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Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world.Today, we delve into the latest from an industry that continues to break new ground in both scientific innovation and regulatory landscapes. The pharmaceutical and biotech sectors are buzzing with activity as companies engage in bold strategies and face significant challenges in their quest for groundbreaking treatments.A recent event illustrating the high-stakes nature of this industry involves Novo Nordisk and its decision to conduct a head-to-head clinical trial for Cagrisema against Eli Lilly's Zepbound. This trial, which typically occurs post-approval, was conducted at the candidate stage. Novo Nordisk aimed to establish market dominance by proving superiority early on. However, the trial did not go as planned, with Cagrisema failing to outperform Zepbound. This outcome serves as a reminder of the competitive dynamics in early-stage testing and the strategic risks companies are willing to take in their bid for market leadership.Meanwhile, Gilead Sciences has made a bold move with a $7.8 billion investment in Arcellx, focusing on CAR T-cell therapy. This investment highlights Gilead's commitment to advanced cancer treatments, particularly Anito-cel for relapsed or refractory multiple myeloma. CAR T-cell therapies involve modifying a patient's T-cells to target cancer cells more effectively, representing a significant leap forward in oncological treatments. With an FDA decision anticipated by December 2026, Gilead's investment underscores its strategic focus on transformative therapies that could redefine cancer care.In legal news, Regenxbio has secured a notable victory against Sarepta Therapeutics regarding adeno-associated virus (AAV) technology patents. The appeals court ruling in favor of Regenxbio emphasizes the intricate nature of patent law in biotechnology, where innovations often intersect with naturally occurring biological processes. This decision not only solidifies Regenxbio's intellectual property but also sets a precedent for future patent disputes within the sector.On the regulatory front, Vanda Pharmaceuticals has rebounded from previous setbacks by securing FDA approval for drugs targeting bipolar disorder and schizophrenia. This achievement marks a promising shift for Vanda, demonstrating resilience and adaptability in redirecting focus towards neuropsychiatric conditions. The approval expands therapeutic options for these complex disorders, addressing long-standing unmet needs within mental health care.Despite these advancements, some areas continue to face hurdles. Gene therapies like Casgevy and Lyfgenia for sickle cell disease have struggled to gain traction two years post-launch. These therapies promise a one-time cure by correcting genetic defects but have encountered challenges in achieving widespread adoption. The difficulties reflect broader issues in transitioning from clinical success to market viability.Moreover, workforce reductions at major companies such as Bristol-Myers Squibb and Catalent signal structural changes within the industry. These layoffs may indicate shifts in strategic focus or responses to evolving market pressures as companies strive for efficiency and innovation.Regulatory practices are also undergoing scrutiny as the FDA considers defaulting to single clinical trial requirements for drug approvals. While this move could streamline development processes, it raises concerns about maintaining rigorous safety standards—a balance that remains crucial as companies push to bring innovative treatments to market swiftly yet safely.The dynamic nature of this industry is further highlighted by Candel Therapeutics' recent $100 million royalty deal aimed at launching its prostate cancer treatment. This strategic move underscores growing interest in innovative oncology solutions thaSupport the show
Send us comments, suggestions and ideas here! In this week's episode, after nearly seven long years of researching vampires, abstruse occult sciences, shadowy conspiracies and the devil we arrive at the crossroads of chapel perilous where these ideas finally gather at the feet of the civilizational-level arch villain, Jeffery Epstein whose emails reveal a plan so vast, so cartoonish and so evil you threaten your very sanity by even considering it. In the free side of the show we explore Jeffery Epstein's network of scientists that he funded and met with on a regular basis in a prolonged effort to direct their various fields of research toward one goal. In the extended show we read victim statements and explore the supporting evidence that leads to a criminal conspiracy that involves baby farms, AI gods and what exactly the hidden rulers actually believe about God, the Devil and other things you're not even supposed to discuss. But we do anyway. Thank you and enjoy the show! In this week's episode we discuss:Deepak ChopraDIY Gene-hacking and designer babiesTransgenic Sperm Pre-OrdersTranshumanist Funding ProgramsEpstein's Evolutionary Science Team at HarvardVictim Statements about Zorro RanchMassacre of the InnocentsIn the extended, uncensored, politically-incorrect side of the show available at www.patreon.com/TheWholeRabbit we go further down into the Epstein library and discover:What Epstein was doing with so many 23&Me kitsEpstein's obsession with Ashkenazi ancestryVictims StatementsHaplogroup R1b-L2A RARE glimpse behind the curtain of Illuminati racial philosophy thanks to the enthusiastic writing of Joscha Bach (found within the Epstein library). Where to find The Whole Rabbit:Spotify: https://open.spotify.com/show/0AnJZhmPzaby04afmEWOAVInstagram: https://www.instagram.com/the_whole_rabbitTwitter: https://twitter.com/1WholeRabbitOrder Stickers: https://www.stickermule.com/thewholerabbitOther Merchandise: https://thewholerabbit.myspreadshop.com/Music By Spirit Travel Plaza:https://open.spotify.com/artist/30dW3WB1sYofnow7y3V0YoThis week's episode was researched by Luke Madrid, Heka Astra with commentaries and quotes provided by Tim Hacker and Mari Sama.Sources:Times of Israel - Ashkenazi Jews Descend From 350 People Study Finds:https://www.timesofisrael.com/ashkenazi-jews-descend-from-350-people-study-finds/Epstein Fileshttps://www.justice.gov/epstein/files/DataSet%209/EFTA01003966.pdfhttps://www.justice.gov/epstein/files/DataSet%2011/EFTA02625362.pdfhttps://www.justice.gov/epstein/files/DataSet%209/EFTA01019439.pdfhttps://www.justice.gov/epstein/files/DataSet%209/EFTA01019438.pdfSupport the show
In this podcast, Deborah Ojutalayo discusses targeted gene therapies for frontotemporal dementia caused by mutations in the GRN gene.
