Clinical Research Weekly Brief: June 10–16, 2025
Welcome to this week’s digest of the most critical developments in Clinical Research! The period of June 10-16, 2025, has been marked by significant FDA approvals, crucial trial milestones, and continued advancements in the integration of cutting-edge technologies. From novel therapies reaching patients to innovative trial designs shaping the future, this report provides a concise overview of what is essential to know to stay informed in our dynamic field.
Key Clinical Research News & Trends
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FDA Approves Andembry for Hereditary Angioedema Prophylaxis
On June 16, 2025, the Food and Drug Administration (FDA) granted approval to Andembry (garadacimab-gxii) Injection, developed by CSL Behring. This new monoclonal antibody functions as an activated Factor XII (FXIIa) inhibitor, offering a prophylactic treatment option for hereditary angioedema (HAE) in adult and pediatric patients aged 12 years and older. Its approval represents a significant advancement in preventing debilitating HAE attacks, providing patients with a crucial new therapeutic pathway. This decision follows a second review by the FDA, after an initial Complete Response Letter.
Published: June 16, 2025
https://www.drugs.com/newdrugs/fda-approves-andembry-garadacimab-gxii-prophylaxis-prevent-attacks-hereditary-angioedema-6551.html -
Penumbra Completes Enrollment for Key Pulmonary Embolism Trial
Penumbra, Inc. announced on June 16, 2025, the successful completion of enrollment for its STORM-PE clinical trial. This prospective, multi-center randomized controlled trial has enrolled 100 patients to compare computer-assisted vacuum thrombectomy (CAVT) using Penumbra’s Lightning Flash system, combined with anticoagulation, against anticoagulation alone. The trial aims to provide high-quality evidence on improving right heart function and clinical outcomes for acute intermediate-high risk pulmonary embolism (PE), addressing a critical unmet need in current PE treatment strategies.
Published: June 16, 2025
Penumbra Completes Enrollment for STORM-PE Randomized Controlled Trial | DAIC -
Sona Nanotech Initiates Clinical Trial for Hyperthermia Therapy in Advanced Melanoma
Sona Nanotech announced on June 16, 2025, the initiation of an early feasibility clinical trial for its Targeted Hyperthermia Therapy (THT) in patients with advanced melanoma. This study, conducted in Chile with Bradford Hill, aims to enroll up to ten patients who have not responded to standard immunotherapy. THT utilizes gold nanorods to deliver localized heat directly to solid tumors, designed to destroy cancerous tissue while minimizing harm to surrounding healthy cells. This first-in-human data will be crucial for advancing the nanotechnology-driven treatment across broader cancer types and patient populations.
Published: June 16, 2025
https://www.proactiveinvestors.com/companies/news/1073065/sona-nanotech-initiates-clinical-trial-for-hyperthermia-therapy-in-advanced-melanoma-patients.html -
FDA Approves Pembrolizumab for Resectable Locally Advanced Head and Neck Squamous Cell Carcinoma
On June 12, 2025, the Food and Drug Administration approved pembrolizumab (Keytruda, Merck) for adults with resectable locally advanced head and neck squamous cell carcinoma (HNSCC) whose tumors express PD-L1 (Combined Positive Score ≥1). This approval allows pembrolizumab to be used as a single agent in a neoadjuvant setting, representing a significant expansion of its indication. It offers a new pre-surgical treatment strategy for a challenging cancer, with the potential to improve patient outcomes by targeting the tumor before surgical removal.
Published: June 12, 2025
FDA approves neoadjuvant and adjuvant pembrolizumab for resectable locally advanced head and neck squamous cell carcinoma | FDA
Tools & Tips
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Advancements in AI-Powered Clinical Data Management Software The landscape of clinical data management (CDM) is being significantly reshaped by Artificial Intelligence (AI) and Machine Learning (ML). New software solutions are emerging that leverage AI to streamline data analysis, identify patterns and anomalies in large datasets, and automate tasks such as data validation and error detection. This leads to faster decision-making, improved data accuracy, and more efficient trial designs. These tools are becoming essential for optimizing patient recruitment, refining study protocols, and ensuring real-time data quality.
Clinical Trial Technology Trends: 7 Powerful Positive Changes 2025 -
Decentralized Clinical Trials (DCTs) and Wearable Technology Integration Decentralized and hybrid clinical trial models continue to gain prominence, leveraging technology to reduce the burden on patients and expand access. Wearable devices have become critical tools for capturing real-time physiological data, enabling continuous monitoring and quicker, more informed decisions by researchers. This shift enhances patient engagement, improves retention, and makes trials more accessible across diverse populations, moving away from traditional, site-centric approaches.
Top 10 Clinical Trial Trends in the US in 2025 - Xtalks
Fun Fact
Did you know? The concept of a controlled clinical trial dates back further than many might imagine! While often credited to James Lind’s 1747 scurvy experiment, the earliest recorded trial-like experiment is found in the biblical “Book of Daniel,” around 562 BC. King Nebuchadnezzar of Babylon conducted a 10-day dietary experiment comparing a meat and wine diet to a diet of legumes and water, concluding that the vegetarians appeared better nourished. Lind’s scurvy trial, however, is celebrated as the first
modern controlled clinical trial, and its start date, May 20th, is now recognized as International Clinical Trials Day!
Evolution of Clinical Research: A History Before and Beyond James Lind - PMC
We’d love to hear from you!
Have you participated in any Clinical Research events or utilized new Clinical Research tools recently? Share your experiences or insights with us—we’re featuring selected community voices in next week’s edition.