Removing Financial Barriers to Boost Trial Diversity
July 10th 2025In this video interview, Heather Horville, solutions consultant at Greenphire, explains how upfront reimbursement, travel stipends, and flexible support services can empower more patients—especially those from underserved communities—to confidently enroll and stay in clinical trials.
Final ENLIVEN Trial Results Confirm Long-Term Benefit of Turalio in Tenosynovial Giant Cell Tumor
July 9th 2025In final data from the Phase III ENLIVEN study, Turalio (pexidartinib) demonstrated durable tumor responses and a consistent safety profile in patients with symptomatic TGCT not amenable to surgery.
Results from the Phase III KEYNOTE-689 trial show that adding perioperative Keytruda (pembrolizumab) to standard-of-care radiotherapy improves event-free survival in patients with resectable, locally advanced head and neck squamous cell carcinoma, potentially setting a new benchmark for treatment in this setting.