In this week's episode of the Xtalks Life Science Podcast, host Ayesha Rashid, Senior Life Science Journalist at Xtalks, spoke with Joseph Sinkule, CEO, Founder and the Chairman of the Board of Directors at Klotho Neurosciences, a biogenetics company developing cell and gene therapies using a patented, secreted form of the “anti-aging” human α-Klotho gene for the treatment of neurodegenerative, age-related disorders such as Alzheimer's disease, amyotrophic lateral sclerosis (ALS), Parkinson's disease and others. Dr. Sinkule has over 40 years of drug, biologic and medical device R&D and commercialization experience. He has managed over eight drug and biotech products successfully through FDA approval to market, as well as five medical devices and eight in vitro diagnostics. After serving in academics and then in industry, Dr. Sinkule has evolved into a successful businessman and entrepreneur. He has led teams of all sizes, managed CROs and CDMOs, serves on two company boards and regularly advises venture capital firms, investment banks and pharmaceutical and biotech companies at all stages. Tune in to learn more about targeting pathways of aging in diseases like Alzheimer's and ALS. For more life science and medical device content, visit the Xtalks Vitals homepage. https://xtalks.com/vitals/ Follow Us on Social Media Twitter: https://twitter.com/Xtalks Instagram: https://www.instagram.com/xtalks/ Facebook: https://www.facebook.com/Xtalks.Webinars/ LinkedIn: https://www.linkedin.com/company/xtalks-webconferences YouTube: https://www.youtube.com/c/XtalksWebinars/featured
This week, in partnership with British Heart Foundation, we explore heart failure. Leading experts from the UK's largest independent funder of cardiovascular research tell us about the condition, the symptoms to look out for, what happens when a heart fails, how heart failure has traditionally been managed, and whether it is possible to regenerate a damaged heart... Like this podcast? Please help us by supporting the Naked Scientists
When Terry Pirovolakis learned his son had an ultra-rare neurodegenerative disease, SPG50, he refused to accept “no options.” What started as a desperate search for hope became Elpida Therapeutics, a nonprofit driving gene therapy innovation for multiple rare diseases. In this episode, Terry shares the remarkable journey from diagnosis to clinical trials, the power of partnerships, and why urgency matters when every day counts.Show NotesFrom Mystery to Medicine: The Science Behind a Mother's Search | PodcastTaking a Customized and Collaborative Approach to Therapeutic Development | PodcastRare Disease Research for Drug Development | Charles RiverRare Disease | Charles RiverDiscovery | Charles RiverBeyond The Diagnosis
Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today, we delve into a series of significant events and decisions in the industry that are shaping the path forward for drug development and patient care.The U.S. Food and Drug Administration (FDA), an agency often at the center of pharmaceutical innovation and scrutiny, has recently made several noteworthy decisions. These decisions not only point to the ongoing regulatory challenges but also highlight scientific advancements within the field.One of the key updates involves the FDA's decision to reject Disc's drug bitopertin, which was intended for the treatment of erythropoietic protoporphyria, a rare blood disease. Despite receiving a national priority voucher for expedited review, the FDA ultimately concluded that the clinical data did not sufficiently support regulatory approval. This decision underscores the FDA's commitment to maintaining rigorous standards even when expedited reviews are in play, emphasizing the necessity of robust clinical evidence for approval.Adding complexity to this situation is the internal dynamics within the FDA itself. Richard Pazdur, a long-standing official at the agency, recently stepped down, revealing disagreements with Commissioner Marty Makary over reducing the number of clinical trials required for new drug applications. Pazdur's departure after an influential 26-year tenure highlights ongoing debates within regulatory bodies on how to balance innovative approval pathways with ensuring safety and efficacy data.In another notable development, Moderna faced setbacks with its mRNA-1010 flu vaccine as the FDA declined to review it. This decision leaves American consumers without access to potentially more effective mRNA-based flu vaccines—a technology embraced by other countries for influenza treatment. This situation points to possible missed opportunities in leveraging cutting-edge vaccine technologies domestically, showcasing both the promise and regulatory complexities surrounding mRNA technology.These regulatory challenges unfold amid leadership changes and strategic shifts within health agencies. For instance, Jim O'Neill's departure from his role as acting director of the Centers for Disease Control and Prevention following Susan Monarez's abrupt ouster illustrates how leadership turbulence can impact policy consistency and strategic direction, potentially affecting how new health initiatives are prioritized and implemented.Meanwhile, companies like Vertex and CRISPR Therapeutics are ambitiously advancing gene therapy solutions such as Casgevy, signaling a broader trend towards personalized medicine and advanced biotechnological approaches. These efforts promise transformative impacts on patient care and reflect an industry-wide move towards precision medicine.Eli Lilly's substantial investment in orforglipron stock ahead of its anticipated approval further indicates confidence in their product pipeline amidst growing competition from Novo Nordisk's Wegovy pill abroad. This competitive landscape highlights increasing interest and investment in innovative treatments for metabolic diseases.Overall, these developments illustrate a dynamic interplay between scientific innovation, regulatory scrutiny, and strategic corporate maneuvers that shape healthcare's future. As companies push technological boundaries, regulators face ongoing challenges in adapting frameworks that ensure patient safety while fostering innovation. The outcomes of these processes will significantly influence not only patient access to cutting-edge therapies but also set precedents for future drug development and approval pathways. As these trends unfold, stakeholders across the industry must remain agile, informed, and collaborative to navigate this evolving landscape effectively.Looking back at 2025, it was a tSupport the show
a16z general partner Jorge Conde talks with Vasant Narasimhan, CEO of Novartis International, about transforming a 250-year-old conglomerate into a pure play medicines company and unlocking $180 billion of value in the process. They cover Novartis's platform technologies: cell and gene therapies, RNA medicines, and radioligand therapies. They also discuss AI in drug discovery, the rise of China as a biotech competitor, and what Vasant looks for when evaluating startup partnerships, including his advice on the killer experiments and CMC work that can make or break a deal. Resources: Follow Vasant Narasimhan on X: https://twitter.com/VasNarasimhanFollow Jorge Conde on X: https://x.com/JorgeCondeBio Stay Updated:Find a16z on YouTube: YouTubeFind a16z on XFind a16z on LinkedInListen to the a16z Show on SpotifyListen to the a16z Show on Apple PodcastsFollow our host: https://twitter.com/eriktorenberg Please note that the content here is for informational purposes only; should NOT be taken as legal, business, tax, or investment advice or be used to evaluate any investment or security; and is not directed at any investors or potential investors in any a16z fund. a16z and its affiliates may maintain investments in the companies discussed. For more details please see a16z.com/disclosures. Hosted by Simplecast, an AdsWizz company. See pcm.adswizz.com for information about our collection and use of personal data for advertising.
Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today, we delve into a series of significant events shaping the landscape of drug development, regulatory scrutiny, and industry advancement. As we navigate this complex terrain, we'll explore how these changes impact both companies and patients.In recent news, Moderna has encountered a substantial hurdle as the FDA declined to review its flu vaccine candidate, mRNA-1010. This decision marks a notable shift from the expedited processes witnessed during the COVID-19 pandemic, reflecting a more cautious regulatory approach under current administrative leadership. Analysts suggest this could indicate broader regulatory changes that might affect future vaccine approvals. Moderna's situation is emblematic of the challenges companies face in maintaining momentum post-pandemic, especially as their research and development spending saw a significant decrease of 31% last year due to completed respiratory trials. This reduction highlights a strategic pivot as the company reassesses its priorities amidst an evolving market landscape.Vertex Pharmaceuticals is making headlines with its ambitious revenue goals outside its established cystic fibrosis franchise. By 2026, Vertex aims to generate $500 million from non-CF medications, with recent launches like Casgevy and Journavx already showing promise by collectively bringing in $175.6 million last year. This diversification strategy is critical for mitigating risks associated with dependence on a single therapeutic area and reflects a broader industry trend towards strategic realignment. Additionally, Vertex remains under close observation within kidney disease portfolios, particularly with Povetacicept—an IgA nephropathy treatment—and the success of Journavx impacting market positions by offering chronic kidney disease patients new therapeutic options.PTC Therapeutics has faced setbacks with its FDA application withdrawal for Translarna, intended for treating nonsense mutation Duchenne muscular dystrophy. The decision came after receiving adverse feedback from the FDA, highlighting the complexities involved in gaining approval for therapies targeting intricate genetic conditions. Such hurdles underscore the high-risk nature of biotech ventures that are heavily reliant on regulatory timelines.Novartis is pushing forward with plans to seek full FDA approval for Vanrafia, its IgA nephropathy drug, despite not meeting primary kidney function goals in Phase 3 trials. This move aligns with a growing trend where companies pursue approval based on secondary endpoints or other supportive data when primary outcomes fall short. Such strategies underscore the competitive and high-stakes environment surrounding drug approval pathways.Novo Nordisk is expanding its production capabilities in Ireland to meet increasing demand for Wegovy, their obesity drug that's seen impressive sales in the U.S. This investment underscores the global potential for obesity treatments and highlights how manufacturing expansions are pivotal to supporting international market entry.In Europe, Amgen has secured approval for Uplizna in treating myasthenia gravis, adding another option to an already crowded treatment landscape but offering patients additional therapeutic choices. Meanwhile, AbbVie has launched a legal challenge against Botox's inclusion in drug pricing negotiations under the Inflation Reduction Act (IRA), arguing it should be excluded due to its plasma-derived nature.Ultragenyx has announced a 10% workforce reduction amid halted gene therapy plans and unsuccessful late-stage trials in brittle bone disease. These adjustments often reflect broader strategic shifts within biopharma companies as they realign focus and resources. Ultragenyx's operational challenges highlight the volatile nature of biotech ventureSupport the show
This episode will cover the background of cellular-based gene therapies from basic cell biology to genetic targets currently used in treatment. Experts will review the mechanisms for modifying cellular genetic material and the common viral vector platforms used in ex-vivo cellular therapy production. An overview of the steps and processes for cellular therapy preparation, manufacturing, handling and administration will be provided. Additionally, this presentation will discuss novel cellular therapy agents currently approved for use and the highly anticipated cellular therapies currently under investigation. CE for this episode expires 2 years after the date it was originally published. The information presented during the podcast reflects solely the opinions of the presenter. The information and materials are not, and are not intended as, a comprehensive source of drug information on this topic. The contents of the podcast have not been reviewed by ASHP, and should neither be interpreted as the official policies of ASHP, nor an endorsement of any product(s), nor should they be considered as a substitute for the professional judgment of the pharmacist or physician.
