UNIVERSITY OF SOUTH FLORIDA
🇺🇸United States
- Country
- 🇺🇸United States
- Ownership
- Private
- Established
- 1956-01-01
- Employees
- 10K
- Market Cap
- -
- Website
- http://www.usf.edu
New Transcatheter Tricuspid Valve Treatments Offer Hope for High-Risk Cardiac Patients
• Innovative catheter-based treatments for tricuspid regurgitation are providing new options for patients deemed too high-risk for traditional open-heart surgery, with procedures allowing discharge within 2-3 days.
• The Evoque Tricuspid Valve Replacement System, FDA-approved in 2024, is being implemented at Sarasota Memorial Hospital, while Tampa General Hospital completed Florida's first TricValve procedure under an FDA Early Feasibility Study.
• Approximately 1.6 million Americans suffer from tricuspid regurgitation, which can lead to heart failure and other life-threatening complications if left untreated with limited options previously available.
Expert Panel Updates Multiple Myeloma Maintenance Therapy Guidelines: Focus on Daratumumab and MRD Monitoring
• Leading multiple myeloma experts discuss evolving maintenance therapy strategies, with daratumumab plus lenalidomide emerging as a potential new standard of care for post-transplant maintenance.
• The PERSEUS trial demonstrates superior MRD negativity rates with D-VRd compared to VRd, showing 63.9% vs 30.8% negativity at 10^-5 threshold up to 36 months.
• Experts emphasize personalized approaches to bone-modifying therapy, with considerations for zoledronic acid, denosumab, and pamidronic acid based on patient characteristics and risk factors.
Fedratinib Shows Efficacy in Rare Myeloid Neoplasms: Phase 2 Trial Results
• Fedratinib demonstrated promising efficacy in a phase 2 trial for patients with atypical chronic myeloid leukemia (aCML), chronic neutrophilic leukemia (CNL), and certain myelodysplastic/myeloproliferative neoplasms (MDS/MPN).
• The study reported an overall response rate of 53% at 24 weeks in evaluable patients, including both symptom and spleen responses, with a manageable safety profile.
• Responses were notably enriched in patients with CSF3R and JAK-STAT pathway mutations, suggesting potential biomarkers for predicting treatment success.
• The findings support the potential use of fedratinib in these rare conditions, where limited standard-of-care options exist, and further studies are warranted.
FDA Sets PDUFA Date for Lower-Dose Neffy Nasal Spray in Young Pediatric Patients with Anaphylaxis
• The FDA has set a PDUFA target action date of March 6, 2025, for ARS Pharmaceuticals' sNDA for a 1 mg dose of Neffy (epinephrine nasal spray).
• This lower dose is intended for pediatric patients weighing 33 to 66 lbs (15 to 30 kg), expanding treatment options for this vulnerable population.
• Neffy was initially approved in August 2024 for anaphylaxis in adults and children over 66 lbs, offering a needle-free alternative to epinephrine injections.
• Pending approval, Neffy 1 mg could be available in the second quarter of 2025, providing a more accessible and less intimidating treatment option for young children.
North American Hospitals Spearhead Clinical Trials for Trigeminal Neuralgia
• Leading hospitals across North America are actively engaged in clinical trials to find effective treatments for trigeminal neuralgia, a condition causing severe facial pain.
• Institutions like the University of Minnesota, Toronto Western Hospital, UCSF Medical Center, Kaizen Brain Center, and the University of South Florida are conducting these trials.
• These trials aim to improve patients' quality of life by exploring innovative approaches to managing this challenging neurological disorder.
• Many of these institutions initiated their first investigations into trigeminal neuralgia in 2022, marking a significant push for new treatment strategies.
Experts Highlight Advances in Lung Cancer Treatment: Immunotherapy, ADCs, and Equity in Care
• Leading oncologists at the Chicago IVBM event discussed the transformation of lung cancer treatment, emphasizing the evolution of immunotherapy from second-line to first-line and early-stage treatments.
• Experts addressed emerging technologies including antibody-drug conjugates like trastuzumab deruxtecan, highlighting significant progression-free survival benefits in second-line settings.
• The panel identified critical challenges in healthcare equity, calling for standardized molecular testing protocols and enhanced collaboration between academic centers and community providers.
Opus Genetics to Present 6-Month Data on OPGx-LCA5 Gene Therapy for LCA5-Associated Inherited Retinal Disease
• Opus Genetics will share detailed 6-month efficacy and safety data on OPGx-LCA5, a gene therapy for LCA5-associated inherited retinal disease, at a virtual KOL event.
