Indiana University School Of Medicine
🇺🇸United States
- Country
- 🇺🇸United States
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- -
- Established
- 1903-01-01
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- Website
- http://www.medicine.iu.edu
Lilly's Olumiant Shows Promise in Preserving Beta Cell Function in Type 1 Diabetes
• Phase 2 BANDIT trial demonstrates Eli Lilly's Olumiant (baricitinib) can slow progression of type 1 diabetes by preserving insulin-producing beta cell function over 48 weeks of treatment.
• Patients receiving Olumiant required significantly less insulin therapy and experienced decreased blood glucose fluctuations compared to placebo, potentially reducing treatment burden.
• Researchers identify TYK2 inhibition as another promising approach for type 1 diabetes treatment, with an FDA-approved psoriasis drug potentially offering a dual mechanism to protect beta cells and reduce inflammation.
GLP-1 Drug Use Surges Among Type 1 Diabetes Patients Despite Safety Concerns
• GLP-1 receptor agonist use has increased dramatically among type 1 diabetes patients, with prescriptions rising from 4% to 33% in severely obese adults over the past decade.
• Obesity rates have climbed significantly in the type 1 diabetes population, increasing from 18% to 26% in children and from 30% to 38% in adults between 2008 and 2023.
• Researchers from Johns Hopkins emphasize the urgent need for clinical trial data on GLP-1 drugs in type 1 diabetes patients, as these medications are not FDA-approved for this population and may pose hypoglycemia risks.
Galectin Therapeutics' Belapectin Fails to Meet Primary Endpoint in MASH Cirrhosis Trial
• Galectin Therapeutics' NAVIGATE trial of belapectin in MASH cirrhosis patients with portal hypertension did not meet its primary endpoint of preventing varices.
• While belapectin reduced varices incidence in the intent-to-treat population, the difference was not statistically significant compared to placebo.
• In a per-protocol analysis, belapectin showed a 48.9% reduction in varices, but this fell short of the targeted 52.5%.
• The safety profile of belapectin remains encouraging, with adverse events comparable to placebo; further analysis and 36-month outcomes are pending.
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.
PDS Biotech to Highlight Phase 3 Trial of Versamune-HPV for HPV16-Positive Head and Neck Cancer
• PDS Biotech will host a Key Opinion Leader (KOL) event on December 17, 2024, to discuss HPV16-positive head and neck squamous cell carcinoma (HNSCC).
• The KOL event will focus on the upcoming VERSATILE-003 Phase 3 clinical trial of Versamune-HPV plus pembrolizumab for first-line treatment of recurrent/metastatic HPV16-positive HNSCC.
• Key experts including Dr. Francis Worden and Dr. Kevin Harrington will participate in the panel discussion, moderated by PDS Biotech's CMO, Dr. Kirk Shepard.
• The event will provide insights into the pathology, prevalence, and treatment landscape of HPV16-positive HNSCC, along with details on the VERSATILE-003 trial design.
ARPA-H Funds Multi-Institutional Consortium to Cure Blindness Through Eye Transplantation
• The University of Colorado Anschutz Medical Campus will receive up to $46 million from ARPA-H to advance vision-restoring human whole eye transplantation.
• The project aims to achieve the first successful vision recovery in six human whole eye transplants by 2030, addressing optic nerve regeneration challenges.
• The multi-disciplinary team includes experts from Johns Hopkins, University of Wisconsin, and the National Eye Institute, focusing on innovative technologies.
• The Foundation Fighting Blindness will strategically align the consortium's progress with program requirements, driving advancements in treating blinding diseases.
SonoMotion's Stone Clear Receives FDA Clearance for Post-Lithotripsy Kidney Stone Clearance
• SonoMotion's Stone Clear device received FDA de novo clearance for facilitating the passage of kidney stone fragments post-lithotripsy.
• The Stone Clear system uses ultrasound propulsion to reposition residual kidney stone fragments, aiding natural clearance.
• A clinical trial demonstrated a 70% lower risk of relapse with Stone Clear compared to observation in patients with residual fragments.
• The procedure is non-invasive, doesn't require anesthesia, and can be completed in approximately 15 minutes.
