Podcasts about aduhelm

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's accelerated approval pathway, established in 1992 to expedite the approval of drugs for serious conditions, has been under scrutiny due to recent market withdrawals and failed confirmatory trials. Despite these setbacks, the program has successfully brought over 200 new drugs to market, with more than half ultimately receiving full FDA approval. The accelerated approval pathway has been particularly successful in the cancer space, but is now expanding to include treatments for neurological, rare, and genetic diseases.Recent withdrawals of drugs like Pfizer's Oxbryta for sickle cell disease and Biogen's Aduhelm for Alzheimer's have raised concerns about the risk-benefit proposition of the accelerated approval pathway. To improve the program, experts suggest implementing tighter completion timelines for confirmatory trials and better understanding which biomarkers should be used as surrogate endpoints. Overall, the accelerated approval pathway has been effective in bringing innovative treatments to patients quickly, but there is a need for greater scrutiny and oversight to ensure the safety and efficacy of these drugs. ## A new study published in Nature Communications highlights the potential of CRISPR gene editing technology to treat genetic diseases. Researchers successfully used CRISPR to correct a mutation in blood stem cells from patients with sickle cell disease, demonstrating the potential for this technology to provide a cure for genetic disorders. The study paves the way for future clinical trials using CRISPR to treat a wide range of genetic diseases, offering hope for patients with conditions that currently have limited treatment options.The study published in Nature Communications showcases the promising potential of CRISPR gene editing technology in treating genetic diseases. Researchers were able to correct a mutation in blood stem cells from patients with sickle cell disease, indicating that this technology could potentially offer a cure for genetic disorders. This breakthrough opens up possibilities for future clinical trials utilizing CRISPR to address a variety of genetic diseases, providing optimism for individuals with conditions that are currently difficult to treat. ## The World Health Organization (WHO) recently announced that it will establish a new global hub for pandemic and epidemic intelligence in Berlin, Germany. The hub is intended to improve data sharing and analysis to help countries better prepare for future health emergencies. It will work closely with existing WHO partners and networks to strengthen global surveillance and response efforts.The establishment of this hub comes in response to lessons learned from the COVID-19 pandemic, highlighting the need for enhanced global collaboration and information sharing to effectively respond to health crises. By centralizing intelligence gathering and analysis, the new hub aims to facilitate early detection and response to emerging threats, ultimately reducing the impact of future pandemics and epidemics.The World Health Organization (WHO) has revealed plans to create a new global hub for pandemic and epidemic intelligence in Berlin, Germany. This initiative is designed to enhance data sharing and analysis in order to assist countries in better preparing for potential health emergencies. The hub will collaborate closely with existing WHO partners and networks to bolster worldwide surveillance and response endeavors. The establishment of this hub follows insights gained from the COVID-19 pandemic, underscoring the necessity for heightened international cooperation and information exchange to effectively address health crises. Through consolidating intelligence collection and analysis, the new hub seeks to streamline early detection and response to emerging threats, ultimately mitigating the impact of fort

Europe's CHMP has again ruled in contrast to FDA for a neurology product, this time on Biogen and Eisai's Leqembi for Alzheimer's disease. On the latest BioCentury This Week podcast, BioCentury editors discuss the similarities and differences between Leqembi lecenamab and Aduhelm aducanumab, the first anti-amyloid mAb from Biogen and Eisai and what it means for the next in line from that class, Kisunia donanemab from Eli Lilly. The editors also break down last week's ODAC meeting, which discussed trials in perioperative cancer for checkpoint inhibitors, and talk about the looming delay in reauthorization of the rare pediatric priority review voucher program. They also assess the implications of the investigation by the House Select Committee on the Chinese Communist Party into clinical trials run in Chinese military hospitals and the Xinjiang Uyghur Autonomous region, a story broken last week by Washington Editor Steve Usdin.View full story: https://www.biocentury.com/article/65301002:06 - CHMP Leqembi Decision09:53 - Perioperative Cancer17:45 - Pediatric Review Vouchers 23:55 - Beyond Biosecure

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma and Biotech world.GSK is relying on its flagship program to help find new drugs and vaccines, following disappointments with Ventyx's tyk2 drug suffering setbacks. New Amsterdam's heart drug hits trial goals but disappoints investors, and Boehringer adds to its cancer drug pipeline with a deal for startup Nerio. The industry is exploring the use of eClinical technology to improve clinical trials, while stakeholders are looking for more efficient ways to innovate with real-world evidence. Overall, the biopharma industry is facing challenges and setbacks, but also opportunities for growth and development in various areas of research and development.Boehringer Ingelheim has acquired Nerio Therapeutics for $1.3 billion in order to strengthen its immuno-oncology pipeline with novel immune checkpoint inhibitors. Additionally, Adaptimmune is preparing for potential approval of their first-in-class engineered T cell therapy. In other news, Wuxi Apptec's U.S. revenue dropped slightly as the Biosecure Act looms, while the FDA has flagged safety risks of compounded versions of Novo Nordisk's semaglutide. AbbVie's Skyrizi has received EU approval for ulcerative colitis, and Merck's Keytruda in combination with Padcev has been granted a positive opinion by CHMP for urothelial carcinoma. Other updates include FDA approvals for new oral Alzheimer's therapy and expanded labels for Grifols' SCIG therapy. The biopharma industry is also experiencing layoffs at companies such as Cue, Anokion, and Glycomimetics. Biogen is facing challenges with its neuro drugs, including a recent EU regulatory rejection for Leqembi due to concerns about brain swelling. The company also had a setback with an essential tremor treatment developed with Sage Therapeutics. Despite these failures, Biogen and Sage will continue to work together as part of a two-drug development deal. The industry is exploring preclinical modeling as a potential solution to improve the success rate of neuro drug development. Overall, Biogen's development pipeline is under pressure, especially following the withdrawal of the Alzheimer's drug Aduhelm earlier in the year. The company is facing obstacles in gaining traction with its treatments in both the US and European markets.Optum is planning to lay off over 500 workers in California, affecting various healthcare facilities and remote workers. CHS posted a $13 million loss in the second quarter, despite increases in surgical and outpatient volumes. Lawmakers are urged to support nursing home staffing regulations to protect the elderly, rather than overturning them. The resumption of the VA Oracle EHR rollout is being questioned at a subcommittee hearing. Healthcare leaders are encouraged to use digital tools to address the shortage of mental health providers and meet the growing need for mental health services. Overall, the healthcare industry is facing challenges related to patient communication, staffing regulations, and financial losses.Support the Show.

