Podcasts about donanemab

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Play Episode Listen Later Jul 12, 2024 19:37

Welcome to the NeurologyLive® Mind Moments® podcast. Tune in to hear leaders in neurology sound off on topics that impact your clinical practice. In this episode, Sameea Husain-Wilson, DO, a movement disorder specialist at the Marcus Neuroscience Institute of Baptist Health, provided clinical perspective on the use of the Syn-One diagnostic test for patients with Parkinson disease (PD). She gave an overview of how the test is utilized in clinic, ways to interpret results, and the right personnel needed to ensure an accurate diagnosis. In addition, she provided clarity on the role of alpha-synuclein in PD, the advances in research in this area, and how the test incorporates this prominent biomarker. Furthermore, Husain-Wilson detailed some of the next steps in further optimizing the test in clinical settings, highlighting the importance of other non-movement disorder specialists who will play a major role in the diagnostic evaluation of future patients with PD. Looking for more movement disorder discussion? Check out the NeurologyLive® movement disorder clinical focus page. Episode Breakdown: 1:10 – Step by step process on how Syn-One test is used; considerations after process is done 3:15 – How the test differentiates PD from other neurodegenerative disorders 9:50 – Neurology News Minute 12:20 – Value and role in assessing alpha-synuclein in PD 14:50 – Ways to further optimize Syn-One going forward The stories featured in this week's Neurology News Minute, which will give you quick updates on the following developments in neurology, are further detailed here: FDA Approves Eli Lilly's Donanemab for Early Symptomatic Alzheimer Disease Buntanetap Improves Motor, Nonmotor and Cognitive Symptoms of Parkinson Disease in Phase 3 Study Gene Therapy AMT-130 Slows Huntington Disease Progression in Interim Phase 1/2 Trials Thanks for listening to the NeurologyLive® Mind Moments® podcast. To support the show, be sure to rate, review, and subscribe wherever you listen to podcasts. For more neurology news and expert-driven content, visit neurologylive.com.

FDA Approves Donanemab for Early Symptomatic Alzheimer Disease

Play Episode Listen Later Jul 9, 2024 11:16

Welcome to this special episode of the NeurologyLive® Mind Moments® podcast. Tune in to hear leaders in neurology sound off on topics that impact your clinical practice. For major FDA decisions in the field of neurology, we release short special episodes to offer a snapshot of the news, including the main takeaways for the clinical community, as well as highlights of the efficacy and safety profile of the agent in question. In this episode, we're covering the recent approval of donanemab as a new treatment for adults with early symptomatic Alzheimer disease (AD). Marketed as Kisunla, donanemab's approval marks the third antiamyloid therapy to get FDA greenlight for early-stage AD, following the controversial approval of aducanumab (Aduhelm; Biogen) in 2021 and lecanemab (Leqembi; Eisai) in 2023. Donanemab, administered as a 350 mg/20 mL once-monthly injection for intravenous infusion, had its approval supported by the phase 3 TRAILBLAZER-ALZ-2 trial (NCT04437511), a large-scale, double-blind, placebo-controlled trial that featured 1736 patients with early-stage AD. Following the approval, NeurologyLive sat down with Joel Salinas, MD, MBA, a behavioral neurologist at NYU Langone and clinical assistant professor in the department of neurology at the NYU Grossman School of Medicine. Salinas, who also serves as the chief medical officer at Isaac Health, discussed the positive impacts of the approval, the importance of patient selection for the medication, and how clinicians should discuss its benefits and harms to patients. In addition, he commented on how approvals like donanemab continue to carry momentum in the AD field going forward. For more of NeurologyLive's coverage of donanemab's approval, head here: FDA Approves Eli Lilly's Donanemab for Early Symptomatic Alzheimer Disease Episode Breakdown: 2:10 – Positive downstream impacts of donanemab's approval 4:20 – Considerations and caution with prescribing donanemab 6:05 – Salinas on patient-clinician conversations about AD treatments 8:00 – Closing remarks and continued progress in AD field Thanks for listening to the NeurologyLive Mind Moments podcast. To support the show, be sure to rate, review, and subscribe wherever you listen to podcasts. For more neurology news and expert-driven content, visit neurologylive.com.

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Kisunla for Alzheimer's, Sirturo for TB, Kar-XT for Schizophrenia, MDMA-based Therapy for PTSD, Seladelpar for PBC, TransCon PTH for Hypoparathyroidism, Afami-Cel for Synovial Sarcoma

Play Episode Listen Later Jul 8, 2024 11:10

Visit learnamastyle.com for free downloads and free courses related to writing in medicine and science. - The FDA has approved donanemab (Kisunla) for early symptomatic Alzheimer's disease, making it the third drug in a new class aimed at slowing cognitive decline in early-stage patients. Eli Lilly will make the drug available within weeks following this approval. Donanemab is an anti-amyloid monoclonal antibody that targets amyloid plaques in the brain, a key feature of Alzheimer's. - The FDA approval was based on clinical trials showing significant benefits in slowing cognitive decline despite concerns about long-term safety. The advisory committee voted unanimously in favor of the drug, with the FDA granting the approval to Eli Lilly. - The FDA has approved bedaquiline (Sirturo) for treating multidrug-resistant pulmonary tuberculosis (TB) in adults and children aged five and above. Sirturo initially received accelerated FDA clearance for adults in 2012, with later label expansions for younger patients. Bedaquiline, the first TB drug with a new action mechanism in over 40 years, inhibits mycobacterial ATP synthase, essential for energy production in TB bacteria.. - The FDA is nearing a decision on KarXT, a novel antipsychotic for schizophrenia developed by Karuna Therapeutics. KarXT has shown efficacy in reducing symptom severity in clinical trials, with a favorable side effect profile compared to older antipsychotics. Concerns about insurance coverage exist due to the availability of cheaper generics, but a decision is expected by September 26. - MDMA-assisted therapy for PTSD, developed by Lykos Therapeutics, has shown significant symptom reduction in clinical trials but faces approval challenges. Despite positive trial results, the FDA advisory panel voted against recommending the drug, citing safety concerns. The FDA's final decision is expected by August 11. - Seladelpar, under consideration for primary biliary cholangitis (PBC), is a drug Gilead recently acquired through the purchase of CymaBay. If approved by August 14, it would expand Gilead's liver disease portfolio. Clinical trials have shown seladelpar to be effective in reducing the itching associated with PBC. - TransCon PTH by Ascendis Pharma is a treatment for hypoparathyroidism, designed to replace parathyroid hormone and help patients achieve normal calcium levels. Despite manufacturing concerns delaying the FDA's decision, the drug has already been approved in Europe and the UK. A final FDA decision is expected by August 14. - Afami-cel, a T-cell receptor therapy for synovial sarcoma developed by Adaptimmune Therapeutics, awaits FDA approval by August 4. The therapy targets the MAGE A4 cancer target and is designed as a single-dose treatment. Clinical trial data supporting the application showed efficacy in treating advanced synovial sarcoma.

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FDA Approves Lilly's Donanemab While Rejections Highlight Manufacturing Issues

Play Episode Listen Later Jul 3, 2024 15:08

The biggest news of the week was the FDA approval of Eli Lilly's Kisunla (donanemab) on Tuesday. While not unexpected, it was one of the year's most highly anticipated decisions. And last week saw another big approval from the FDA—that of Verona's novel COPD drug. But the regulator has also dropped three Complete Response Letters on drugmakers in the last seven days. Two of these were directly related to issues with third-party manufacturers. Though it's unclear if those contract development and manufacturing organizations (CDMOs) were overseas, the FDA has flagged several concerns regarding manufacturers in India and China that have contributed to extreme drug shortages in the U.S. This will be particularly important in the face of a potential decoupling from Chinese CDMOs should the BIOSECURE Act become law, as India has been one country eyeing the opportunity. Meanwhile, Korean company Samsung Bio struck a $1 billion manufacturing contract with an undisclosed U.S. biopharma company. Among the many products the manufacturer makes are the piping hot antibody-drug conjugates, or ADCs. The global market has already exceeded $10 billion and is estimated to grow to nearly $30 billion by 2028. As evidence of the excitement surrounding ADCs are five major deals struck by biopharma companies this year. It's not all good news for the ADC space, though, as one of those three FDA rejections was handed to Merck and partner Daiichi Sankyo's investigational ADC for the treatment of certain non-small cell lung cancers. Meanwhile, BMS backed out of a collaboration with Eisai to develop an ADC being investigated in ovarian, peritoneal and fallopian tube cancers, as well as non-small cell lung cancer. We will continue to watch the industry's strategies unfold as biopharma firms compete for a piece of that exploding ADC market.

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Activan planes DN-III-E y GN-A en Campeche, Q. Roo y Yucatán

Noticentro

Play Episode Listen Later Jul 2, 2024 1:35

-En Hidalgo, derivado de las lluvias, se reportan afectaciones, en 26 municipios-TEPJF analizará impugnaciones de MC y PRD en contra de cómputos distritales -Aprueban uso del medicamento Donanemab que ralentiza el alzhéimer -Más información en nuestro podcast

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Adbry for Atopic Dermatitis, Augtyro for NTRK Tumors, Donanemab for Alzheimer's, Iqirvo for Primary Biliary Cholangitis, Retevmo in Thyroid Cancer, OTC Continuous Glucose Monitors

Play Episode Listen Later Jun 17, 2024 8:38

Check out Nascentmc.com for medical writing assistance. visit learnAMAstyle.com for free downloads on medical writing and editing Adbry for Atopic Dermatitis The FDA has approved tralokinumab-ldrm (Adbry) as a 300 mg single-dose autoinjector for moderate-to-severe atopic dermatitis (AD) in adults, offering a more convenient delivery method. Adbry, which inhibits IL-13, was previously approved for adults in December 2021 and for pediatric patients aged 12 and older in December 2023. The approval was granted to LEO Pharma Inc. Augtyro for NTRK Tumors The FDA has approved repotrectinib (Augtyro) for treating solid tumors with NTRK gene fusions in patients aged 12 and older, based on Phase 1/2 trials showing significant response rates in both TKI-naïve and previously treated patients. The approval was granted to Bristol Myers Squibb, with additional clinical data required to confirm safety and efficacy. Donanemab for Alzheimer's FDA advisors unanimously recommended the approval of donanemab for Alzheimer's disease, emphasizing its efficacy in slowing early-stage disease and manageable risks. Donanemab, targeting amyloid plaques, offers potential advantages over Leqembi with monthly infusions. The FDA decision is expected soon. Iqirvo for Primary Biliary Cholangitis The FDA granted accelerated approval to elafibranor (Iqirvo) for primary biliary cholangitis (PBC) to be used with ursodeoxycholic acid or as monotherapy. Elafibranor targets PPAR-α and PPAR-δ, with Phase 2 trials showing significant biochemical responses. The approval was granted to GENFIT and Ipsen. Retevmo in Thyroid Cancer The FDA granted full approval to selpercatinib (Retevmo) for advanced or metastatic RET fusion–positive thyroid cancer in patients aged 2 years and older, based on the LIBRETTO-001 trial showing high response rates. The approval was granted to Eli Lilly and Company. OTC Continuous Glucose Monitors The FDA approved Abbott Laboratories' continuous glucose monitoring systems, Libre Rio and Lingo, for over-the-counter use. Libre Rio is for Type 2 diabetes patients not on insulin, while Lingo targets non-diabetic consumers for health improvement. These systems provide real-time glucose monitoring via a smartphone app. Check out Nascentmc.com for medical writing assistance.visit learnAMAstyle.com for free downloads on medical writing and editing