FDA Clears SonoMotion's Stone Clear Device for Post-Lithotripsy Kidney Stone Fragment Clearance
• The FDA has granted de novo clearance to SonoMotion's Stone Clear device for non-invasive clearance of residual kidney stone fragments post-lithotripsy.
• Clinical data showed ultrasonic propulsion with Stone Clear significantly reduced the risk of stone relapse compared to observation alone (HR, 0.30; 95% CI, 0.13-0.68).
• A study revealed that 63% of patients in the Stone Clear arm visually passed kidney stone fragments within 3 weeks, compared to 5% in the observation arm.
• Stone Clear offers a clinic-based, anesthesia-free option for managing kidney stones, potentially reducing complications and repeat procedures.
SonoMotion's Stone Clear Receives FDA De Novo Clearance for Post-Lithotripsy Kidney Stone Fragment Clearance
• SonoMotion's Stone Clear device has received FDA de novo clearance for non-invasive removal of kidney stone fragments post-lithotripsy.
• The device utilizes external ultrasound pulses to facilitate the movement and passage of residual kidney stone fragments.
• Clinical trials showed a 70% reduction in relapse risk with Stone Clear compared to standard observation for post-lithotripsy patients.
• Stone Clear offers a non-anesthetic, in-clinic treatment option, potentially reducing complications and repeat procedures.
Donanemab's Modified Titration Significantly Reduces ARIA-E Risk in Alzheimer's Patients
• A modified titration protocol for donanemab, involving a stepwise increase in dosage over the first four months, significantly reduced the risk of ARIA-E by 40% in clinical trials.
• The stepwise titration was particularly effective in APOE4 homozygotes, reducing their ARIA-E risk to levels comparable with heterozygotes, without compromising amyloid clearance.
• New appropriate use recommendations (AUR) for donanemab emphasize stricter MRI criteria and caution in patients with pre-existing conditions to enhance safety.
• The AUR suggest clinicians consider stopping donanemab based on a visually negative amyloid PET scan taken after 12 to 18 months of infusions.
Adipo Therapeutics Presents Promising Preclinical Data for Obesity Treatment ADPO-002NP
• Adipo Therapeutics presented data on ADPO-002NP, a potential obesity treatment, at The Obesity Society annual meeting, showing promise for human translation.
• Studies demonstrated that ADPO-002NP increases key browning markers in human fat cells and tissues, supporting its mechanism for mitochondrial biogenesis and activation.
• ADPO-002NP uniquely increases energy expenditure by browning white adipose tissue, offering a potential standalone or complementary approach to existing weight loss drugs.
• Adipo Therapeutics is seeking $8 million to advance ADPO-002NP to Phase I clinical trials, aiming to demonstrate safety and clinical proof of concept.
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.
Antibiotic Prophylaxis May Protect Kidney Function in Children with Febrile UTIs
• A new analysis of the RIVUR trial suggests that antibiotic prophylaxis may protect kidney function in children with vesicoureteral reflux during febrile urinary tract infections (UTIs).
• Children with more than one febrile UTI during the study period had a significantly lower eGFR compared to those with one or fewer UTIs, but this decline was not observed in children receiving antibiotic prophylaxis.
• The study challenges the current standard of care, suggesting that continuous antibiotic prophylaxis may have value in preserving kidney function in children with vesicoureteral reflux.
• Researchers suggest monitoring GFR in children with vesicoureteral reflux instead of relying solely on DMSA scans, and involving nephrologists early in care.
Semaglutide Associated with Reduced Alzheimer's Risk in Type 2 Diabetes Patients
• A recent study published in Alzheimer's & Dementia links semaglutide, the active ingredient in Ozempic and Wegovy, to a lower risk of Alzheimer's disease in individuals with type 2 diabetes.
• The study compared semaglutide to other diabetes drugs, revealing a significant reduction in Alzheimer's risk, particularly when compared to insulin, with a 70% lower risk observed.
• Ongoing phase 3 clinical trials by Novo Nordisk are evaluating semaglutide against placebo in patients with mild cognitive impairment or early-stage Alzheimer's, with results expected next year.
