Podcasts about leqembi

Pushback against the Trump administration's massive government cuts exploded this weekend across America—and biopharma is no exception. Taking a deep dive into the leadership cuts, we found that more than half of the senior FDA leaders from six months ago are no longer there, and that's just the leadership. Across the Department of Health and Human Services, some 20,000 people will be leaving—of their own accord or otherwise—amounting to a 25% reduction in headcount that would leave HHS with around 62,000 employees. With many of these people likely destined for biopharma, does this pose an ethical problem?   Meanwhile, the escalating tariff war is beginning to ring alarm bells for the economy, with Goldman Sachs now predicting a 45% chance of a recession happening in the next 12 months. While pharma has historically been considered resistant to the challenges of a recession—people always need medicines—this time around could be different, in part because of the consumer-led obesity market. Thanks to the Trump administration's decision to nix a Biden era proposal to cover GLP-1s under Medicare Part D—at least for now—these drugs will continue to cost consumers a pretty penny.   Even without a recession being declared, Eli Lilly's and Novo Nordisk's stocks are falling significantly with the rest of the market. Lilly has lost more than $95 billion in market value in one month. Novo's value has declined $72 billion.   The drugmakers are also still battling makers of knockoff versions of their drugs. Most recently, Lilly filed a lawsuit against a med spa in Indianapolis for allegedly taking vials of tirzepatide and splitting them up into single doses that are sold to patients without the packaging inserts.  Of course, Lilly and Novo aren't the only pharma drug rivalry out there. There's also Keytruda vs. Opdivo, Leqembi vs. Kisunla and more.   Finally, we take a look at seven late-stage MASH candidates that could hit the market in the next few years, following the FDA's 2024 approval of Madrigal's Rezdiffra, the first treatment for the metabolic disorder. 

Biopharma's reaction to the forced resignation of venerable CBER director Peter Marks has been swift and furious, with former FDA Commissioner Robert Califf saying on LinkedIn that “the FDA as we've known it is finished.” Analysts, meanwhile, called Marks' exit “arguably biotech investors' greatest fear,” as company shares across the industry tumbled.   Marks' announcement added insult to injury for the agency, which was already reeling from the announced cuts of 10,000 employees across the Department of Health and Human Services, including 3,500 FDA staffers. Those layoffs began to roll out on Tuesday as some employees showed up to work only to discover they no longer had a job. Amid all this chaos, Cantor Fitzgerald analysts called for Kennedy himself to get the axe, saying in part that he was “undermining the trusted leadership of health care in this country.”    Despite the turmoil, drug development continues in the obesity space, with Novo Nordisk presenting mixed data from its semaglutide franchise at the American College of Cardiology's annual conference last weekend. While an oral version of the blockbuster drug showed cardiovascular benefits for some patients, it failed to change the trajectory of other major adverse cardiovascular events. Meanwhile, Novo continues its battle against compounding pharmacies manufacturing copycat versions of semaglutide—as multiple players scramble for a piece of this massive pie.    On the Alzheimer's front, Eli Lilly's Kisunla failed last week to win the recommendation of the EU's Committee for Medicinal Products for Human Use. This decision is consistent with CHMP's recent stance on anti-amyloid antibodies, as Biogen and Eisai have also struggled to get Leqembi approved in Europe.    On a positive note, pharma R&D returns grew again in 2024, but Deloitte warned that this progress is “fragile.” The firm urged companies to be bold and embrace cutting edge technology like gene therapy and AI. These returns can't help everyone, however, as the past week has seen an uptick in layoffs across biopharma, including at Carisma Therapeutics, Organon and Tenaya Therapeutics.   Finally, as April kicks off cancer conference season, BioSpace took a deep dive into the recent action in the always-hot in radiopharmaceuticals space.  

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma and Biotech world.The European Union has rejected Lilly's Alzheimer's drug Kisunla, citing potential risks of brain swelling and bleeding. This decision follows a similar rejection of a rival drug, Leqembi. Novo Nordisk is facing challenges in its weight loss business due to compounded versions of its drug Semaglutide making up a significant portion of the market. Milestone Pharmaceuticals experienced a setback when the FDA issued a complete response letter for its tachycardia drug Cardamyst. The company is now focusing on restructuring and streamlining operations.Merck's injectable Keytruda has shown promising results in a pivotal trial, and BioNTech's bispecific treatment has elicited positive responses in the majority of patients with small cell lung cancer. Novo Nordisk's stock dipped after disappointing weight loss results for Cagrisema, and Biogen and Eisai's drug Leqembi faced setbacks in the UK and Australia. In other news, United States Pharmacopeia is offering career opportunities in various fields including science, technology, regulatory affairs, and quality assurance. Stay tuned for more updates on the latest developments in the pharmaceutical and biotechnology industries.

Good morning from Pharma and Biotech Daily, the podcast that gives you only what's important to hear in the Pharma and Biotech world. J&J has recently halted a late-stage depression trial due to lack of efficacy. Analysts do not believe this will have a significant impact on the company's broader neuroscience strategy. Meanwhile, there seems to be confusion at the FDA with terminations and reversals happening. In other news, Novo Nordisk has conducted limited studies on GLP-1s for addiction. Biogen and Eisai are facing setbacks with Leqembi overseas. There are potential FDA changes under commissioner Marty Makary. The FDA's priority review vouchers are in need of transparency. AstraZeneca has presented strong data for Imfinzi in stomach cancer. Atea Pharmaceuticals has made the decision to cut its workforce. Novo Nordisk is entering a legal battle against GLP-1 compounders, while Lilly has achieved a victory in a different matter. Pharmaceutical executives have recently shared insights on trust, technology, and the future at the WEF. Overall, there are various developments happening in the Pharma and Biotech industry that are worth keeping an eye on.

Are new Alzheimer's treatments finally offering hope? In this episode, we're diving into the latest breakthroughs in Alzheimer's treatment—what's been approved, what's in the pipeline, and what these medications can and cannot do. If you or a loved one are concerned about cognitive decline, this is an episode you don't want to miss!What to Listen For[02:28] – Why Alzheimer's research has been so challenging—did you know a major 2006 study was exposed as fraudulent?[03:59] – The amyloid plaque controversy—why has it dominated research for so long?[05:45] – Three alternative Alzheimer's theories that could reshape treatment: the Tau Hypothesis, Inflammation Hypothesis, and Environmental Toxicity Hypothesis.[09:04] – Why drug development takes so long—did you know it can take up to 30 years from research to standard treatment?[13:28] – The hard truth: We still have no cure, and no medication reverses Alzheimer's symptoms. So what do current drugs actually do?[14:08] – The most commonly prescribed Alzheimer's drugs—what they target and how they work.[16:05] – The new FDA-approved drugs Leqembi and Casenla—how they work, their risks, and why they're so expensive.[18:20] – The serious risks of new Alzheimer's treatments—brain swelling, bleeding, and the need for regular IV infusions.[20:30] – Why weight-loss drugs like Ozempic and Wegovy are now being studied for Alzheimer's prevention.[25:00] – The importance of early detection—why treatments work best when started as early as possible.While we don't yet have a cure for Alzheimer's, the latest treatments offer new possibilities for slowing cognitive decline. But with high costs, serious risks, and the need for early detection, it's crucial to stay informed. If you or a loved one are at risk, talk to your doctor about the latest research and what steps you can take today.Enjoyed this episode? Don't forget to subscribe, leave a review, and share this with someone who could benefit from the latest Alzheimer's research!RESOURCES: Book a FREE Discovery Call with Amy Lang Sign up for Mini-Intensive: Create Your Roadmap (90 minutes) Order Amy's book Thoughts Are Habits Too: Master Your Triggers, Free Yourself From Diet Culture, and Rediscover Joyful Eating. Join our private Facebook group: Moxie Club Meetup Follow Amy on Instagram @habitwhisperer

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma and Biotech world. Bristol Myers Squibb is seeking to broaden the use of its CAR T cell therapy, Breyanzi, to address marginal zone lymphoma as a strategy to offset losses from exclusivity. In other news, Boehringer Ingelheim has seen promising results in a Phase III trial for its lung fibrosis drug, randomilast, aimed at progressive pulmonary fibrosis. However, Pliant has experienced a stock decline following the halt of its Phase IIb/III study for idiopathic pulmonary fibrosis. Additionally, Vertex has received FDA approval for its non-opioid pain treatment, while AbbVie has secured approval for a new antibiotic. Bain's acquisition of Tanabe for $3.3 billion is also making headlines. Regeneron is currently in a legal battle with Sanofi over the Dupixent pact, and Equillium's itolizumab is undergoing testing against Humira for ulcerative colitis. On the horizon, Acelyrin and Alumis are joining forces to address immune-mediated diseases, while Eisai is seeking subq approval for Leqembi due to sluggish US sales. Job opportunities are available at ATCC, AbbVie, Regeneron Pharmaceuticals, and Dren Bio.