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.

FDA aprueba Kisunla, un tratamiento innovador contra el Alzheimer tempranoLa Administración de Alimentos y Medicamentos (FDA) ha aprobado Kisunla, un nuevo fármaco de Eli Lilly para tratar el Alzheimer en sus etapas iniciales. Este tratamiento, que se administra mensualmente por vía intravenosa, ha demostrado en ensayos clínicos que puede ralentizar el deterioro cognitivo de los pacientes. Kisunla es el segundo medicamento de este tipo aprobado en Estados Unidos, ofreciendo una nueva esperanza a los afectados por esta devastadora enfermedad.Kisunla promete ralentizar el Alzheimer, con ciertos riesgosLa FDA es la agencia del gobierno de los Estados Unidos responsable de proteger la salud pública mediante la regulación de alimentos, medicamentos y otros productos. Recientemente, ha aprobado Kisunla, un nuevo fármaco desarrollado por Eli Lilly, una importante compañía farmacéutica estadounidense. Eli Lilly es conocida por su trabajo en la investigación y desarrollo de medicamentos innovadores. Kisunla está destinado a tratar el Alzheimer en sus fases iniciales, una enfermedad neurodegenerativa que afecta la memoria y otras funciones cognitivas. La administración de este fármaco es mensual y se ha demostrado que puede ralentizar el deterioro cognitivo, ofreciendo una nueva esperanza a los pacientes.Aunque Kisunla ofrece una nueva esperanza, también presenta algunos inconvenientes. Los efectos secundarios, como la hinchazón y el sangrado cerebral, son preocupaciones significativas. En los ensayos clínicos, alrededor del 20% de los pacientes experimentaron microhemorragias, un porcentaje mayor comparado con Leqembi. Además, el costo del tratamiento es elevado, con un año de terapia estimado en $32,000. Estos factores complican su accesibilidad y uso generalizado, especialmente en entornos con recursos limitados. La implementación del tratamiento requiere una infraestructura compleja y personal capacitado, lo que podría ser un obstáculo para muchos centros de salud.La aprobación de Kisunla marca un avance significativo en la lucha contra el Alzheimer, pero no es la primera vez que un medicamento genera expectativas. En el pasado, tratamientos como Aduhelm también prometieron mucho, pero enfrentaron críticas debido a su efectividad limitada y efectos secundarios. Kisunla, al igual que Leqembi, se basa en la reducción de placas amiloides en el cerebro, un enfoque que ha generado tanto esperanza como escepticismo en la comunidad científica. Los médicos deben evaluar cuidadosamente cada caso para decidir la viabilidad del tratamiento, considerando los beneficios potenciales y los riesgos asociados.La historia de los tratamientos para el Alzheimer está llena de altibajos. Aduhelm, aprobado en 2021, fue retirado del mercado debido a controversias sobre su eficacia y seguridad. Los nuevos medicamentos, como Kisunla y Leqembi, representan un nuevo enfoque basado en la eliminación de placas amiloides, un componente clave en el desarrollo del Alzheimer. Aunque estos tratamientos han mostrado resultados prometedores en ensayos clínicos, la comunidad médica permanece cautelosa. Los efectos secundarios, como ARIA, una anomalía relacionada con la imagen amiloide, siguen siendo una preocupación importante. Es esencial continuar investigando para comprender completamente los beneficios y riesgos de estos tratamientos.Para más detalles y análisis sobre este y otros temas de salud, escucha el pódcast El Siglo 21 es Hoy.

“I'm a short-term pessimist and a long-term optimist” about the potential for AI to transform drug development, Derek Lowe, author of the In the Pipeline blog, told BioCentury Washington Editor Steve Usdin on the latest BioCentury Show. Lowe's skepticism about claims that AI will rapidly transform the field is driven by a belief that the “problems that we have in the drug industry that we want to solve are almost inversely proportional to the ability of AI to solve them." Lowe also discussed the Biosecure Act and U.S. reliance on Chinese contract manufacturing and development organizations; talked about why he hopes and believes the Supreme Court will rule for FDA in litigation over the abortion drug mifepristone; and explained his view that approval of Aduhelm to treat Alzheimer's disease was one of FDA's worst decisions. The BioCentury Show is now available as an audio podcast. The Show, featuring BioCentury one-on-one with an industry KOL, is available on Apple, Spotify and wherever you listen to your favorite podcasts and in video podcast format on BioCentury's YouTube channel.  View full story: https://www.biocentury.com/article/65242700:00 -  The BioCentury Show Podcast 01:51 - Lowe's Blog05:30 - Biosecure Act09:53 - AI & Drug Discovery17:33 - FDA, The Abortion Drug, & Aduhelm22:05 - Lessons from COVID

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.

Aduhelm is a type of drug called a monoclonal antibody, and it's used to remove some of the aberrant proteins thought to cause Alzheimer's disease. Lolita Nidadavolu, a geriatrics expert at Johns Hopkins, says there is much to consider when … Who is a candidate for monoclonal antibodies for Alzheimer's disease? Elizabeth Tracey reports Read More »

Monoclonal antibodies for Alzheimer's disease, like the drug called Aduhelm, attach to aberrant proteins thought to be one cause of the disease, but they only stand to benefit a small number of the people who might be at risk. That's … Only a small percentage of people are candidates for monoclonal antibodies to treat Alzheimer's disease, Elizabeth Tracey reports Read More »

Pink Sheet reporters and editors discuss the FDA's approach to psychedelic drugs (:25), whether postmarket clinical trial data from the Alzheimer's drug Aduhelm will be published (16:32), and the FDA offering more time to find candidates for its new Genetic Metabolic Diseases Advisory Committee (27:19). More On These Topics From The Pink Sheet Lykos' MDMA NDA Leads Upcoming Tests Of US FDA's Psychedelics Draft Guidance: https://pink.citeline.com/PS149813/Lykos-MDMA-NDA-Leads-Upcoming-Tests-Of-US-FDAs-Psychedelics-Draft-Guidance For Psychedelics, US FDA Is Open To Creative Thinking But Firm On Approval Standards: https://pink.citeline.com/PS149812/For-Psychedelics-US-FDA-Is-Open-To-Creative-Thinking-But-Firm-On-Approval-Standards A Visual Trip Through The Psychedelic Pipeline: https://pink.citeline.com/PS149831/A-Visual-Trip-Through-The-Psychedelic-Pipeline Aduhelm's Post-Marketing Studies: At Least One More Data Dump Likely Required By NIH: https://pink.citeline.com/PS149826/Aduhelms-Post-Marketing-Studies-At-Least-One-More-Data-Dump-Likely-Required-By-NIH New US FDA Genetic Metabolic Adcomm Needs More Candidates: https://pink.citeline.com/PS149819/New-US-FDA-Genetic-Metabolic-Adcomm-Needs-More-Candidates