Donanemab's Promise, BIO Wrap and Mass Layoffs

Ask the Naked Scientists Podcast

Play Episode Listen Later Jun 12, 2024 16:24

The big news of this week so far was Monday's FDA advisory committee for Eli Lilly's Alzheimer's drug donanemab, where the vote was unanimous in support of the anti-amyloid antibody. If approved, donanemab would be a direct competitor of Biogen and Eisai's Leqembi, but analysts believe there's plenty of room in the market for both, and even predict that donanemab's potential approval could be beneficial for Leqembi in the long run by increasing investments in advocacy and infrastructure. The mood was decidedly different from last week's FDA adcomm, which voted overwhelmingly against approving Lykos Therapeutics' MDMA-assisted PTSD therapy. Interestingly, that vote came down less an hour before BioSpace Senior Editor Heather McKenzie hosted a panel at BIO where Dan Karlin, chief medical officer at MindMed, said he'd hoped the conversation would have been different. In other conference news, Eli Lilly and partners Boehringer Ingelheim and Zealand Pharma presented mid-stage results for their GLP-1 products in the MASH space at the Congress of the European Association for the Study of the Liver. These companies are eyeing a piece of the MASH market that Madrigal Pharmaceuticals first tapped into earlier this year when its therapy, Rezdiffra, was approved in March. Finally, CBRE published a report on challenges in finding R&D and manufacturing talent, and thousands of layoffs continue to hit the biopharma industry. According to our Layoff Tracker, there have been 14,000 positions cut this year, with BMS and Bayer being the unfortunate leaders, each with more than 1,500 layoffs underway. Still, analysts are optimistic that the second half of 2024 could be better, as an uptick in the financial markets might provide companies with money to spend on growing their workforces.

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How were the pyramids built?

Play Episode Listen Later May 24, 2024 15:18

This time on Ask!, Dr Chris explains how tree rings helped scientists confirm last summer was the hottest for 2000 years. Also, how were the pyramids built? And where are we with understanding and treating Alzheimer's disease? Like this podcast? Please help us by supporting the Naked Scientists

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How were the pyramids built?

Ask the Naked Scientists

Play Episode Listen Later May 24, 2024 15:18

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DEMENTIA ACTION WEEK: A Defining Year

Tony Robinson's Cunningcast

Play Episode Listen Later May 16, 2024 53:16

To mark Dementia Acton Week, Tony is bringing you a special episode dedicated to the past, present and future of this difficult disease with his expert guest Fiona Carragher, Director of Research and Influencing at the Alzheimer's Society. Dementia the UK's number one killer, 1 in 3 people will develop dementia in their lifetime and yet most of us don't know a great deal about it. But this is a defining year in the history of Alzheimer's with two new drugs: Lecanemab and Donanemab which have been found, for the first time ever, to slow the progression of the disease. Hosted by Sir Tony RobinsonWithFiona Carragher, Director of Research and Influencing at the Alzheimer's Society. X @alzheimersoc | FB @alzheimers society | IG @alzheimerssocIf you're worried about yourself, or someone close to you, then check your symptoms today using Alzheimer's Society's symptom checklist. Visit alzheimers.org.uk/checklist or call the Dementia Support Line on 0333 150 3456Follow: X @cunningcastpod Instagram @cunningcastpod YouTube @Cunningcast Credits: Series Producer: Melissa FitzGerald X @melissafitzg Executive Producer: Dominic de Terville Cover Art: The Brightside A Zinc Media Group production If you enjoyed my podcast, please leave us a rating or review. Thank you, Love Tony x Hosted on Acast. See acast.com/privacy for more information.

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ASGCT, Adcomm for Lilly's Donanemab, Vertex Vs. Bluebird

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Play Episode Listen Later May 8, 2024 11:54

In this edition of The Weekly, Managing Editor Jef Akst and News Editor Greg Slabodkin share their insights from the American Society of Gene & Cell Therapy's 27th annual conference, including advances around adeno-associated viruses and the ongoing discussion about the FDA's accelerated approval program and how it relates to rare diseases. Also, on Tuesday, Eli Lilly announced that an advisory committee meeting will be held for its Alzheimer's drug donanemab on June 10. Lilly is aiming for full approval of the anti-amyloid antibody after accelerated approval was denied in January 2023. And the race between Vertex and bluebird bio's gene therapies Casgevy and Lyfgenia is heating up.

Medicines and global warming, donanemab for AD, and cytisine for smoking cessation

DTB podcast

Play Episode Listen Later Apr 25, 2024 26:02

In this podcast recorded in early April, James Cave (Editor-in-Chief) and David Phizackerley (Deputy Editor) talk about the May 2024 issue of DTB. They discuss the editorial that highlights the effect medicines have on greenhouse gas emissions and the need to consider the environmental impact of all aspects of the patient care pathway (https://dtb.bmj.com/content/62/5/66). They review the results of a study that assessed the effect of donanemab on early symptomatic Alzheimer's disease (https://dtb.bmj.com/content/62/5/67). The main article considers the evidence for cytisine, a nicotine receptor partial agonist, that has recently been licensed to facilitate quitting smoking (https://dtb.bmj.com/content/62/5/71). They begin by highlighting some useful resources relating to the safe use of valproate. Other links: https://www.england.nhs.uk/patient-safety/sodium-valproate/ https://www.england.nhs.uk/publication/decision-support-tool-is-valproate-the-right-epilepsy-treatment-for-me/ https://www.gov.uk/government/collections/valproate-safety-measures https://www.gov.uk/guidance/valproate-use-by-women-and-girls Please subscribe to the DTB podcast to get episodes automatically downloaded to your mobile device and computer. Also, please consider leaving us a review or a comment on the DTB Podcast iTunes podcast page (https://podcasts.apple.com/gb/podcast/dtb-podcast/id307773309). If you want to contact us please email dtb@bmj.com. Thank you for listening.

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ME/CFS and long COVID; negative outcomes for ALS drug; donanemab

Neurology Today - Neurology Today Editor’s Picks

Play Episode Listen Later Apr 18, 2024 4:31

Neurology Today Editor-in-Chief Joseph E. Safdieh,MD, FAAN, highlights new research that explores an association between myalgic encephalomyelitis/chronic fatigue and long COVID; negative phase 3 findings on AMX0035 for ALS, and the pending approval of donanemab for Alzheimer's disease.

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The Bumpy Road To Approving New Alzheimer's Drugs

Science Friday

Play Episode Listen Later Apr 2, 2024 17:52

In the past few years pharmaceutical companies have developed a string of new Alzheimer's drugs called anti-amyloids, which target amyloid plaques in patients' brains. These plaques are one of the key biomarkers of the disease.The first of these drugs, Aduhelm, was approved by the FDA in 2021 amid enormous controversy. The FDA approved the drug despite little evidence that it actually slowed cognitive decline in patients. Biogen, the maker of Aduhelm, pulled the plug on further research or sales of the drug last month.In January 2023 The FDA approved another anti-amyloid medication from Biogen, lecanemab, sold under the brand name Leqembi. This time, there was much stronger evidence. Clinical trial results showed that the drug showed a modest improvement in cognitive decline in the early phases of the disease. But the drug comes with risks, including brain swelling and bleeding.Most recently, at the beginning of March, the FDA delayed approval of another anti-amyloid drug, donanemab, created by Eli Lilly. The FDA said it will be conducting an additional review to further scrutinize the study design and efficacy data.From the outside looking in, these Alzheimer's drugs appear to be mired in controversy. How well do they actually work? And why has there been so much back and forth with the FDA?To answer those questions and more, guest host Arielle Duhaime-Ross talks with Dr. Jason Karlawish, professor of medicine, medical ethics and health policy, and neurology at the University of Pennsylvania's Perelman School of Medicine, and co-director of the Penn Memory Center.Transcripts for each segment will be available after the show airs on sciencefriday.com. Subscribe to this podcast. Plus, to stay updated on all things science, sign up for Science Friday's newsletters.

Pharma and Biotech Daily: Navigating the Latest Industry Updates with Precision

Pharma and BioTech Daily

Play Episode Listen Later Mar 13, 2024 3:41

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma e Biotech world. 3M has named William Brown as its new CEO, replacing Michael Roman who has led the company since 2018. Abbott has recalled its HeartMate LVAD communication system due to reported injuries linked to the device malfunctioning. 3M's board has approved a health spinoff, with investors set to receive shares of Solventum. An FDA panel has backed Lumicell's agent for breast cancer imaging tool, despite some risks. A report by AdvaMed has found racial disparities in care, particularly in cardiovascular procedures, and proposes solutions to address these issues. The medtech industry is seeing trends in digital health and AI applications, which are becoming more prominent in the medical device space. Cigna is capping cost increases for pricey GLP-1 weight loss drugs, showing how major players are adapting to meet high demand for these medications.Pfizer's antibody-drug conjugate, ADCetris, showed improved overall survival in patients with relapsed or refractory diffuse large b-cell lymphoma when used with rituximab or lenalidomide. The unique trial design of the study is expected to be the focus of an upcoming advisory committee meeting. Additionally, Roche presented promising mid-stage data for an investigational therapy for Alzheimer's disease, showing rapid and robust amyloid plaque reduction. Acadia Pharmaceuticals is terminating development of its antipsychotic drug after it failed to demonstrate a statistically significant improvement over placebo in a late-stage study. Merck is making a potential $1 billion bet on Pearl Bio's genomically recoded organisms. FDA updates guidelines for Alzheimer's drug development, while biopharma companies like BMS and Innovent Bio announce layoffs and site closures.Roche is focusing on its next Alzheimer's drug after setbacks, while Acadia faces a setback in a schizophrenia trial. Boehringer and Sosei Heptares have teamed up in a deal for a schizophrenia drug. Biotech stock fundings are on track for the best quarter in 3 years. ALS doctors are preparing for tough conversations with patients after a surprise trial failure, and Acadia's drug failure sets back the company's expansion plans. Other news includes the use of social determinants of health data to identify patient populations for weight loss drugs, and a deal between Boehringer and Sosei Heptares to develop medicines for neurological diseases. Publicly traded biotech companies have raised nearly $10 billion in follow-on stock offerings in January and February, driving a sector recovery according to Jefferies.The text discusses the concept of precision medicine and the All of Us research program, which aims to build a diverse health database. The program has revealed risk factors for Alzheimer's disease. The delay in the approval of Eli Lilly's drug for Alzheimer's, Donanemab, is seen as a potential opportunity to improve drug development and pave the way for a more personalized approach to treatment. Additionally, a liquid biopsy for colorectal cancer screening from Guardant Health could make precision medicine in cancer more feasible.In an upcoming webinar, marketers can learn how to execute bigger ideas in a simpler and more cost-effective way using creative automation. Many businesses struggle to balance costs, speed, and creative quality in today's complex marketing landscape. By automating creatives, marketers can accelerate digital ad production, distribution, and impact. Automation enables marketers to increase collaboration between teams, accelerate ad production, and execute bigger ideas more efficiently.Participants can register for the webinar to discover how automation can help streamline marketing efforts and drive ROI.