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma e Biotech world.Eisai reports lagging sales of Leqembi in the US and is now looking towards gaining approval for a subcutaneous version. Novo Nordisk executives are trying to boost sentiment after the failure of obesity candidate Cagrisema, without providing hard numbers. Regeneron is suing Sanofi for allegedly withholding information about the sales of Dupixent. Nasdaq newcomers Acelyrin and Alumis have merged to focus on immune-mediated diseases. The AAPS National Biotechnology Conference will cover trends in research and biopharma markets.Equillium's Itolizumab is competing with Humira in ulcerative colitis. FDA approval of Vertex's non-opioid Jornavx signals a new era in pain treatment. Novo's bispecific for hemophilia has aced a phase III pediatric trial. Lilly has increased Zepbound supply, prompting analysts to question if it is sustainable. BMS has added $2 billion to cost-cutting plans and is eyeing deals after the success of Cobenfy. AstraZeneca has axed two Alexion assets as Q4 earnings exceed expectations.

Ozempic gains expanded approval; MS treatment gets Boxed Warning added to label; Monotherapy approval granted for treatment resistant depression Tx Spravato; Leqembi gains  maintenance regimen; Enhertu gains new Breast CA indication.  

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma e Biotech world. Sage has rejected Biogen's unsolicited buyout offer and will seek strategic alternatives. Biogen and Eisai have received approval for a monthly maintenance regimen for Alzheimer's drug Leqembi. Veru's drug has shown promise in sparing lean mass in overweight adults on Wegovy. The Duchenne muscular dystrophy space is on the verge of a pivotal era with several companies developing investigational therapies. Akero has rebounded in a mid-stage trial, Daiichi Sankyo is optimistic for 2025, and Allakos is cutting its workforce. The text discusses the advancements in the Duchenne Muscular Dystrophy (DMD) space as it enters a pivotal era, with companies such as Capricor Therapeutics, Wave Life Sciences, and RegenxBio working on investigational therapies to address unmet needs. It also mentions Daiichi Sankyo's recent success with the approval of Astrazeneca-partnered Dato-DXD. Additionally, new treatments are in development for Achondroplasia to challenge Biomarin's Voxzogo. Novo's obesity drug shows promising results, Merck's Keytruda combo fails in a Phase III trial for GI cancer, and Tris Pharma wins late-stage for a non-opioid painkiller. The text also invites feedback from readers on topics they would like to see covered in the future.

Dr. K speaks with Alzheimer's expert Jason Karlawish, MD, about the new anti-amyloid Alzheimer's medications lecanemab (Leqembi) and donanemab (Kisunla). They discuss how biomarkers have changed diagnosing Alzheimer's disease, how well these new drugs work, and much more.

We're at BIO-Europe in Stockholm

President-elect Donald Trump announced last week that he would nominate prominent anti-vaxxer Robert F. Kennedy Jr. to lead the HHS. While this news caused a dip in biotech stocks, one analyst said the selloff was an overreaction. Meanwhile, fall conference season continues with the American College of Rheumatology Convergence (ACR) and American Heart Association's 2024 Scientific Sessions (AHA). Lupus was the indication du jour at ACR, where BMS, Kyverna, Fate Therapeutics and Cabaletta Bio presented data from early-stage trials of their CAR T candidates, and Biogen and UCB detailed data behind their unexpected late-stage victory for dapirolizumab pegol. This was a much-needed win for Biogen, which has seen its shares decline 36% this year.  Neurogene's stock, meanwhile, tumbled 36% on Monday alone, following the release of details about an adverse event in a trial for its Rett syndrome gene therapy. This followed a 35% fall last week when the adverse event was first announced. And the company decided to drop its gene therapy in Batten disease after the FDA declined to grant Regenerative Medicine Advance Therapy designation to support the program. We also took a look at bluebird bio's cash problem, with the company slated to exhaust its runway to reach a breakeven point before the end of next year. On a more positive note, RegenxBio announced this week it has aligned with the FDA on path to possible accelerated approval for its investigational gene therapy for Duchenne muscular dystrophy, following behind Sarepta's Elevydis, which faced controversy after it received accelerated approval in June 2023, only to miss the primary functional endpoint in its confirmatory trial four months later. And speaking of accelerated approval, we released a special edition of ClinicaSpace Monday focused on this very topic. Sign up to receive it here.

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma e Biotech world.Amgen's obesity candidate, maritide, faced new safety concerns related to bone density, causing a drop in the company's stock. Biogen's shares have also plummeted due to issues such as a slow launch for their Alzheimer's medicine and a lackluster pipeline. Meanwhile, the biotech company Metsera raised significant funds for their long-acting GLP-1 drug despite competition in the weight loss space. Additionally, Kezar's autoimmune drug faced a second FDA clinical hold, and Syros experienced a significant drop in stock value due to a late-stage MDS failure. Novo's deal with Catalent is seen as a significant moment for the CDMO sector. These developments indicate ongoing challenges and opportunities in the biotech industry.Biogen's shares have dropped by 36% in 2024 due to factors such as a slow launch for Alzheimer's medicine Leqembi and a lackluster pipeline. The Novo-Catalent deal is seen as a defining moment for the CDMO industry, with concerns about consolidation limiting competition but also providing opportunities for smaller-scale CDMDs to find new partners. Other news includes Amgen facing bone density safety concerns for Maritide, AbbVie shares plummeting due to a failed schizophrenia asset, and Bayer's CEO admitting that their earnings are not looking good. In the biopharma job market, positions such as Executive Director of Biologics Analytical Research and Development at Merck & Co. and Vice President of Global Program Head - Ophthalmology at Regeneron Pharmaceuticals are available.

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma and Biotech world.Eisai's sales of its Alzheimer's disease therapy Leqembi have disappointed analysts, leading the company to lower its fiscal 2024 guidance. The underwhelming sales are attributed to barriers such as coverage, infusion centers, and time to diagnosis. In other news, Pfizer has made a $1 billion commitment in China to boost innovation and target the Chinese market, while AstraZeneca's China head has been taken into custody by Chinese authorities for reasons that remain unclear. There is also a dispute between Lilly and Novo over Catalent's GLP-1 work, as regulators review Novo Holdings' buyout of Catalent and the work the contract drug manufacturer may or may not be performing for Eli Lilly remains contentious.Additionally, a gene therapy webinar on successful preparation for scaling gene therapy processes is highlighted. Other news includes the impact of a Trump victory on the biopharma industry, cell therapy biotechs shifting focus to autoimmune expertise, and updates on Lilly's Q3 performance and more.