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma and Biotech world.Biogen is facing additional troubles as the Department of Justice (DOJ) and Securities and Exchange Commission (SEC) have issued subpoenas seeking more information. The DOJ is specifically looking into the company's overseas operations, while the SEC is investigating the launch of Biogen's now-discontinued Alzheimer's disease therapy, Aduhelm.In other news, the Federal Trade Commission (FTC) and Department of Health and Human Services (HHS) have launched a probe into the ongoing generic drug shortage. The investigation will focus on possible involvement of group purchasing organizations and drug wholesalers in exacerbating the shortage.Ipsen's Onivyde has been approved as a first-line treatment for metastatic pancreatic cancer. This marks the first new frontline treatment option in over 10 years for adults living with this type of cancer.Latigo Biotherapeutics has raised $135 million in a Series A funding round to enter the non-opioid pain medicine space. The company plans to develop its own Nav1.8 inhibitor for pain management.Bristol Myers Squibb is leading the future of protein degradation with its targeted protein degradation approach. The company aims to design next-generation degraders with precision, agility, and intention to attack disease targets.In other funding news, European-based venture capital firm Earlybird Health has closed a $186 million fund focused on cancer and neuroscience investments in biopharma. Additionally, ADC-focused ProfoundBio has raised $112 million in an oversubscribed Series B round.Brivant, a subsidiary of Roivant Sciences, has announced plans to shut down its MDS-focused division, Vant, following disappointing Phase I/II trial results.The FDA has pushed back the Prescription Drug User Fee Act (PDUFA) date for Rocket Pharmaceuticals' gene therapy for a rare blood disorder.Patients taking semaglutide have seen benefits after total hip replacement surgery, according to recent studies.In other news, Novo Nordisk has acquired Catalent's gene therapy manufacturing business for $1.2 billion.These are the top stories in the biopharmaceutical industry today.

This week, Greg, Heather and Tyler discuss reaction to Novo Nordisk's purchase of Catalent and speculate on what that means for existing manufacturing contracts, customers and consequences with regulators; as well as discussion around the ongoing issues with drug shortages and manufacturing challenges and whether it the move will help accelerate manufacturing for Wegovy and Ozempic. Plus, what's next for Alzheimer's treatment following Biogen's withdrawal of Aduhelm? As mentioned in this episode: you can subscribe to ClinicaSpace for our latest special edition on Leqembi.

Good morning from Pharma and Biotech Daily, the podcast that gives you only what's important to hear in the Pharma and Biotech world. Today, we have several news updates from the industry. Let's dive in.Cigna has sold its Medicare businesses to HCSC for $3.7 billion, exiting a sector that has seen its earnings potential shrink. Despite the sale, Cigna still sees Medicare Advantage as an area for future growth. In other news, the No Surprises Act prevented 10 million surprise bills in the first nine months of 2023, according to insurer groups AHIP and BCBSA. However, they also criticized providers for allegedly abusing the billing dispute resolution process set up by the law. Tenet Healthcare plans to sell four California hospitals to UCI Health for $975 million as part of its efforts to reduce debt. An AI-powered solution is being touted as a way to alleviate the critical shortage of medical coders and boost efficiency and revenue in healthcare systems.In the biotech world, Arch is raising $3 billion for startup investing, continuing its track record of creating and investing in biotech startups. Vertex's non-opioid drug showed positive results in a major trial for pain relief, although it fell short compared to a widely prescribed opioid on a secondary goal. Cell therapy for lupus is gaining attention, with several drugmakers conducting trials in this area. Biogen has decided to discontinue its controversial drug Aduhelm and return the rights to the original developer. AstraZeneca and Daiichi are seeking FDA approval for their drug Enhertu as a "tumor agnostic" treatment. Roche has made changes to its early-stage pipeline, focusing on experimental programs for obesity.In recent developments, Philips has stopped selling sleep and respiratory devices in the US due to a consent decree from the FDA. Teleflora used a documentary approach in its marketing campaign to overcome cynicism about love, while Lay's released time-loop ads inspired by the movie "Groundhog Day." Ocean Spray revealed its first major brand overhaul in over 20 years, and Miller Lite turned fans into walking beer ads for the Super Bowl. McDonald's also made headlines with its Hamburglar character hitting the road in a getaway vehicle. Pepsi Wild Cherry created excitement around the Super Bowl with a Vegas sphere takeover.Cigna is still interested in the Medicare Advantage market despite selling its Medicare division. Providence plans to settle allegations of not fulfilling charity care obligations. Walgreens has confirmed additional layoffs as part of its ongoing efforts to achieve cost savings. The Department of Health and Human Services has finalized a rule on telehealth at opioid treatment programs. A new study found that the availability of telehealth for mental healthcare varies by state. Healthcare executives must consider workforce and consumer concerns about generative AI, according to a survey.Alto Neuroscience and Fractyl Health have both gone public in separate IPOs, joining the recent surge of biotech IPOs. The CMS has sent initial price proposals to drugmakers as part of efforts to reform drug pricing. Kyverna Therapeutics is planning an IPO to support the development of its anti-CD19 CAR-T therapies. The Department of Health and Human Services released new data showing that Americans pay significantly more for prescription drugs compared to other developed countries. The ASGCT Annual Meeting will cover topics such as genome editing, muscular dystrophy, and cell and gene therapy.In financial news, AbbVie reported a beat in its Q4 earnings but expects sales decline in oncology and immunology. Bristol Myers Squibb exceeded Q4 estimates and is looking towards new products and M&A following exclusivity loss. Merck posted $60 billion in sales for 2023 driven by Keytruda and HPV vaccine. GlaxoSmithKline saw an increase in sales thanks to vaccines for RSV and shingles. Takeda reported lower profits but closed a $300 million deal with Protagonis

Biogen will stop selling its Alzheimer's drug, Aduhelm, amid controversy. The Biden Administration makes its initial offers to drug companies on the first ten drugs to be negotiated through Medicare, as courts weigh lawsuits brought by pharmaceutical companies challenging the negotiation process. And, participation in Medicare accountable care organizations is up. That's coming up on today's episode of Gist Healthcare Daily. Hosted on Acast. See acast.com/privacy for more information.