The skinny on weight loss, donanemab and the State of the Union

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Play Episode Listen Later Mar 13, 2024 15:37

The weight loss market is the gift that keeps on giving—at least for Novo Nordisk—as Wegovy continues to demonstrate its prowess with label expansion. Also discussed: biosimilar approvals for Fresenius Kabi, and Sandoz. More news at the forefront of Alzheimer's treatment: Eli Lilly's donanemab decision date got pushed and now the FDA wants to discuss the drug's safety and efficacy at an upcoming adcomm. And finally, politics: President Biden's State of the Union address ruffles feathers as he strikes out at Big Pharma and drug prices, and how the industry is reacting to the election.

OTC Glucose Monitor, Semaglutide and CVD risk, Juvederm Additional Indication, Nivolumab in mUC, Zanubrutinib in FL, Donanemab and Alzheimer's, Tocilizumab Biosimilar, Denosumab Biosimilars, Clobetasol Propionate Eye Drops

Brain Talk | Being Patient for Alzheimer's & dementia patients & caregivers

Play Episode Listen Later Mar 11, 2024 13:04

Here is information on the latest US FDA approvals, the week of March 4 – March 8, 2024 · ChatGPT4 in medical writing and editing—visit learnAMAstyle.com · Nascentmc.com for medical writing assistance for your company. Visit nascentmc.com/podcast for full show notes - **OTC Glucose Monitor**: The FDA has approved the Dexcom Stelo Glucose Biosensor System for over-the-counter sale, a first for a continuous glucose monitor. Designed for people aged 18 and older not using insulin, it helps manage diabetes with oral medications or monitors the impact of diet and exercise on blood sugar levels. Scheduled for release in Summer 2024, the system offers a 15-day sensor wear time and does not alert users to low blood sugar episodes. - **Semaglutide in CVD Risk**: The FDA has approved semaglutide (Wegovy) for reducing cardiovascular risk in adults with known heart disease who are overweight or obese, specifically targeting the reduction of major adverse cardiovascular events. This approval makes semaglutide the first weight-loss medication also indicated for preventing life-threatening cardiovascular events in patients with established cardiovascular disease and obesity or overweight. - **Juvederm Additional Indication**: JUVÉDERM® VOLUMA® XC, a hyaluronic acid dermal filler, has received FDA approval for treating moderate to severe temple hollowing in adults over 21, marking it as the first HA filler for this purpose. With effects lasting up to 13 months, clinical studies show significant improvement and patient satisfaction with facial symmetry post-treatment. This approval highlights Allergan Aesthetics' commitment to innovation in aesthetic treatments. - **Nivolumab in mUC**: The FDA approved nivolumab in combination with cisplatin and gemcitabine for first-line treatment of metastatic urothelial carcinoma, based on significant improvements in survival outcomes from the CHECKMATE-901 trial. This expands nivolumab's indications, which include treatments for melanoma and lung cancer, among others, demonstrating its broad applicability in cancer treatment. - **Zanubrutinib in FL**: The FDA has granted accelerated approval to zanubrutinib and obinutuzumab for relapsed or refractory follicular lymphoma patients after two or more systemic therapies. This combination targets key pathways in B cell survival, offering a new treatment option for patients. Approval was based on the ROSEWOOD trial, highlighting significant patient outcome improvements. - **Donanemab and Alzheimer's**: The FDA has postponed the decision on the approval of Eli Lilly's donanemab for Alzheimer's treatment to convene an advisory meeting for further examination of safety and efficacy data, indicating a significant delay. This reflects the complex nature of Alzheimer's drug approval and Eli Lilly's confidence in donanemab's potential benefits. - **Tocilizumab Biosimilar**: Tyenne® (tocilizumab-aazg), the first FDA-approved biosimilar to Actemra® for various inflammatory diseases, is now available in both IV and subcutaneous formulations. This approval introduces a new treatment option for patients with conditions like rheumatoid arthritis and juvenile idiopathic arthritis, emphasizing advancements in biosimilar medications. - **Denosumab Biosimilars**: The FDA approved Jubbonti and Wyost as interchangeable biosimilars to Prolia and Xgeva, respectively, marking a first for biosimilars targeting the RANKL inhibitor used in osteoporosis and cancer-related bone conditions. These approvals offer new treatment options for managing bone health, underlining the importance of biosimilar development in expanding patient care. - **Clobetasol Propionate Eye Drops**: The FDA's approval of clobetasol propionate 0.05% eye drops for post-operative eye inflammation and pain introduces the first ophthalmic formulation of this corticosteroid and the first new steroid in ophthalmology in over 15 years. Developed using proprietary nanoparticle technology for twice-daily dosing, this approval offers a new option for effective pain and inflammation management post-eye surgery.

Pharma and Biotech Daily: FDA Delays Decision on Donanemab, Biden Addresses Drug Prices, Brukinsa Approval, ALS Drug Uncertainty, and Industry Layoffs.

Pharma and BioTech Daily

Play Episode Listen Later Mar 11, 2024 0:47

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma e Biotech world. The FDA has delayed its decision on Eli Lilly's Alzheimer's drug, Donanemab, and will convene a committee to discuss the application. President Biden addressed drug prices in the State of the Union, calling for lower prescription drug prices. Additionally, Beigene's Brukinsa was approved for follicular lymphoma, and Amylyx's ALS drug faced uncertainty after a Phase III trial failure. Other news included BMS gaining FDA approval for Opdivo in first-line bladder cancer and Merck KGaA discontinuing a BTK inhibitor after a Phase III trial failure. The biopharma industry is experiencing layoffs, with companies like Sumitomo and Evonik cutting staff.

Lou Niles: An Inside Account of the Donanemab Drug Trial | Patient Perspective

Play Episode Listen Later Feb 21, 2024 21:38

Lou Niles joins Being Patient Live Talks to discuss his experience taking part in the donanemab clinical trial. The monoclonal antibody drug was revealed to have promising results in late 2023 and is currently awaiting FDA approval. Now retired, Niles previously served as an army officer, a combat helicopter pilot in Vietnam, and as a firefighter and paramedic in San Diego. Because his mother died from Alzheimer's, he was aware that he could be susceptible to cognitive decline, which led him to do a 23&Me DNA test a decade ago. The test revealed that he had one mutation associated with a higher risk for Alzheimer's. That's why, when he saw that there was an Alzheimer's study in Orlando, FL, where he currently lives, Niles decided to participate. Over the course of the trial, he discovered that he indeed has cognitive decline and amyloid in his brain. In the talk, Niles will speak about his experience with cognitive decline and participating in the donanemab trial. Watch now to learn more about the clinical trial experience with MAB drugs. ------------ If you loved watching this Live Talk, visit our website to find more of our Alzheimer's coverage and subscribe to our newsletter: https://www.beingpatient.com/ Follow Being Patient: Twitter: https://twitter.com/Being_Patient_ Instagram: https://www.instagram.com/beingpatientvoices/ Facebook: https://www.facebook.com/beingpatientalzheimers LinkedIn: https://www.linkedin.com/company/being-patient

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FDA Approves First State Request to Import Drugs From Canada and 5 Upcoming FDA Approvals

canada english phd md drugs phase alzheimer's disease fda import stellar merck approves eli lilly hodgkin first state approvals pah regeneron pharmaceuticals dlbcl donanemab

Play Episode Listen Later Jan 8, 2024 10:06

Use Your Scientific or Medical Background in Medical Editing & Factchecking so you can supplement your income while working from anywhere on your own schedule. Visit learnAMAstyle.com for a free step-by-step checklist. Get immediate medical writing assistance from experienced, excellent, native-English speaking MD- and PhD-medical writers. Nascentmc.com Today's episode: FDA approves first state request to import drugs from Canada: The FDA has approved Florida's request to import certain drugs from Canada, marking the first time a state has been authorized to buy lower-cost medications in bulk from abroad.https://www.cnn.com/2024/01/05/politics/florida-canada-drug-imports-fda/index.html https://www.flgov.com/2024/01/05/florida-becomes-first-in-the-nation-to-have-canadian-drug-importation-program-approved-by-fda/ · 5 FDA decisions to watch for: o Donanemab from Eli Lilly, if approved, could be a significant Alzheimer's treatment, with Phase 3 trial results showing substantial cognitive and functional decline slowing. o Resmetirom, an oral thyroid hormone receptor agonist, manufactured by Madrigal Pharmaceuticals showed promise in addressing nonalcoholic steatohepatitis (NASH), a leading cause of liver transplantation. o Sotatercept, acquired by Merck, is being evaluated for treating pulmonary arterial hypertension (PAH) based on promising results from the Phase 3 STELLAR trial. o Lifileucel, in a phase 3 trial for melanoma, is the first tumor-infiltrating lymphocyte (TIL) therapy for advanced melanoma. FDA's decision on lifileucel is expected by mid-February, and it offers potential as a one-time cell therapy for solid tumor cancer. o Odronextamab, developed by Regeneron Pharmaceuticals, could become the first bispecific antibody approved for both FL and DLBCL, common non-Hodgkin lymphoma subtypes. This content was independently written by Dr. Emma Hitt Nichols, but the idea for the 5 upcoming drugs came from this article https://www.biopharmadive.com/news/5-fda-approval-decisions-watch-first-quarter-2024/703377 Use Your Scientific or Medical Background in Medical Editing & Factchecking so you can supplement your income while working from anywhere on your own schedule. Visit learnAMAstyle.com for a free step-by-step checklist. Get immediate medical writing assistance from experienced, excellent, native-English speaking MD- and PhD-medical writers. Nascentmc.com