It's too soon to conclude anti-amyloid therapies are safe for use by Alzheimer's patients in the real world, even as early reports are encouraging, argues BioCentury Executive Editor Selina Koch on the latest BioCentury This Week podcast. Koch and colleagues discuss takeaways from this year's Clinical Trials on Alzheimer's Disease annual meeting, including conclusions from adverse event data for Leqembi lecanemab and what the true test of appropriate use and safety for the drug might look like.BioCentury's editors also assess Phase II data presented at CTAD by UCB that provide some of the first clues about what species of tau to target and in which patients. And they discuss what results of Tuesday's presidential contest in the U.S. will mean for FDA, as well as the state of play for China biotech as the industry continues to grind out its first bear market.View full story: https://www.biocentury.com/article/65407500:00 - Introduction01:23 - CTAD: Anti-amyloids14:22 - CTAD: UCB's tau data19:47 - FDA & the Election28:16 - China Summit DebriefTo submit a question to BioCentury's editors, email the BioCentury This Week team at podcasts@biocentury.com.Reach us by sending a text

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma e Biotech world. Eli Lilly experienced lower-than-expected sales for its weight loss and diabetes drugs in the third quarter, causing its stock to drop by over 13%. Biogen, on the other hand, exceeded expectations for its Alzheimer's drug Leqembi. Biomarin surpassed sales estimates for its drug Voxzogo, while Sage reported revenue growth for Zurzuvae. Biogen also signed a deal with Neomorph. Additionally, Lilly has modified the dosing of its Alzheimer's drug Kisunlan to lower brain swelling, and Novartis has secured expansion for its CML drug Scemblix. Small funds are investing in early-stage science, and there have been recent job openings in the biotech industry.

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma and Biotech world.CVS is laying off 2,900 employees as part of a cost-cutting plan and potential business breakup. Humana's Medicare Advantage star ratings have dropped significantly, impacting profits. Healthcare workers face burnout, while the payer-provider relationship is evolving. Mission Hospital in North Carolina is struggling after Hurricane Helene, and Steward CEO Ralph de la Torre is being sued by senators. Healthcare companies are urged to prioritize patient-centric experiences. The text also highlights upcoming healthcare conferences, telehealth trends, and insights into the relationship between providers and payers.The FDA has officially declared the end of the shortage of Zepbound and Mounjaro, putting pressure on companies selling compounded alternatives. Biopharma conferences in 2025 are important for showcasing clinical trial results. The FDA is set to make several key decisions in the fourth quarter, including approving a rival to a popular Pfizer heart drug. Roche plans to address an $8 billion sales gap due to biosimilar competition. Lilly is investing $4.5 billion in a "foundry" for advanced drug manufacturing. Additionally, there are resources available on topics such as AI in clinical research, genetic screening, gene therapy, and biosimilars. Other industry news includes potential sales of pharma units by Chinese company Wuxi, and the US's commitment to African manufacturing in HIV programs.Sanofi has sold the global rights to a rare autoimmune drug for cold agglutinin disease to Recordati in a potential $1 billion deal. Recordati will make an upfront payment of $825 million to Sanofi, with milestone payments of up to $250 million. Meanwhile, Novo's lowest dose of Wegovy remains on the FDA's drug shortage list. AbbVie has trimmed its full-year earnings guidance due to R&D milestone costs, following the success of its Parkinson's disease candidate Tavapadon. Relay Therapeutics is laying off 10% of its workforce to streamline its research organization. The pharma industry is prioritizing scaling GLP-1 manufacturing capacity to meet the demand for weight loss drugs. Lilly has ended its obesity drug shortage, while Novo continues to face shortages. WBL's proprietary library prep for cfDNA whole genome sequencing aims to enhance specificity, sensitivity, and data quality at low concentrations. In other news, BMS has received FDA approval for an Opdivo regimen in NSCLC and Bavarian Nordic's MPox shot shows antibody responses wane after 6 to 12 months.Dr. Matthew Schrag, a vascular neurologist at Vanderbilt University, is not prescribing the new Alzheimer's disease treatments, Kisunla and Leqembi, due to concerns over risks and costs. Schrag has a history of challenging prevailing science in Alzheimer's and has exposed instances of potential misconduct by researchers. In 2021, he raised allegations of data manipulation against Cassava Sciences, leading to ongoing scrutiny and calls for their phase 3 trials to be stopped. Despite distancing himself from the controversy, Schrag's findings have had a significant impact on the company. The article also discusses Roivant's unique approach to drug development, the latest advances in oncology research, and the challenges in navigating the path from preclinical studies to regulatory approval for gene therapies. The text highlights the importance of efficient therapeutic development processes and increasing diversity in clinical trials. Additionally, it provides links to resources on selecting clinical trial sites, unlocking partnerships for small biotech firms, and optimizing AAV manufacturing processes. The newsletter also includes updates on Medicare drug price talks, a groundbreaking trial for lung cancer treatment, and a map of a fruit fly's brain that has impressed neuroscientists.

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma e Biotech world.Leqembi, a new biotech drug, has been approved in the UK, but reimbursement may not follow due to concerns about the cost to the NHS. The FDA defended its med device chief's tenure after ethics concerns were raised. Employers are expecting higher health costs next year, driven by rising pharmacy spending on drugs like GLP-1 for obesity. BridgeBio has sent rare disease drugs to a new company called GondolaBio, backed by investors including Viking Global Investors and Sequoia Capital. Versant has launched a new startup called Borealis Biosciences with funding from Novartis.New Jersey has announced plans to erase $100 million in medical debt for nearly 50,000 residents, following similar initiatives by other states and federal regulators. Molina Healthcare has extended CEO Joe Zubretsky's contract through 2027, along with a stock grant potentially worth $51 million. Additionally, CMS has received 12,000 complaints of noncompliance with the No Surprises Act, resulting in $1.7 million in restitution.Novartis and Versant have launched Borealis Biosciences with $150 million in funding to develop RNA therapeutics for kidney diseases, following the success of Chinook Therapeutics. Meanwhile, Wuxi Biologics reported a 24% drop in net profit in the first half of 2024 despite signing a record number of new projects. In other news, Biogen and Eisai's Alzheimer's drug Leqvembi has been approved in the UK but deemed too expensive by NICE, while Biomarin has brought on Roche and Amgen alums in an executive restructuring.The text discusses the potential impact of the Democrats' proposed changes to Medicare drug price negotiations on the pharmaceutical industry's research and development (R&D) efforts. Kamala Harris is expected to address these issues during the Democratic National Convention, with the party aiming to lower drug prices by increasing the number of drugs subject to negotiations.TE Connectivity offers sensor solutions for minimally invasive devices, providing precision and safety for procedures such as cardiac mapping and ablation. Their sensor technology can enhance efficacy in heart arrhythmia treatments. The comprehensive sensor solutions guide provides detailed applications, key features, and benefits of their sensors.The text discusses the importance of collecting and using social determinants of health (SDOH) data in health economics and outcomes research (HEOR). It highlights the challenges of collecting SDOH data and provides insights on how to effectively use the data while ensuring privacy and security. The text emphasizes the significance of diverse and inclusive research practices, evaluating data validity and sourcing, and effectively utilizing SDOH data to gain more accurate insights in HEOR.