Biogen discontinue Alzheimer treatment; The American Academy of Dermatology issue new acne vulgaris management guidelines; Update for ongoing availability of Paxlovid; Narcolepsy/ADHD treatment recalled for containing wrong drug; FDA warn against copycat eye drop products

Feb. 1, 2024 ~ WJR Senior News Analyst Marie Osborne talks with Paul W about how Biogen ditched Aduhelm, an Alzheimer's drug that was approved amid controversy.

Feb. 1, 2024 ~ After research showed the Alzheimer's drug, Aduhelm wasn't working; they are giving up the rights to it two years after the FDA approved it. Marie Osborne tells Kevin and Tom everything we need to know.

Plus: EBay will pay the federal government to settle allegations that it sold pill presses on its marketplace. And Biogen pulls the plug on its controversial Alzheimer's drug, Aduhelm. Alex Ossola hosts.  Learn more about your ad choices. Visit megaphone.fm/adchoices

In this episode of “The Top Line,” we delve into the FDA's controversial approval of Aduhelm, a drug for Alzheimer's disease, despite an independent advisory committee's resounding rejection. The decision has sparked questions about potential bias within the regulatory body.   Genevieve Kanter, Ph.D., a professor at the USC Sol Price School of Public Policy, joins Fierce's Kevin Dunleavy to discuss the implications of a study published in July in JAMA Health Forum, which found the FDA's propensity to favor positive panel recommendations. They explore the impact of this potential bias on drug development and public health. See omnystudio.com/listener for privacy information.

I discuss the safety and efficacy of the newest Alzheimer's drug treatments, aducanumab (Aduhelm) and lecanemab (Leqembi).

It's been over two years since one of the worst product launches of all time - Aduhelm (aducanumab).  Praised by the FDA, Alzheimer's Association (AA), and Pharma as a “game changer”, but derided by others for the drug's lack of clinical efficacy, risk of severe adverse effects, absence of diversity in trial populations, high costs, and an FDA approval process that was in the kindest words “rife with irregularities”. Instead of Biogen's expected billions of dollars of revenue from Aduhelm, they brought in only $3 million in revenue for all of 2021 (here is my Twitter summary of this fiasco). The outlook on amyloid antibodies are looking brighter though in 2023.  Phase III studies for lecanemab and donanemab have been published showing less worsening of cognition and function receiving these agents versus placebo. This led the FDA to give full approval for lecanemab, which will likely be followed by full approval of donanemab sometime this year. However, as noted in our editorial published with the donanemab trial, the modest benefits of amyloid antibodies would likely not be questioned by patients, clinicians, or payers if amyloid antibodies were low risk, inexpensive, and simple to administer.  However, they are none of these.  So what is the role of individuals like geriatricians in prescribing amyloid antibodies and caring for individuals who are receiving them?  We invited three geriatricians and memory care doctors, Nate Chin, Sharon Brangman, and Jason Karlawish, to talk about this question and many others swirling around on how to safely prescribe these drugs and manage patients on them (like what to do about anticoagulation). Lastly, we also spend a little bit of time talking about the NIA-AA draft statement on redefining Alzhiemers disease.  There is a lot to digest with these draft clinical guidelines but the big change from the 2018 guideline is moving Alzheimers to a biological diagnosis (biomarker evidence only) not just for a research framework but now from a clinical one.  One outcome would be a very large population of older adults with normal cognition could now be classified as having Alzheimer's disease (maybe about a 1/3 of cognitively normal 75 year olds based on PET). So if you have thoughts on the matter, please give your feedback here to the NIA and AA. https://aaic.alz.org/nia-aa.asp By: Eric Widera

Leqembi was just approved to treat early stage Alzheimer's. In this solo episode, host David Williams shares five thoughts.Leqembi is just different enough from Aduhelm to survive scrutinyPatient registry requirement is a good ideaThe delivery system isn't readyHealth equity will sufferPublic health and prevention would be money better spentSupport the showHost David E. Williams is president of healthcare strategy consulting firm Health Business Group. Produced by Dafna Williams.

FDA just approved Leqembi, a drug to slow the cognitive decline of Alzheimer's patients, and Medicare has agreed to pay for it. Is it time for patients, families and physicians to be excited? Or do we need to temper our hopes?ABOUT CARETALKCareTalk is a weekly podcast that provides an incisive, no B.S. view of the US healthcare industry. Join co-hosts John Driscoll (President U.S. Healthcare and EVP, Walgreens Boots Alliance) and David Williams (President, Health Business Group) as they debate the latest in US healthcare news, business and policy.GET IN TOUCHBecome a CareTalk sponsorGuest appearance requestsVisit us on the webFOLLOW CARETALKSpotifyApple PodcastsGoogle PodcastsFollow us on LinkedIn#leqembi #alzheimers #pharma #FDA #medicare #medicaid #aduhelmSubscribe to the CareTalk Newsletter to access exclusive content and insights covering the biggest topics in healthcare today. Check out the CareTalk Store for official merch!CareTalk is produced by Grippi Media

Holyoke Media, en asociación con WHMP radio, emiten diariamente la Síntesis informativa en español a través del 101.5 FM y en el 1240 / 1400 AM. Esta es la síntesis informativa del viernes 7 de julio de 2023: La representante estadounidense Marjorie Taylor Greene, una fiel aliada del expresidente Donald Trump, fue expulsada del grupo House Freedom Caucus de línea dura después de enfrentarse con una colega legisladora, dijo un miembro del caucus. La decisión de expulsar a la incendiaria Greene del grupo de línea dura de aproximadamente tres docenas de personas se produjo semanas después de que ella participara en un acalorado enfrentamiento en el piso de la Cámara de Representantes con la representante Lauren Boebert sobre el plan de esta última para tratar de forzar una votación para destituir al presidente demócrata Joe Biden. En una declaración a los medios el jueves por la noche, Greene no se dirigió directamente a su membresía en Freedom Caucus, pero dijo: "En el Congreso, sirvo al noroeste de Georgia primero y no sirvo a ningún grupo en Washington". Greene agregó: "El Partido Republicano tiene menos de dos años para mostrarle a Estados Unidos lo que hará un Congreso fuerte y unificado liderado por republicanos cuando el presidente Trump gane la Casa Blanca en 2024. Este es mi enfoque, nada más". FUENTE: REUTERS Las autoridades estadounidenses otorgaron el jueves la aprobación total a un fármaco para el Alzhe imer que se sigue de cerca, allanando el camino para que Medicare y otros planes de seguros comiencen a cubrir el tratamiento de las personas con la enfermedad que les roba el cerebro. La Administración de Alimentos y Medicamentos aprobó el fármaco intravenoso, Leqembi, para pacientes con demencia leve y otros síntomas causados por la enfermedad de Alzheimer temprana. Es el primer medicamento que se ha demostrado de manera convincente que ralentiza modestamente el deterioro cognitivo causado por el Alzheimer. El proceso de conversión de un medicamento a la aprobación completa de la FDA generalmente atrae poca atención. Pero los pacientes y defensores de la enfermedad de Alzheimer han estado presionando al gobierno federal durante meses después de que los funcionarios de Medicare anunciaran el año pasado que no pagarían el uso rutinario de medicamentos como Leqembi hasta que recibieran la aprobación total de la FDA. La gran mayoría de los estadounidenses con Alzheimer obtienen su cobertura de salud a través de Medicare. Y las aseguradoras privadas han seguido su ejemplo al retener la cobertura de Leqembi y un medicamento similar, Aduhelm, hasta que reciban el respaldo completo de la FDA. La administradora de Medicare, Chiquita Brooks-LaSure, dijo en un comunicado el jueves que el programa comenzará a pagar por el medicamento ahora que cuenta con la aprobación total de la FDA. Pero el gobierno también está estableciendo requisitos adicionales, incluida la inscripción en un registro federal para rastrear la seguridad y eficacia del medicamento en el mundo real. FUENTE: AP

