Yesterday, we celebrated another important milestone in Alzheimer’s treatment. The U.S. Food and Drug Administration (FDA) granted traditional approval of donanemab, sold under the brand name Kisunla, for the treatment of people living with early symptomatic Alzheimer’s disease, which includes mild cognitive impairment and the mild dementia stage of Alzheimer’s disease, with confirmed amyloid plaques. This is the third FDA approval granted for an Alzheimer’s treatment that changes the underlying course of the disease. Learn more here. 👇 https://lnkd.in/eE938Zdw This is real progress. Yesterday’s action gives people more options and greater opportunity to have more time. 💜 #AlzheimersTreatment #Kisunla #MedicalBreakthrough
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"The notion of finding new uses for existing drugs has been around for a long time. Once the FDA approves a drug, doctors can prescribe it off-label to patients with other conditions they think it will help. Ozempic, originally approved for people with Type 2 diabetes, is now used by millions of people without the disease for weight loss. The National Institutes of Health and research institutions have invested over the years in drug repurposing, hoping it would be faster and less costly to find new uses for drugs that have already made it to market, a process that can take more than a decade and cost $2 billion. But systematically matching approved treatments to unmet needs has been hard. Every Cure’s database will use artificial intelligence to rank FDA-approved drugs that are most likely to work against every known disease. The rankings will be based on what Fajgenbaum calls “the world’s biomedical knowledge”: studies, case reports, clinical-trial data, health records and adverse-event reports that contain tantalizing clues that haven’t been systematically mined to help many patients." #medicalresearch #drugtesting #raredisease
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💡 NEW SPOTLIGHT 💡 Inter-individual variability in drug response often leads to adverse drug reactions or low drug efficacy, posing significant challenges for patient health. In this spotlight, we explored a published study by Zhou et al (2023) investigating how CYP2C29 allele frequencies translate into functional metabolic consequences. Learn more today 👉 https://lnkd.in/eNKTSQkZ
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Associate Professor Of Medicine and Medical Director of Weight Wellness at UT Southwestern Medical Center
🚨Generic semaglutide and tirzepatide aren't available 🚧Be aware of the potential risks of using compounded alternatives to evidence-based obesity meds!🚧 Thanks Sumathi Reddy at The Wall Street Journal for interviewing Katherine Saunders, MD and Jaime Almandoz, MD, MBA, FTOS about this alarming trend!
Cheaper Ozempic Alternatives Are Out There. Be Wary of Fakes and Fraudsters.
wsj.com
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𝐄𝐚𝐫𝐥𝐲 𝐀𝐥𝐳𝐡𝐞𝐢𝐦𝐞𝐫’𝐬 𝐃𝐢𝐬𝐞𝐚𝐬𝐞: 𝐃𝐞𝐯𝐞𝐥𝐨𝐩𝐢𝐧𝐠 𝐃𝐫𝐮𝐠𝐬 𝐟𝐨𝐫 𝐓𝐫𝐞𝐚𝐭𝐦𝐞𝐧𝐭-Revised Draft guidance 📌The Food and Drug Administration (FDA or Agency) is announcing the availability of a revised draft guidance for industry entitled “Early Alzheimer’s Disease: Developing Drugs for Treatment.” This draft guidance is intended to assist sponsors in the clinical development of drugs for the treatment of the stages of sporadic Alzheimer’s disease (AD) that occur before the onset of overt dementia. 📌This draft guidance revises the previous draft guidance for industry of the same name issued on February 16, 2018. ◾Content current as of: 03/11/2024 #usfda #alzheimersdisease
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We are delighted to announce that we have now successfully completed our phase 2b clinical trial in obesity; SESAM, meeting all clinical endpoints. The SESAM trial, conducted over 6 months, involved 320 participants across 3 clinical sites in Sweden. The results of the trial have demonstrated our drug product, EMP16, will be a future affordable sustainable treatment of obesity. Of particular importance is the lean/fat mass weight loss which is highly competitive in the repsonder group. With this data we are now ready to initiate phase 3 clinical trials. With the high and increasing obesity prevalence globally, there is an urgent need for an increased number of effective and accessible treatment options with alternative modes of action. EMP16 is one of the few drug candidates with a possible launch in 2027. #drugdevelopment #obesity #obesitytreatment #lifescience