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma and Biotech world.The FDA approved Ascendis' drug for a rare endocrine condition, while rejecting MDMA as a therapy aid for PTSD. Pfizer presented new data on their RSV shot for immunocompromised adults. Halda, a startup, raised $126 million to advance targeted cancer therapy. A journal retracted papers on MDMA-assisted therapy due to undisclosed unethical conduct. Biopharma Dive provides in-depth coverage of news and trends in the biotech and pharma industries, from clinical trials to FDA approvals and research partnerships. Companies like Pfizer and Lilly are shifting towards more patient-centric commercialization strategies.Stryker has announced plans to acquire smart hospital technology firm Care.ai, following a statement by CEO Kevin Lobo about an active deal pipeline for the second half of 2024. Unilabs has partnered with C2N Diagnostics to sell Alzheimer's blood tests in Europe, with C2N recently receiving an investment from Eisai, the developer of the Alzheimer's drug Leqembi. Smiths Medical is recalling infusion pumps due to software issues, while Solventum has raised its earnings forecast after a successful first independent quarter following its separation from 3M. Axogen has named ex-Abbott executive Michael Dale as CEO, replacing Karen Zaderej. Other news includes initial US commercial triclip cases offering hope, FDA rejecting MDMA as a therapy aid for PTSD, and the approval of an EpiPen alternative nasal spray for anaphylaxis. Medtech Dive provides industry news and insights on topics such as medical devices, diagnostics, digital health, regulation/compliance, and more, catering to decision-makers in competitive industries.For-profit health systems received a boost in earnings from Medicaid supplemental payments in the second quarter, although executives stated that it was not enough to cover their costs. Nonprofits in the healthcare sector experienced a record-low cash on hand in 2023, with little improvement in cash flow between 2022 and 2023. In a significant decision, the FDA rejected the use of MDMA as a therapy aid for PTSD, impacting the growing field of psychedelics research. The importance of integrating generative AI in healthcare organizations for success is highlighted, with advice on choosing the right vendor for AI solutions. Additionally, the newsletter covers topics such as data management for improving patient outcomes, navigating the future of mental healthcare, and updating sales approaches in healthcare. Healthcare Dive provides in-depth journalism and insights on trends shaping healthcare, covering areas such as health IT, policy and regulation, insurance, digital health, payer-provider partnerships, and value-based care.Pfizer has achieved a pivotal Phase III win for its RSV vaccine in immunocompromised adults, showing a strong neutralizing response against both subtypes of the virus. Ascendis Pharma's hypoparathyroidism drug has secured FDA approval after facing regulatory challenges. Halda Therapeutics has raised $126 million to advance two cancer candidates. In the obesity space, there are several clinical trials ongoing, with five candidates expected to release data by the end of 2024. Additionally, other news includes MDMA papers being retracted for unethical conduct, FDA approvals and rejections, and biopharma layoffs.The biotech and pharma industry has been experiencing layoffs due to economic uncertainty, with companies like Entero Therapeutics and Precigen announcing workforce reductions. However, there is hope that an increase in mergers and acquisitions (M&A) could help alleviate the trend of layoffs. Pharma companies are turning to smaller deals and taking companies private to navigate the tough market environment. The rise in M&A, fueled by the impact of the GLP-1 boom, couldSupport the Show.

A substantial part of the biopharma ecosystem involves deals between biotechs and academics, with smaller companies accessing assets to add to their pipelines and technologies to help solve problems. On the latest BioCentury This Week podcast, BioCentury's editors discuss the interplay of biotech and academia, including how deals between the groups often come outside the hubs of Boston and the Bay Area and what types of indications and technologies are common focus points. They also discuss new data in Alzheimer's for Leqembi from Eisai and Biogen that provide insight into how to get the most out of anti-amyloid mAbs for the disease, and what's next for James Wilson now that the gene therapy pioneer is moving on from the University of Pennsylvania.View full story: https://www.biocentury.com/article/65317400:00 - Intro04:25 - Biotech-Academia Deals12:04 - Leqembi's Latest Data19:20 - What's Next for James Wilson

Audio roundup of selected biopharma industry content from Scrip over the business week ended 2 August 2024. In this episode: Pfizer bullish on its oral GLP-1; BMS's rising confidence about Medicare pricing of Eliquis; more long term data for Leqembi; NewAmsterdam's CETP inhibitor shows promise; and a look at Mankind's Bharat Serums buy. https://scrip.citeline.com/SC150698/Quick-Listen-Scrips-Five-MustKnow-Things Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma e Biotech world. The CEO of 23andme, Anne Wojcicki, has proposed to take the company private by buying shares at 40 cents each. GE Healthcare is facing pressure in China as hospitals delay orders, impacting revenue growth for Johnson & Johnson and Philips as well. The FDA and Health Canada are working together to raise awareness of a recall for J&J's Megadyne electrode pads. Stryker plans to be very active in mergers and acquisitions and is launching an orthopedic robot in the second half of the year. Labcorp is expanding its partnership with Ultima Genomics to boost genomic diagnostics by using a machine designed to sequence the genome for $100.Transitioning to the next segment, Moderna's shares fell due to a lower sales outlook for their RSV and COVID shots, while Otsuka acquired startup Jnana in a deal worth $800 million. Biogen is optimistic about the future of their Alzheimer's drug, Leqembi, and Cigna's CEO promises a strong defense of pharmacy benefit managers. The biotech M&A market is on the rise, with Otsuka's acquisition of Jnana being the 16th deal for a private startup with at least $50 million upfront. The industry is also exploring the use of eClinical technologies in research to improve efficiency. Overall, the biopharma sector is experiencing significant developments and changes that are shaping the industry landscape.Moving on to the following update, Moderna's stock price plummeted over 20% after the company reduced its revenue guidance for 2024 due to decreased demand for its COVID-19 vaccine in the second quarter. Meanwhile, Lilly's tirzepatide successfully cleared a Phase III cardiovascular study, showing a 38% reduction in heart failure risk. Otsuka Pharmaceutical is acquiring Jnana Therapeutics for up to $1.1 billion, adding to its drug discovery capabilities. The FDA is questioning the evidence supporting Zevra's rare disease therapy ahead of an advisory committee meeting. Novo Nordisk lost a legal case regarding price negotiations, while Sanofi sued Sarepta over alleged patent infringement.Shifting gears to marketing news, Carter's is targeting Gen Z parents by focusing on more than just cute clothing, with insights and strategy from CMO Jeff Jenkins. Meta is utilizing AI to automate creative and personalize ads in real time, leading to a 22% increase in revenue. Hyundai has split the CMO role into creative and performance positions, with Angela Zepeda becoming Chief Creative Officer. Shapermint's proprietary AI ad tool, Altair, has helped streamline content production and attract new customers. Additionally, the role of print in marketing strategies is explored in a webinar, and tips for creating successful loyalty programs are shared.Finally, pharma executives are turning their attention to health equity and increasing diversity in clinical trials. A trendline explores strategies to boost diversity in trials. While business literature like "The First 90 Days" by Michael Watkins helps with career moves, real-life medical thrillers like "Last Night in the OR" and "Empire of Pain" offer insights into healthcare and pharma. Six books that pharma execs swear by are also highlighted. Pfizer's CEO remains confident in the company's position in the obesity drug market, despite delays. The newsletter also covers inflation penalties for big pharma companies, the potential impact of a combo COVID/flu shot on vaccinations, and best practices for new drug applications and biologics license applications.That's all for today on Pharma and Biotech daily - bringing you the latest updates and insights from the world of pharmaceuticals and biotechnology.Support the Show.

On this week's episode, hosts Josh Schimmer, Sam Fazeli, Brian Skorney, Michal Preminger and Eric Schmidt kick off the show by discussing the recent growth in XBI performance. The group weighs in on IPO dynamics, hypothesizing on the influence of investors and the power of FOMO. They go on to note the success of Viking Therapeutics as they're moving into Phase 3 for their GLP-1 agonist, and what the future may hold for the weight-loss drug market. Shifting gears, the hosts raise concerns on CHMP issuing a negative opinion of Leqembi for Alzheimer's disease, signaling a shift in the relation of CHMP and FDA standards. The group also discusses PBM execs facing heat from the House Oversight Committee as well as recent rare disease news including the FDA's launch of a Rare Disease Innovation Hub. The hosts also highlight the growing success of gene therapy and close the show by discussing one of the top ten rules of engagement for biotech executives. *This episode aired on July 26, 2024.

