Clinical Trial News
Weight Gain Combined with Delayed Motherhood Nearly Triples Breast Cancer Risk, Study Finds
• New research reveals women who gain significant weight after age 20 and delay childbirth until after 30 (or remain childless) face a 2.7 times higher risk of developing breast cancer.
• The study, presented at the European Congress on Obesity, is the first to establish how weight gain and age of first birth interact to affect breast cancer risk in women.
• Researchers analyzed data from nearly 48,500 women with an average age of 57, identifying over 1,700 breast cancer cases during the six-year follow-up period.
Dupilumab Reduces Asthma Exacerbations in Children Regardless of Disease Duration
• Children with uncontrolled moderate to severe asthma experienced significantly fewer exacerbations when treated with dupilumab compared to placebo, regardless of how long they had been living with the disease.
• The 52-week VOYAGE trial demonstrated that dupilumab improved asthma control in 6-11 year olds across all disease duration groups, with 62-79% of treated children achieving well-controlled status versus 35-56% on placebo.
• Researchers noted that while longer asthma duration was associated with more frequent exacerbations overall, dupilumab provided consistent clinical benefits that could help reduce the impact of persistent symptoms on developing lungs.
Highlighted Clinical Trials:
FDA Clears Brainstorm Cell Therapeutics' Phase 3b Trial of NurOwn for ALS Treatment
• Brainstorm Cell Therapeutics has received FDA clearance to initiate a Phase 3b trial of NurOwn for the treatment of Amyotrophic Lateral Sclerosis (ALS), marking a significant advancement in their clinical development program.
• The company's proprietary NurOwn technology utilizes Mesenchymal Stem Cells (MSC) that are differentiated into neurotrophic factor-secreting cells and transplanted near damaged areas, offering a novel approach to treating neurodegenerative diseases.
• Following the FDA announcement, Brainstorm's stock surged by 31.82% in premarket trading, reflecting strong investor confidence in the potential of this stem cell therapy for ALS patients.
Post-Marketing Safety Analysis of Voclosporin Reveals New Adverse Event Patterns in Lupus Nephritis Treatment
• A comprehensive pharmacovigilance study analyzing FAERS data from 2021-2024 identified eight significant adverse event categories associated with voclosporin, including previously unreported gastrointestinal disorders.
• Nearly one-third of voclosporin-related adverse events occurred within the first month of treatment, with renal and infectious complications typically appearing later with a median onset time of 133 and 130.5 days respectively.
• Gender and age differences were observed in adverse event patterns, with females experiencing more headaches and gastrointestinal issues while males showed higher rates of renal function abnormalities and elevated uric acid levels.
UC Davis Scientists Develop Non-Hallucinogenic LSD Derivative That Shows Promise for Schizophrenia Treatment
• Researchers at UC Davis created JRT, a novel compound derived from LSD by repositioning just two atoms in its molecular structure, potentially offering a breakthrough treatment for schizophrenia without hallucinogenic effects.
• In preclinical studies, JRT demonstrated remarkable ability to regrow brain cells and repair neural pathways in mice, reducing negative schizophrenia symptoms like cognitive fog and social withdrawal.
• The compound also exhibited potent antidepressant properties, proving to be 100 times more effective than ketamine at a fraction of the dose, suggesting broad therapeutic potential for mental health conditions.
Interpace Biosciences Secures US Patent for MicroRNA Technology in Thyroid Cancer Diagnosis
• Interpace Biosciences has been granted a US patent for using microRNAs to differentiate between benign and malignant thyroid neoplasms, enhancing their diagnostic capabilities.
• The patented technology underpins ThyraMIR®, a microRNA classifier that works with ThyGeNEXT® to provide actionable results for indeterminate thyroid nodules, potentially reducing unnecessary surgeries.
• This intellectual property strengthens Interpace's position in personalized medicine, specifically in molecular diagnostics for improved thyroid cancer detection and patient management.
RHONE-X Trial: Faricimab Shows Sustained 4-Year Benefits with Reduced Injection Burden in DME Patients
• The RHONE-X trial demonstrates that faricimab maintains vision improvements and reduced central subfield thickness in diabetic macular edema patients for up to 4 years using a treat-and-extend dosing regimen.
• Patients achieved consistent 10-letter vision gains across all treatment arms, with a median of only 3 injections required in the fourth year of treatment.
• The study followed nearly 1,500 eyes with an 82% retention rate, showing many patients could extend treatment intervals to 12-16 weeks while maintaining clinical benefits.
IMVARIA Presents Real-World Data on FDA-Authorized AI Diagnostic Service for Pulmonary Fibrosis at ATS 2025
• IMVARIA's Fibresolve, the first FDA-authorized AI adjunctive diagnostic service for lung fibrosis, demonstrates real-world clinical utility in multi-site experiences presented at ATS 2025 Conference.
• The AI-powered diagnostic service enables pulmonologists to evaluate suspected Interstitial Lung Disease (ILD) and Idiopathic Pulmonary Fibrosis (IPF) without workflow disruption or complex system installation.
• IMVARIA is also presenting data on two additional AI solutions: ScreenDx for ILD assessment (FDA-cleared in 2025) and Bronchosolve, an investigational tool for lung nodule evaluation.
Fecal Microbiota Therapy Shows 95% Success Rate in Preventing Recurrent C. difficile Infection
• Phase 3b trial demonstrates colonoscopic administration of Rebyota (fecal microbiota live-jslm) achieves 95.1% treatment success in preventing recurrent C. difficile infection with minimal adverse events.
• The CDI-SCOPE study spanning 12 US sites received overwhelmingly positive physician feedback, with over 90% reporting satisfaction with both the procedure and patient outcomes.
• This microbiota-based therapy represents a significant advancement over traditional fecal transplant approaches by providing a more structured and accessible restoration technique for gut microbiome.
FDA Approves Novavax COVID-19 Vaccine with Restricted Use for High-Risk Groups
• The FDA has granted full approval for Novavax's protein-based COVID-19 vaccine, but with unusual restrictions limiting its use to adults 65 and older or those 12-64 with health risk factors.
• Novavax's vaccine represents the only traditional protein-based coronavirus vaccine option in the US market, previously available under emergency authorization for anyone 12 and older.
• The restricted approval comes amid shifting vaccine policies under the Trump administration, with the FDA requiring Novavax to conduct additional post-approval studies on potential heart conditions and benefits for certain age groups.