Guest: Courtney Crawford, MD, FACS Guest: Raj Maturi, MD While anti-VEGF therapy can deliver vision gains with consistent, frequent injections in clinical trials, it may be challenging to sustain this in real-world practice.1 Ocular gene therapy could be a potential option for patients with neovascular age-related macular degeneration if approved. With this approach, transgenes are delivered to the eye by adeno-associated viruses (AAVs).2-4 Learn more with Drs. Courtney Crawford and Raj Maturi, who shared their perspectives on investigational gene therapy, patient conversations, and surgical considerations at the 2025 American Academy of Ophthalmology annual meeting in Orlando, Florida. Dr. Crawford is a board-certified retina specialist and founder of Star Retina in Burleson, Texas. He previously served for 10 years as a physician in the U.S. Army, where he attained the rank of Lieutenant Colonel. Dr. Maturi is a board-certified retina specialist at the Midwest Eye Institute and founder of Retina Partners Midwest in Carmel, Indiana, where he focuses on macular, retina, and vitreous care. References: Weng CY, Singh RP, Gillies MC, Regillo CD. Optimizing visual outcomes in patients with neovascular age-related macular degeneration: the potential value of sustained anti-VEGF therapy. Ophthalmic Surg Lasers Imaging Retina. 2023;54:654–659. Petrich J, Marchese D, Jenkins C, Storey M, Blind J. …
Continua con questa puntata il viaggio di Smart City nel PNRR per la ricerca. A pochi mesi dalla chiusura del piano, quale eredità lascia il PNRR al sistema dell'innovazione e della ricerca, e come viene gestita? Oggi parliamo del Centro Nazionale RNA & Gene therapy, uno dei cinque centri nazionali per la ricerca costituiti nel 2022 dal MIUR con fondi PNRR pari a 320 milioni di euro. Il centro lavora su due filoni terapeutici su cui ci sono enormi aspettative; una medicina di frontiera con una lunga storia di ricerca scientifica ma un approdo solo recente alla pratica clinica/medica, con moltissime diramazioni. Per citare le più importanti: malattie genetiche e metaboliche, vaccini, lotta al cancro. In tutti questi ambiti, le terapie geniche e a RNA hanno da offrire un ventaglio di approcci terapeutici semplicemente inesistente fino a pochi anni fa. Ne parliamo con Rosario Rizzuto, Presidente del Centro Nazionale per la Terapia Genica e i Farmaci con Tecnologia a RNA; medico e professore di Patologia Generale; già Rettore dell'Università di Padova.
Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. In today's episode, we delve into the dynamic landscape of these industries, exploring ambitious strategic plans, regulatory hurdles, scientific breakthroughs, and emerging trends that are shaping the future of healthcare.Let's begin with AstraZeneca, which has set an ambitious target to achieve $80 billion in revenue by 2030. This goal reflects their intention to bring over 25 blockbuster drugs to market, underscoring a commitment to innovation and expansion in their therapeutic portfolio. The focus on cutting-edge research is not just a strategy for growth but also a sign of the broader industry trend where large pharmaceutical companies pursue high-value targets to strengthen their market positions. AstraZeneca is also making strides in the weight-loss market with its new candidate elecoglipron, undergoing an extensive late-stage program to evaluate its efficacy as a monotherapy and in combination treatments for various indications. This development positions AstraZeneca competitively in the burgeoning sector, offering a novel therapeutic option for obesity management.Meanwhile, CSL Limited is undergoing a leadership transition. CEO Paul McKenzie has stepped down under pressure, and Gordon Naylor has been appointed as interim chief. This change highlights the critical role of strategic leadership in navigating industry challenges and maintaining growth trajectories amidst a rapidly shifting market landscape.In a display of financial success, Novartis reported a record-breaking performance for 2025. This achievement led to a 30% increase in CEO Vas Narasimhan's compensation, reaching $32 million. The company's robust financial health is attributed to advancing innovative treatments targeting unmet medical needs, emphasizing how achieving innovation milestones can significantly enhance corporate valuation and leadership rewards.Incyte is preparing for the patent expiration of its blood cancer drug Jakafi in 2028 by focusing on Opzelura, a topical cream that has witnessed a 33% sales increase from the previous year. With sales reaching $678 million, Opzelura's success highlights Incyte's strategic pivot to diversify its product offerings and mitigate risks associated with patent cliffs. This exemplifies how companies must continuously innovate and adapt to maintain competitive advantages.Moderna has entered into a long-term agreement with Mexico to ensure local mRNA vaccine supply through technology transfer to Laboratorios Liomont. This partnership extends Moderna's global footprint and underscores the critical role of mRNA technology in pandemic preparedness and vaccine accessibility, reinforcing its transformative impact on public health strategies.Regulatory landscapes have also seen notable activity. The FDA issued untitled letters concerning potentially misleading drug advertisements from companies like Novo Nordisk, Argenx, and Sobi. Such actions emphasize regulatory vigilance in marketing practices. Additionally, Lilly's Kinsunla failed to secure approval in Scotland, while Regenxbio faced rejection for its gene therapy for Hunter syndrome. These regulatory hurdles highlight the rigorous oversight pharma companies face and the complex pathways drugs must navigate before market approval.Collaborations within the industry are proving crucial for innovation. Merck's collaboration with Calla Lily Clinical Care aims to enhance delivery systems for vaginal therapeutics. Similarly, Bristol Myers Squibb's partnership with Evinova focuses on integrating AI into clinical development processes. These alliances reflect an industry-wide emphasis on leveraging technology to improve drug delivery efficiency and streamline clinical trial operations.Shifting our focus now to scientific advancements and clinical trial results that aSupport the show
Last Thursday, Hims & Hers launched a compounded versionof Novo's oral Wegovy, approved just before Christmas and launched in early January. Novo was, not surprisingly, none too pleased. FDA Commissioner Marty Makary denounced“illegal copycat drugs” in an X post the same day without naming Hims, which then said it would notsell the oral weight loss drug. Novo sued the consumer healthcare company for patent infringement, seeking potentially hundreds of millions in damages. Thenit emerged that FDA hit Hims with a warning letter last year about infestations of vermin at a facility it owns, including rodents, birds and insects, as well as a live spider in a production area.The timing of all the Hims drama is interesting, because BioSpace was already covering Novo, Lilly and their blockbuster GLP weight loss drugs as both companies—and others—reported 2025 fourth quarter and full year earnings. EliLilly and Novo both reported last Wednesday, and both spoke of Novo's oral Wegovy launch positively. But the calls had two very different tones, as Lilly beat Q4 2025 analyst consensus by more than a billion dollars while Novo projected sales to decline by 5% in 2026.In other recent earnings calls, AbbVie touted strong Skyriziand Rinvoq sales, and the company continues to follow Johnson & Johnson's lead into the psychedelics space. And Biogen discussed the highly anticipated readout of its tau-targetingtherapy for Alzheimer's.Finally, in gene therapy, Sarepta struggles to recover from last year's patient deaths as other DMD contenders near the market; uniQure pauses two arms of a clinical trial for Fabry disease; and Ultragenyx resubmits its in vivo gene therapy UX111 for the treatment of Sanfilippo syndrome type A.
Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today, we delve into a fascinating array of stories that highlight the scientific advancements, regulatory updates, and strategic maneuvers shaping our industry.Let's begin with Biogen's efforts to breathe new life into its spinal muscular atrophy treatment, Spinraza. In response to declining sales, Biogen is launching a high-dose version in Japan, aiming to enhance therapeutic efficacy and regain market competitiveness. This move underscores the company's strategy to offset projected revenue declines by 2026. The decision to pursue this high-dose version reflects Biogen's commitment to maintaining its foothold in a challenging market landscape where innovation is key to survival.Shifting gears to regulatory news, the FDA, led by Commissioner Marty Makary, has taken a firm stance against the proliferation of illegal copycat drugs. This announcement comes on the heels of Hims & Hers' controversial introduction of a compounded version of Novo Nordisk's obesity drug, Wegovy. The FDA's commitment to protecting intellectual property and patient safety is crucial in an era where health tech firms increasingly challenge traditional pharmaceutical boundaries. Novo Nordisk's aggressive marketing strategy for Wegovy, including a high-profile Super Bowl advertisement, highlights the competitive pressures in this growing market segment and underscores the legal tensions between established pharma giants and emerging tech-driven companies.In an unexpected turn of events, BridgeBio faced a significant setback as Pfizer withdrew its tafamidis patent in Europe. This led to a notable drop in BridgeBio's stock price and raised concerns about earlier generic entries into the ATTR-CM market. Such developments signal potential shifts in market dynamics and pricing strategies that companies must navigate carefully.On the clinical front, Bayer's phase 3 study of asundexian has demonstrated remarkable results—a 26% reduction in stroke risk. This positions Bayer favorably against competitors Bristol Myers Squibb and Johnson & Johnson, setting a new benchmark in the high-stakes anticoagulant market. Innovation continues to be paramount as companies strive for superior clinical outcomes that can significantly impact patient care.Regulatory landscapes are evolving as well, with Gilead's Yescarta receiving clearance for expanded use. These milestones are crucial for broadening therapeutic indications and enhancing patient access, underscoring ongoing efforts to address unmet medical needs while sustaining growth trajectories.Meanwhile, Pfizer-backed Priovant has reported promising mid-stage results for brepocitinib in treating dermatomyositis and other rare skin conditions. As a TYK2/JAK1 inhibitor, brepocitinib exemplifies precision medicine's expanding role in addressing autoimmune disorders through targeted therapies.The IPO scene remains vibrant with Agomab Therapeutics and Spyglass Pharma making substantial entries into Nasdaq, collectively raising $350 million. This influx indicates continued investor confidence in biopharma innovation despite broader economic uncertainties—a testament to the sector's resilience and potential for groundbreaking advancements.Corporate dynamics are also shifting as seen with Moderna's Chief Medical Officer Jacqueline Miller stepping down after a brief tenure. Leadership changes such as these often signal strategic realignments within companies as they adapt to complex regulatory environments and competitive pressures.Summarizing these developments illustrates a dynamic landscape marked by scientific innovation, regulatory vigilance, and strategic marketing initiatives. As companies strive for competitive advantage through new drug formulations and market expansions, they must also navigate legal challenges and regSupport the show
How do you build an organization that can absorb change, learn from failure, and keep patients at the center—even when the science is uncertain? Nelly Viseux shares lessons from over 20 years in biotech and a decade leading cell and gene therapy development.Nelly discusses how she structured a 100-person CMC organization at Regeneron to balance innovation with operational execution, why documenting your assumptions is critical to managing risk, and what it really takes to maintain resilience when you're literally holding patient lives in your hands.A few of Nelly's key takeaways:Resilience is adaptability—build organizations that absorb and anticipate change rather than resist itSeparate innovation from execution with intentional gates for when new approaches are ready to implementDocument your assumptions so you can revisit decisions effectively when circumstances changeFailure is a process problem, not a personal one—root cause analysis should improve systems, not assign blameData is the common language that aligns scientists, regulators, and stakeholdersEveryone is a leader in cell therapy—manufacturing and QC teams hold patient lives in their handsAbout Nelly ViseuxNelly Viseux is Vice President of Cell Therapies Development, Manufacturing, Supply & Quality at Regeneron, leading a 100-person organization supporting autologous cell therapy programs. She has over 20 years of biotechnology experience spanning large pharma (Shire, Biogen, Baxter) and startups, working across cell and gene therapies, biologics, and nanoparticles. Her accomplishments include building a Phase 1 cell therapy manufacturing facility that achieved 100% cGMP success and first IND submission within two years. She holds a Ph.D. in Biochemistry and Molecular Biology from University of Lille and is a member of the Society for Immunotherapy of Cancer and the American Society of Gene & Cell Therapy.About The FDA GroupThe FDA Group helps life science organizations rapidly access the industry's best consultants, contractors, and candidates. Our resources assist in every stage of the product lifecycle—from clinical development to commercialization—with a focus on staff augmentation, auditing, remediation, QMS, and other specialized project work in Quality Assurance, Regulatory Affairs, and Clinical Operations. Learn more: https://www.thefdagroup.com/
Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today, we're diving into a series of transformative events reshaping the industry landscape, from regulatory advancements to scientific breakthroughs and strategic business maneuvers.Kicking off with a significant regulatory update, the FDA's Rare Pediatric Disease Voucher Program has been rejuvenated through a newly signed government funding bill. This initiative is designed to expedite the development of treatments for rare pediatric diseases, offering crucial incentives to companies targeting this critical healthcare segment. By reauthorizing this program, there's an expectation of stimulating innovation and potentially bringing more treatments to market for conditions with limited existing therapies. This move underscores a broader commitment to addressing unmet medical needs through incentivized innovation.Turning to corporate developments, Eli Lilly is anticipating substantial growth in revenue despite facing pricing pressures on its key products, Mounjaro and Zepbound. The company projects revenues between $80 billion and $83 billion for 2026, marking a 25% increase from 2025 at the midpoint. This growth is attributed to strong product performance and strategic maneuvers within their pipeline. Eli Lilly has also made strategic decisions by optimizing its pipeline through dropping three clinical-stage drugs, including a gene therapy acquired via Prevail Therapeutics. This move points towards Lilly's focus on concentrating efforts on more promising candidates within their expansive pipeline. Additionally, Eli Lilly is expanding its GLP-1 franchise beyond metabolic diseases into immunology and inflammation with ongoing clinical