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.

Stocks rallying after wages in December grew at a slower than expected rate. We dig into what it means for the Fed and your money. The FDA expected to decide on Biogen's second Alzheimer's treatment, Jefferies' analyst Michael Yee tells us what makes this drug different than its maligned first drug Aduhelm. Plus, “A Random Walk Down Wall Street” 50 years later. Wall St. legend Burt Malkiel makes his case for passive investing and why investors shouldn't trust historic returns…especially now.

There were a lot of moments in 2022 that left us scratching our heads. In this episode, we'll recap biotech's top blunders, boondoggles, gaffes and missteps in our "Rotten Tomatoes" report—plus, we highlight two ripened tomatoes that gave us hope.   Also in this episode, we cover the week's biggest headlines including drug approvals late in the last stretch of 2022, Moderna's first buy and why Biogen and the FDA are in hot water.  To learn more about topics in this episode: Fierce Biotech's Rotten Tomatoes of 2022 Roche gets FDA nod for Lunsumio, offering convenient option to gene therapies in follicular lymphoma After overcoming vial issue, Gilead wins FDA approval for long-acting HIV injectable Sunlenca After FDA's Ukoniq pull, TG Therapeutics wins commercial mulligan with Briumvi to enter crowded MS arena Biogen, FDA's inappropriate Aduhelm coordination detailed in blistering congressional report Moderna makes its first-ever acquisition, buying Japanese DNA manufacturer OriCiro for $85M Moderna CEO says mpox vaccine is 'fantastic.' It may never see the market GE HealthCare completes spinout into 'more focused, more agile' standalone company We're looking for the fiercest companies for Fierce Medtech's 2022 Fierce 15 Fierce JPM Week "The Top Line" is produced by senior multimedia producer Teresa Carey with managing editor Querida Anderson and senior editors Annalee Armstrong, Ben Adams, Conor Hale and Eric Sagonowsky. The sound engineer is Caleb Hodgson. The stories are by all our “Fierce” journalists. Like and subscribe wherever you listen to your podcasts.See omnystudio.com/listener for privacy information.

The U.K. government is signaling that life sciences companies will be shielded from changes to an R&D tax relief policy that would otherwise leave small biotechs losing millions of pounds, Washington Editor Steve Usdin said on the latest BioCentury This Week podcast. Usdin and his BioCentury colleagues discuss the behind-the-scenes initiative by the U.K. BioIndustry Association to protect companies from being affected by serious unintended consequences of the policy changes as they continue to weather the bear market.BioCentury's editors also assess documents released by Congress that shed light on Biogen's rationale for how it priced Alzheimer's drug Aduhelm, trends in FDA's 2022 approvals and what the editorial team is looking for in the year ahead.

New findings from a congressional investigation into the Food and Drug Administration and the biotech company Biogen find the FDA broke its own protocols to approve a new Alzheimer's drug last year. The report said the FDA worked too closely with Biogen despite significant concerns over the limited benefits and side effects of the new drug, Aduhelm. Geoff Bennett reports. PBS NewsHour is supported by - https://www.pbs.org/newshour/about/funders

New findings from a congressional investigation into the Food and Drug Administration and the biotech company Biogen find the FDA broke its own protocols to approve a new Alzheimer's drug last year. The report said the FDA worked too closely with Biogen despite significant concerns over the limited benefits and side effects of the new drug, Aduhelm. Geoff Bennett reports. PBS NewsHour is supported by - https://www.pbs.org/newshour/about/funders

Three events: The failure to pass Chile's new constitution, Biogen's new Alzheimer drug Aduhelm's price gouging, & the complete corporatization of Ukraine illustrates a systemic media fail. Biogen's Aduhelm's story, the failure to pass a very progressive Chilean constitution, and Ukraine selling out to the privatization of rebuilding have a central core. These events happened because citizens are misinformed about the reality of these events & how they will ultimately hurt citizens. They are misinformed not because the media is all bad. After all, much of the information we provide has its genesis in some parts of the mainstream media. It is about which stories are highlighted and given traction. It is also about acquiescing to corporate narratives and pushback. --- Send in a voice message: https://anchor.fm/politicsdoneright/message Support this podcast: https://anchor.fm/politicsdoneright/support

Last week, senior editor Annalee Armstrong and staff writer Gabrielle Mason covered the Clinical Trials on Alzheimer's Disease conference. We'll hear from them as they discuss the latest news and what surprised them.   Also in this episode, we cover the week's biggest headlines including an investigation into Neuralink, Google's DeepMind and why things aren't working out for PI3Ks. To learn more about topics in this episode: Eisai, Biogen rocked by 2nd lecanemab death report ahead of Alzheimer's data reveal Facing a familiar side effect problem, Eisai makes the case for its next Alzheimer's drug after patient deaths Roche thins Alzheimer's program after phase 3 failure, may seek 'external partnerships' A winner is crowned in head-to-head Alzheimer's battle between Biogen's Aduhelm and Lilly Neuralink under federal investigation for animal testing practices: Reuters Elon Musk claims Neuralink is 6 months from implanting brain-computer interfaces in humans—and, someday, he'll be one of them 'Troubling' study finds Google's kidney disease-predicting AI performs worse in women—and may not have a quick fix In fresh blow to floundering PI3K space, FDA feedback drives MEI, Kyowa to halt blood cancer program Rigel scores green light in AML just 4 months after buying asset from Forma UPDATED: J&J bows out of Horizon bid as Amgen and Sanofi eye cash plays for rare disease drugmaker Pfizer plots €1.2B investment—and up to 500 new jobs—at Irish manufacturing plant Fierce JPM Week "The Top Line" is produced by senior multimedia producer Teresa Carey with managing editor Querida Anderson and senior editors Annalee Armstrong, Ben Adams, Conor Hale and Eric Sagonowsky. The sound engineer is Caleb Hodgson. The stories are by all our “Fierce” journalists. Like and subscribe wherever you listen to your podcasts.See omnystudio.com/listener for privacy information.

