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- CastleVax has dosed the first participant in a Phase 2 clinical study of CVAX-01, an intranasal COVID-19 vaccine candidate designed to elicit mucosal immunity and prevent breakthrough infections. - The study will enroll approximately 200 adults to evaluate safety, tolerability, and immunogenicity compared to FDA-approved mRNA vaccines, with participants followed for 6 months. - Preclinical studies demonstrated that the Newcastle Disease Virus-vectored vaccine protected animals from SARS-CoV-2 infection and blocked virus transmission through mucosal immune responses. - The vaccine utilizes HexaPro technology and has already received full regulatory approval in Thailand and Emergency Use Authorization in Mexico for intramuscular administration.
- Pelthos Therapeutics has commercially launched ZELSUVMI (berdazimer) topical gel 10.3%, the first FDA-approved prescription medication for molluscum contagiosum that can be applied at home by patients or caregivers. - The nitric oxide-releasing gel demonstrated significant efficacy in the largest Phase 3 molluscum study to date, achieving complete lesion clearance in 33% of patients versus 19.7% with placebo at 12 weeks. - Molluscum contagiosum affects an estimated 16.7 million Americans with up to 6 million new cases annually, yet up to 73% of pediatric cases go untreated due to limited therapeutic options and inconvenient procedural treatments.
- One-year clinical trial data for Medtronic's investigational Sphere-360™ single-shot PFA catheter demonstrated 88% freedom from arrhythmia recurrence in paroxysmal atrial fibrillation patients, with no reported safety events in the optimized waveform subgroup. - The Sphere-9™ catheter, which received FDA approval in October 2024, has shown efficacy for linear ablation in persistent atrial fibrillation patients, offering physicians treatment flexibility with its wide area focal design. - Medtronic continues to strengthen its position in electrophysiology as the only company with two pulsed field ablation offerings, addressing a condition that affects more than 60 million people worldwide.
- The second phase of Boston Scientific's ADVANTAGE AF trial demonstrated 73.4% freedom from atrial fibrillation, atrial flutter, and atrial tachycardia in patients with persistent AF, exceeding the performance goal of 40%. - The FARAPULSE Pulsed Field Ablation System showed a strong safety profile with only a 2.4% event rate and no reports of serious complications such as pulmonary vein stenosis or atrio-esophageal fistula. - Boston Scientific anticipates FDA approval to expand labeling for persistent AF and regulatory approvals for the FARAPOINT PFA Catheter in the second half of 2025, potentially offering new treatment options for the approximately 25% of AF patients with persistent forms.
- Precision Neuroscience has received FDA 510(k) clearance for its Layer 7 Cortical Interface, marking the first full regulatory approval for a next-generation wireless brain-computer interface technology. - The high-resolution cortical electrode array is now authorized for commercial use with implantation durations of up to 30 days, enabling longer data collection periods critical for neural decoding algorithm development. - The company has already tested its device in 37 patients through partnerships with leading institutions including Mount Sinai, UPenn, and Beth Israel Deaconess Medical Center, with plans to expand clinical research programs.
- The COVID-19 pandemic has fundamentally transformed oncology care delivery, with telemedicine emerging as a permanent fixture that improves access while presenting challenges in patient assessment and reimbursement. - Significant disruptions in cancer screenings during the pandemic have led to persistent stage migration, with oncologists reporting continued diagnoses of more advanced cancers across multiple tumor types. - Clinical trial operations faced severe setbacks during the pandemic, with lingering effects on enrollment, staffing, and research progress, while oncologist burnout has increased from 45% in 2013 to 59% in 2023.
• Orchestra BioMed has appointed renowned cardiac electrophysiologist Dr. Vivek Reddy as Executive Chairman of the BACKBEAT Study Steering Committee, strengthening leadership for their global pivotal trial. • Dr. Reddy, Director of Cardiac Arrhythmia Services at Mount Sinai, will also chair the Bioelectronic Therapies Scientific Advisory Board to advance the company's therapeutic portfolio. • The appointment leverages Dr. Reddy's expertise in cardiac electrophysiology to enhance the development and clinical validation of Orchestra BioMed's bioelectronic therapies.
- A Mount Sinai study elucidates that lurbinectedin, a second-line therapy for SCLC, enhances the immune response against tumors by activating the STING-IFN signaling pathway. - Lurbinectedin promotes the production of interferons and pro-inflammatory chemokines, crucial for immune cells to recognize and attack cancer cells. - The research indicates that lurbinectedin's immune-modulatory effects can significantly improve the efficacy of PD-L1 blockade therapies in SCLC. - Findings from this study support combining lurbinectedin with immune therapies like atezolizumab to improve survival and quality of life for SCLC patients.
- Johns Hopkins researchers successfully trained a robot to perform surgical tasks using surgical videos and ChatGPT's machine learning architecture, marking a significant advancement in AI-assisted surgery. - The American College of Radiology launched a groundbreaking AI quality registry to monitor real-world performance of AI imaging algorithms in clinical settings, enhancing quality control in radiology. - Mount Sinai Health System established a major AI and human health research center, staffing 40 principal investigators and 250 specialists to advance healthcare AI innovation.
- A Phase 2 trial of tulisokibart, an anti-TL1A monoclonal antibody, demonstrated superior efficacy compared to placebo in inducing clinical remission in patients with moderate to severe ulcerative colitis. - The study utilized a genetic-based diagnostic test to identify patients more likely to respond to tulisokibart, showing improved remission rates in this subgroup. - Tulisokibart modulates inflammation and the body's anti-inflammatory mechanisms, offering a novel approach compared to existing IBD treatments that can exacerbate inflammation. - The safety profile of tulisokibart appeared comparable to placebo, with similar rates of adverse events, supporting its potential as a valuable new treatment option.