第2023期:Researchers Return to Alzheimer's Vaccines

英语每日一听 | 每天少于5分钟

Play Episode Listen Later Dec 2, 2023 4:18

Researchers are renewing efforts to find Alzheimer's disease treatments that remove harmful proteins from the brain. Such vaccines could possibly offer an easier and lower-cost choice for millions of people, several scientists and industry leaders say. 研究人员正在继续努力寻找消除大脑中有害蛋白质的阿尔茨海默病治疗方法。几位科学家和行业领袖表示，此类疫苗可能为数百万人提供更简单、成本更低的选择。 The brain-wasting disease causes thinking and memory problems.这种脑消耗性疾病会导致思维和记忆问题。 The U.S. government website ClinicalTrials.gov shows that at least seven possible Alzheimer's vaccines are in human testing or have completed such trials. The experimental treatments are designed to use the body's natural defense system to destroy Alzheimer's-linked proteins in the brain. The proteins are beta amyloid and tau. 美国政府网站ClinicalTrials.gov显示，至少有七种可能的阿尔茨海默病疫苗正在进行人体测试或已经完成此类试验。这些实验性治疗旨在利用人体的自然防御系统来破坏大脑中与阿尔茨海默病相关的蛋白质。这些蛋白质是β淀粉样蛋白和tau蛋白。 The renewed interest in Alzheimer's vaccines follows a promising first attempt more than 20 years ago. That vaccine work halted after six percent of study volunteers developed a life-threatening brain condition called meningoencephalitis. 继 20 多年前首次尝试后，人们对阿尔茨海默病疫苗重新产生了兴趣。在百分之六的研究志愿者患上一种名为脑膜脑炎的危及生命的脑部疾病后，疫苗工作停止了。 Researchers then found a safer method using closely targeted synthetic antibodies in patients. These antibodies avoid extreme immune system reaction. 研究人员随后找到了一种更安全的方法，在患者体内使用紧密靶向的合成抗体。这些抗体避免了极端的免疫系统反应。 Health care companies Eisai and Biogen launched a new medication called Leqembi and health care company Eli Lilly launched Donanemab. American government drug experts are reviewing the treatments. 医疗保健公司卫材 (Eisai) 和百健 (Biogen) 推出了一种名为 Leqembi 的新药，医疗保健公司礼来 (Eli Lilly) 推出了 Donanemab。美国政府药物专家正在审查这些治疗方法。 The reported success of the drugs has strengthened the theories that amyloid removal is critical to fighting Alzheimer's. 这些药物的成功报道强化了这样的理论：去除淀粉样蛋白对于对抗阿尔茨海默病至关重要。 Scientists believe they now understand what went wrong with the first vaccine. They are testing shots they hope will cause an immune reaction without causing too much inflammation. 科学家相信他们现在明白第一种疫苗出了什么问题。他们正在测试注射剂，希望能引起免疫反应，而又不会引起太多炎症。 Dr. Reisa Sperling is an Alzheimer's researcher at Mass General Brigham in Boston. She said she believes vaccines will play an important part as researchers look to prevent Alzheimer's. She said, “I'm very keen that that's where we need to go.” Reisa Sperling 博士是波士顿麻省总医院的阿尔茨海默病研究员。她说，她相信疫苗将在研究人员寻求预防阿尔茨海默病时发挥重要作用。她说：“我非常热衷于这就是我们需要去的地方。” Sperling is leading a trial in people with Alzheimer's proteins in their brains but showing no signs of related problems. She is considering vaccines for her next study in people who have Alzheimer's proteins in their blood, but not enough to show on imaging of the brain. 斯珀林正在领导一项针对大脑中含有阿尔茨海默病蛋白但没有显示出相关问题迹象的人的试验。她正在考虑在下一项研究中使用疫苗，该研究的对象是血液中含有阿尔茨海默病蛋白的人，但这些蛋白不足以在大脑成像中显示出来。 Alzheimer's vaccines are still in the early stages and will require large, years-long trials to show they work. 阿尔茨海默病疫苗仍处于早期阶段，需要进行长达数年的大规模试验才能证明它们有效。 But a vaccine given two or four times a year could offer a lower-cost solution than Leqembi. Leqembi is given twice a month. That could expand available treatment among the estimated 39 million people around the world with Alzheimer's. 但每年注射两到四次的疫苗可以提供比 Leqembi 成本更低的解决方案。Leqembi 每月给予两次。这可以扩大全球约 3900 万阿尔茨海默病患者的可用治疗范围。 Dr. Walter Koroshetz is director of the part of U.S. National Institutes of Health that deals with disorders involving the brain. He said of the vaccines, “They could be worldwide, and not that expensive.” 沃尔特·科罗谢茨 (Walter Koroshetz) 博士是美国国立卫生研究院处理大脑疾病部门的主任。他谈到这些疫苗时说：“它们可能是全球性的，而且不会那么贵。”

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A Closer Look At Lecanemab Donanemab And Amyloid

Dementia Researcher

Play Episode Listen Later Nov 13, 2023 54:21

In this podcast Dr Anna Volkmer, convenes a panel of world-renowned experts from University College London. They discuss the discovery of amyloid and its role in Alzheimer's Disease and take an in-depth look into the latest developments surrounding Lecanemab and Donanemab, monoclonal antibodies (mAbs) as a treatment and Gene Silencing. This week's guests are Professor Sir John Hardy, Geneticist and trailblazer in neurodegenerative disease research, Professor Nick Fox, Neurologist, and eminent figure in the fields of neuroimaging and clinical neuroscience, and Dr Cath Mummery, Neurologist and leading light in cognitive disorders and clinical trials. -- Listeners can expect: 1.

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Episode 16: Alzheimer's and the amyloid hypothesis

The Studies Show

Play Episode Listen Later Nov 7, 2023 63:09

What causes Alzheimer's? The main theory is that it's due to a build-up of amyloid plaques in the brain. But some scientists think that's hopelessly wrong, and that a hidebound belief in the amyloid hypothesis is stopping us from finding a cure.In this episode of The Studies Show, Tom and Stuart talk about the amyloid hypothesis of Alzheimer's, ask whether all the hype over the three recent Alzheimer's drugs (“a momentous breakthrough!”) is justified, and look at some ways we could do better research on dementia.The Studies Show is supported by the i, the UK's smartest daily newspaper. You can get a money-off deal on your digital subscription—which includes full access to all Stuart's science writing—by following this special podcast link.The Studies Show is brought to you by Works in Progress, the online magazine about science, technology, and human progress. If you're a listener to The Studies Show, it's a dead-cert that you'll love Works in Progress - and it's all available for free. Find the magazine at this link.Show notes* The Mini-Mental State Examination (MMSE) - the test Stuart quotes at the start* NHS list of Alzheimer's symptoms* List and discussion of possible theories for the cause of Alzheimer's* Chris Hemsworth interview about finding out he's at high genetic risk of Alzheimer's* Potential clues about the origin of Alzheimer's from Down Syndrome* Sharon Begley's STAT article on “how an Alzheimer's ‘cabal' thwarted progress toward a cure for decades”* Science investigation of potential fraud in the original Aβ*56 study* Explanation of why it's bad, but not devastating for the amyloid hypothesis* Independent panel urges the FDA not to approve Aducanumab - but they do so anyway* Derek Lowe's highly sceptical discussion of the “disgraceful” approval* Stuart's sceptical article in the i on Lecanemab (link to the trial itself)* BBC article on the “momentous breakthrough”* “16 cautionary notes” on Lecanemab* Stuart's sceptical article in the i on Donanemab (link to the trial itself)* And Stuart's Twitter thread on “clinically meaningful” effects in Alzheimer's* BBC More or Less episode discussing the problems with measuring the effect of an Alzheimer's drug* How do the new Alzheimer's drugs work in theory? One potential explanation* Paper by Elliot Tucker-Drob on how we measure dementia and how we forget about individual differences while doing soCreditsThe Studies Show is produced by Julian Mayers at Yada Yada Productions. This is a public episode. If you'd like to discuss this with other subscribers or get access to bonus episodes, visit www.thestudiesshowpod.com/subscribe

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Radio-Visite: Alzheimer und die Bedeutung neuer Medikamente

NDR Info - Radio-Visite

Play Episode Listen Later Oct 11, 2023 4:54

Lecanemab richtet sich gegen die zerstörerischen Plaques im Gehirn. Der Wirkstoff soll auch in der EU zugelassen werden. Donanemab könnte bald folgen. Ein Gamechanger in der Therapie früher Alzheimer-Stadien? Eine Zusammenfassung der Redezeit-Visite.

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Check-up Semanal: Donanemab no Alzheimer; ACLF na insuficiência hepática crônica agudizada; novos tratamentos da fibrose cística e muito mais!

PEBMED - Notícias médicas

Play Episode Listen Later Sep 11, 2023 8:54

No episódio de hoje do Check-up Semanal, confira as últimas notícias sobre: Donanemab no Alzheimer; ACLF na insuficiência hepática crônica agudizada; novos tratamentos da fibrose cística; cirurgia bariátrica e NASH e sintomas neuropsiquiátricos na demência. Fique por dentro dando o play! Confira esse e outros posts no Portal PEBMED e siga nossas redes sociais! Facebook Instagram Linkedin Twitter

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Endovascular treatment and intracranial tumors; guideline on IVIG use for neuromuscular disorders, pros and cons of donanemab.

Neurology Today - Neurology Today Editor’s Picks

Play Episode Listen Later Sep 7, 2023 5:27

Neurology Today Editor-in-chief Joseph E. Safdieh, MD, FAAN, discusses research that assesses the safety of endovascular treatment post-stroke for people with intracranial tumors, the AANEM guideline on IVIG use for neuromuscular disorders, and the latest data on donanemab.