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma e Biotech world. GSK's vaccine sales are slowing down, while Merck's Gardasil sales dropped in China, leading to a slide in Merck's shares. Keytruda reached a sales milestone of $7 billion. Leqembi was voted down by European regulators. Bristol Myers' beat completes a strong week of pharma earnings. Vertex's pain drug received speedy FDA review, and trends in the obesity drug market are discussed. Eisai plans to appeal the negative recommendation for their Alzheimer's drug. Overall, the pharma industry is experiencing various developments and challenges, with companies adjusting their forecasts and strategies to navigate the changing landscape.Stryker plans to be "very active" in mergers and acquisitions, with the CEO hinting at potential interest in soft tissue robots after a record quarter of orthopedic robot installations. Labcorp is expanding its Ultima pact to boost genomic diagnostics by using Ultima Genomics' machine to sequence genomes for $100. The FDA sent a warning letter to defibrillator battery manufacturer Amco, which supplies batteries to companies like Philips, Stryker, and Zoll. At the FDA's first home health hub meeting, a patient shared a day in the life with diabetes, aiming to improve health equity by considering living conditions in device design. FDA officials outlined the benefits of AI lifecycle management, presenting a seven-stage diagram for monitoring artificial intelligence software development. Other news includes Flo Health reaching unicorn status with a $200 million raise, Google cutting ties with Amazon's One Medical, and a study finding that a blood test accurately diagnosed Alzheimer's 90% of the time.Humana is expected to lose a 'few hundred thousand' Medicare Advantage members next year after reducing its plan footprint for 2025. CHS is selling 3 hospitals and exiting Pennsylvania as part of plans to offload assets worth $1 billion this year. Google has cut ties with Amazon's One Medical, which was a major setback for the company. North Carolina is offering enhanced Medicaid funds to hospitals that help eliminate medical debt, with experts calling it a "win-win" for patients and providers. Additionally, a data breach at Healthequity could affect 4.3 million individuals.GSK is cutting vaccine forecasts due to slower U.S. sales of their shingles vaccine, while predicting faster overall growth. Pfizer's CEO remains confident in the company's position with an obesity drug, despite delays. Merck's shares dropped as sales of Gardasil decreased in China. Vertex's pain drug is getting a speedy FDA review, Keytruda hit a sales milestone, and biotech startup Airna raised $60 million for RNA editing medicines.GSK has lowered its full-year vaccine guidance for 2024 due to disappointing Q2 sales and challenges with updated CDC guidelines on RSV shots for seniors. The Biosecure Act could impact biotech and biopharma markets in the US and China. Other top stories include new data on Leqembi, rising biopharma investment activity, and updates on various companies in the industry.Experian has launched a retail media solution for networks looking for richer data, while Shapermint's AI ad tool is helping drive profits. Retail media networks are expanding their scope, potentially leading to challenges. Creators and marketers are advised to protect themselves while using AI. NBCUniversal has broken Olympics ad records, with over $1.2 billion in ad sales.Pharma companies are facing penalties for raising drug prices faster than the rate of inflation, with the negotiation period for price talks with Medicare set to expire soon. These penalties are part of the Inflation Reduction Act, which has been met with resistance from the pharma world.The Biosecure Act could have significant implications for biopharma marketSupport the Show.

Second-quarter earnings season continues with Big Pharma beating Wall Street expectations, the author of an encrypted email sent to BioSpace has a proposal for Moderna and Merck, Roche and Viking seek quicker entry to the obesity market, and AAIC is in full swing. As July comes to a close, biopharma second-quarter earnings continue to roll in with Pfizer, Merck, AbbVie, AstraZeneca and many more reporting. So far, everything is coming up roses with most major companies beating Wall Street expectations. But every rose has its thorn and for biopharma executives this has long been drug price negotiations under the Inflation Reduction Act. Recently, however, drugmakers have expressed confidence that the IRA will not greatly impact their bottom lines. Speaking of bottom lines, in an anonymous email sent to the CFOs of Merck and Moderna and shared with BioSpace, a shareholder made the case that Merck should buy Moderna out of its 50/50 partnership involving Keytruda and their shared investigational personalized cancer vaccine. Meanwhile, M&A activity picked up in the second quarter of 2024 with nearly $18 billion changing hands, according to J.P. Morgan. Q3 has been no stranger to deals so far, either, with Boehringer Ingelheim acquiring Nerio Therapeutics for up to $1.3 billion to boost its immuno-oncology pipeline, and GSK and Flagship Pioneering striking a potential $7B deal to develop a portfolio of novel vaccines and medicines starting with immunology and respiratory treatments. Pfizer raised its full-year outlook after reporting positive Q2 results and announced layoffs this week at two North Carolina sites, with a total of 210 workers losing their jobs. Cuts at the Sanford, N.C. gene therapy manufacturing site come on the heels of Pfizer's Duchenne muscular dystrophy gene therapy failed a Phase III trial. On the obesity front, both Viking Therapeutics and Roche indicated that they will seek entry to the market more quickly than originally anticipated, and the FDA issued a warning on Monday about possible safety risks associated with compounded versions of Novo Nordisk's semaglutide. And the Alzheimer's Association International Conference (AAIC) this week revealed some interesting nuggets, including long-term data regarding Eisai and Biogen's Leqembi, and a small Phase IIb study showing that Novo's GLP-1 liraglutide slowed cognitive decline in Alzheimer's patients by up to 18%.

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.

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma e Biotech world.Medtronic is focusing on prediction as the next frontier in heart disease management, utilizing artificial intelligence to reduce false positives in its insertable cardiac monitors. The company's cardiovascular diagnostics and services business leader emphasizes the time-saving benefits for clinicians. Additionally, diabetes device firm Embecta is considering a sale two years after spinning out of BD, while Dexcom shares have plunged due to a lower sales outlook. The FDA has sent warning letters to Chinese syringe manufacturers, and the top five medtech deals in the first half of 2024 include Johnson & Johnson's takeover of Shockwave Medical. Roche Diagnostics' base business has grown 9 percent in the first half of 2024, and Tricares has raised $50 million to trial a tricuspid heart valve replacement system.Sanofi's bet on immunology is starting to pay off, with analysts noting that the pipeline of immune system therapies is underappreciated by investors. Pfizer's hemophilia gene therapy has shown positive results in late-stage studies, but questions remain about long-term potential. A startup led by former J&J executives, Third Arc Bio, raised $165 million for cancer and immune disease drugs. The US government declined to clear Bluebird Fertility Support for Zynteglo patients, and the GLP-1 drug race is heating up as pharma companies compete in the obesity market. The biopharma industry is evolving rapidly, with advancements in cell therapy and personalized cancer treatments.Steward Health System failed to attract qualified bidders during the first round of hospital sales in Ohio and Pennsylvania. Humana's CenterWell will open 23 primary care clinics in Walmart stores, while CMS is cracking down on ACA brokers to prevent unauthorized plan switching. AI is being used to power clinical trials and improve patient answer rates in healthcare organizations. The text also highlights stories from other publications, including the challenges faced by hospitals in non-Medicaid expansion states and the impact of Medicaid on insurers during the pandemic.Dexcom shares plunged due to a lower sales outlook, Abbott recalled Freestyle Libre 3 sensors for incorrect glucose readings, and a study found that AI's expert-level image analysis can be flawed. Edwards spent $1.2 billion on 2 heart device firms, Inspire Medical's COO is leaving for a CEO role at another company. Abbott stated that the sensor recall may affect less than 1% of users in the U.S. Researchers discovered that AI can generate expert-level image analysis with flawed reasoning. Edwards reported a slowdown in its core business, causing share prices to drop.Bristol Myers had a strong week of pharma earnings, with all five large pharmaceutical companies reporting raised profit or revenue guidance. Roche plans to move quickly with differentiated obesity drugs. Leqembi was voted down by European regulators, but Eisai plans to appeal. Two biotechs cut staff, while Abbvie weathers biosimilar threats. Sanofi's immunology pipeline is starting to pay off. The pharma industry is racing to develop GLP-1 drugs for obesity treatment.Gilead's $4.3 billion acquisition of Cymabay Therapeutics will face a significant test next month when the FDA decides on their autoimmune disease drug, Seladelpar. The treatment targets primary biliary cholangitis, a liver disease with no cure. Positive interim results have shown improvements in liver injury markers and reduced inflammation. Similarly, Citius Pharmaceuticals awaits an FDA decision on their rare blood cancer drug, Lymphir, with CEO Leonard Mazur personally investing $22.5 million in the company.The text discusses various marketing campaigns and initiatives, including Hyundai's shift to more emotional advertising for the Summer Olympics, Palo Alto Networks equipping Keanu Reeves with AI-powered weapons for a

Por segundo día vecinos de la zona paran los trabajos de construcción de la L2 del Suburbano en Tultitlán  Muere un mexicano albergue Guatemala  Agencia Europea de Medicamentos desaconseja uso de Leqembi contra AlzheimerMás información en nuestro podcast

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.

