UNIVERSITY OF TEXAS SOUTHWESTERN MEDICAL CENTER
🇺🇸United States
- Country
- 🇺🇸United States
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- Established
- 1943-01-01
- Employees
- 8.1K
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Actinium Enrolls First Patient in Groundbreaking Iomab-ACT CAR-T Conditioning Trial
• Actinium Pharmaceuticals has enrolled the first patient in a pioneering trial evaluating Iomab-ACT as a targeted radiotherapy conditioning agent with commercial CAR-T therapy, with initial data expected in late 2025.
• Iomab-ACT targets CD45 on immune cells and has shown promise in reducing serious CAR-T toxicities including ICANS and CRS, potentially addressing major barriers to CAR-T therapy access and efficacy.
• The therapy could significantly expand the $4 billion CAR-T market by replacing conventional chemotherapy conditioning regimens, potentially benefiting approximately 150,000 patients diagnosed annually with eligible conditions.
American Heart Association Awards $1M to Study GLP-1 Medications' Impact on Cardiovascular Risk
• The American Heart Association has funded seven research projects with $1 million to identify which patients with obesity and cardiovascular disease benefit most from GLP-1/GIP medications.
• Research teams from seven prestigious institutions will investigate biological, clinical, and social factors influencing treatment response, using the AHA's Precision Medicine Platform for data analysis.
• Studies will examine how GLP-1/GIP medications affect cardiovascular outcomes across different populations, with aims to develop more personalized treatment approaches and address health disparities.
Immunovia's Next-Generation Pancreatic Cancer Test Shows 77% Detection Rate in Early-Stage Disease
• Immunovia's VERIFI study demonstrated 77% detection accuracy for stage I and II pancreatic cancer in high-risk patients, marking the second successful clinical validation of their blood-based diagnostic test.
• The company plans to launch the next-generation test in Q3 2025, with additional clinical studies planned to support regulatory submissions and secure insurance reimbursement.
• Early detection remains critical for pancreatic cancer, which has only a 13% five-year survival rate, with an estimated 1.8 million high-risk individuals in the USA who could benefit from annual surveillance testing.
Cagent Vascular Launches 500-Patient Registry to Evaluate Serranator® Balloon Technology for PAD Treatment
• Cagent Vascular initiates POINT FORCE Registry, a multicenter study across 30 U.S. centers to evaluate their Serranator® PTA Serration Balloon Catheter in treating peripheral artery disease.
• The prospective registry will assess device safety and efficacy in real-world clinical settings, with Yale Cardiovascular Research Group serving as the core laboratory for analysis.
• First patient enrollment completed at UT Southwestern Medical Center, with the study targeting various vessel territories including iliac, fem-pop, and infra-malleolar regions.
ADCs Reshape NSCLC Treatment Landscape: Key Trials Show Promise and Challenges
Recent clinical trials demonstrate the evolving role of antibody-drug conjugates (ADCs) in non-small cell lung cancer treatment. Notable results from TROPION-Lung01 trial showed modest PFS improvement with datopotamab deruxtecan compared to docetaxel, while studies like HERTHENA-Lung01 and DESTINY-Lung02 explore targeted approaches for specific mutations.
Intensive Blood Pressure Control Shows Long-Term Cognitive Benefits in Landmark SPRINT Trial
• Intensive blood pressure management for 3.3 years significantly reduces the risk of mild cognitive impairment and dementia in adults with hypertension.
• The SPRINT trial's follow-up study reveals that cognitive benefits persist for up to seven years, even after the intensive treatment is discontinued.
• Maintaining a systolic blood pressure target of 120 mmHg shows a 13% reduction in mild cognitive impairment compared to the standard target of 140 mmHg.
• Findings emphasize intensive blood pressure control as a crucial strategy for preventing cognitive decline and promoting healthy aging.
FDA Approves Monthly IV Maintenance Dosing for Leqembi, Eases Treatment Burden for Alzheimer's Patients
• The FDA has approved a monthly intravenous (IV) maintenance dose for Leqembi, offering a more convenient treatment schedule for early Alzheimer's disease.
• Patients completing the initial 18-month biweekly IV treatment can transition to monthly dosing, potentially improving long-term adherence and quality of life.
• Approval is based on data modeling showing sustained clinical and biomarker benefits with monthly dosing, addressing the continuous neurotoxic processes of Alzheimer's.
• Leqembi, developed by Eisai and Biogen, is now approved in multiple countries, offering a significant advancement in managing early Alzheimer's disease.
Advances and Challenges in Hepatocellular Carcinoma (HCC) Treatment Highlighted in Recent Studies
• Screening for HCC in patients with risk factors is associated with reduced mortality, emphasizing the importance of early detection.
• Immunotherapies and combination regimens are improving outcomes, progression-free survival, and overall survival for HCC patients.
• Adding durvalumab and bevacizumab to TACE significantly improves progression-free survival in patients with unresectable HCC.
• A small study found that adding PD-1 inhibitors to TACE plus lenvatinib did not improve progression-free survival in unresectable HCC.
Vagus Nerve Stimulation Shows Promise for Treatment-Resistant Depression
• A large-scale clinical trial reveals that vagus nerve stimulation (VNS) can significantly improve depressive symptoms, quality of life, and daily functioning in individuals with severe, treatment-resistant depression.
• The study, involving nearly 500 participants, showed that VNS therapy led to measurable improvements, even in patients who had previously failed multiple treatments.
• VNS delivers focused stimulation to mood-regulating brain regions and can be used alongside other treatments, offering sustained relief for those who do not fully respond to antidepressants or therapy.
• The RECOVER trial aims to provide data that could lead to health insurance coverage for VNS, making it more accessible for patients with treatment-resistant depression.
