Kyverna Therapeutics’ Post

💊Polypharmacy in T2D on the Rise! 📈 Managing comorbidities and curbing CVD is vital, but so is being aware of the risks. 🚨 Drug interactions, adverse effects, and the challenges of over/underprescribing are crucial to address. Stay informed and stay safe! 💊✨ #Healthcare #Diabetes #T2D #Polypharmacy #CVD #MedicalAwareness

🧠 SetPoint Medical reports positive results from neuroimmune modulation device study SetPoint System is a neuroimmune modulation device that showed a clinical benefit in adults living with moderate-to-severe rheumatoid arthritis (RA). RESET-RA is a two-staged, multicentre, randomised, sham-controlled, double-blind clinical trial that enrolled a total of 242 patients across 41 sites in the US. The study evaluated the system as a potential neuroimmune modulation treatment for RA patients who are intolerant to disease-modifying anti-rheumatic drugs (DMARDs). Read more online: https://lnkd.in/eErbvxEM 📰 Follow Medical Device Developments to receive the latest medical device news daily and to subscribe to our weekly newsletter #MedicalDeviceDevelopments #medicaldevices #medicalmanufacturing

The FDA has issued a revised draft guidance - "Early Alzheimer’s Disease: Developing Drugs for Treatment Guidance for Industry." “FDA is committed to reducing the burden of Alzheimer’s disease,” said Teresa Buracchio, MD, Director of CDER’s Office of Neuroscience. “This guidance document provides the agency’s current thinking about diagnostic criteria and clinical staging and the selection of appropriate outcome measures, including the use of surrogate endpoints, for the early stages of Alzheimer’s Disease.” (more here: https://lnkd.in/gGm6mijy) Antoine Leuzy Lars Lau Raket Gregory Klein Viswanath Devanarayan Maria Carrillo Heather M. Snyder Rebecca Edelmayer Christopher Weber Hartmuth Kolb #alzheimersdisease #drugdevelopment #drugdiscovery #clinicalresearch #clinicaltrials #biomarkers #staging #neurodegenerativediseases https://lnkd.in/gW2FpucX

Are you a myositis patient with ILD? Have you wanted to participate in a clinical trial from the comfort of your own home? The MINT clinical trial is for patients with ILD (pulmonary fibrosis) associated with myositis. The goal of this study is to gain a better understanding of how anti-fibrotic drugs can help treat myositis associated with ILD. The study will focus on the drug Nintedanib (brand name Ofev), an oral anti-fibrotic medication approved by the Food and Drug Administration (FDA) for the treatment of various types of ILD This clinical trial is unique as you can participate from the comfort of your own home. There is no need, or worry, about traveling long distances or spending time away from your surroundings. To inquire and find out if you're eligible, please contact Dr. Rohit Aggarwal, medical director of Arthritis and Autoimmunity Center at University of Pittsburgh Medical Center To inquire please email; MINTcc@pitt.edu or call #412-648-4005 #ClinicalTrial #MINTStudy #ILD #Myositis #InterstitialLungDisease #LungDisease #MyositisStudy #ILDStudy #MINTtrial #MyositisPatients

Happy to share the results of this interesting paper just published by Mumoli et al on the application of Group for Venous Access Devices (GAVeCeLT) bundle in Internal Medicine Units. This strategy seems to minimize the risk of bleeding complications after urgent internal jugular central venous catheter implantation even in patients on antithrombotic drugs. Full paper is available at https://lnkd.in/d-PRhKxX #vascularaccess #bleeding #anticoagulation

❗Are you a myositis patient with ILD? Have you wanted to participate in a clinical trial from the comfort of your own home? The MINT clinical trial is for patients with ILD (pulmonary fibrosis) associated with myositis. The goal of this study is to gain a better understanding of how anti-fibrotic drugs can help treat myositis associated with ILD. The study will focus on the drug Nintedanib (brand name Ofev), an oral anti-fibrotic medication approved by the Food and Drug Administration (FDA) for the treatment of various types of ILD This clinical trial is unique as you can participate from the comfort of your own home. There is no need, or worry, about traveling long distances or spending time away from your surroundings. To inquire and find out if you're eligible, please contact Dr. Rohit Aggarwal, medical director of Arthritis and Autoimmunity Center at University of Pittsburgh Medical Center To inquire please email; MINTcc@pitt.edu or call #412-648-4005 #LungDisease #MyositisLungDisease #myositis #ILD #MyositisTrial #ClinicalTrial #InterstitialLungDisease #MINTtrial #ClinicalTrials #MyositisCommunity #MyositisAwareness #MyositisDisease