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Dr Richard Oakley

Well I Know Now with Pippa Kelly

Play Episode Listen Later Aug 30, 2023 42:56

I am sure that many people listening to my podcasts will be aware of two ground-breaking medical breakthroughs that have occurred in recent months. These are the immunotherapy drugs Lecanemab and Donanemab, which is shown to have slowed the decline in memory and cognition of people with early stage Alzheimer's disease by up to 40pc. These drugs do not, like others before them, merely mask the symptoms of Alzheimer's, which accounts for over 60pc of all dementia cases – they modify the disease itself. They bind to the Amyloid plaque that builds up in the brains of those with Alzheimer's, triggering the body's own immune cells to remove the destructive plaque. My guest, Dr Richard Oakley, the Alzheimer's Society's Associate Director of Research, has described the arrival of Donanemab as a turning point in the fight against the disease.Dr Oakley says that treatments like Donanemab are the first steps towards a future where Alzheimer's could be considered a long-term condition. People may have to live with it, but they could have treatments allowing them to manage their symptoms and continue to live fulfilled lives. The big question is: if the drugs become available in the UK, will the NHS be able to deliver them to those they would most benefit? Hosted on Acast. See acast.com/privacy for more information.

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Redaktørens hjørne #51: Vestibulære schwannomer, donanemab mot Alzheimers sykdom, «total body scans»

Stetoskopet – Tidsskriftets podkast

Play Episode Listen Later Aug 24, 2023 22:13

Hva er den biologiske mekanismen bak sammenhengen mellom akutt delirium hos eldre og økt risiko for demens (1, 2)? Bør middelsstore vestibulære schwannomer behandles stereotaktisk ved diagnosetidspunkt, eller bør man vente og se om de vokser (3)? Resultatene av en ny, stor multisenterstudie på bruk av donanemab mot Alzheimers sykdom ble publisert i JAMA i sommer (4–9). Kan den såkalte MIND-dietten forebygge kognitiv svikt (10)? Hvor effektivt er det å bruke transkraniell stimulering mot alvorlig depresjon (11, 12)? En nylig publisert metaanalyse har sett på sykdomsbyrden ved covid-19 i høyinntektsland og lavinntektsland (13). Syfilisforekomsten i USA er på sitt høyeste på over 70 år (14). Stemmer det at antiretroviral terapi (ART) gjør at hivsmittede ikke kan smitte andre (15, 16)? Hvor viktig er det egentlig at du velger riktig størrelse på mansjetten når du skal måle pasientens blodtrykk (17, 18)? Hva skjer når et offentlig helsevesen gradvis privatiseres (19, 20)? Visste du at 83 % av alle land tilbyr gratis skolemat (21)? Influensere har begynt å reklamere for dyre «total body scans» (22). Are Brean deler siste nytt fra internasjonale vitenskapelige tidsskrifter. Se hele litteraturlista her: https://tidsskriftet.no/2023/08/redaktorens-hjorne-51-vestibulaere-schwannomer-donanemab-mot-alzheimers-sykdom-total-body Tilbakemeldinger kan sendes til stetoskopet@tidsskriftet.no. Stetoskopet produseres av Synne Muggerud Sørensen, Are Brean og Julie Didriksen ved Tidsskrift for Den norske legeforening. Ansvarlig redaktør er Are Brean. Jingle og lydteknikk: Håkon Braaten / Moderne media Coverillustrasjon: Stephen Lee

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Donanemab for Alzheimer Disease, Sugary Drinks and Liver Disease, Cervical Cancer Screening, and more

JAMA Editors' Summary: On research in medicine, science, & clinical practice. For physicians, researchers, & clinicians.

Play Episode Listen Later Aug 8, 2023 8:28

Editor's Summary by Anne Rentoumis Cappola, MD, ScM, Associate Editor of JAMA, the Journal of the American Medical Association, for the August 8, 2023, issue.

journal md alzheimer's disease jama associate editor american medical association cancer screenings liver disease scm sugary drinks cervical cancer screening donanemab

Revolutionizing the Dementia fight: Donanemab emerges as a promising breakthrough in medicine - மறதி நோய்க்கான சக்திமிக்க புதிய மருந்து எப்படி செயல்படும்

SBS Tamil - SBS தமிழ்

Play Episode Listen Later Jul 31, 2023 6:44

Game-changing drug Donanemab is found to be slowing Alzheimer's cognitive decline in global trial. Insights from veteran broadcaster, R Sathyanathan." Produced by RaySel. - மறதி நோய் எனப்படும் Dementia அல்லது Alzheimers நோய்க்கு புதிய மருந்து ஒன்று கண்டுபிடிக்கப்பட்டுள்ளதாக அறிவிக்கப்பட்டுள்ளது. இந்த புதிய மருந்தின் பின்னணியை விளக்குகிறார் பல ஆண்டுகளாக ஊடகத்துறையில் பணியாற்றும் இரா.சத்தியநாதன் அவர்கள். அவரோடு உரையாடியவர்: றைசெல்.

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How close are we to ending Alzheimer's?

The Real Story

Play Episode Listen Later Jul 28, 2023 48:39

A new drug, Donanemab, has been hailed as a turning point in the fight against Alzheimer's after a global trial confirms it slows cognitive decline. One trial was shown to have “significantly slowed” the progression of the disease—by 35%. Earlier this year, Lecanemab, the first drug to slow the destruction of the brain in Alzheimer's, received regulatory approval in America. Lecanemab was shown to slow the rate of cognitive decline by 27% in an 18 month study involving participants in the early stages of Alzheimer's. Although not a cure, charities say the results in the journal JAMA mark a new era where Alzheimer's can be treated. The drug works in Alzheimer's disease, not in other types of dementia, such as vascular dementia. But the new drugs are not risk-free treatments. Brain swelling was a common side-effect in up to a third of patients in the Donanemab trial. The World Health Organisation forecasts more than 150m people around the world will be living with dementia by 2050. Until recently, we've been told that there are currently no approaches that have been proven to prevent Alzheimer's disease and related dementias. But are we beginning to see a future where we can make dementia a chronic condition, one you live with and die with but don't die from? Are we inching closer towards a treatment for dementia? Can we ultimately prevent or cure the disease? In the battle against dementia, is the end in sight? Shaun Ley is joined by: Reisa Sperling - Professor of Neurology at Harvard Medical School and Director of the Center for Alzheimer's Research and Treatment at Brigham and Women's Hospital. Dr Sandeep Jauhar - cardiologist and the author of "My Father's Brain", a memoir of his relationship with his father as he succumbed to dementia. Sir John Hardy - Professor of Neurodegenerative Disease at University College London. Also featuring: Paola Barbarino - chief executive of Alzheimer's Disease International. (Photo: Caregiver Nadia Chebil (L) helps Alzheimer's patient Jean-Marie (R) at "Les Papillons de Marcelle" house, in Arles, southeastern France, on May 9, 2023. Credit: Clement Mahoudeau/AFP via Getty Images)

94: The Discussion Surrounding Lecanemab's Approval for Alzheimer Disease

BioLab Collective with Jack Wang

Play Episode Listen Later Jul 28, 2023 47:36

Welcome to the NeurologyLive® Mind Moments® podcast. Tune in to hear leaders in neurology sound off on topics that impact your clinical practice. This episode features an in-depth dive into the recent approval of lecanemab (Leqembi; Eisai) for Alzheimer disease and the ongoing debate about its potential benefit, the amyloid-targeting class of medicines, and the communication of data. Featured in this episode is commentary from 2 experts in neurology clinical care: Anton P. Porsteinsson, MD, the William B. and Sheila Konar Professor of Psychiatry, Neurology, Neuroscience, and Medicine, and the director of the Alzheimer's Disease Care, Research and Education Program at the University of Rochester School of Medicine and Dentistry; and Alberto Espay, MD, PhD, the division director and Research Endowed Chair of the James J. and Joan A. Gardner Family Center for Parkinson's Disease and Movement Disorders, and a professor of clinical neurology and rehabilitation medicine at the University of Cincinnati. Looking for more Alzheimer disease discussion? Check out the NeurologyLive® dementia and Alzheimer disease clinical focus page. Episode Breakdown: 1:45 – Introduction and main findings 3:15 – Espay, with his perspective on the downstream effects of the approval 10:10 – Porsteinsson, with his perspective on the downstream effects of the approval 18:30 – Secondary end points and safety data 20:05 – Porsteinsson, on the recent progress in AD 23:05 – Espay, on contextualizing the effect of amyloid clearance 26:00 – Porsteinsson, on the logistics of the approval 34:20 – Espay, on the lingering unanswered questions 38:20 – Espay, on the communication of data to the public around the amyloid therapies 42:25 – Porsteinsson, on how things evolve going forward This episode is brought to you by Medical World News, a streaming channel from MJH Life Sciences®. Check out new content and shows every day, only at medicalworldnews.com. The stories and studies featured in this week's show, as well as additional expert interviews on lecanemab, can be found here: Show notes: Alberto Espay's lecanemab data infographic Lecanemab CLARITY data Donanameb TRAILBLAZER data Additional reading and coverage: FDA Grants Traditional Approval to Lecanemab as Therapy for Early-Stage Alzheimer Disease Medicare Expands Coverage for Fully Approved Alzheimer Agent Lecanemab Lecanemab to be Tested in Preclinical Alzheimer Disease Therapeutics Aim at Modifying Alzheimer Disease Additional expert interviews: David Bates, PhD: Downstream Impacts of Lecanemab on Alzheimer Disease, Future Drug Development Howard Fillit, MD: Lecanemab's Impact on Care and Diagnosis and the Future of Alzheimer Disease Treatment Nicole Fowler, PhD, MHSA: Preparing Primary Care Centers for New Wave of Alzheimer Agents Ronald C. Petersen, MD, PhD: Lessons Learned About Clinically Meaningful Benefit from Antiamyloid Trials Sharon Cohen, MD, FRCPC: Significance of Expanding Antiamyloid Therapy Class, Toolbox to Treat Alzheimer Thanks for listening to the NeurologyLive® Mind Moments® podcast. To support the show, be sure to rate, review, and subscribe wherever you listen to podcasts. For more neurology news and expert-driven content, visit neurologylive.com. REFERENCES 1. FDA Converts Novel Alzheimer's Disease Treatment to Traditional Approval. FDA. News release. July 6, 2023. Accessed July 27, 2023. https://www.fda.gov/news-events/press-announcements/fda-converts-novel-alzheimers-disease-treatment-traditional-approval 2. van Dyck CH, Swanson CJ, Aisen P, et al. Lecanemab in early Alzheimer's disease. N Engl J Med. 2023;388:9-21. doi:10.1056/NEJMoa2212948 3. Sims JR, Zimmer JA, Evans CD, et al. Donanemab in Early Symptomatic Alzheimer Disease: The TRAILBLAZER-ALZ 2 Randomized Clinical Trial. JAMA. Published online July 17, 2023. doi:10.1001/jama.2023.13239

#015: Leqembi vs Donanemab - Cure for Alzheimer's?