-Gobierno de Tulum emite declaratoria de emergencia ante impacto de Beryl-Aseguran predio donde se ubicó una toma clandestina en la GAM-Aprueban uso del fármaco Leqembi para combatir el Alzheimer-Más información en nuestro podcast

Noticias Económicas y Financieras Los niveles de deuda son una gran preocupación, ya que ambos candidatos presidenciales han sumado billones de dólares al déficit nacional durante sus primeros mandatos. Es un problema porque medidas como el aumento de impuestos y los recortes de gastos no son populares entre los contendientes que solo consideran cuatro años a la vez, mientras que puede llevar un tiempo sentir los mayores costos relacionados con el servicio de la deuda. De hecho, Estados Unidos tiene previsto gastar $892B en pagos de intereses en el año fiscal actual, más que la cifra destinada al gasto de defensa, y se prevé que esa cifra supere el billón de dólares en 2025, lo que está cerca del presupuesto total para Medicare. El legendario gladiador gastronómico Joey Chestnut no se atragantará con los perritos calientes empapados en el Nathan's Famous Hot Dog Eating Contest de este año, el 4 de julio. Según ESPN, el 16 veces campeón acordó un acuerdo de patrocinio con Impossible Foods $IMPF, que fabrica alternativas vegetales a la carne y el pescado, incluidos los perritos calientes vegetales, lo que lo hace inelegible para competir. Los perritos calientes de Nathan son fabricados por Smithfield, una subsidiaria de la empresa china de procesamiento de carne y alimentos WH Group (OTCPK:WHGLY), pero el sitio del Nathan's Famous Hot Dog Eating Contest sigue siendo propiedad privada de la familia del fundador Nathan Handwerker. La FDA ha aprobado Kisunla (donanemab) de Eli Lilly $LLY como tratamiento para la enfermedad de Alzheimer en sus inicios. La terapia, que se administra mediante infusión una vez al mes, costará 12.522 dólares durante seis meses o 32.000 dólares para un tratamiento más amplio durante un año. Kisunla competirá con Leqembi (lecanemab) de Biogen $BIIB y Eisai (OTCPK:ESAIY), que está disponible en Estados Unidos desde el año pasado. Las acciones de Eli Lilly no recibieron ningún impulso de las últimas noticias, ya que el presidente Biden y el senador Bernie Sanders instaron al gigante farmacéutico a reducir sustancialmente los precios y dejar de "estafar al pueblo estadounidense". La Comisión Federal de Comercio ha presentado una demanda para bloquear la compra por $4B que Tempur Sealy (NYSE: TPX) planea realizar del minorista Mattress Firm. Como mayor proveedor y fabricante de colchones del mundo, Tempur Sealy tendrá la capacidad y el incentivo para "suprimir la competencia" y aumentar los precios de los colchones para millones de consumidores, según la FTC. La empresa respondió que "la perspectiva no refleja todos los hechos y la ley relevantes", destacando que la industria de la ropa de cama es altamente competitiva. Otras fusiones y adquisiciones están bajo la lupa a raíz de la sentencia, como el acuerdo de Walmart $WMT para adquirir el fabricante de televisores Vizio $VZIO. La fortaleza de Tesla $TSLA hace que el Nasdaq cierre por encima de los 18.000 puntos. $MRNA Moderna firma un contrato para desarrollar una vacuna de mRNA contra la gripe aviar. $WMT Walmart explora la posible venta de centros de salud.

The biggest news of the last week was easily the expanded approval of Sarepta's Duchenne muscular dystrophy gene therapy, Elevidys. CBER Director Peter Marks again overruled FDA staff members and review teams to grant the therapy full approval and a broad label expansion despite its missing the primary endpoint in a Phase III confirmatory study. This approval has us thinking about other big FDA decisions to watch this year, first and foremost, Eli Lilly's anti-amyloid antibody donanemab. If given the green light, donanemab will be a direct competitor to Biogen and Eisai's Leqembi, also a disease-modifying anti-amyloid antibody. Beyond that, Verona Pharma is expecting a decision Wednesday on ensifentrine, which could be the first novel mechanism for chronic obstructive pulmonary disease in over a decade, and in August, the FDA is set to decide on Lykos' MDMA-assisted PTSD therapy, which an advisory committee voted against earlier this month. Then this week, Alnylam scored big with a Phase III win in transthyretin amyloidosis with cardiomyopathy (ATTR-CM). In what Alnylam CMO Pushkal Garg called “overwhelmingly positive data,” Amuvttra significantly lowered the risk of death and recurrent cardiovascular events in patients with ATTR-CM. Meanwhile, biopharma conference season continues with the American Diabetes Association's annual conference held this past weekend. Eli Lilly's blockbuster drug Zepbound “significantly improved” disease severity in patients with obesity and sleep apnea, and Altimmune racked up a Phase II victory for pemvidutide, which was effective at helping patients lose weight while retaining lean muscle.

Dr. Zahydie L. Burgos Ribot cares for her husband, Francisco, also known as Paco, who is living with Young Onset Familial Alzheimer's Disease. In this episode, Zahydie and Paco share their caregiving journey. They talk about how they took time to understand and cope with Paco's diagnosis and process their feelings of grief before telling others. They also discuss Paco's treatment, including E2814 therapy and Leqembi medication, which help slow down Paco's Alzheimer's. And they talk about how they focus on living each day with intention and are enjoying crossing off things from their bucket list. Show notes with product and resource links: https://bit.ly/HHCPod184 Receive the podcast in your email here: http://bit.ly/2G4qvBv Order a copy of Elizabeth's book Just for You: a Daily Self Care Journal: http://bit.ly/HHCjournal For podcast sponsorship opportunities contact Elizabeth: https://happyhealthycaregiver.com/contact-us/ The Happy Healthy Caregiver podcast is part of the Whole Care Network. Rate and Review the podcast: https://bit.ly/HHCPODREVIEW

Dr. Zahydie L. Burgos Ribot cares for her husband, Francisco, also known as Paco, who is living with Young Onset Familial Alzheimer's Disease. In this episode, Zahydie and Paco share their caregiving journey. They talk about how they took time to understand and cope with Paco's diagnosis and process their feelings of grief before telling others. They also discuss Paco's treatment, including E2814 therapy and Leqembi medication, which help slow down Paco's Alzheimer's. And they talk about how they focus on living each day with intention and are enjoying crossing off things from their bucket list. Show notes with product and resource links: https://bit.ly/HHCPod184 Receive the podcast in your email here: http://bit.ly/2G4qvBv Order a copy of Elizabeth's book Just for You: a Daily Self Care Journal: http://bit.ly/HHCjournal For podcast sponsorship opportunities contact Elizabeth: https://happyhealthycaregiver.com/contact-us/ The Happy Healthy Caregiver podcast is part of the Whole Care Network. Rate and Review the podcast: https://bit.ly/HHCPODREVIEW

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  

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.