Adalimumab Biosimilars Drive 45% Drop in Net Spending Despite Limited Market Share
• Analysis reveals adalimumab biosimilar competition led to a 45% reduction in net spending during Q4 2023 compared to Q4 2022, despite biosimilars capturing only 1.35% of prescriptions.
• AbbVie's Humira maintained market dominance through increased rebates and discounts to insurers, while simultaneously raising list prices by 8% in early 2023.
• CVS Health's recent decision to prefer biosimilars over Humira in commercial formularies signals potential shift in market dynamics for adalimumab products.
4-Phenylbutyrate Shows Promise in Treating Genetic Epilepsy in Children
• Early clinical trial results indicate that 4-phenylbutyrate (PBA) significantly reduces seizure activity in children with genetic epilepsies affecting GABA.
• Some children in the trial, who had previously failed multiple anti-seizure medications, experienced complete seizure freedom with PBA treatment.
• The research, supported by patient advocacy groups, highlights the potential of PBA in treating epilepsies resulting from SLC6A1 and GABA-A receptor mutations.
• Further studies are underway to explore additional strategies for enhancing GABA signaling and restoring normal gene function in these epilepsies.
Clearside Biomedical Highlights Suprachoroidal Delivery Technology at Global Medical Meetings
• Clearside Biomedical presented its suprachoroidal delivery technology and pipeline program data at medical meetings across Asia, Europe, and the United States.
• ODYSSEY trial topline results for CLS-AX in wet AMD were presented at the Ophthalmology Innovation Summit and the Asia-Pacific Vitreo-Retina Society (APVRS) Congress.
• Clearside hosted suprachoroidal injection procedure demonstrations at APVRS, showcasing the SCS Microinjector® technology and novel delivery approach.
• Arctic Vision is advancing XIPERE towards potential approval in China, Australia, and Singapore, increasing interest in Clearside's delivery approach.
Perioperative IO/TKI Combo Shows Promise in Renal Cell Carcinoma
• Perioperative treatment with a tyrosine kinase inhibitor (TKI) following immuno-oncology (IO) showed improved tumor outcomes in renal cell carcinoma (RCC).
• An updated analysis of the CheckMate 214 trial demonstrated a sustained survival advantage with nivolumab/ipilimumab combination versus sunitinib in advanced RCC.
• Selective metastasectomy in metastatic RCC showed potential for slowing disease progression and extending overall survival in selected patients.
Real-World Mesothelioma Outcomes Mirror CheckMate 743 Trial Results
• A multicenter study assessed the real-world outcomes of ipilimumab and nivolumab in mesothelioma patients, comparing them to the CheckMate 743 clinical trial.
• The real-world analysis showed no significant difference in progression-free survival between frontline and post-progression treatment with the ipilimumab and nivolumab combination.
• Median overall survival in the real-world setting was similar to that reported in the CheckMate 743 study, validating the trial's findings.
• Researchers plan to expand the study with a larger sample size and a chemotherapy-only control arm to further refine treatment strategies.
FDA Advisory Committee Backs Elamipretide for Barth Syndrome Despite Data Concerns
• The FDA's Cardiovascular and Renal Drugs Advisory Committee voted 10-6 in favor of elamipretide for treating Barth syndrome, a rare genetic disorder.
• The decision was made despite concerns about the strength and design of the clinical trial data presented by Stealth BioTherapeutics.
• If approved, elamipretide would be the first FDA-approved therapy for Barth syndrome, addressing a significant unmet medical need.
• The FDA's final decision on elamipretide is expected by January 29, 2025, and will consider the advisory committee's recommendation.
Rivus Pharmaceuticals' HU6 Shows Muscle-Sparing Weight Loss in HFpEF Trial
• Rivus Pharmaceuticals' HU6 demonstrated statistically significant reductions in fat mass and visceral fat in obese patients with heart failure with preserved ejection fraction (HFpEF).
• The Phase IIa HuMAIN trial showed that HU6 preserved lean body mass, a crucial benefit for HFpEF patients where muscle loss is linked to increased mortality.
• HU6 also showed promise in improving systolic and diastolic blood pressure and markers of cardiovascular disease, according to trial data presented at HFSA 2024.
• Rivus plans to engage with health authorities in 2025 to discuss a Phase 3 study of HU6 in obesity-related HFpEF, aiming to address the unmet need for targeted therapies.
Beyond LDL: Novel Cholesterol Targets and Therapies Show Promise in Reducing Cardiovascular Risk
• Researchers are exploring treatments for lipoprotein(a), a genetically influenced cholesterol type unaffected by statins, with therapies showing potential in early trials.
• HDL cholesterol research shifts focus from simply raising levels to improving functionality, exemplified by CSL112, though recent trials showed it did not meet its primary endpoint.
• Triglyceride-lowering strategies face scrutiny as studies yield conflicting results, suggesting triglycerides may be indicators rather than direct causes of cardiovascular issues.
• Emerging focus on remnant cholesterol highlights its potential role in atherosclerosis, prompting investigation into novel treatments to clear these particles from the bloodstream.
Tenaya Therapeutics' Gene Therapy TN-201 Shows Promise with Projected $165M Revenue for Cardiomyopathy Treatment
• Tenaya Therapeutics' lead candidate TN-201, an AAV9-based gene therapy targeting MYBPC3, is being developed for treating hypertrophic cardiomyopathy with projected annual revenues of $165 million by 2038.
• The novel gene therapy utilizes adeno-associated virus serotype 9 vectors for intravenous delivery of the cardiac myosin-binding protein-C gene, representing a potential breakthrough in cardiac disease treatment.
• Despite operating losses of $131.2 million in FY2023, Tenaya continues advancing its diverse cardiovascular pipeline, including treatments for various forms of cardiomyopathy and heart failure.
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