trials in conditions such as asthma, psoriatic arthritis, Crohn's disease, and ulcerative colitis. This strategic expansion could lead to novel therapeutic options for chronic inflammatory diseases.Similarly, Bristol Myers Squibb is focusing on new growth drivers amid declining sales of legacy drugs. With $48.2 billion in revenue projected for 2025 largely stemming from newer products, BMS is strategically repositioning itself to maintain momentum amidst market changes.Novartis faces its largest patent expiry challenge but remains optimistic about its trajectory. CEO Vas Narasimhan suggests robust strategies are in place to counteract these patent expiries, indicating a strong focus on innovation and strategic planning to navigate these hurdles. Novartis is also refining its oncology strategy by cutting early-stage cancer candidates while adding new ones focused on promising therapeutics—a broader trend of adopting data-driven approaches to streamline drug development pipelines.Meanwhile, AbbVie continues its stronghold in the inflammatory bowel disease market with its blockbuster immunology drugs Skyrizi and Rinvoq. These products significantly contribute to AbbVie's $61.1 billion revenue, highlighting their commitment to maintaining leadership in immunology despite competitive pressures from rivals like Johnson & Johnson.Astellas has exceeded expectations with its cancer drug Vyloy overcoming a trial setback to quadruple sales in the third quarter fiscal year 2025 results. This success underscores the resilience and potential of innovative oncology treatments even when faced with clinical challenges.In financial markets, Veradermics successfully raised $256 million through its IPO, signaling strong investor interest in biotech firms with promising dermatological applications. Concurrently, Eikon Therapeutics marked the largest biotech IPO since 2024 with a $381 million listing on Nasdaq, reflecting renewed investor confidence in biotech ventures. Industry trends indicate a resurgence of interest in public markets exemplified by Eikon Therapeutics' upsized IPO alongside Veradermics' successful Support the show
This episode will provide opportunities for the health-system pharmacist to improve understanding of in vivo and viral-based therapies on an institutional level, outline strategies for toxicity prevention and management, and provide recommendations to ensure availability of supportive care therapies to maintain patient safety, when needed. CE for this episode expires 2 years after the date it was originally published. The information presented during the podcast reflects solely the opinions of the presenter. The information and materials are not, and are not intended as, a comprehensive source of drug information on this topic. The contents of the podcast have not been reviewed by ASHP, and should neither be interpreted as the official policies of ASHP, nor an endorsement of any product(s), nor should they be considered as a substitute for the professional judgment of the pharmacist or physician.
AAP maintains routine vaccine recs despite CDC changes; FDA warns of serious injury with wound and burn products; subcutaneous Alzheimer disease treatment under review; Cardamyst nasal spray available; and the FDA places clinical hold on 2 gene therapies.
Marking an important milestone for this rare form of retinitis pigmentosa (RP)
Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today, we explore a landscape marked by dynamic shifts and groundbreaking advancements in the industry.The European Union has recently taken a significant step forward by eliminating pharmaceutical export tariffs through a comprehensive free trade agreement with India. This landmark deal, nearly two decades in the making, is a strategic response to the turbulence in global markets. By potentially enhancing market access and reducing costs for drug manufacturers involved in transcontinental trade, this agreement sets a precedent for future international trade negotiations. It could also catalyze more collaborations in drug development and distribution, offering a template for how regions can work together to streamline pharmaceutical trade.Siegfried has made headlines by extending its mergers and acquisitions streak, acquiring three sites from SK Capital as part of its U.S. onshoring strategy. The acquisition of active pharmaceutical ingredient sites in Delaware, Georgia, and Australia is aimed at boosting production capabilities while reducing supply chain vulnerabilities. This move aligns with broader industry trends that emphasize geographical diversification and supply chain resilience, reflecting the industry's ongoing adaptation to global economic pressures.Meanwhile, China's National Medical Products Administration has suspended sales of Sun Pharma's dementia medication following site inspections that revealed manufacturing deficiencies. This regulatory action underscores the critical importance of compliance with stringent manufacturing standards and highlights the potential repercussions of lapses in quality control. It also demonstrates the increasing scrutiny from regulatory bodies worldwide to ensure drug safety and efficacy.On the clinical front, Roche has reported promising results for its dual GLP-1/GIP receptor agonist, showing a 22.5% weight loss at 48 weeks. This development is significant given the rising global demand for effective weight management therapies amid increasing obesity rates. The progression of this asset into phase 3 trials could herald a new class of therapeutics with substantial implications for patient care.In another strategic shift, Catalent has decided to wind down operations at its EU cell therapy manufacturing hub, reflecting a reassessment of facility utilization amidst changing market demands. This move is indicative of broader industry adjustments as companies streamline operations to focus on core competencies and emerging therapeutic areas.Turning to promising new therapies, United Therapeutics' bioengineered external liver assist system has shown potential in treating acute chronic liver failure based on early phase 1 trial results. Innovations like these highlight the transformative potential of bioengineering in addressing unmet medical needs and improving patient outcomes.Boehringer Ingelheim's significant investment in Simcere's preclinical bispecific antibody for inflammatory bowel disease underscores the industry's commitment to advancing novel therapeutic modalities. This EUR 1.05 billion deal reflects confidence in biologic therapies as essential components in managing complex chronic diseases.As we look towards 2026, biopharma companies are strategizing long-term amid evolving rules and heightened stakes. The sector is poised for transformation driven by scientific breakthroughs, regulatory challenges, and strategic alliances that promise enhanced patient care through innovative therapies. These developments reflect an industry that remains agile and resilient as it navigates complex global landscapes.In other news, Qilu Pharmaceutical's $120 million alliance with Insilico Medicine marks a significant step towards leveraging artificial intelligence (AI) for drug discSupport the show