How the FDA was shaped by public health crises and patient advocacy, told against a background of the contentious hearings on the breast cancer drug Avastin. Food and Drug Administration approval for COVID-19 vaccines and the controversial Alzheimer's drug Aduhelm made headlines, but few of us know much about how the agency does its work. Why is the FDA the ultimate US authority on a drug's safety and efficacy? In Drugs and the FDA: Safety, Efficacy, and the Public's Trust (MIT Press, 2022), Mikkael Sekeres--a leading oncologist and former chair of the FDA's cancer drug advisory committee--tells the story of how the FDA became the most trusted regulatory agency in the world. It took a series of tragedies and health crises, as well as patient advocacy, for the government to take responsibility for ensuring the efficacy and safety of drugs and medical devices. Before the FDA existed, drug makers could hawk any potion, claim treatment of any ailment, and make any promise on a label. But then, throughout the twentieth century, the government was forced to take action when children were poisoned by contaminated diphtheria and smallpox vaccines, an early antibiotic contained antifreeze, a drug prescribed for morning sickness in pregnancy caused babies to be born disfigured, and access to AIDS drugs was limited to a few clinical trials while thousands died. Sekeres describes all these events against the backdrop of the contentious 2011 hearings on the breast cancer drug Avastin, in which he participated as a panel member. The Avastin hearings, he says, put to the test a century of the FDA's evolution, demonstrating how its system of checks and balances works--or doesn't work. Galina Limorenko is a doctoral candidate in Neuroscience with a focus on biochemistry and molecular biology of neurodegenerative diseases at EPFL in Switzerland. Learn more about your ad choices. Visit megaphone.fm/adchoices Support our show by becoming a premium member! https://newbooksnetwork.supportingcast.fm/new-books-network

How the FDA was shaped by public health crises and patient advocacy, told against a background of the contentious hearings on the breast cancer drug Avastin. Food and Drug Administration approval for COVID-19 vaccines and the controversial Alzheimer's drug Aduhelm made headlines, but few of us know much about how the agency does its work. Why is the FDA the ultimate US authority on a drug's safety and efficacy? In Drugs and the FDA: Safety, Efficacy, and the Public's Trust (MIT Press, 2022), Mikkael Sekeres--a leading oncologist and former chair of the FDA's cancer drug advisory committee--tells the story of how the FDA became the most trusted regulatory agency in the world. It took a series of tragedies and health crises, as well as patient advocacy, for the government to take responsibility for ensuring the efficacy and safety of drugs and medical devices. Before the FDA existed, drug makers could hawk any potion, claim treatment of any ailment, and make any promise on a label. But then, throughout the twentieth century, the government was forced to take action when children were poisoned by contaminated diphtheria and smallpox vaccines, an early antibiotic contained antifreeze, a drug prescribed for morning sickness in pregnancy caused babies to be born disfigured, and access to AIDS drugs was limited to a few clinical trials while thousands died. Sekeres describes all these events against the backdrop of the contentious 2011 hearings on the breast cancer drug Avastin, in which he participated as a panel member. The Avastin hearings, he says, put to the test a century of the FDA's evolution, demonstrating how its system of checks and balances works--or doesn't work. Galina Limorenko is a doctoral candidate in Neuroscience with a focus on biochemistry and molecular biology of neurodegenerative diseases at EPFL in Switzerland. Learn more about your ad choices. Visit megaphone.fm/adchoices Support our show by becoming a premium member! https://newbooksnetwork.supportingcast.fm/political-science

How the FDA was shaped by public health crises and patient advocacy, told against a background of the contentious hearings on the breast cancer drug Avastin. Food and Drug Administration approval for COVID-19 vaccines and the controversial Alzheimer's drug Aduhelm made headlines, but few of us know much about how the agency does its work. Why is the FDA the ultimate US authority on a drug's safety and efficacy? In Drugs and the FDA: Safety, Efficacy, and the Public's Trust (MIT Press, 2022), Mikkael Sekeres--a leading oncologist and former chair of the FDA's cancer drug advisory committee--tells the story of how the FDA became the most trusted regulatory agency in the world. It took a series of tragedies and health crises, as well as patient advocacy, for the government to take responsibility for ensuring the efficacy and safety of drugs and medical devices. Before the FDA existed, drug makers could hawk any potion, claim treatment of any ailment, and make any promise on a label. But then, throughout the twentieth century, the government was forced to take action when children were poisoned by contaminated diphtheria and smallpox vaccines, an early antibiotic contained antifreeze, a drug prescribed for morning sickness in pregnancy caused babies to be born disfigured, and access to AIDS drugs was limited to a few clinical trials while thousands died. Sekeres describes all these events against the backdrop of the contentious 2011 hearings on the breast cancer drug Avastin, in which he participated as a panel member. The Avastin hearings, he says, put to the test a century of the FDA's evolution, demonstrating how its system of checks and balances works--or doesn't work. Galina Limorenko is a doctoral candidate in Neuroscience with a focus on biochemistry and molecular biology of neurodegenerative diseases at EPFL in Switzerland. Learn more about your ad choices. Visit megaphone.fm/adchoices Support our show by becoming a premium member! https://newbooksnetwork.supportingcast.fm/medicine