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Lecanemab: Promising Cure or Expensive Gamble? Image by Gerd Altmann from Pixabay Debate rages over Alzheimer’s drug lecanemab as UK limits approval https://lnkd.in/gEzz_2w7 By Diana Kwon The debate over lecanemab, one of the first Alzheimer’s drugs to slow cognitive decline, is heating up. While the UK has approved it, the NHS has refused to offer it, citing high costs and small benefits. Lecanemab clears amyloid buildup in the brain, but questions remain about whether this leads to meaningful improvements. Supporters argue it gives patients valuable time, while critics worry about potential risks, like brain swelling. With costs topping $20,000 a year, and long-term effects still unclear, the question lingers: is lecanemab worth the risk? #WesternCanadaReason #wecanreason #criticalthinking #skeptics #science
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Type 1 #Diabetes Research! 📢 Learn more about a clinical study of an investigational medication for #T1D and severe low blood sugar (#hypoglycemia). Complete the prescreener: https://t1dx.co/3KYXHdD · #diabetesresearch #t1d #type1diabetes #lowbloodsugar
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Imagine the life of a person who is affected by an unknown or a complex disease which itself is caused by a very own immune system. First, they might need time to clearly understand what sort of things they are facing in their life. Second, they need guidance that helps them manage their struggle and improve their quality of life rather than creating an unnecessary fear that can mislead. Today, we are going to debunk the myths that have surrounded the autoimmune disorder for many years. Read more: https://lnkd.in/gGmZbepq #autoimmunedisorder #immunesystem #healthcare #pharma #criticalcare
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Mind boggling how media spins things out of proportion. On average, it costs $2 Billion to get approval for a new drug in the US (R&D, trials etc.). the manufacturing cost is just part of the COGS. the study author actually highlighted this fact in an interview. I do not know how much Novo spent on Ozempic and I am not saying $1000 is the right price; but a rationale pricing model would yield a positive NPV for the whole project, not just turn a manufacturing profit. If the price of a drug is way off in the US vs. other regions, do not attack a single company, fix the policies and regulations to address the issues in the healthcare system categorically.
NEW: Ozempic could be profitably produced for less than $5 a month even as maker Novo Nordisk charges almost $1,000 in the US, according to a study that revives questions about prices for top-selling treatments for diabetes and obesity. “The profit margin is immense,” on drugs like Ozempic, Melissa Barber, a public health economist at Yale and the study’s corresponding author, told us. “There should be a conversation in policy about what is a fair price.” Read more here from me and Robert Langreth (no paywall): https://lnkd.in/g_X9eEm6
Ozempic, Novo’s $1,000 Diabetes Drug, Can Be Made for Less Than $5 a Month, Study Says
bloomberg.com
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The rise of fentanyl and synthetic opioids has become a concerning global health issue, including in Australia. Fentanyl, a potent synthetic opioid, was first synthesized in 1959 as a powerful pain management medication. Its potency and its short-term effect make it an ideal pain medication for hospital procedures like surgeries. However, its illicit production and distribution have led to a surge in overdose deaths worldwide. In recent years, we have seen an increase in both prescription and illicit opioid misuse here in Australia. The illegal trafficking of fentanyl has resulted in a number of Australian deaths and serious injury. Synthetic opioids are cheaper, more potent and easier to produce compared to historical, plant-based opioids like heroin. Fentanyl's potency, often 50 to 100 times stronger than morphine, contributes to its high risk of overdose. For these reasons, we need to take the threat of synthetic opioids seriously. If you would like to know more about fentanyl and other synthetic opioids, and what this alarming trend means for Australian workplaces, get in touch with our pharmacology expert, Judith Griffin, today via 1300 230 231 or email to info@dasa.net.au #workplacewellbeing #drugtesting #workplacesafety #DASA
The Rise of Fentanyl
dasa.net.au
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2moHopeful news. 🙏🏼 Jenna Boytek MS RD LD