Most brain decline, mood instability, and impulsive behavior start with a breakdown in how the brain's immune cells produce and use energy. This episode shows how mitochondrial health inside microglia influences cognition, emotion, and long-term brain resilience, and how everyday inputs quietly push those systems toward damage or repair. Watch this episode on YouTube for the full video experience: https://www.youtube.com/@DaveAspreyBPR Host Dave Asprey is joined by Dr. David Perlmutter, a board-certified neurologist and six-time New York Times bestselling author whose work focuses on the intersection of neurology, nutrition, metabolism, and brain health. A Fellow of the American College of Nutrition and member of the Editorial Board of the Journal of Alzheimer's Disease, Dr. Perlmutter brings decades of clinical and research experience to this conversation on how inflammation and mitochondrial function shape the brain across the lifespan. Together, they explore how microglial cells shift their behavior based on metabolic conditions, and how those shifts influence neurodegeneration, emotional regulation, impulse control, and cognitive performance. The discussion covers real-world inputs that shape these systems, including sleep optimization, fasting, ketosis, glucose regulation, gut signaling, environmental toxins, and tools referenced in the episode such as red and infrared light, 40 Hz light and sound, hyperbaric oxygen, lithium, nicotine, supplements, nootropics, GLP-1 agonists, and dietary approaches like carnivore and ketosis. The conversation connects brain biology to lived experience, showing how metabolism influences behavior, decision making, and long-term human performance through a Smarter Not Harder lens. You'll Learn: • How microglia shift between supportive and destructive states and why metabolism drives that change • How mitochondrial function inside immune cells influences inflammation and brain resilience • How inflammation affects the prefrontal cortex, impulse control, and reward-driven behavior • What the episode says about GLP-1 agonists and behavior changes like reduced cravings and gambling • How gut-derived signaling and short-chain fatty acid balance (butyrate vs propionate) relates to brain function • How tools like red and infrared light, hyperbaric oxygen, and 40 Hz light and sound connect to microglia • The lifestyle levers discussed in the episode: sleep optimization, fasting, ketosis, glucose control, and toxin reduction • The compounds mentioned, including lithium, nicotine, urolithin A, CoQ10, rosmarinic acid, and dihydromyricetin Dave Asprey is a four time New York Times bestselling author, founder of Bulletproof Coffee, and the father of biohacking. With over 1,000 interviews and 1 million monthly listeners, The Human Upgrade is the top podcast for people who want to take control of their biology, extend their longevity, and optimize every system in the body and mind. Each episode features cutting edge insights in health, performance, neuroscience, supplements, nutrition, hacking, emotional intelligence, and conscious living. Thank you to our sponsors! KILLSwitch | If you're ready for the best sleep of your life, order now at https://www.switchsupplements.com/ and use code DAVE for 20% off. BodyGuardz | Visit https://www.bodyguardz.com/ and use code DAVE for 25% off. Stop cooking with toxic cookware and upgrade to Our Place today. With a 100-day risk-free trial, plus free shipping and returns, you can experience this game-changing cookware with zero risk. Visit: fromourplace.com/DAVE Use code: DAVE for 10% off sitewide Establish a powerful foundation for sustained wellness with Pique. Unlock 20% off: piquelife.com/DAVE Dave Asprey is a four-time New York Times bestselling author, founder of Bulletproof Coffee, and the father of biohacking. With over 1,000 interviews and 1 million monthly listeners, The Human Upgrade brings you the knowledge to take control of your biology, extend your longevity, and optimize every system in your body and mind. Each episode delivers cutting-edge insights in health, performance, neuroscience, supplements, nutrition, biohacking, emotional intelligence, and conscious living. New episodes are released every Tuesday, Thursday, Friday, and Sunday (BONUS). Dave asks the questions no one else will and gives you real tools to become stronger, smarter, and more resilient. Keywords: microglia brain health, brain immune system mitochondria, neuroinflammation podcast, mitochondrial dysfunction brain, david perlmutter podcast, dr david perlmutterneurologist, grain brain author podcast, alzheimers brain metabolism, parkinsons microglia, autism brain inflammation, gut brain immune signaling, short chain fatty acids brain, butyrate propionate brain, glp-1 brain behavior, glp-1 addiction research, red light therapy brain, infrared light mitochondria brain, 40 hz light sound brain, hyperbaric oxygen brain health, lithium microglia brain Resources: • Learn More About Dr. Perlmutter at: https://drperlmutter.com/ • Get My 2026 Biohacking Trends Report: https://daveasprey.com/2026-biohacking-trends-report/ • Join My Low-Oxalate 30-Day Challenge: https://daveasprey.com/2026-low-ox-reset/ • Dave Asprey's Latest News | Go to https://daveasprey.com/ to join Inside Track today. • Danger Coffee: https://dangercoffee.com/discount/dave15 • My Daily Supplements: SuppGrade Labs (15% Off) • Favorite Blue Light Blocking Glasses: TrueDark (15% Off) • Dave Asprey's BEYOND Conference: https://beyondconference.com • Dave Asprey's New Book – Heavily Meditated: https://daveasprey.com/heavily-meditated • Upgrade Collective: https://www.ourupgradecollective.com • Upgrade Labs: https://upgradelabs.com Timestamps: 0:00 - Introduction 1:45 - Autism Spectrum 4:38 - Alzheimer's & Beta Amyloid 7:02 - Brain Immune Cells 8:06 - GLP-1 & Parkinson's 10:44 - M1 vs M2 Microglia 13:08 - Pharmaceutical Microdosing 15:51 - Gene Therapy 19:09 - Mold & Toxins 21:58 - Environmental Pollution 26:05 - MPTP Discovery 29:07 - Healing Interventions 31:39 - Light & Sound Therapy 36:35 - Mitochondrial Function 44:57 - Inflammation & Prefrontal Cortex 48:00 - GLP-1 Global Impact 52:11 - Mitochondrial Community 56:05 - Consciousness & The Field 1:00:00 - Psychedelics 1:01:59 - Love & Judgment 1:06:35 - Death & Knowing 1:09:06 - Heart-Brain Connection 1:11:06 - Closing Thoughts See Privacy Policy at https://art19.com/privacy and California Privacy Notice at https://art19.com/privacy#do-not-sell-my-info.
During this episode of Pharmacy Friends you'll hear about the rapidly evolving world of cell and gene therapy, highlighting its promise, complexity, and growing impact across the health care ecosystem. Learn about the foundational definitions, emerging clinical innovations, and the expanding pipeline of therapies expected to reach the market in the coming years. It also examines regulatory developments, forecasting approaches, financial considerations, and the human elements that shape patient and provider decision‑making. Through expert insights and real‑world examples, the conversation illustrates how Prime is helping stakeholders navigate this dynamic landscape while preparing for the transformative potential of next‑generation therapies.Listen to the latest episode of the “Pharmacy Friends” podcastRead the latest Cell & Gene Pipeline OutlookLearn more about how Prime manages cell and gene therapiesIn this episode:03:46 What is Cell & Gene Therapy?04:34 What is the Cell & Gene Therapy Pipeline?08:13 Why pay attention to cell & gene therapies?12:45: Collaboration with all stakeholders is important to get the right therapies to patients20:35: Digging in new therapies that are on the horizon 22:56: Importance of the FDA commissioner's national priority voucher25:52: What to consider when these therapies are an option28:40: Is cost a barrier to these therapies?31:41: 2026 cell and gene therapy outlook36:18: Closing - books and fishing
Milestone brings hope to patients with rare inherited retinal disease
Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today, we delve into the latest innovations, strategic shifts, and regulatory updates shaping the industry.Johnson & Johnson's Tecvayli, a promising monotherapy for multiple myeloma, has shown remarkable efficacy in clinical trials. By reducing the risk of disease progression or death by 71% among patients resistant to anti-CD38 therapies, Tecvayli is setting a new standard in oncological treatment. This breakthrough underscores not only its potential as a standalone therapy but also highlights significant advancements in managing multiple myeloma—a cancer notoriously difficult to treat and manage.In regulatory developments, Sanofi has recently completed pricing negotiations with U.S. policymakers, gaining much-needed clarity on drug pricing regulations. However, Sanofi remains cautious as evolving policies could impact future operations. This scenario is emblematic of the broader industry challenge: navigating an uncertain regulatory landscape while maintaining stability and profitability in volatile markets.Astellas Pharma is adapting to its looming patent cliff for the prostate cancer drug Xtandi by focusing on innovation as a strategy for sustainable growth. With patent protection set to expire next year, Astellas emphasizes innovation over acquisitions for revenue protection, reflecting a broader industry trend towards long-term growth strategies rather than short-term gains.Meanwhile, Jazz Pharmaceuticals has sold a priority review voucher for $200 million, highlighting the persistent value of these vouchers which expedite FDA review processes. Such vouchers are becoming essential strategic assets as companies seek competitive advantages through faster market entry.On the technological front, Becton Dickinson's $110 million investment to expand syringe production capabilities demonstrates efforts to meet rising demand for injectable medications like GLP-1s. This initiative not only addresses immediate supply chain needs but also aligns with broader discussions about reshoring pharmaceutical manufacturing in the U.S., enhancing domestic production capabilities.Financially, strategic trends were a focal point at the recent J.P. Morgan Healthcare Conference. Although large-scale mergers and acquisitions were anticipated, none materialized, suggesting an evolving focus towards strategic partnerships and incremental innovations over mega-mergers among industry stakeholders.Looking ahead, AbbVie's projection of strong growth into the 2030s is driven by a robust pipeline and strategic initiatives. As companies navigate a complex landscape defined by innovation demands and regulatory changes, such outlooks underscore the industry's commitment to sustaining growth and innovation while improving patient outcomes through novel treatments and technologies.Italian pharmaceutical company Alfasigma's acquisition of rights to an injectable treatment for HSV encephalitis from a German biotech firm further exemplifies strategic investments aimed at expanding therapeutic portfolios with innovative solutions addressing critical health needs. This move is significant given the limited therapeutic options available for this severe condition.The Novo Nordisk Foundation's $860 million investment in Denmark's BioInnovation Institute underscores efforts to strengthen local biotech ecosystems. By nurturing homegrown biotech and deep tech companies, this initiative positions Denmark as a prominent hub for research and development while facilitating the translation of scientific discoveries into viable therapeutic solutions.Ocugen's promising mid-phase data for its gene therapy targeting eye disease positions it as a potential competitor against market leaders like Apellis and Astellas. The positive phase 2 results highlight gene therapy's growiSupport the show
Amber Freed transformed the shock of her son's diagnosis with an ultra-rare neurodevelopmental disorder into a determined campaign for gene therapy. With no clinical roadmap, sparse literature, and doctors offering only symptomatic care, she taught herself biology basics, established a nonprofit, and assembled a scientific team. She focused on gene replacement therapy as the most viable path, and son became the first patient treated in a clinical trial of the experimental gene therapy last September. We spoke to Freed, founder and CEO of SLC6A1 Connect, about how a parent with no scientific background catalyzed the development of the first experimental gene therapy for SLC6A1-related disorder, mobilized scientists, and what other rare disease communities can learn from her journey.
Broadcast from KSQD, Santa Cruz on 1-08-2026: Dr. Dawn concludes her 2025 medical advances recap, noting that while GLP-1 weight loss drugs showed unexpected benefits for addiction, schizophrenia, and dementia risk, Novo Nordisk recently reported semaglutide had no effect on cognition in people with existing dementia or mild cognitive impairment. She describes the first successful human bladder transplant performed on May 4th. The 41-year-old recipient received both kidney and bladder due to the bladder's complex blood vessel network. Surgeons practiced on cadavers with active circulation before achieving success, opening pathways for future bladder-only transplants for the 84,000 Americans diagnosed with bladder cancer annually. An emailer follows up about purslane for cognitive health. Dr. Dawn reviewed the referenced studies and found neither actually supported claims about purslane and cognition—one discussed the Lyon Heart Study's Mediterranean diet, the other described antioxidant properties. She cautions listeners that websites citing "scientifically proven" claims often reference articles that don't support their assertions. An emailer asks about statin alternatives after developing severe muscle pain on both atorvastatin and rosuvastatin. Dr. Dawn suggests he shouldn't be on statins given his classic adverse reaction. She recommends ezetimibe plus oat bran for cholesterol, metformin for his elevated triglycerides indicating insulin resistance, and checking LDL particle size and inflammation markers. She emphasizes that cholesterol is a risk factor, not a disease, and treating 50 low-risk people for 10 years prevents only one heart attack. A caller discusses plaque formation theory, comparing it to calluses. Dr. Dawn explains Linus Pauling's similar hypothesis that plaque forms at vessel bifurcations to protect against turbulent blood flow damage. She warns against driving total cholesterol below 130, as it disrupts steroid hormone production. The caller shares his mother's near-fatal rhabdomyolysis from statins—muscle breakdown releasing myoglobin that clogs kidneys—and criticizes data transfer failures between hospital systems. An emailer reports four UTIs in two months at age 79. Dr. Dawn questions whether all were true infections, since vaginal contamination causes false positives on dipstick tests. For confirmed UTIs, she recommends D-mannose and cranberry to prevent bacterial adhesion, post-void residual ultrasound to check for incomplete emptying, lactobacillus probiotics, and vaginal DHEA (Intrarosa) to restore mucosal thickness and disease resistance. Dr. Dawn describes Stanford's Phase III trial for dystrophic epidermolysis bullosa, where defective collagen-7 causes skin layers to separate at the slightest touch. Researchers take patient skin biopsies, use retroviruses to insert corrected genes, grow credit-card-sized skin grafts over 25 days, then suture them onto wounds. At 48 weeks, 65% of treated wounds fully healed versus 7% of controls. She reports a Stanford study showing premature babies who heard recordings of their mothers reading for 2 hours 40 minutes daily developed more mature white matter in language pathways. The left arcuate fasciculus showed greater development than controls, demonstrating how early auditory stimulation shapes brain circuitry even in NICU settings. Dr. Dawn concludes with tattoo safety concerns. Modern vivid inks contain compounds developed for car paint and printer toner, including azo dyes that break down into carcinogenic aromatic amines—especially during laser removal. Pigment particles migrate to lymph nodes and persist in macrophages, causing prolonged inflammation. She advises those with tattoos to avoid laser removal, wear sunscreen, practice lymphatic hygiene, and reconsider extensive new tattoos.