Play Episode Listen Later Jul 27, 2023 28:27

After decades of failed drug trials, two new drugs have emerged in slowing memory loss associated with Alzheimer's disease: Leqembi and Donanemab. In Episode #015 I deep dive into novel Alzheimer's therapies to discuss their effectiveness, safety, and how to find out if you're at risk.Chapters:(0:00) Introduction (2:00) Who's most at risk of Alzheimer's Disease? (5:52) The Amyloid Hypothesis (7:14) Leqembi approved by FDA (9:16) Donanenmab may be next (12:10) Alzheimer's drugs, brain bleeding, and death (16:01) How do you know if you have Alzheimer's? (21:20) Dementia and CTE (22:49) Do taking smart drugs make us more productive? Is it worth the risk? (27:00) The Connect - viewers' comments from previous episodesShow Notes:Alzheimer's drug being tested Leqembi or Lecanemabhttps://www.abc.net.au/news/2023-07-07/alzheimer-s-disease-drug-leqembi-gets-green-light-in-us/102575974Donanemab:https://www.abc.net.au/news/2023-05-04/eli-lilly-drug-alzheimer-cognitive-decline-by-35-per-cent/102301474Systematic failure of Alzheimer's drug trials:https://www.abc.net.au/news/health/2020-02-26/alzheimers-drug-failure-raises-questions-about-research/11996258Are these drugs safe?https://www.science.org/content/article/alzheimer-s-trial-shows-clear-benefits-and-significant-risks-eli-lilly-antibodySymptoms of Alzheimer's:https://www.dementia.org.au/about-dementia/types-of-dementia/alzheimers-disease?gclid=Cj0KCQjwzdOlBhCNARIsAPMwjbz46yEPHVQnD-rqxwHOQrtlHnD2gWQdBRIGW9fc-bDlQzjxd2M-TfgaAvMOEALw_wcBMini Mental State Examination (MMSE)https://cgatoolkit.ca/Uploads/ContentDocuments/MMSE.pdfCTE in female athlete:https://theconversation.com/australian-researchers-confirm-worlds-first-case-of-dementia-linked-to-repetitive-brain-trauma-in-a-female-athlete-208929Smart drugs make you dumb:https://theconversation.com/smart-drugs-make-you-worse-at-solving-complex-problems-new-study-finds-207711Thanks for reading BioLab Collective with Jack Wang! Subscribe for free to receive new posts and support my work. Get full access to BioLab Collective with Jack Wang at biolabcollective.substack.com/subscribe

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Edo Richard and Craig Ritchie: Are Alzheimer's drugs false hope? | Talk to Al Jazeera

Talk to Al Jazeera

Play Episode Listen Later Jul 22, 2023 25:50

Dementia affects 55 million people worldwide, and its most common form, Alzheimer's, accounts for about 70 percent of all cases.At the Alzheimer's Association International Conference, the largest congress advocating dementia science, held in Amsterdam this month, a pharmaceutical company disclosed details of its trials of a new drug: donanemab.The American company, Eli Lilly, expects the United States Food and Drug Administration (FDA) to decide by the end of 2023 whether to approve what it is calling a "breakthrough" drug.But is this medication the best way forward? Or does it just supply cash flow for the pharmaceutical industry?Leading dementia scientists Edo Richard and Craig Ritchie talk to Al Jazeera.Subscribe to our channel http://bit.ly/AJSubscribeFollow us on Twitter https://twitter.com/AJEnglishFind us on Facebook https://www.facebook.com/aljazeeraCheck our website: http://www.aljazeera.com/Check out our Instagram page: https://www.instagram.com/aljazeeraenglish/@AljazeeraEnglish#Aljazeeraenglish#News

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Alzheimer's drug, and algae vegan vitamins

The Naked Scientists Podcast

Play Episode Listen Later Jul 21, 2023 27:49

A new drug in the fight against Alzheimer's disease: how does it work? Plus, we'll also have the latest on measles cases in London, look at the calls to reset the lunar clock, and could algae help people who are seeking to increase vitamin B12 in their diet? Like this podcast? Please help us by supporting the Naked Scientists

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Jami Dulaney MD Plant Based Running and Wellness Podcast: Episode 440:Be In Control of Your Healthspan

Jami Dulaney MD Plant Based Wellness

Play Episode Listen Later Jul 21, 2023 37:07

Welcome! and Thank you for listening. Donanemab for Alzheimers. Muscle fatigue and its affect on your heart and lungs. Fitness affects on cancer risk and mortality Hypertension treatment and risks. How do these things affect your quality of life? I believe that you have more control than you realize. Are you worrying? Are you living life with your head in the sand? Are you training for an active life? I will tie these topics together during this episode. Enjoy the day, it will be a good one. Email me at jami@doctordulaney.com Website:doctordulaney.com https://www.amazon.com/Plant-based-Wellness-Cookbook-Generations-Cooking/dp/1733967702/ref=sxts_sxwds-bia-wc-nc-drs1_0?cv_ct_cx=doctor+and+diva&dchild=1&keywords=doctor+and+diva&pd_rd_i=1733967702&pd_rd_r=b4b3e11f-e7c1-4a71-a571-54903174e969&pd_rd_w=jpaTr&pd_rd_wg=GNibG&pf_rd_p=8f655ecb-bc8c-4750-9088-950aa74d52dd&pf_rd_r=JMDW81JEWW3K2VMA0JND&psc=1&qid=1608320722&sr=1-1-88388c6d-14b8-4f70-90f6-05ac39e80cc0

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S4 E15: Donanemab & Alzheimer's Disease; Diet Against Dementia; Weekend Exercise; Opioids & Acute Back Pain

NB Hot Topics Podcast

Play Episode Listen Later Jul 21, 2023 16:33 Transcription Available

Welcome to the Hot Topics podcast from NB Medical with Dr Neal Tucker. School's out for summer but general practice never stops. This week we look at the medical news story of the week: donanemab for Alzheimer's disease - can this monoclonal antibody revolutionise dementia care? Also in research, prevention is better than a cure, so can a Mediterranean-DASH diet keep cognitive decline at bay? For you weekend warriors out there, is cramming exercise into the weekend as good as exercising throughout the week. A new paper in JAMA answers this question. And is there ANY role for opioids in acute back pain? A new Australian study goes strong to see if there is benefit with this common problem.Don't forget to check out all our upcoming courses including the new Hot Topics course in September and much more on www.nbmedical.com. ReferencesJAMA DonanemabNEJM MIND diet for dementia preventionJAMA Weekend warriors and CVD riskLancet Opioids for Low back and neck pain

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Cosa cambia per le piante geneticamente modificate

Ci vuole una scienza

Play Episode Listen Later Jul 21, 2023 32:29

La Commissione Europea ha presentato un'attesa proposta per aggiornare le normative sulle modifiche genetiche in agricoltura, riducendo i vincoli per le nuove tecniche che permettono di modificare in modo più preciso e diretto il DNA e che diventeranno sempre meno costose e accessibili, rispetto a quelle “classiche” per gli OGM che già conosciamo. È l'inizio di una rivoluzione che ci riguarderà da vicino, a partire da cosa ci troveremo nel piatto. Vedremo poi novità promettenti per trattare la malattia di Alzheimer e la storia delle quarantene lunari.LEGGI SUL POST- Che cos'è CRISPR/Cas9 e come funziona- La vera sfida di una tecnica rivoluzionaria per modificare il DNA- Siete sicuri di sapere cosa sono gli OGM?- La proposta della Commissione Europea sulle nuove tecniche genomiche- Donanemab nella malattia di Alzheimer sintomatica precoce- Nuovi trattamenti per la malattia di Alzheimer e riesame della politica di rimborso farmaceutico negli Stati Uniti- Un piccolo passo per l'uomo, un enorme balzo per i microbi lunari? Interpretazioni del rischio e i limiti della quarantena nel programma Apollo della NASACi vuole una scienza è un podcast del Post condotto da Emanuele Menietti e Beatrice Mautino.

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Lo que deben de saber sobre el nuevo tratamiento para el Alzheimer - Jueves 20 de julio del 2023

Martha Debayle

Play Episode Listen Later Jul 20, 2023 27:15

Hoy les vamos a hablar sobre el nuevo tratamiento para el Alzheimer, que promete ayudar aún más a los pacientes. . Posiblemente uno de los padecimientos más difíciles para pacientes y sus familias sea el Alzheimer, pero acaban de descubrir que un nuevo tratamiento para el Alzheimer llamado Donanemab hace más lenta la progresión de la enfermedad hasta en un 35%, viene Erwin Chiquete para hablarnos de él.

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Could new drug be a turning point in fight against Alzheimer's?

RTÉ - Morning Ireland

Play Episode Listen Later Jul 18, 2023 4:14

Dr. Laura O'Philbin, Research and Policy Manager at the Alzheimer Society of Ireland, reacts to studies showing a new drug called Donanemab can slow the progression of Alzheimer's.

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Behind the new groundbreaking Alzheimer's drug

Tech and Science Daily | Evening Standard

Play Episode Listen Later Jul 18, 2023 6:55

How Donanemab gives patients months without symptoms. Extreme weather like Europe's heatwave is ‘new normal' - WMO. Could face scans end queues for Eurostar? Neopets are making a comeback. In this episode:Alzheimer's Society's Sian Gregory explains Donanemab drug breakthroughHow hearing aids might reduce cognitive decline in adults at higher dementia riskMillions of US military emails ‘sent to Russia ally Mali by mistake due to typing errors'Face scans set up to cut congestion for Eurostar passengersGreen turtles fed at same seagrass meadows 3,000 years agoFollow us on Twitter or on Threads. Hosted on Acast. See acast.com/privacy for more information.

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Groundbreaking new drug could change the life of Alzheimer's patients

Mornings with Gareth Parker

Play Episode Listen Later Jul 18, 2023 7:57

A groundbreaking treatment study into Alzheimer's disease has shown how the drug Donanemab can slow the progression of the disease. See omnystudio.com/listener for privacy information.

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New Alzheimer's drug hailed a 'miracle'

Global News Podcast

Play Episode Listen Later Jul 17, 2023 27:59

A large trial has confirmed the drug, Donanemab, slows cognitive decline by a-third. Also: Working From Anywhere - the trend taking off in offices across the world, and the 80-year-old who's finally going into space.