CDC is updating its Expanded Access-Investigational New Drug (EA-IND) protocol to clarify eligibility for TPOXX, the antiviral drug used to treat mpox. This update ensures that people who might most benefit from TPOXX will still get treatment either through CDC or the STOMP trial, which will help us understand how effective TPOXX is in treating mpox and which patients might benefit from this drug. Learn more: https://bit.ly/4abPM6R

https://buff.ly/461XDU8Not 𝐌𝐃𝐌𝐀 𝐟𝐨𝐫 𝐏𝐓𝐒𝐃: 𝐓𝐡𝐞 𝐑𝐞𝐠𝐮𝐥𝐚𝐭𝐨𝐫𝐲 𝐑𝐨𝐥𝐥𝐞𝐫𝐜𝐨𝐚𝐬𝐭𝐞𝐫 𝐂𝐨𝐧𝐭𝐢𝐧𝐮𝐞𝐬 🎢 Lykos Therapeutics was confident in their Phase 3 results, believing they had secured approval for their new treatment. However, an FDA advisory panel expressed significant reservations, raising concerns about the trial design, safety monitoring, and data collection methods. Additionally, they highlighted cardiovascular and liver risks associated with this type of medication. This setback is one of many we have witnessed in psychedelic space. How do we design better trials for mind-altering drugs? Can we balance innovation with safety? The path to approving new CNS drugs, especially for PTSD, was never going to be easy. 𝑾𝒉𝒂𝒕'𝒔 𝒚𝒐𝒖𝒓 𝒕𝒂𝒌𝒆? 𝑰𝒔 𝒕𝒉𝒊𝒔 𝒂 𝒔𝒕𝒖𝒎𝒃𝒍𝒊𝒏𝒈 𝒃𝒍𝒐𝒄𝒌 𝒐𝒓 𝒂 𝒍𝒆𝒂𝒓𝒏𝒊𝒏𝒈 𝒐𝒑𝒑𝒐𝒓𝒕𝒖𝒏𝒊𝒕𝒚 𝒇𝒐𝒓 𝒑𝒔𝒚𝒄𝒉𝒆𝒅𝒆𝒍𝒊𝒄 𝒎𝒆𝒅𝒊𝒄𝒊𝒏𝒆? 💬 #PsychedelicMedicine #ClinicalTrials #RegulatoryAffairs #BiotechInnovation #CNSDrugs #DrugDevelopment #MentalHealthInnovation #clinicaldevelopment #roadmapping #licensing

In this post hoc analysis of a randomized 24-week clinical trial with 428 participants, the percentage of urine samples negative for opioids among participants with fentanyl use was 28.5% for subcutaneous buprenorphine and 18.8% for buprenorphine-naloxone and 36.7% for subcutaneous buprenorphine and 30.6% for buprenorphine-naloxone among those without fentanyl use; among participants with fentanyl use, the percentage of urine samples negative for fentanyl was 74.6% for subcutaneous buprenorphine vs 61.9% for buprenorphine-naloxone. #buprenorphine #opioids #treatment #research Braeburn https://lnkd.in/gvxHaxPG

Partners Daiichi Sankyo and Esperion are celebrating approval from the European Commission for expanded labeling of two non-statin drugs to treat hypercholesterolemia and reduce the risk of cardiovascular events by lowering LDL cholesterol. The treatments can be used alone or in combination with statins. An identical label expansion in the US earlier this year increased the treatable population there to about 70 million patients. Up to 80% of European patients are not reaching the recommended guidelines for LDL cholesterol goals. These new treatment options may benefit patients who have not seen improvement on their current medications. https://hubs.la/Q02yk4Bh0 #cardiovasculardisease #cvd #hypercholesterolemia #ldlcholesterol #daiichisankyo #esperion