VANDERBILT UNIVERSITY MEDICAL CENTER
🇺🇸United States
- Country
- 🇺🇸United States
- Ownership
- Private, Subsidiary
- Established
- 1925-01-01
- Employees
- 10K
- Market Cap
- -
- Website
- http://www.vumc.org
EMA Suspends Valneva's IXCHIQ Chikungunya Vaccine for Elderly Following Safety Concerns
• European Medicines Agency has suspended the use of Valneva's IXCHIQ chikungunya vaccine in people over 65 years old following reports of 17 serious adverse events, including two deaths, in elderly patients.
• The suspension is temporary while authorities review safety data, with EMA maintaining current recommendations for IXCHIQ use in people aged 12 to 64 years, affecting over 40,000 doses administered worldwide.
• Similar precautionary measures were previously implemented in the United States and France, with Valneva's Chief Medical Officer pledging full cooperation with health authorities while exploring potential updates to the product's indication.
CareDx Showcases Extensive Clinical Evidence for Transplant Monitoring Solutions at ISHLT 2025
• CareDx presented 60 abstracts including 19 oral presentations at the 2025 ISHLT meeting, demonstrating the growing clinical adoption of their transplant monitoring solutions across 92 transplant centers.
• New findings from the SHORE study revealed that HeartCare is prognostic of long-term graft outcomes independent of biopsy results and is being used by clinicians to guide immunosuppression management decisions.
• Data from the ALAMO study showed AlloSure Lung may predict development of Chronic Lung Allograft Dysfunction (CLAD) and effectively monitors acute cellular rejection and treatment response in lung transplant patients.
nference and BeiGene Partner on AI-Driven Research to Advance B-Cell Cancer Treatment
• nference and BeiGene have launched a collaboration leveraging AI technology to analyze treatment patterns for chronic lymphocytic leukemia and small lymphocytic lymphoma from real-world data.
• The retrospective study will examine over 700 patient charts using nference's proprietary Agentic AI platform to identify treatment patterns and improve clinical decision-making for B-cell malignancies.
• This partnership aims to generate comprehensive real-world evidence that could lead to more personalized and effective care options for patients with CLL, which is the most common adult leukemia in the United States.
FDA Delays Moderna's Combination Flu-COVID Vaccine Amid Increased Regulatory Scrutiny
• Moderna's combination flu-COVID vaccine faces FDA delay until 2026, as regulators now require Phase 3 flu efficacy data before approval, signaling potentially heightened scrutiny for vaccine developers.
• The regulatory setback comes amid growing concerns about anti-vaccine sentiment within government, with some states introducing legislation to restrict or ban mRNA-based vaccines despite their established safety profile.
• If eventually approved, Moderna's mRNA-1083 would be the first vaccine in the US to offer protection against both flu and COVID-19 in a single shot, potentially improving vaccination rates through increased convenience.
Novel Drug Lorundrostat Shows Significant Promise for Uncontrolled Hypertension in Phase 2b Trial
• Cleveland Clinic-led clinical trial demonstrates lorundrostat, an aldosterone synthase inhibitor, reduced systolic blood pressure by 8 points more than placebo in patients with uncontrolled hypertension.
• The 12-week Advance-HTN trial included 285 participants with 53% being Black Americans, a population that carries disproportionately high risk for hypertension complications.
• Lorundrostat represents a new class of blood pressure medications that directly reduces aldosterone production, potentially offering treatment options for the 30-40% of patients whose hypertension remains uncontrolled with current therapies.
Clinical Trial Diversity Crisis: Dr. Karen Winkfield Outlines Solutions for Inclusive Patient Participation
• Clinical trial participation faces major barriers, with trial unavailability and lack of physician referrals identified as primary obstacles to patient enrollment in research studies.
• Vanderbilt's NCI-designated cancer center is implementing AI-driven screening systems to match eligible patients with clinical trials, addressing the challenge of comprehensive patient screening.
• The Meharry-Vanderbilt Alliance, partnering with a historically Black medical institution, focuses on building community trust and expanding trial access through education and local support networks.
Breakthrough Bone Marrow Transplant Shows 88% Cure Rate for Sickle Cell Disease
• A novel reduced-intensity haploidentical bone marrow transplant procedure developed at Johns Hopkins demonstrates a 95% two-year survival rate and 88% cure rate for sickle cell disease patients.