• OPGx-LCA5 uses an AAV8 vector to deliver a functional LCA5 gene to the outer retina, potentially addressing the unmet need in this early-onset severe retinal dystrophy.
• The Phase 1/2 clinical trial at the University of Pennsylvania is evaluating the safety and preliminary efficacy of OPGx-LCA5 in patients with LCA5 gene mutations.
• Key opinion leaders will discuss the potential of Opus Genetics’ therapeutic approach and the next steps in the development program for OPGx-LCA5.
SimX Awarded $1.25M AFWERX Grant to Enhance VR Medical Training for Expeditionary Support
• SimX received a $1.25 million Phase II STTR grant from AFWERX to advance its Virtual Reality Medical Simulation System (VRMSS) for expeditionary medical support training.
• The VR training aims to address critical challenges faced by the Department of the Air Force, focusing on perioperative surgical team preparedness in remote and challenging environments.
• SimX collaborates with USF Health CAMLS, integrating VR technology with traditional teaching methods to provide accessible and effective training for healthcare professionals.
• The initiative seeks to elevate healthcare training standards, particularly for military personnel, by offering immersive, personalized instruction and expert mentorship feedback.
Precision Medicine in Prostate Cancer Faces Implementation Challenges Despite Progress
• Current real-world treatment patterns in metastatic prostate cancer, particularly prior ARPI use, create challenges in translating clinical trial data to practice.
• PARP inhibitors like olaparib and rucaparib show promise in mCRPC treatment, but their effectiveness is limited to specific genetic mutations, highlighting access disparities.
• Experts emphasize the critical need to identify additional biomarkers and therapeutic targets to expand precision medicine options for a more diverse patient population.
FDA Accepts Dupilumab sBLA for Chronic Spontaneous Urticaria Treatment
• The FDA has accepted the sBLA for dupilumab for treating chronic spontaneous urticaria (CSU) in patients 12 years and older inadequately controlled by H1 antihistamines.
• The sBLA includes data from the LIBERTY-CUPID phase 3 trial program, demonstrating significant reductions in itch and hive activity with dupilumab compared to placebo.
• Dupilumab met both primary and key secondary endpoints in study C, showing improvements in itch severity, disease control, and complete response rates.
• The target action date for the FDA decision is set for April 18, 2025.
FDA Accepts Resubmission of Dupixent Application for Chronic Spontaneous Urticaria
• The FDA has accepted the resubmitted sBLA for Dupixent (dupilumab) for chronic spontaneous urticaria (CSU) treatment in patients aged 12 years and older.
• The resubmission includes data from the LIBERTY-CUPID Phase III clinical trial program, specifically Study C, evaluating Dupixent with standard antihistamines.
• Study C results showed Dupixent significantly reduced itch severity and urticaria activity compared to placebo in patients uncontrolled on antihistamines.
• The FDA's target action date for the decision on Dupixent for CSU is set for April 18, 2025.
FDA Sets April 2025 Target Date for Dupixent sBLA in Chronic Spontaneous Urticaria
• The FDA has accepted the resubmission of the sBLA for Dupixent (dupilumab) for treating adults and children aged 12 and older with chronic spontaneous urticaria (CSU).
• The target action date for the FDA decision regarding Dupixent's application for CSU is set for April 18, 2025.
• The resubmitted sBLA is supported by data from the Phase 3 LIBERTY-CUPID clinical program, demonstrating Dupixent's efficacy in reducing itch and hives in CSU patients.
• Study C within the LIBERTY-CUPID program showed that 41% of patients on Dupixent achieved well-controlled disease status, with 30% experiencing complete response at 24 weeks.
Telehealth CBT Reduces Suicide Attempts and Suicidal Ideation in Clinical Trial
• A randomized clinical trial found that brief cognitive behavioral therapy (CBT) delivered via telehealth effectively reduces suicide attempts and suicidal ideation.
• The study compared brief CBT to present-centered therapy, demonstrating CBT's superiority in reducing suicide attempts among adults with recent suicidal thoughts or behaviors.
• Researchers emphasize that telehealth CBT can increase access to evidence-based treatments, especially for individuals in rural or underserved areas.
• The findings support the use of virtual mental health care to safely and effectively treat high-risk suicidal patients, expanding care options post-COVID-19 pandemic.
Senhwa Biosciences Initiates Trial of Silmitasertib for Rare Pediatric Cancers
• Senhwa Biosciences has begun a Phase 1/2 clinical trial of silmitasertib for children and young adults with relapsed or refractory rare cancers.
• The trial will evaluate silmitasertib, a first-in-class casein kinase 2 (CK2) inhibitor, in patients with neuroblastoma, Ewing's sarcoma, osteosarcoma, rhabdomyosarcoma, and liposarcoma.