Pink Sheet editors discuss Medicare spending projections for the Alzheimer's treatment Leqembi (:28), Janet Woodcock's new post-FDA role (12:28), and ongoing preparations for new pneumococcal vaccines that will reach the market soon (17:28). #business #pharma More On These Topics From The Pink Sheet Medicare Spending Forecast For Leqembi Reflects CMS Angst About Alzheimer's Drug Costs: https://pink.citeline.com/PS150095/Medicare-Spending-Forecast-For-Leqembi-Reflects-CMS-Angst-About-Alzheimers-Drug-Costs Woodcock Takes On Rare Disease Challenges In Retirement, Keeps FDA, Industry At Arm's Length: https://pink.citeline.com/PS150111/Woodcock-Takes-On-Rare-Disease-Challenges-In-Retirement-Keeps-FDA-Industry-At-Arms-Length Change Is Constant For Pneumococcal Vaccines: US CDC Prepares For Merck's V116: https://pink.citeline.com/PS150029/Change-Is-Constant-For-Pneumococcal-Vaccines-US-CDC-Prepares-For-Mercks-V116

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, Ian Kremer, executive director of the leaders Engaged on Alzheimer's Disease (LEAD) coalition, spoke about several relevant topics regarding Alzheimer care as new novel therapeutics emerge. He talked about the lessons learned from the recent discontinuation of aducanumab, and the potential and limitations lecanemab (Leqembi; Eisai) and donanemab (Eli Lilly) may bring. Additionally, he provided comments about what matters to patients, the perception of the FDA approval process, and what is considered "clinically meaningful." Furthermore, he gave perspective on ways to improve drug development and emphasized the need for policy decisions to be based on scientific evidence and not by sensationalized headlines. Looking for more Alzheimer disease/dementia discussion? Check out the NeurologyLive® Alzheimer disease/dementia clinical focus page. Episode Breakdown: 1:10 – Promise in the Alzheimer field in 2024 4:05 – Ways of improving efficiencies with drug develpment 9:10 – Discontinuation of aducanumab 11:10– Neurology News Minute 13:50 – Lessons learned from aducanumab, antiamyloid therapies  22:10– Conversations between clinicians and patients surrounding expectations/limitations of antiamyloid therapies and available treatments 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 Agrees to New Specialized Protocol for Phase 3b Study of ALS Agent NurOwn FDA Approves Alternate Administration Routes for Antiseizure Medication Cenobamate Extended Use of Investigational Agent IPX203 Safe in Parkinson Disease 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.

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.

Dr. K explains mild cognitive impairment (MCI) and discusses scientifically tested approaches to treating this memory condition, including the role of medications, supplements, hearing support, Leqembi and more.

In the past few years, new therapies shown to slow the progression of Alzheimer's disease in people in the early stages of the disease have been making their way through the U.S. Food and Drug Administration's (FDA) approval process. With these treatments now available, there are a growing number of questions surrounding who is eligible to take these medications and what processes are needed to ensure they are prescribed safely and effectively. Host Dr. Nathaniel Chin examines the guidelines for geriatricians and clinicians prescribing lecanemab and breaks down the eligibility requirements necessary to receive this treatment. Show Notes Read Eisai/Biogen's “Prescribing Information” for Leqembi online. Read “Lecanemab: Appropriate Use Recommendations” on the National Library of Medicine website. Read the U.S. Department of Veterans Affairs' (VA) guidelines for prescribing lecanemab, “Lecanemab-irmb (LEQEMBI) Criteria for Use August 2023,'' online. Listen to previous Dementia Matters episodes on lecanemab, including “Putting Lecanemab into Practice: A Clinician's Perspective on the New Alzheimer's Treatment,” “A Closer Look at the Lecanemab Clinical Trials,” and “Introducing Lecanemab, The Latest Alzheimer's Disease Drug to Receive FDA Accelerated Approval,” on our website and all major podcast platforms. Connect with Us Find transcripts and more at our website. Email Dementia Matters: dementiamatters@medicine.wisc.edu Follow us on Facebook and Twitter. Subscribe to the Wisconsin Alzheimer's Disease Research Center's e-newsletter. Enjoy Dementia Matters? Consider making a gift to the Dementia Matters fund through the UW Initiative to End Alzheimer's. All donations go toward outreach and production.

Our guest on the podcast today is Howard Gleckman. He is the author of a book called Caring for Our Parents and an expert on the topic of aging and caregiving. Howard is also a senior fellow at the Urban Institute where he is affiliated with the Tax Policy Center and the Program on Retirement Policy. He also writes a tax and budget policy blog called TaxVox, which is available at Forbes.com. Before joining the Urban Institute, he was a senior correspondent in the Washington Bureau of Businessweek.BackgroundBioUrban InstituteTaxVox blogCaring For Our Parents, by Howard GleckmanLong-Term Care and Cognitive Decline“Is Long-Term Care a Predictable Need, or an Unexpected One?” by Howard Gleckman, Forbes.com, April 15, 2022.“The U.S. Needs to Help Seniors and Their Families Navigate Long-Term Care,” by Howard Gleckman, Forbes.com, Oct. 11, 2022.“The Quiet Struggles With Those Living Alone With Memory Loss,” by Howard Gleckman, Forbes.com, July 18, 2023.“Which States Provide the Best—and Worst—Long-Term Care Services?” by Howard Gleckman, howardgleckman.com, Oct. 2, 2023.“Why Are Care Delivery Models for People With Dementia Developing so Slowly?” by Howard Gleckman, howardgleckman.com, June 27, 2023.“FDA Has Approved the Anti-Alzheimer's Drug, Leqembi. What You Need to Know,” by Howard Gleckman, howardgleckman.com, July 6, 2023.“Experts Raise Questions About the Safety of Anti-Alzheimer's Drug Leqembi,” by Howard Gleckman, howardgleckman.com, April 25, 2023.“Aging in Place Is all the Rage, But It's Not Easy,” by Howard Gleckman, Forbes.com, March 21, 2022.Cost of Care“Medicaid Will Pay for a Common Alzheimer's Test But It May Not Be Reliable,” by Howard Gleckman, howardgleckman.com, Jan. 9, 2024.“Why Medicare Is Right to Negotiate Drug Prices,” by Howard Gleckman, howardgleckman.com, Aug. 30, 2023.“The Biggest Barrier to New Anti-Alzheimer's Drugs May Be Cost, Not Medicare Rules,” by Howard Gleckman, howardgleckman.com, June 14, 2023.“The War Over Whether Medicare Should Pay for new Anti-Alzheimer's Drugs,” by Howard Gleckman, howardgleckman.com, May 17, 2023.“The U.S. Predicts Big Increases in Skilled Nursing and Long-Term Care Costs,” by Howard Gleckman, howardgleckman.com, April 14, 2023.“Should You Enroll in a Medicare Advantage Plan?” by Howard Gleckman, howardgleckman.com, Nov. 1, 2022.Government and Policy“CMS' New Transparency Rule Can Help ‘Weed Out a Few Bad Actors' but Won't Impact Deals Much, Other Factors at Play,” by Shelby Grebbin, skillednursingnews.com, Dec. 6, 2023.“Forbes' Gleckman: Biden's PE Ownership Scrutiny Is ‘Two Beats Behind,'” by Amy Stulick, skillednursingnews.com, April 28, 2022.“Who Really Owns Nursing Homes, and How the Feds Are About to Learn More,” by Howard Gleckman, howardgleckman.com, Nov. 27, 2023.“Should State Long-Term Care Insurance Funds Invest in Stocks?” by Howard Gleckman, howardgleckman.com, June 22, 2023.Caregivers“Forget National Caregivers Month. Think About What Family Caregivers Need,” by Howard Gleckman, howardgleckman.com, Nov. 7, 2023.“For the First Time, Traditional Medicare Will Pay to Support Family Caregivers,” by Howard Gleckman, howardgleckman.com, Aug. 23, 2023.OtherLotsa Helping HandsMedicare.govFive-Star Quality Rating System