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Ep. 186 - 3Q Markets Preview, Donanemab & Lilly-Versanis

BioCentury This Week

Play Episode Listen Later Jul 17, 2023 19:16

With investors seeing the worst days fading into the rearview mirror, the sector has begun to chart a path out of the biotech bear market. On the latest BioCentury This Week podcast, BioCentury's editors discuss the indicators to watch for a recovery as described in the 3Q23 Financial Markets Preview. They also analyze the latest data from Alzheimer's therapy donanemab from Eli Lilly, noting it sheds light on which patients stand to benefit from the therapy, and they discuss the pharma's takeout of Versanis Bio to expand its obesity portfolio and improve the quality of weight loss it can achieve.

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New Alzheimer's drug 'very significant' in slowing disease's progression

Highlights from The Hard Shoulder

Play Episode Listen Later Jul 17, 2023 6:32

A new drug has been found to slow the progression of Alzheimer's, with experts hailing it as a "turning point". Donanemab was shown to reduce cognitive decline by up to 35 percent, if the disease is detected early. Roger Highfield, Science Director at the London Science Museum joined Kieran to discuss...

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Lilly looks to lead in Alzheimer's

The Pharma Letter Podcast

Play Episode Listen Later Jul 17, 2023 17:20

With an Accelerated nod for Aduhelm (aducanumab) and now full approval for Leqembi (lecanemab) in the USA, Biogen (Nasdaq: BIIB) and Eisai (TYO: 4523) have overturned decades of failure in Alzheimer's.But at the annual meeting of the Alzheimer's Association (AAIC), it's another neurology heavyweight taking center stage, as Eli Lilly (NYSE: LLY) makes clear its intention to remain a leader in the treatment of this challenging disease.At the AAIC in Amsterdam, we're speaking with two key figures from the development program for donanemab, a candidate which could slow cognitive decline for millions of people with early Alzheimer's, while generating billions in annual revenues.Lilly is presenting full results from a key Phase III trial of its antibody, which like Leqmebi, clears aberrant proteins from the brain with the goal of combatting neurodegeneration.There are important differences between the way the two molecules work, however, and Lilly is confident its approach, which includes limited duration dosing, offers the best chance of success.The new data, which form part of a regulatory submission for approval in the USA, seem to bear this out. As with other therapies in this class, all eyes will be on safety, and Lilly hopes that “treating to clear,” and then holding off on dosing, could help avoid side effects.Like Eisai, Lilly is also interested in developing a subcutaneous treatment in future, with early data for another molecule, remternetug, showing strong potential in this regard.We discuss all of this and more, in Episode 24 of The Pharma Letter Podcast.

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AAIC preview with Eisai deputy CCO Michael Irizarry

The Pharma Letter Podcast

Play Episode Listen Later Jul 6, 2023 22:43

In the runup to the annual meeting of the Alzheimer's Association, this week we are speaking with Michael Irizarry, deputy chief clinical officer at Eisai US.At the event in July, there will be plenty to discuss, with recent new data from Eli Lilly (NYSE: LLY) suggesting its anti-amyloid candidate, donanemab, is likely to provide healthy competition for Eisai's (TYO: 4523) own Alzheimer's product, lecanemab - marketed in the USA as Leqembi.Like Lilly, Eisai has been a pioneer in neurology, sticking with its Alzheimer's research even when times were tough and it looked like a clinical breakthrough would never come.That we are now talking about potentially three approved products for early Alzheimer's shows how quickly development has advanced - as both Lilly and Eisai look ahead to the possibility of offering more beneficial subcutaneous treatments in future.In the podcast this week, we will discuss Eisai's upcoming presentations at AAIC and consider what the future might hold for the treatment of Alzheimer's.

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Positive Results in Alzheimer's: Are We Now Pushing the Right Buttons?

On Medical Grounds

Play Episode Listen Later Jun 29, 2023 25:03 Transcription Available

Dr. Curtis Schreiber is the medical director at the Missouri Memory Center and was a principal investigator of a Phase III study for donanemab for patients with Alzheimer's Disease. Many of his patients were enrolled in the trial and the encouraging results were recently released. Dr. Schreiber is with us today to discuss his work and the findings from this important study. The full read-out of the top line results for donanemab will be coming out on July 17 at an international Alzheimer's conference followed by a publication in the Journal of the American Medical Association (JAMA) which will be linked here on release.MISSOURI MEMORY CENTER STUDY SUMMARY:In the phase III study, donanemab significantly slowed cognitive and functional decline in patients with early symptomatic Alzheimer's. Results reported by Eli Lilly & Co. include:• 47% of participants on donanemab showed no decline based on a key measure of disease severity at one year compared to 29% of participants on placebo.• Participants on donanemab had a 40% less decline in their ability to perform activities of daily living at 18 months.• Participants on donanemab experienced a 39% lower risk of progressing to the next stage of disease compared to placebo.Another Alzheimer's drug, lecanemab is expected to receive full FDA approval on July 6th. Phase III trial results showed that lecanemab slowed cognitive decline by 27%.(00:48) Introducing Dr. Curtis Schreiber(01:43) Optimizm for Alzheimer's treatment(03:03) Statistical findings from phase III donanemab trial(05:50) Participant recruitment and selection(07:07) What is donanemab?(08:05) Why does it work and how is it administered?(09:19) Donanemab side effects(13:58) How does donanemab compare to other drugs?(15:14) Lifestyle of study participants(16:30) Lifestyle modifications for Alzheimer's risk(17:49) Alzheimer's genetics(21:05) Why Dr. Schreiber switched from engineering to neurology(22:30) His personal reason for studying Alzheimer's (23:54) Hope for Alzheimer'sVisit us at OnMedicalGrounds.com for more podcasts! You can subscribe through your podcast platform, our website, or follow us on social media for podcast updates and medical news. Some of our podcasts offer FREE CME/CE credits.LinkTreeTwitterLinkedInInstagram

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June is Alzheimer's Awareness month: New research provides hope for new treatment

Steve Cochran on The Big 89

Play Episode Listen Later Jun 6, 2023 18:42

Northwestern Medicine Central DuPage Hospital Chief Medical Officer Dr. Kevin Most joins the Steve Cochran Show to discuss the discovery of Alzheimer's disease, how to tell the difference between old age forgetfulness & dementia, and treatments to slow the progression of this disease. Read all of Dr. Most's notes below and listen every Tuesday morning for more medical news. June is Alzheimer's Awareness month Alzheimer's is named after Dr. Alzheimer, who in 1906 had a patient who died with what was then unusual mental illness- after she died he examined her brain and found abnormal clumps, now known to be amyloid and tangled fibers Alzheimer's is the most common cause of Dementia, accounting for 60-80% of all dementia cases- Close to 7 million Americans are living with dementia, 230,000 in Illinois alone Alzheimer's is the 6th leading cause of death The number of cases is felt to be much higher as many cases will go undiagnosed and untreated There is no blood test or screening test to predict Alzheimer's , the diagnosis is made after symptoms are noted, by this time the disease has caused significant damage The age group of over 65 is growing dramatically so the number of cases of dementia is expected to rise. 1 in 9 adults over the age of 65 is in some stage of Alzheimer's We do not have enough long term care facilities or care givers for the expected increase in cases. It is thought that Alzheimer's begins 20 years before memory loss or other symptoms begin, stressing how important it is for research to work on early detection Alzheimer's moves thru stages- Mild- some memory loss- cognitive function decreases- wandering- getting lost- paying bills a problem- personality and behavior changes Moderate- loss of language control, sensory processing- memory loss is worse- difficulty learning new things- difficulty carrying out multitask steps- getting dressed- Severe- loss of ability to communicate- completely dependent on others for their care- mobility is limited The greatest risk factor is age, but Alzheimer's is not a part of normal aging Rosalynn Carter shared diagnosis of Dementia this past week 10 Early Signs of Alzheimer's Memory that disrupts daily life- forgetting recently learned information- asking the same question over and over. With age related change- we will forget names or events but remember them later Challenges in planning or problem solving- signs include things as common as following a recipe, or keeping track of monthly bills Difficulty completing familiar tasks- like driving to a familiar location, organizing a grocery list Confusion with time and place- lose track of dates and seasons, forgetting where they are or how they got there Vision problems that may lead to difficulty with balance or reading, difficulty judging distances Trouble following or joining a conversation. Stop in middle of a conversation and have no idea how to continue, Difficulty naming a familiar object Misplacing things or placing objects in unusual places and then be unable to retrace steps Poor judgement or decision making- may notice this with money decisions or even grooming Withdrawal from work or social activities- unable to converse in a group, or keeping up with a team activity Changes in mood/personality- confusion- suspicious- depressed- fearful Basics of the brain Made up of 3 main parts- Cerebrum-memory- problem solving- thinking- feeling- movement- vision. Cerebellum- coordination and balance Brainstem- connects the brain to the spinal cord- controls breathing- heart rate- blood pressure The brain uses a lot of energy and oxygen- it uses about 25 % of oxygen and fuel, yet doesn't weigh much as a percentage The brain works with chemicals and electrical activity- amazing- think about it, you see something or read something and an electrical and chemical activity stores that in your brain for future use. Your brain tells your arm to move whether you are doing surgery, playing an instrument or taking out the garbage. It tells you what to do and how to do it. In Alzheimer's we see brain cell death and plaques and tangles making the communication between cells impossible When these healthy connections are stopped those brain cells then die In Alzheimer patients proteins called beta amyloid clump together and build plaques- these block the areas where the signals in the brain occur. The progression of this illness follows a pattern of spread in the brain. Cause of Alzheimer's There is not a single cause of Alzheimer's that has been identified. There are risk factors- age- family history-head injury- heart/head connection Treatment options for Alzheimer's Recently there have been medications that have shown to slow the pace of Alzheimer's by a third There are 2 that are close to approval- ADUHELM and LEQEMBI – these are placed on an accelerated approval The most recent medication is an antibody that is designed to attack beta amyloid- DONANEMAB- they also are looking for accelerated approval. Medicare announced Thursday that it will cover drugs that are granted full approval. For a drug to go from accelerated approval to full approval more clinical trials are required. RUSH and U of C, are all participating in current trials, awaiting now to see what trials will open for more patients Each of these medications is expected to cost over $25,000 a year, placing them out of reach for most patients. Will Medicare be able to push for a lower cost? These medications appear to slow the build up of the amyloid, thus slowing the progression of the disease The latest drug from Lilly--- Donanemab, was given to 1700 individuals, it was given as a monthly infusion- pace of disease was slowed by 30-35%, it also improved daily functions The medication is given once a month by infusion. The medication worked so well that over half of the individuals were able to stop the medication within one year. The patients who stopped taking the medication are continued to be monitored to see if the amyloid returns and at what rate Plaque buildup of amyloid is the hallmark of Alzheimer's, it was unclear what role amyloid played. There are individuals with no signs of dementia yet still have significant amyloid Many drugs are in development focused on slowing amyloid, or breaking down amyloid, even though the link is not clear, it is part of the of the development it appears This study shows that removing the amyloid, slows the cognitive decline in patients with early Alzheimer's Lilly plans on filing for approval within the next 2 months and will be asking for accelerated approval This is exciting as other drugs are in the pipeline also looking at the slowing of amyloid plaque as well as removing plaque. Now that we have 2 drugs that attack beta amyloid with some success it has convinced scientists they are on the right track These drugs work in the early stages of Alzheimer's, so now we know the key to success here will also be in early diagnosis. Studies are now going on using Artificial Intelligence looking at MRI scans and other medical data points and identifying Alzheimer's before symptoms or at an early stage, Studies are being done at Mass General, Emory and University of Florida Once the algorithm is set and tested this could be expanded across the country. See omnystudio.com/listener for privacy information.