• Experts suggest that semaglutide's positive effects on inflammation, diabetes, obesity, and heart disease, all risk factors for dementia, may contribute to its potential protective effect against Alzheimer's.
Real-World Data Confirms High Effectiveness of RSV Vaccines in Older Adults
• A real-world study found RSV vaccines offer approximately 80% protection against severe illness and hospitalization for adults aged 60 and older.
• The study included data from multiple U.S. healthcare networks, representing 230 hospitals and 245 emergency departments nationwide.
• The analysis showed the vaccine's benefit was particularly evident in adults aged 75 and older, the most vulnerable age group.
• Findings highlight the potential for significant cost savings due to reduced RSV-related hospitalizations, estimated between $1.2 and $5 billion annually.
FDA-Cleared Medical Devices Face Scrutiny Over Lack of Rigorous Vetting
• A recent study reveals that many FDA-cleared heart devices, including pacemakers and stents, underwent limited clinical testing prior to approval, raising concerns about patient safety.
• The FDA's 501(k) pathway, which allows devices onto the market if they are similar to existing ones, accounts for most recalled devices, highlighting potential gaps in the regulatory process.
• Experts advocate for more rigorous clinical studies and enhanced postmarket surveillance to ensure the safety and effectiveness of medical devices, citing issues with current reporting systems.
• Patients are urged to discuss potential risks with their doctors before receiving implanted medical devices, considering the possibility of device failure and the implications of recalls.
Laura J. van 't Veer Honored with 2024 William L. McGuire Memorial Lecture Award for Breast Cancer Advancements
• Laura J. van 't Veer, PhD, will receive the William L. McGuire Memorial Lecture Award at the San Antonio Breast Cancer Symposium (SABCS) 2024 for her contributions to breast oncology.
• Van 't Veer is recognized for her work in risk stratification and treatment of early breast cancer through the development of MammaPrint.
• Her efforts in the I-SPY 2 trials led to the development of biomarkers that predict patient response to specific therapies.
• Van 't Veer's research focuses on personalized medicine, aiming to improve patient management using the genetic makeup of tumors.
Advancements in Oncology: CAR-T Therapy for Myeloma, Cologuard Plus Approval, and NSCLC Treatment
• HBI0101, a novel BCMA-directed CAR T-cell therapy, shows high efficacy and manageable safety in relapsed/refractory multiple myeloma patients, offering a promising treatment option.
• Cologuard Plus receives FDA approval as a noninvasive stool DNA test for colorectal cancer screening in adults 45 and older, demonstrating improved detection rates.
• Neoadjuvant nivolumab plus chemotherapy, followed by adjuvant nivolumab, gains FDA approval for operable stage IIA to IIIB non-small cell lung cancer, significantly improving event-free survival.
• Belantamab mafodotin-blmf combined with pomalidomide and dexamethasone shows meaningful improvements in relapsed/refractory multiple myeloma compared to bortezomib-based regimens.
FDA Approves Exact Sciences' Cologuard Plus for Colorectal Cancer Screening
• The FDA has approved Exact Sciences' Cologuard Plus, a next-generation stool DNA test, for colorectal cancer screening in adults 45 and older.
• Cologuard Plus demonstrated 95% sensitivity for detecting colorectal cancer and 43% sensitivity for advanced precancerous lesions in clinical trials.
• The test significantly outperformed the fecal immunochemical test (FIT) in detecting colorectal cancer and advanced precancerous lesions.
• Exact Sciences plans to launch Cologuard Plus in 2025, with Medicare coverage and inclusion in preventive care guidelines.
RPLND Shows Promise in Early-Stage Seminoma, Reducing Need for Chemo
• Retroperitoneal lymph node dissection (RPLND) is emerging as an effective treatment for early-stage II seminoma, potentially reducing reliance on chemotherapy.
• Studies show RPLND yields 2-year recurrence-free survival rates of 70-90% without adjuvant therapy, influencing updated AUA and NCCN guidelines.
• Most recurrences post-RPLND occur within two years, emphasizing the need for vigilant surveillance and the effectiveness of salvage chemotherapy.
• Refinements in RPLND techniques have led to fewer complications and shorter hospital stays, enhancing its viability as a primary treatment option.
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