• Silmitasertib has demonstrated anticancer activity in preclinical studies and is being investigated for its potential to enhance the effects of chemotherapy drugs.
• Beyond cancer, silmitasertib is also being explored as a treatment for severe COVID-19, targeting the excessive cytokine storm immune response.
Senhwa Biosciences' Silmitasertib Enters Phase I/II Trial for Pediatric Solid Tumors
• Senhwa Biosciences initiates a Phase I/II clinical trial of Silmitasertib in combination with chemotherapy for children and young adults with relapsed or refractory solid tumors.
• The trial aims to establish a safe and effective dose of Silmitasertib alongside chemotherapy, focusing on cancers like neuroblastoma, Ewing's sarcoma, osteosarcoma, rhabdomyosarcoma, and liposarcoma.
• The study, involving up to 114 participants across the U.S., will evaluate treatment activity based on individual responses and disease control duration to develop novel therapeutic approaches.
• This research is a collaborative effort with Penn State College of Medicine and the Beat Childhood Cancer Research Consortium, supported by funding from the Beat Childhood Cancer Foundation and the Little Warrior Foundation.
Trump Administration Reshapes Health Agencies; FDA Approves Novel Cancer Therapies
• President-elect Trump nominates Robert F. Kennedy Jr. as HHS Secretary, Mehmet Oz to lead CMS, and Marty Makary to head the FDA, signaling a shift in healthcare priorities.
• The FDA grants accelerated approval to asciminib for chronic myeloid leukemia and obecabtagene autoleucel for B-cell acute lymphoblastic leukemia, marking advancements in cancer treatment.
• Revumenib receives approval for relapsed or refractory acute leukemia with KMT2A translocation, offering a targeted therapy for this specific genetic alteration.
• A new Surgeon General's report highlights disparities in tobacco use, emphasizing the need for tailored interventions in vulnerable populations.
Multidisciplinary Teams Transform Stage 3A Lung Cancer Care with Precision Medicine Approach
• Moffitt Cancer Center experts demonstrate how integrated teams combining nurse navigators, oncologists, pathologists, and pharmacists are revolutionizing Stage 3A lung cancer treatment through coordinated care delivery.
• Advanced genetic testing and NGS sequencing are enabling more precise treatment selection, with targeted therapies like alectinib for ALK-positive patients showing promising outcomes in clinical trials.
• The comprehensive care model addresses both clinical and practical challenges, including financial barriers, treatment access, and patient education, while incorporating the latest advances in immunotherapy and targeted treatments.
Dupilumab Shows Efficacy in Chronic Spontaneous Urticaria
• Dupilumab significantly reduced itch severity in chronic spontaneous urticaria (CSU) patients uncontrolled by H1-antihistamines, with an 8.64-point reduction versus 6.10 for placebo.
• Urticaria activity also saw a significant reduction with dupilumab, showing a 15.86-point decrease compared to an 11.21-point reduction with placebo.
• Almost twice as many patients on dupilumab achieved well-controlled urticaria (UAS7 score ≤6) compared to placebo at week 24, indicating a potential for higher remission rates.
• The LIBERTY-CUPID study C results support regulatory resubmission in the U.S. for dupilumab as a targeted therapy for CSU.
Dupixent Shows Positive Phase 3 Results for Chronic Spontaneous Urticaria
• Dupixent significantly reduced itch and urticaria activity in patients with uncontrolled chronic spontaneous urticaria (CSU) in the Phase 3 LIBERTY-CUPID Study C.
• The study demonstrated that a higher proportion of patients treated with Dupixent achieved well-controlled disease status compared to those receiving a placebo.
• Safety results were consistent with Dupixent's known profile, reinforcing its potential to alleviate symptoms and improve disease control in CSU patients.
• Dupixent, a monoclonal antibody, targets IL-4 and IL-13 pathways, offering a novel approach for CSU treatment, especially for those inadequately controlled by antihistamines.
Dupixent Shows Positive Phase 3 Results in Chronic Spontaneous Urticaria
• Phase 3 LIBERTY-CUPID Study C demonstrates Dupixent significantly reduces itch and urticaria activity in biologic-naive patients with uncontrolled chronic spontaneous urticaria (CSU).
• At 24 weeks, Dupixent showed significant improvements in itch severity, urticaria activity score, well-controlled disease status, and complete response compared to placebo.
• The safety profile of Dupixent in Study C was consistent with its known safety profile in approved dermatological indications, with similar rates of adverse events.
• Dupixent is approved for CSU in Japan and the UAE and is under regulatory review in the EU, offering a potential new treatment option for patients inadequately controlled by antihistamines.
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