Alzheimer's warning signs to watch for — as new drugs give patients hope

Minnesota Now

Play Episode Listen Later May 30, 2023 9:20

More than six million people in the United States have Alzheimer's disease, a brain wasting disease that has been notoriously difficult to treat. Earlier this month, new research came out from the drugmaker Eli Lilly about a potential new Alzheimer's drug called Donanemab. It was shown to slow cognitive decline by more than 30 percent. That hopeful news comes right before Alzheimer's and Brain Awareness Month, which occurs in June. With that in mind, we've asked Dr. Jay Sheree Allen from the Mayo Clinic to share warning signs and treatment for Alzheimer's disease.

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Le Donanemab, candidat médicament contre la maladie d'Alzheimer - Focus

Podcasts sur Alzheimer, la radio

Play Episode Listen Later May 22, 2023 14:58

Le Donanemab, candidat médicament contre la maladie d'Alzheimer, valide une étude clinique de phase 3. Développé par le laboratoire Lilly, le donanemab est un anticorps monoclonal dirigé contre la protéine amyloïde. L'étude clinique de phase 3 TRAILBLAZER-ALZ 2 remplit ses attentes et montre un ralentissement du déclin cognitif et fonctionnel chez des patients atteints d'une maladie d'Alzheimer à un stade léger.

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Big Picture Medicine

Play Episode Listen Later May 12, 2023 32:20

0:00 Intro 0:38 VC Dirty Money (LP Sources) 8:30 Power Dynamics Founder vs VC 12:56 Trillion $ Alzheimer's Opportunity 14:26 Eli Lily's New Alzheimer's Blockbuster (?) Donanemab 19:01 More Issues with Donanemab Phase III Results 21:48 Will Anyone Pay for Donanemab? 24:13 Donanemab Side Effects 27:15 Startup Opportunities in Alzheimer's 31:34 Outro Articles Mentioned Founders need to take a stand against VC's 'dirty money': https://sifted.eu/articles/founders-vc-dirty-money Eli Lily Donanemab Phase III Press Release: https://investor.lilly.com/news-releases/news-release-details/lillys-donanemab-significantly-slowed-cognitive-and-functional Cost Effectiveness of Donanemab: https://pubmed.ncbi.nlm.nih.gov/35344024/ Podcast Links YouTube: https://www.youtube.com/@bigpicturemedicine Apple: https://podcasts.apple.com/gb/podcast/big-picture-medicine/id1500446262 Spotify: https://open.spotify.com/show/5707RPmWOJkVZyUHNRSUfS?si=96c7fff6bccb456a People Dr Imran Mahmud: https://www.imranmahmud.com/ Dr Adam Bataineh: https://twitter.com/DrAdamBat?s=20 Dr Mustafa Sultan: https://www.musty.io/

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Donanemab: A New Ray of Hope in the Fight Against Alzheimer's

Brain Health and Beyond with Team Sherzai, MD

Play Episode Listen Later May 11, 2023 48:18

Welcome to the latest episode of our podcast, where we discuss the latest breakthrough in the fight against Alzheimer's disease. In today's episode, we discussed the new monoclonal antibidy, Donanemab, that is offering hope to Alzheimer's patients and their families, and how Donanemab is different from other treatments. Donanemab is a monoclonal antibody that has shown promising results in clinical trials. It works by targeting a protein called amyloid-beta, which is believed to play a significant role in the development of Alzheimer's disease. The drug binds to the amyloid-beta protein and clears it from the brain, reducing the amount of plaque buildup that causes damage to brain cells. While the results of the clinical trials are promising, there are still many challenges to overcome. Donanemab is expensive and requires regular infusions, which may limit its accessibility. There is also a need for further research to determine the long-term effects of the drug and its efficacy in treating different stages of Alzheimer's. Follow us: Join the NEURO Academy: NEUROacademy.com Follow us on social media: Instagram: The Brain Docs @thebraindocs Facebook: The Brain Docs TikTok: @thebraindocs Website: TheBrainDocs.com

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Lauren Ashburn with the Alzheimer's Association on trial results of donanemab

WBEN Extras

Play Episode Listen Later May 5, 2023 5:19

Lauren Ashburn with the Alzheimer's Association on trial results of donanemab

trial alzheimer's disease ashburn donanemab

Eli Lilly's Alzheimer's Drug Shows Greatest Benefit Yet

TIME's Top Stories

Play Episode Listen Later May 4, 2023 3:23

Donanemab slowed cognitive decline in people with early Alzheimer's disease by 35%, according to the company.

alzheimer's disease benefit drug eli lilly donanemab

Alzheimer-Forschung: Neues Medikament Donanemab kann Verlauf abmildern

SWR2 Impuls - Wissen aktuell

Play Episode Listen Later May 4, 2023 2:44

Ein neues Alzheimer-Medikament mit dem Antikörper Donanemab verlangsamt einer Studie des Herstellers Eli Lilly zufolge, dass die Krankheit im frühen Stadium fortschreitet. Fachleute sprechen von einem „wirklichen Fortschritt“, warnen aber auch vor Nebenwirkungen.

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El drama de cruzar la peligrosa selva del Darién

Noticiero Univision

Play Episode Listen Later May 3, 2023 21:21

En otras noticias: Francisco Oropesa fue detenido en Conroe, Texas y ahora enfrenta 5 cargos de asesinato premeditado. Su pareja también fue detenida por obstrucción a las autoridades.Ante la noticia del arresto de Oropesa, las familias de las víctimas exigen justicia desde Honduras.Atlanta está en máxima alerta luego de que un hombre escapara tras asesinar a tiros a una mujer y dejar varios heridos en un centro médico. Ante el inminente fin del Título 42 y la creciente crisis migratoria en la frontera que comparten ambos países, México y Estados Unidos llegaron a nuevos acuerdos para frenar y organizar la migración irregular. Autoridades buscan al responsable de varios apuñalamientos en serie del que se conocen pocas pistas.

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Business Models in Neurotech

Neurotech Pub

Play Episode Listen Later Mar 3, 2022 105:42

Welcome back to the Season 2 premiere of Neurotech Pub!In this episode, host and Paradromics CEO Matt Angle sits down with fellow Founder/CEOs Carolina Aguilar, Brian Pepin, and Kunal Ghosh to talk shop about building cutting edge neurotech companies from the ground up. We dive deep into business strategies, the neurotech fundraising landscape, emerging therapeutics, and more. We also provide an insider's view of the intersections of data, pharma, and med devices that are shaping the future of healthcare. Pour yourself a cold one and settle in! Check out full video with transcript here: Check out video and a full episode transcript here. 00:00 | Updates & News >> INBRAIN Neuroelectronics raised a $17M Series A >> Rune Labs raised a $22.8 Million Series A >> Inscopix Launched Cloud-Based Platform for Data Management and Analysis2:15 | Meet the panel and pick up a book1:54 | Jester King Brewery 2:25 | Rune Labs 2:50 | Neurostimulator for deep brain stimulation therapy 3:23 | INBRAIN Neuroelectronics 4:11 | Inscopix 5:24 | Ursula K. Le Guin's 'The Dispossessed' 6:19 | Yuval Noah Harari's 'Sapiens: A Brief History of Humankind' 6:32 | Daniel G. Miller's 'The Tree of Knowledge' 6:40 | Jiddu Krishnamurti's 'The Book of Life' 7:34 | Barack Obama's 'A Promised Land,' ‘Dreams from my Father,' & ‘The Audacity of Hope' 7:56 | Karl Popper's 'The Open Society and Its Enemies'9:25 | Venture Capital in Neurotech34:44 | Business Strategy in Neurotech40:32 | Tom Oxley, CEO, Synchron 43:58 | Dr. Thomas Insel 44:06 | Mindstrong Mental Health Care 44:35 | Aduhelm controversy 52:25 | Galvani Bio 59:39 | Percept Neurostimulator 1:00:32 | Neuromodulation and the future of treating brain disease 1:07:21 | Software as a Medical Device FDA Guidance1:09:12 | State of Animal Model Systems1:14:28 | α-Synuclein in Parkinson's Disease 1:18:01 | Alto Neuroscience 1:18:36 | Flatiron Foundation 1:18:45 | Gaurdent Health 1:19:03 | Melanoma Trends & Rates1:21:41 | The Pharma-Data-Device Ecosystem 1:21:42 | Frank Fischer, Chairman of Neuropace 1:22:28 | Neurotech Pub Season 1, Episode 9 1:26:35 | Roche acquisition of Flatiron Health & merger with Foundation Medicine 1:27:12 | Companion Diagnostics 1:28:29 | Adhulem and PET imaging 1:29:09 | Resignations at the FDA over Alzheimer's Drug 1:29:32 | Derek Lowe's take on the Aducanumab Approval, FDA Committee Votes, Halting the Aducanumab Trials, & The FDA Advisory Committee Briefing Document on Aducanumab 1:31:39 | Donanemab receives breakthrough therapy designation in 2021 1:36:58 | Mapping the Frontal-Vagal Pathway 1:37:09 | The Human Connectome Project 1:40:07 | Teal Organizations and Holacracy 1:41:18 | Society for Neuroscience 1:44:37 | Affymetrix (Thermo Fisher Scientific) 1:44:39 | IlluminaWant more?Follow Paradromics & Neurotech Pub on Twitter Follow Matt, Brian, Carolina, & Kunal on Twitter

50: Genetic Testing for Huntington Disease