It's earnings season again. Biogen offered a look at its second foray into Alzheimer's disease during its investor call, but listeners were still left dubious. All eyes—and ears—are on whether its lecanemab partnership with Eisai can outperform the ill-fated Aduhelm. In this episode, we chat about what went down during the earnings presentation, including rumors of a shaky relationship between the two drugmakers. We also explore AstraZeneca finally claiming an FDA approval for its long-troubled cancer immunotherapy Imjudo. The CTLA-4 drug has failed more than a few trials among different tumors over the years, and, now, it will enter a crowded and highly competitive liver cancer market.  UPDATED: Biogen insists Eisai relationship 'solid' as questions remain over lecanemab commercialization Despite Aduhelm cost cuts, Biogen still has Alzheimer's manufacturing firepower on deck, CFO says AstraZeneca's Imjudo finally snags first approval—only in an ever-crowded liver cancer field AIDS advocacy group hits out at 'Greediad' Gilead for drug pricing hikes J&J's BCMA bispecific Tecvayli wins FDA approval in multiple myeloma—but as a late-line therapy Medtronic to spin out respiratory, patient monitoring divisions amid flagging ventilator sales Sumitomo nets Myovant in $2.9B buyout, adding IVF asset to pipeline "The Top Line" is produced by senior multimedia producer Teresa Carey with managing editor Querida Anderson and senior editors Annalee Armstrong, Ben Adams, Conor Hale and Eric Sagonowsky. The sound engineer is Caleb Hodgson. The stories are by all our “Fierce” journalists. Like and subscribe wherever you listen to your podcasts.See omnystudio.com/listener for privacy information.

Aducanumab (brand name Aduhelm) drew headlines when it was approved by the FDA in 2021 against the recommendations of the FDA advisory committee. Today it's almost commercially dead. On this episode are joined by P4 student Ise Brockmann to dive into aducanumab's story. email: econrxpodcast@gmail.com Twitter/Instagram: @EconRx LinkedIn: www.linkedin.com/company/econrx Website: https://econrx.libsyn.com/

For decades Alzheimer's research was centered around one theory, the amyloid-beta hypothesis. That theory is now being called into question after evidence of potential fraud. In this episode, Rachel (Rae) woods invites life sciences expert Nick Hula and senior care expert Miriam Sznycer-Taub to talk about what this means for the scientific and medical community, how to restore trust in medical research, and where the industry may look to next when it comes to memory care. Links: Is a key Alzheimer's theory based on manipulated research? Ep. 90: Aaron Carroll on how clinicians can combat medical misinformation As we emerge from the global pandemic, health care is restructuring. What decisions should you be making, and what do you need to know to make them? Explore the state of the health care industry and its outlook for next year by visiting advisory.com/HealthCare2023.

Eisai and Biogen's Alzheimer's disease drug lecanemab did surprisingly well in a phase 3 trial. The results support the idea that an anti-amyloid drug like lecanemab could be a way to treat Alzheimer's—a hypothesis that has been under fire since Biogen's debacle with its approved anti-amyloid med, Aduhelm. And, while lecanemab's approvability isn't being debated—unlike the case with Aduhelm after its phase 3 program read out—commercial reimbursement could still be a challenge for the Eisai drug. We'll also talk about football, or at least Pfizer's COVID vaccine ad campaign that kicked off during the NFL season. The company's marketing strategy over the last almost two years has changed over time and with various approvals. Recently, Pfizer ramped up its campaign with branded advertising for shots in teens, but its NFL season push is focused on its new, tweaked booster vaccine and takes a more subtle approach but with big money behind it.   To learn more about topics in this episode:  It's a hit: Eisai springs 'major surprise' with phase 3 win for Biogen-partnered Alzheimer's drug  Eisai and Biogen's phase 3 Alzheimer's win puts amyloid back in the driver's seat, for now Editor's Corner: Eisai and Biogen need to meet CMS halfway after lecanemab's Alzheimer's clinical trial win NFL season sees Pfizer kick off major Comirnaty COVID vaccine ad offensive for teens, boosters  Pfizer offers a soft sell with a strong message on vaccines in first COVID ad The inside story behind Pfizer and BioNTech's new vaccine brand name, Comirnaty Sign of the times? US stocks up on Amgen's radiation sickness drug Nplate  Capacity to spare: US has manufacturing firepower to crank out more essential medicines, researchers say  Illumina pitches $200 genomes with new line of DNA sequencers  Novo Nordisk ready to submit once-weekly insulin to FDA after scoring final phase 3 win  Ocaliva fails NASH trial just as Intercept charts path toward FDA application The Top Line is produced by senior multimedia producer Teresa Carey with managing editor Querida Anderson and senior editors Annalee Armstrong, Ben Adams, Conor Hale and Eric Sagonowsky. The sound engineer is Caleb Hodgson. The stories are by all our “Fierce” journalists. Like and subscribe wherever you listen to your podcasts.See omnystudio.com/listener for privacy information.

New Alzheimer's Drug Reduces Cognitive Decline, Say Biotech Firms This week, the biotech firms Biogen and Eisai released preliminary data from the clinical trials for their new Alzheimer's drug, lecanemab. The companies said that the drug slowed cognitive decline by 27% in patients treated with the intravenous medication. It's likely the drug will get the FDA's approval by the end of the year. This all comes after the recent controversy surrounding Biogen's last Alzheimer's drug Aduhelm. Medicare recently announced that they will not cover that drug and others like it, unless patients are enrolled in a clinical trial. Guest host John Dankosky talks with science journalist Roxanne Khamsi about this and other top science news of the week including a diamond that hints that Earth's mantle contains water, brainy birds, and hearing aids made of false teeth.   Bangladeshi Farmers Found A Way To Save Massive Amounts Of Water The People's Republic of Bangladesh is one of the most densely populated countries on Earth, with a population of 165 million people living in an area a bit smaller than the state of Iowa. To feed all those people, farmers in Bangladesh work year-round: Instead of just growing crops during the rainy monsoon season, they grow a second or even third crop during the dry season—using groundwater to irrigate, and creating a more food-secure region. Research published in the journal Science this month found something amazing about all that groundwater. By pumping water for crops in the dry season, Bangladeshi farmers were leaving space in the aquifers to recharge during the rainy monsoon season. And this space allowed the aquifers to recapture more than 20 trillion gallons of water, or twice the capacity of China's massive Three Gorges Dam, over the last 30 years. The researchers call this the Bengal Water Machine, evidence for a similar concept that was first proposed nearly 50 years ago called the Ganges Water Machine. Guest host John Dankosky talks to lead author Mohammad Shamsudduha and International Water Management Institute researcher Aditi Mukherji about how this groundwater pumping benefits farmers, and the need for more data as climate change continues.   This Soundscape Artist Has Been Listening To The Planet For Decades Jim Metzner is one of the pioneers of science radio—he's been making field recordings and sharing them with audiences for more than 40 years. He hosted shows such as “Sounds of Science” in the 1980s, which later grew into “Pulse of the Planet,” a radio show about “the sound of life on Earth.” Over the decades, Metzner has created an incredible time capsule of soundscapes, and now, his entire collection is going to the Library of Congress. John Dankosky talks with Metzner about what he's learned about the natural world from endless hours of recordings and what we can all learn from listening. Plus, they'll discuss some of his favorite recordings. To hear the best audio quality, it might be a good idea to use headphones if you can.  