บรรยากาศการจัดรายการ https://www.youtube.com/watch?v=UmJfT6jX-_E ข่าว พบฟอสซิลหนังที่เก่าแก่ที่สุดตั้งแต่เคยเจอมา อายุเกือบ 300 ล้านปี -1,2 หนังนี้มาจากยุคเปอร์เมียน ประมาณ 300-250 ล้านปีก่อน สันนิษฐานว่าเป็นของสัตว์เลื้อยคลานตัวเล็กๆ เหมือนกิ้งก่า ชื่อ Captorhinus aguti มีชีวิตอยู่ยุคก่อนไดโนเสาร์ ข่าววิเคราะห์สาเหตุการสูญพันธุ์ของเอปยักษ์ Gigantopithecus -1,2 ข่าวใช้เทคโนโลยี Lidar แสกนเจอผังเมืองโบราณที่อเมซอน - 1 ข่าวเพนกวินมีการนอนแบบ microsleep หลับครั้งละ 4-10 วินาที แต่หลับวันละหมื่นรอบ -1,2,3 ข่าว เฮอริเคนพัดผ่านแพขยะกลางทะเลแล้วพาไมโครพลาสติกขึ้นบก -1,2 ข่าวปี 2023 ทำลายสถิติอุณหภูมิผิวน้ำทะเลสูงสุด -1 เรื่องเด่นปีที่แล้ว - FDA อนุมัติยาชะลอสาเหตุอัลไซเมอร์ตัวแรก (Leqembi) -1,2 ข่าวนกกระเต็นมียีนผลิตโปรตีนแบบเดียวกับที่สะสมแล้วทำให้เป็นอัลไซเมอร์ แต่สำหรับนกน่าจะมีส่วนเกี่ยวข้องกับการกันสมองกระแทกเวลาพุ่งลงน้ำไปจับปลา -1,2 Breakthrough of the Year 2023 นิตยสาร Science มอบให้ ยาตระกูล GLP-1 agonist เช่น Ozempic และ Wegovy ถล่มวงการลดน้ำหนัก (ทำให้อิ่มและอาหารย่อยช้าลง) ต้านเบาหวาน และมีศักยภาพจะช่วยบำรุงหัวใจ ไต และอาจช่วยเลิกพฤติกรรมเสพติดได้ด้วย -1 https://www.youtube.com/watch?v=QnmMSMF7wO4 https://www.youtube.com/watch?v=P6gt4A_3Whs เฉลย / / / / / 1. หลอก -1 ข้อ 2 จริง - รวมคำขวัญวันเด็ก ข้อ 3 จริง - งานวิจัยความสุขเด็ก -1,2

In today's Bonus policy episode, Howard Gleckman joins Anne in discussing policy changes in 2023. Howard is a published author and writer whose professional expertise is founded on long-term care, health care, elder care, tax policy, budget policy and economics.   Howard was also a senior correspondent in the Washington bureau of Business Week. In our episode today, we discuss some of the major policy happenings in 2023 - the GUIDE program, CMS staffing standards, the decision to cover Leqembi and more. SHOW NOTES Howard Gleckman.com

Join Ken Blaker, a health care and technology consultant, and Cuong Do, a health care executive, as they shed light on the latest developments in combating these challenging conditions. From the recent FDA approval of Leqembi to promising anti-neuroinflammation drugs and genetic approaches, we uncover the cutting-edge strategies that could change the future of Alzheimer's care. Ken Blaker is a Los Angeles-based health care and technology consultant focused on medical devices and FDA compliance. As an author, Ken has written on a variety of topics, including treatments for neurodegenerative diseases, cancer research, and the opioid epidemic. Cuong Do is a health care executive. They discuss the KevinMD article, "Rising longevity and cognitive health: Navigating dementia and treatment." Careers by KevinMD is your gateway to health care success. We connect you with real-time, exclusive resources like job boards, news updates, and salary insights, all tailored for health care professionals. With expertise in uniting top talent and leading employers across the nation's largest health care hiring network, we're your partner in shaping health care's future. Fulfill your health care journey at KevinMD.com/careers. VISIT SPONSOR → https://kevinmd.com/careers Discovering disability insurance? Pattern understands your concerns. Over 20,000 doctors trust us for straightforward, affordable coverage. We handle everything from quotes to paperwork. Say goodbye to insurance stress – visit Pattern today at KevinMD.com/pattern. VISIT SPONSOR → https://kevinmd.com/pattern SUBSCRIBE TO THE PODCAST → https://www.kevinmd.com/podcast RECOMMENDED BY KEVINMD → https://www.kevinmd.com/recommended GET CME FOR THIS EPISODE → https://earnc.me/aWcRJM Powered by CMEfy.

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

-  PRADO el abogado asesoraba en posible demanda a suegro y esposa de Verdejo - Jay Fonseca app  - Sentencian hoy a los primos del gobe - Jay Fonseca app  - Lluvias esta noche y mañana por onda - Elizabeth Robaina  - OTAN considera entrar a Ucrania en el club - Financial Times  - Botox fatulo invade a PR - Vocero  - Hoy es Prime Day  - Foto del presunto asesino de hermanos en Ropa Vieja - Policia  - Divorcio de Ricky Martin por supuesta relación abierta - Primera Hora  - Gobernador vetaría reforma electoral segíun delegación PNP - PH  - Nueva secretaria de Educación borra redes sociales - Primera Hora  - Leqembi es buena para los hombres, no ayuda tanto a las mujeres - Axios - Precios de aguacates y siracha por las nubes ante clima de México - QZ - Nueva presidenta de la CEE empieza hoy - El Nuevo Día  - Inspector fatulo de Salud timando restaurantes pedía pagos en cash - WAPA TV   ¿Quién no ha visto alguna vez cuando se llevan un carro en grúa por no tener el marbete al día? Y más fuerte es la multa que también hay que pagar.  Gente, hay que pagar el marbete a tiempo. Es un requisito de ley, pero, además, no tener el marbete puede tener serias consecuencias en caso de estar involucrado en un accidente de tránsito. Lo triste es que muchas veces esto ocurre porque simplemente se te olvidó la fecha de renovación.  Si llevar el calendario no es lo tuyo, ASC puede enviarte recordatorios antes de la fecha de vencimiento del marbete y hasta te ayudan en el proceso de la renovación enviándote GRATIS la licencia del vehículo por email.  Regístrate en http://www.EscogeASC.com y podrás recibir tus recordatorios e información importante.   Al renovar el marbete, escoge a los expertos.  Escoge ASC. incluye auspicio

Friday briefing: Cluster bombs; Trump classified documents case; Alzheimer's drug Leqembi; Taylor Swift; and moreRead today's briefing.

Eisai Co., Ltd. and Biogen Inc. announced on January 6th that under the Accelerated Approval Pathway the U.S. Food and Drug Administration (FDA) has approved lecanemab-irmb, which has the brand name in the United States of LEQEMBITM, for the treatment of Alzheimer's disease.  The approval is based on Phase 2 data that demonstrated that LEQEMBI reduced the accumulation of Aβ plaque in the brain, a defining feature of Alzheimer's disease.  Newt's guest is Dr. Marwan Sabbagh, MD.  He is a behavioral neurologist in the Alzheimer's and Memory Disorders Program and a professor in the Department of Neurology at Barrow Neurological Institute and was one of the leading doctors of the study.See omnystudio.com/listener for privacy information.