👇 Learn about the crucial role of the FDA's accelerated approval pathway in providing #PatientAccess to innovative treatments for rare diseases. 💡 🎙 Amazing insights from Thayer Surette Roberts, Senior Vice President at Thorn Run Partners at the #LivingRareForum! #RareDisease #RareDiseaseAwareness
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Rare Disease Day takes place on February 29 this year. Read the new blog to discover how regulatory approvals for rare diseases follow a unique trajectory compared to medicines for common illnesses, with more flexibility in regulatory pathways. Discover how biotechs can use this flexibility to their advantage during trial design. https://ow.ly/W4iT50QHR1T #RareDiseaseDay
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From common to rare diseases, PPR is well-versed in expertly managing clinical trials in all aspects of #drugdevelopment. Explore our extensive range of services here: https://ppr-cro.com/ #PharmaPeakResearch #PPRStrength #ClinicalTrials #CommonDiseases #RareDiseases #DrugDevelopment
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Board Director| CEO | FDA Regulatory Strategy| Pharmaceuticals| Life Sciences Startup Advisor| Healthcare Policy| Investment Analysis |Orphan Drugs| Rare Diseases |PhD Candidate
In celebration of Rare Disease Day today, Feb. 29, may there be more targeted research, successful clinical trials, flexible regulation and appropriate reimbursement of therapies for the more than 7000 rare diseases affecting 30 million Americans and 350 million worldwide....#rarediseaseday2024 #rarediseaseawareness #rarediseaseday #raredisease #clinicaltrials #biomedicalresearch #orphandrugs
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𝐅𝐃𝐀 𝐀𝐩𝐩𝐫𝐨𝐯𝐞𝐬 𝐃𝐨𝐧𝐚𝐧𝐞𝐦𝐚𝐛: 𝐀 𝐌𝐢𝐥𝐞𝐬𝐭𝐨𝐧𝐞 𝐢𝐧 𝐀𝐥𝐳𝐡𝐞𝐢𝐦𝐞𝐫'𝐬 𝐓𝐫𝐞𝐚𝐭𝐦𝐞𝐧𝐭 𝐑𝐞𝐚𝐝 𝐌𝐨𝐫𝐞: https://lnkd.in/dsuJKU7v Discover how the FDA's approval of donanemab offers new hope in slowing 𝐀𝐥𝐳𝐡𝐞𝐢𝐦𝐞𝐫'𝐬 disease progression. Learn about its groundbreaking potential and what it means for patients and families. #alzheimersresearch #fdaapproval #donanemab #neurologynews #medicalbreakthrough
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This book provides a detailed body of information important to an understanding of the clinical aspects and management of such a challenging disease. https://lnkd.in/eGMK6Zhw #newbook #ovariancancer #medicine
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DRS Corporation recognizes Rare Disease Day and the importance of research and development of drug treatment of these diseases and disorders. While DRS Corporation plays a small role in an overall clinical trial, we know the importance of accurate data capturing and data organization through the life of a trial. Hopefully our small part can help make a difference in the treatment and lives of those living with rare diseases. 🌐 http://www.drscorp.com 📧 info@drscorp.com #RareDiseaseDay #ResearchEquality #eTMF #clinicaldatamanagement #clinicalresearch #clinicaltrials
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Enrol in our drug repurposing course for FREE on the Resources Hub! 💊 In this course, you'll explore how drug repurposing can be a more efficient and cost-effective way to develop treatments for rare diseases. Learn more: https://ow.ly/Cny650Qk7hN
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I'm not sure if this is what we were waiting for: Per an FDA document, treatment-emergent adverse events (TEAEs) were reported by 89% of donanemab-treated patients. The most common AEs were amyloid-related imaging abnormalities (ARIA)–edema/effusions (ARIA-E; 24%), ARIA-hemorrhage/hemosiderin deposition (ARIA-H; 18%), COVID-19 (14%), fall (13%), and headache (13%). Serious AEs were reported by 17% of donanemab-treated patients. To make it worse, in TRAILBLAZER-ALZ clinical trial, 27.5 % experienced ARIA-E and 30.5% of donanemab patients had ARIA-H. Alzheimer's Association should not wait to recommend interventions. Plenty of nonpharmaceutical interventions have been proven to be significantly more effective than Donanemab in well-designed clinical trials. Some even reversed the cognitive decline.
Breaking News: The FDA has granted approval of Kisunla (donanemab) for the treatment of people living with early symptomatic Alzheimer’s disease. We celebrate Kisunla’s approval as more options mean greater opportunity for more time. This is the third approval of an Alzheimer’s treatment that changes the underlying course of the disease. bit.ly/3XIyyvf
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Every year on February the last, rare disease supporters, researchers, and patients alike gather to celebrate Rare Disease Day. February is designated as Rare Disease Day since it has a "rare" number of days. Globally, there are more than 300 million individuals who suffer from an uncommon illness. Collaborating across national boundaries and encompassing over 10,000 rare diseases, several researchers and businesses strive towards achieving more fair access to diagnosis, care, treatment, and social opportunities. This year, the RegOrbit participates in the Rare Disease Day event. It unites the entire community in order to draw attention to the difficulties that individuals with uncommon diseases encounter. #raredisease #day #february #accesstomedicine #rarediseaseday #rarediseaseawareness #fda #ema #euorpe #regorbit #regulatoryaffairs #drugs #drugdevelopment #medicine
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#Clinicalcasestudy "Peripheral Arterial Disease. We Can Fight the Disease, Slow its Progression, But Not Defeat it" by Carlos Sánchez Fernández De La Vega is published in Acta Scientific Clinical Case Reports Journal. Check it out: https://lnkd.in/gwpRdbhD Journal page: https://lnkd.in/gEyzrUrh Submissions are open!!! Share to : casereports@actascientific.com #casereports #clinicalcase #medicines #casereport #OpenAccess #openaccessjournal #onlinepublishing #onlinepublication #actascientific
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2wGo Thayer Surette Roberts !!!!