Dr. Mandy Leonard, Senior Director of Drug Use Policy and Formulary Management at Cleveland Clinic and Steven Lucio, Senior Principal in Pharmacy Solutions at Vizient discuss their insights on the approval, role, and coverage of Aducanumab, the first drug in a new class approved for Alzheimer's by the FDA's accelerated approval process.   Guest speakers: Mandy Leonard, PharmD, BCPS Senior Director of Drug Use Policy and Formulary Management  Cleveland Clinic   Steven Lucio, PharmD, BCPS Senior Principal in Pharmacy Solutions  Vizient   Moderator: Gretchen Brummel, PharmD, BCPS Pharmacy Executive Director Vizient Center for Pharmacy Practice Excellence   Show Notes: [00:47 -3:06] Other factors driving aducanumab formulary decision making [03:07-6:35] How CMS is managing this medication [06:36-9:04] What should patients and families know about this medication? [09:05-12:33] What frontline pharmacists should know about this medication   Links | Resources: To use Aduhelm or not to use Aduhelm- that is the question…now what is the evidence? Part 1 EMERGE and ENGAGE American Academy of Neurology statement   Subscribe Today! Apple Podcasts Amazon Podcasts Google Podcasts Spotify Stitcher Android RSS Feed  

Dr. Jeff Burns talks with Dr. Ron Petersen, Director of the Mayo Clinic Alzheimer's Disease Research Center, about Medicare's recent decision to officially limit Aduhelm (aducanumab) coverage to patients in clinical trials. Read the full article discussed in this interview in the New York Times.

Dr. Ron Petersen, Director of the Mayo Clinic Alzheimer's Disease Research Center, discusses Medicare's recent decision to officially limit Aduhelm (aducanumab) coverage to patients in clinical trials. Read the full article discussed in this interview in the New York Times.

CVS launches a virtual primary care service for Aetna and Caremark members. Medicare Part B premiums will stay flat, despite the agency's decision to limit coverage of controversial and expensive Alzheimer's drug Aduhelm to beneficiaries in clinical trials. And the American Medical Association opposes a bill that would require training on opioid use disorder treatment. See acast.com/privacy for privacy and opt-out information.

An update on our coverage of the Alzheimer's drug Aduhelm. And a resident of San Francisco's drug-riddled Tenderloin District talks about the nightmarish turn she says the neighborhood has taken with the City's permission. Subscribe to my two podcasts: “The Sharyl Attkisson Podcast” and “Full Measure After Hours.” Leave a review, subscribe and share with your friends! Support independent journalism by visiting the new Sharyl Attkisson store.Order “Slanted: How the News Media Taught Us to Love Censorship and Hate Journalism” by Sharyl Attkisson at Harper Collins, Amazon, Barnes & Noble, Books a Million, IndieBound, Bookshop!Visit JustTheNews.com, SharylAttkisson.com and www.FullMeasure.news for original reporting. Do your own research. Make up your own mind. Think for yourself.See Privacy Policy at https://art19.com/privacy and California Privacy Notice at https://art19.com/privacy#do-not-sell-my-info.

Who's going to run Biogen? Does Aduhelm have a future? And is it OK to shame reporters? This week, we delve into Biogen's twin announcements that the company is pulling the plug on Aduhelm and replacing its embattled CEO, discussing the future of Alzheimer's disease and just who might want to lead the company. We also explain the latest on Covid-19 vaccines, a strange situation for Vertex Pharmaceuticals, and the controversy surrounding the White House Correspondents' Dinner.

If the leaked Supreme Court abortion decision is finalized, medical training for the procedure could become limited for nearly half of obstetrics and gynecology residents. In Illinois, a private equity-backed physician group gets state approval to build a hospital in Quincy. And after Medicare's decision to restrict coverage of Alzheimer's drug Aduhelm, Biogen searches for a new CEO. See acast.com/privacy for privacy and opt-out information.

Congress is in recess, so the slower-than-average news week gives us a chance to catch up on underreported topics, like Medicare's coverage decision for the controversial Alzheimer's disease drug Aduhelm and ominous new statistics on drug overdose deaths and sexually transmitted diseases.Margot Sanger-Katz of The New York Times, Joanne Kenen of Politico and the Johns Hopkins Bloomberg School of Public Health, and Alice Miranda Ollstein of Politico join KHN's Julie Rovner to discuss these issues and more.Plus, for extra credit, the panelists recommend their favorite health policy stories of the week they think you should read, too:Julie Rovner: Politico's “Mice Occupy FDA Offices After Food Left Behind in Pandemic,” by David Lim and Lauren GardnerMargot Sanger-Katz: Health Affairs' “Many Medicare Beneficiaries Do Not Fill High-Price Specialty Drug Prescriptions,” by Stacie B. Dusetzina et. alJoanne Kenen: Vox's “America Needs More Doctors and Nurses to Survive the Next Pandemic,” by Dylan ScottAlice Miranda Ollstein: Politico's “Republicans See CDC's Policy Change as ‘Massive Political Loser for Democrats,'” by Alice Miranda Ollstein and Krista MahrClick here for a transcript of the episode. See acast.com/privacy for privacy and opt-out information.

After Medicare's decision to restrict coverage of the controversial new Alzheimer's drug Aduhelm, we look at how this one drug has forced the nation to reexamine how to balance the needs of desperate patients, incomplete evidence and larger economic realities.Guests:Phil Gutis, Alzheimer's patient and advocateHolly Fernandez Lynch, JD, MBe, John Russell Dickson, MD Presidential Assistant Professor of Medical Ethics, University of PennsylvaniaHave a look at some additional resources and a full transcript.Support this type of journalism today, with a gift.Follow us on Twitter. See acast.com/privacy for privacy and opt-out information.

Are we supposed to just get used to superspreader events? What's going with Editas Medicine? And why are people on Twitter so angry? Leana Wen, an emergency medicine physician and public health professor at George Washington University, joins us to talk about the many complexities of living with Covid-19 and the tricky task of defining "normal" in 2022. We also discuss the latest news in the life sciences, including Editas' new CEO, Aduhelm's future, and the data on Covid-19 vaccines for kids.