• The treatment accepts half-matched donors and costs significantly less than gene therapy at $467,747 versus $2-3 million, while requiring shorter hospital stays and fewer blood transfusions.
• Clinical trial results from 42 patients show the procedure is safe and effective, with minimal serious side effects, making it a viable alternative to recently approved gene therapy treatments.
Ataciguat Shows Promise in Slowing Aortic Valve Stenosis Progression, Mayo Clinic Study Reveals
• A groundbreaking study at Mayo Clinic demonstrates that ataciguat reduced aortic valve calcification progression by 69.8% over six months compared to placebo in patients with moderate aortic valve stenosis.
• The novel drug shows potential to delay or prevent valve replacement surgery, particularly benefiting younger patients who might otherwise need multiple surgeries throughout their lifetime.
• Clinical trials confirm ataciguat's safety profile with minimal side effects, maintaining bone health while effectively slowing valve calcification, paving the way for upcoming Phase 3 trials.
Fotivda-Opdivo Combination Shows Comparable Quality of Life Outcomes to Fotivda Alone in Advanced Kidney Cancer
• Phase 3 TiNivo-2 study demonstrates that combining Fotivda (tivozanib) with Opdivo (nivolumab) maintains similar patient-reported outcomes compared to Fotivda monotherapy in advanced renal cell carcinoma patients.
• Approximately 75% of patients in both treatment arms reported improved or stable kidney cancer symptoms, with consistent quality of life scores maintained throughout the study period.
• Safety profile analysis reveals lower rates of certain side effects in the combination therapy group, potentially due to lower dosing requirements, while maintaining established efficacy parameters.
Evolution of CRS and ICANS Management in CAR T-Cell Therapy: New Consensus Guidelines Transform Treatment Approach
• Recent ASTCT consensus criteria have standardized the diagnosis and management of cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS), replacing multiple previous grading systems.
• Studies reveal 4-1BB-based CAR T-cell therapies demonstrate lower toxicity rates compared to CD28-based products across various hematologic malignancies, while maintaining therapeutic efficacy.
• Research has disproven the assumption that toxicity correlates with treatment effectiveness, enabling more proactive management strategies without compromising patient outcomes.
UCSF Performs World's First OnQ Prostate-Assisted Robotic HIFU Procedure
• Cortechs.ai and EDAP TMS SA achieved a milestone with the first-ever OnQ Prostate-assisted Focal One Robotic HIFU procedure performed at UCSF Prostate Center.
• UCLA researchers found that early radiation therapy side effects in prostate cancer patients may indicate higher risks of serious long-term urinary and bowel complications.
• Vanderbilt researchers discovered that the inherited mutated WNT9B gene, crucial in embryonic prostate development, increases adult prostate cancer risk.
Novel Therapies Show Promise in Reshaping Frontline Metastatic RCC Treatment Landscape
• Current immunotherapy and TKI combinations have significantly improved survival in metastatic RCC over the past decade, though treatment advances have reached a plateau.
• The phase 3 LITESPARK-012 trial is investigating belzutifan, a HIF-2α inhibitor, in combination with pembrolizumab and lenvatinib as a novel frontline treatment approach.
• Emerging cellular therapies, including CAR T-cell treatments, show potential for earlier use in RCC treatment, particularly given patient willingness to pursue curative options.
World Cancer Day Highlights Critical Need to Address Oncology Care Disparities
• Financial hardship affects 50-70% of cancer patients in community settings, leading to treatment adherence issues and worse outcomes, particularly among underserved populations.
• Social determinants of health contribute to a 20% higher cancer mortality rate in underserved populations, with factors like food, housing, and transportation insecurity creating significant barriers to care.
• Miami Cancer Institute implements innovative solutions including bilingual patient navigation, community partnerships, and expanded clinical trial access to bridge the cancer care gap for underrepresented populations.
Alzheimer's Drugs Leqembi and Kisunla Face Scrutiny Over Safety and Efficacy
• Leqembi and Kisunla, new Alzheimer's drugs, are under scrutiny for potential risks, including brain hemorrhages and swelling, with some experts questioning their overall safety.
• Clinical trial data reveals modest cognitive benefits, with concerns raised about whether these benefits are clinically meaningful and outweigh the serious adverse events observed.
