FDA’s Post

𝐈𝐍𝐃𝐔𝐒𝐓𝐑𝐘 𝐍𝐄𝐖𝐒 𝐅𝐃𝐀 𝐈𝐬𝐬𝐮𝐞𝐬 𝐃𝐫𝐚𝐟𝐭 𝐆𝐮𝐢𝐝𝐚𝐧𝐜𝐞: 𝐏𝐞𝐝𝐢𝐚𝐭𝐫𝐢𝐜 𝐈𝐧𝐟𝐥𝐚𝐦𝐦𝐚𝐭𝐨𝐫𝐲 𝐁𝐨𝐰𝐞𝐥 𝐃𝐢𝐬𝐞𝐚𝐬𝐞: 𝐃𝐞𝐯𝐞𝐥𝐨𝐩𝐢𝐧𝐠 𝐃𝐫𝐮𝐠𝐬 𝐟𝐨𝐫 𝐓𝐫𝐞𝐚𝐭𝐦𝐞𝐧𝐭. This is the agency’s first guidance focused on clinical studies for pediatric IBD treatments. The FDA has issued the draft guidance to spur the development of new treatments for pediatric ulcerative colitis and pediatric Crohn’s disease, two types of inflammatory bowel disease. The guidance addresses the study population, study design, efficacy considerations, and safety assessments. This guidance couldn't come at a better time since the prevalence of IBD is dramatically rising. 🔸 From 2007 to 2016, the prevalence of IBD in children in the United States increased by 133%, from 33 per 100,000 to 77 per 100,000. This guidance will be crucial in advancing new treatments for pediatric ulcerative colitis and Crohn's disease. Because Children Can't Wait! https://lnkd.in/e45GyWEj #pediatricclinicaltrials #IBD #ChildrenCantWait

Expanding Roles, New Approaches for Pharmacists in Managing Graft-Vs-Host Disease: When treating patients with graft-vs-host disease, pharmacists are often responsible for selecting treatment regimens while navigating other spheres of care. #finance #pharmacy #lifesciences

Improved outcomes are expected in children with #Eosinophilic #Esophagitis (EoE) through the use of #dupilumab, according to a recent Q&A. The article highlights the potential benefits of dupilumab, a medication that has shown promise in treating EoE. #EoE #medicaladvancements

Patients with IBD can stomach this news! New study suggests that switching from brand name Remicade to a biosimilar medication is safe and effective, meaning more affordable treatment options could be available for patients who rely on these medications! Want to know more?  Check out the full article here: https://lnkd.in/e5pxaFRi

An FDA advisory committee has recommended the approval of donanemab for treating Alzheimer’s disease, highlighting its effectiveness in slowing cognitive decline as demonstrated in the Phase 3 TRAILBLAZER-ALZ 2 trial. This unanimous recommendation marks a significant advancement in Alzheimer’s treatment. If approved by the FDA, donanemab will provide a much-needed therapeutic option for patients with early Alzheimer’s. Read more about this decision and its implications. #Alzheimers #FDA #Donanemab #ClinicalTrials #Healthcare #ConexiantNews

Join us for International Society of Glomerular Disease's groundbreaking webinar, ‘Are You Prepared for Prepare-NS?” On January 25th at 12pm ET, come learn about the pioneering efforts of the FDA-funded Prepare-NS study, which is focused on the development of patient-reported and caregiver-reported questionnaires to measure impacts of edema. Some of the discussions will include: 🔹Edema's impact on progressive disease 🔹Development of health questionnaires by Prepare-NS 🔹Patient-reported and caregiver-reported measures 🔹Lived experiences shared by patients 🔹Insights from pediatric and adult nephrology experts 🔹Patient-focused drug development commentary By the end of the webinar, you'll be well-versed in patient-focused approaches to capturing edema (or swelling) in nephrotic syndrome for clinical trials! Click the link below to register now for the webinar! https://lnkd.in/e28Qtj9P

Clinical trials play a pivotal role in advancing medical knowledge and improving outcomes for asthma patients. By participating in clinical trials, asthma patients contribute to the development and evaluation of new treatments, medications, and interventions aimed at better managing asthma symptoms and preventing exacerbations. These trials provide researchers with valuable insights into the effectiveness and safety of potential therapies, ultimately leading to the development of more targeted and personalized treatment approaches. Additionally, participation in clinical trials empowers patients by offering access to cutting-edge treatments and the opportunity to play an active role in shaping the future of asthma care. Through collaborative efforts between researchers, healthcare professionals, and patients, clinical trials pave the way for innovative advancements that can enhance the quality of life for individuals living with asthma.

There is still time to register! Join us, the National Organization for Rare Disorders, and the Myasthenia Gravis Foundation of America, Inc. for an in-depth discussion on individualized dosing for #gMG ➡ bit.ly/496C2uI #MedEd #MedicalEducation #PatientOutcomes

Nice 📑 survey from 7 European countries about Patients` 🤔preferences for Treatment Attributes in Inflammatory Bowel Disease 💡 To maximize benefits of treatment before choosing therapy good to read and remember 🧠 🫴 importance of personalized care 🤌shared decision making 👉 most important 👇 for #IBDpatients adverse effects risk🫷 & 🫵way of drug administration https://lnkd.in/dD2x_2qr #PersonalizedCare 🔑 #PersonalizedMedicine #PatientPreference #SharedDecisionMaking #QualityOfLife #QoL #IBD #IBDpatients #InflammatoryBowelDisease #NChZJ #NieswoisteChorobyZapalneJelit #UC #UlcerativeColitis #WJZG #WrzodziejąceZapalenieJelitaGrubego #CD #CrohnsDisease #ChL_C #ChorobaLeśniowskiego_Crohna European Federation of Crohn's and Ulcerative Colitis Associations Crohn's & Colitis Foundation Crohn's & Colitis UK BIRD - Belgian Inflammatory Bowel Disease Research and Development #ECCO #J_elita

2023 clinical trials: The LODESTAR trial: Failed to show that rosuvastatin is superior to atorvastatin among patients with coronary artery disease. Among patients with coronary artery disease, rosuvastatin was not superior to atorvastatin at preventing adverse cardiac events within 3 years. This lack of benefit was despite a higher frequency of subjects achieving LDL-C level <70 mg/dL at 3 years in the rosuvastatin group versus the atorvastatin group. Rosuvastatin was associated with an excess incidence of initiation of diabetic medications and cataract operations. Based on this study, high-intensity atorvastatin therapy may be preferential to rosuvastatin.