• The FDA's approval process and the influence of pharmaceutical funding on patient advocacy groups are being questioned, particularly regarding the accelerated approval pathway.
• Neuropathologists suggest that the drugs' mechanism of action, which involves removing amyloid from brain blood vessels, may lead to toxic effects, including potentially lethal brain damage.
Pfizer's Braftovi Combo Shows Survival Benefit in BRAF-Mutated Metastatic Colorectal Cancer
• Pfizer's Braftovi, combined with cetuximab and mFOLFOX6, significantly improved progression-free survival in metastatic colorectal cancer patients with BRAF V600E mutation.
• The BREAKWATER trial demonstrated a clinically meaningful improvement in overall survival with the Braftovi regimen compared to chemotherapy.
• The FDA granted accelerated approval to the Braftovi combination in December 2024, marking it as a first-line targeted therapy option.
• Pfizer plans to share the BREAKWATER data with regulatory authorities to support full approval and broader use of the Braftovi combination.
Alterity's ATH434 Shows Promise in Phase 2 Trial for Multiple System Atrophy
• Alterity Therapeutics' ATH434 demonstrated a statistically significant 48% slowing of clinical progression in early-stage MSA patients at the 50 mg dose.
• MRI biomarkers indicated that ATH434 reduced iron accumulation in key brain regions affected by MSA, suggesting a potential disease-modifying effect.
• The Phase 2 trial showed a favorable safety profile for ATH434, with most adverse events being mild to moderate and no treatment-related serious adverse events reported.
• Alterity plans to engage with the FDA to discuss accelerating the development of ATH434, addressing the unmet need for MSA treatments.
P-BCMA-ALLO1 Demonstrates Promising Efficacy and Safety in Relapsed/Refractory Multiple Myeloma
• P-BCMA-ALLO1, an allogeneic CAR-T therapy, shows an 88% overall response rate in relapsed/refractory multiple myeloma patients in a phase 1/1b trial.
• The therapy demonstrates a 100% ORR in BCMA-naive patients and a 75% ORR in those previously treated with BCMA-targeted therapies.
• No grade 3 or higher cytokine release syndrome or neurotoxicity was observed, indicating a favorable safety profile for P-BCMA-ALLO1.
• P-BCMA-ALLO1 offers a readily available, off-the-shelf treatment option, eliminating the wait time associated with autologous CAR-T therapies.
Ifetroban Shows Promise in Improving Heart Function for DMD Patients in Phase 2 Trial
• Ifetroban, an oral thromboxane receptor antagonist, significantly improved left ventricular ejection fraction (LVEF) in Duchenne muscular dystrophy (DMD) patients.
• The FIGHT DMD trial demonstrated a 3.3% improvement in LVEF with high-dose ifetroban, contrasting with a decline in the placebo group.
• Compared to natural history controls, high-dose ifetroban showed a 5.4% overall LVEF improvement, suggesting a potential disease-modifying effect.
• Ifetroban has received Orphan Drug and Rare Pediatric Disease designations, potentially becoming the first targeted therapy for DMD-related heart disease.
Liso-cel Demonstrates Significant Response in Relapsed/Refractory Marginal Zone Lymphoma
• Bristol Myers Squibb's liso-cel achieved a statistically significant and clinically meaningful overall response rate in patients with relapsed or refractory marginal zone lymphoma.
• The Phase 2 trial results highlight the potential of liso-cel as an effective treatment option for this challenging patient population.
• The data were presented at the 2025 Tandem Meetings, showcasing advancements in cell therapy for hematological malignancies.
Nivolumab Plus Ipilimumab Shows Durable Survival Benefit in Advanced RCC
• Eight-year data from CheckMate 214 show nivolumab plus ipilimumab demonstrates long-term efficacy in intermediate- and poor-risk advanced renal cell carcinoma (RCC).
• In favorable-risk patients, nivolumab plus ipilimumab shows a hazard ratio of 0.82, surpassing historical IO-TKI trial results, suggesting its viability in this group.
• IO-TKI combinations are beneficial for patients needing rapid response due to high disease burden, while IO-IO combinations offer potential for long-term disease control.
• Ongoing trials are exploring novel targets like HIF2α inhibitors to overcome resistance to immune checkpoint inhibition in RCC management.
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