Broadcast from KSQD, Santa Cruz on 1-01-2025: An emailer asks about omega-3 supplementation for memory at age 72. Dr. Dawn advises checking that fish oil capsules contain adequate DHA—at least 1,000 mg—since many omega-3 products have low DHA levels. She notes Medicare covers the same testing at standard labs as proprietary labs like OmegaQuant that charge patients directly. Beyond omega-3s, she emphasizes glucose control (hemoglobin A1c below 5.6) since the enzyme that breaks down insulin also clears beta-amyloid, and weight training to raise brain-derived neurotrophic factor (BDNF), which promotes new synapse formation essential for memory. Dr. Dawn reviews Popular Science's top 2025 health innovation: eye drops from Lens Therapeutics containing aceclidine that correct age-related farsightedness for 10 hours. The drops shrink the pupil to increase depth of field, improving near vision by three or more lines on eye charts within 30 minutes without affecting distance vision. Side effects include eye irritation, dimmed night vision, and headache. She describes Duke University's breakthrough allowing heart transplants from circulatory death donors using an on-table reanimation technique. This could expand the pediatric donor pool by 20%—critical since up to 20% of children die waiting for transplants. Dr. Dawn celebrates CAR-T immunotherapy for multiple myeloma, which saved her husband's life. Of 97 heavily pretreated patients, 38% achieved complete remission still present at five years, with over 50% total survival. The therapy removes T-cells, uses CRISPR to add receptors targeting cancer cell antigens, then reinfuses the modified cells. She highlights a UC Davis study showing remote blood pressure monitoring with home technology, education, and coaching dropped patients' average blood pressure from 150/80 to 125/74 in months—low-tech with high impact. Dr. Dawn explains the Nano Knife for prostate cancer, which uses localized electrical pulses delivered through thin wires to destroy tumors while sparing surrounding nerves. This minimally invasive approach could reduce erectile dysfunction and incontinence common with traditional surgery. She describes Gilead's Sunlenca, a twice-yearly injection for HIV prevention that's 99% effective. At $14,000 per injection in the US, proceeds help fund access in resource-limited countries where it can be distributed like a vaccination. Dr. Dawn discusses Journavx (suzetrigine), a new non-opioid pain medication working on sodium channels to block pain signals before reaching the brain. At $30 for 50 pills on GoodRx, it offers an alternative for surgical pain in patients with addiction history or genetic vulnerability to opioid dependence. She details the landmark case of Baby KJ, the first person to receive personalized CRISPR gene therapy. Born with a CPS1 enzyme deficiency causing toxic ammonia buildup, KJ was too small for liver transplant. Scientists identified his specific mutation and used CRISPR base editing delivered via lipid nanoparticles to correct a single DNA letter—changing an A to G—in his liver cells which restored enough function to be discharged home. Dr. Dawn reports surprising findings that COVID mRNA vaccines amplify cancer immunotherapy. Lung cancer patients who received COVID vaccination within 100 days of checkpoint inhibitor treatment had 56% three-year survival versus 31% for unvaccinated patients. The mechanism is unknown but may involve mRNA generally alerting the immune system. She revisits research showing Zostavax shingles vaccination reduced dementia risk by 20% over seven years. A natural experiment in Wales—where an age cutoff created comparable vaccinated and unvaccinated groups—provided strong evidence that preventing herpes zoster inflammation protects brain health. Dr. Dawn concludes with Huntington's disease breakthrough: microRNA therapy delivered by virus directly into the brain slowed disease progression by 75% over three years. The microRNA binds to Huntington protein mRNA, preventing ribosome translation and toxic protein production. Some patients returned to work; others expected to need wheelchairs are still walking.
Molecular Therapy Editor-in-Chief Dr. Joseph Glorioso joins researchers Kathy Steece-Collier (Michigan State University), Jeffrey Kordower (Arizona State University), and Fredric Manfredsson (Barrow Neurological Institute) to discuss their groundbreaking work on RNA interference for Parkinson’s disease. This episode focuses on their recent article titled "Disease-modifying, multidimensional efficacy of putaminal CaV1.3-shRNA gene therapy in aged parkinsonism male and female macaques." Music: 'Electric Dreams' by Scott Buckley - released under CC-BY 4.0. www.scottbuckley.com.auShow your support for ASGCT!: https://asgct.org/membership/donateSee omnystudio.com/listener for privacy information.
Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today, we delve into a series of groundbreaking advancements and strategic movements shaping the future of healthcare.The pharmaceutical and biotech sectors are undergoing significant transformations, driven by scientific breakthroughs, regulatory developments, and strategic shifts. At the forefront is Eli Lilly's impressive lineup of investigational cardiometabolic drugs, spotlighted in Clarivate's "Drugs to Watch in 2026" report. This signals a robust focus on combating cardiometabolic disorders, which have vast implications for global health due to their widespread prevalence. The report also highlights Johnson & Johnson's competitive position in this therapeutic area, indicating a dynamic landscape where innovation is key.In oncology, Jazz Pharmaceuticals is making waves with its bispecific antibody, Ziihera, positioning it as a preferred HER2-targeted therapy for stomach cancer. This development marks a shift towards precision medicine and targeted therapies, which are gradually supplanting traditional treatments like Herceptin. The promising efficacy of Ziihera could revolutionize treatment protocols for HER2-positive gastric cancer patients, enhancing survival outcomes and quality of life.Meanwhile, a legal confrontation has erupted between Bayer and leading COVID-19 vaccine developers such as Moderna, Johnson & Johnson, and Pfizer-BioNTech. Bayer alleges patent infringement on intellectual property developed years prior. This lawsuit underscores the intricate relationship between innovation and intellectual property rights in the pharmaceutical industry, especially poignant in the aftermath of the COVID-19 pandemic.Daiichi Sankyo's collaboration with Genesis to commercialize Vanflyta—an acute myeloid leukemia treatment—across 13 European countries highlights strategic movements in oncology. Approved in 2023, this partnership exemplifies Daiichi's commitment to expanding its European market presence and improving patient access to critical cancer therapies.GSK's promising Phase 3 results for its hepatitis B drug candidate represent a potential breakthrough as a "functional cure." Such advancements could redefine management strategies for hepatitis B, a chronic infection affecting millions worldwide. The positive trial outcomes pave the way for FDA submission, showcasing GSK's dedication to addressing unmet medical needs through innovative approaches.Amgen's strategic partnership with Disco Pharmaceuticals illustrates ongoing investment in oncology research. With a $618 million agreement focused on cancer target discovery, Amgen leverages Disco's expertise to fortify its oncology pipeline. This collaboration underscores the significance of cooperative innovation in drug development and enhancing therapeutic options.In gene therapy, Ikarovec and VectorBuilder are advancing eye disease treatments through an innovative partnership. Their $1 billion deal aims to make gene therapies more accessible by enabling administration outside specialized settings—a transformative approach that could democratize advanced treatments.Hope Biosciences' Phase 2 study results offer hope for Parkinson's disease patients through stem cell therapy improvements in motor function. Despite some data discrepancies, these findings set the stage for Phase 3 trials and underscore the potential of stem cell therapies in neurological disorders.The pharmaceutical industry also grapples with economic challenges as layoffs rise by 16% year-over-year in 2025. Concurrently, despite regulatory hurdles and macroeconomic uncertainties, the FDA approved 55 new treatments and vaccines—a testament to resilience and innovation within biopharma.In regulatory dynamics, GSK's Exdensur received approval in Japan for treating severe asthma and chronic rhinosinusitisSupport the show
Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today we're diving into a landscape rich with scientific advancements, strategic industry shifts, and regulatory developments that are shaping the future of healthcare.Let's start with AstraZeneca's recent success in the lupus treatment field. Their Phase 3 clinical trial for a self-administered subcutaneous form of Saphnelo marks a significant milestone. This new administration route could enhance patient convenience and accessibility, positioning AstraZeneca favorably against competitors like GlaxoSmithKline's Benlysta. The move underscores a growing trend in the industry towards more patient-friendly drug delivery systems, which could revolutionize treatment adherence and outcomes for autoimmune diseases.Turning our attention to Argenx, the company is navigating a pivotal leadership transition following the launch of Vyvgart, their autoimmune drug. This shift highlights the company's strong footing in the market after successfully obtaining regulatory approval and introducing Vyvgart. The potential expansion of its reach could further solidify Argenx's standing in the competitive autoimmune sector.Alumis is also making waves with its TYK2 inhibitor for psoriasis treatment, having reported promising Phase 3 data. This development places it as a formidable contender to Bristol Myers Squibb's Sotyktu. The positive trial results have not only boosted Alumis' stock value but also reflect a broader interest in immunomodulatory treatments which offer patients alternative therapeutic options with potentially fewer side effects.In an innovative leap within obesity management, Arrowhead Pharmaceuticals is advancing its dual gene-silencing assets aimed at reducing fat. Early-phase data indicates promising results, highlighting gene therapy's potential as a viable strategy for tackling complex conditions like obesity. This approach could pave the way for more personalized and effective treatments, aligning with the industry's gradual shift towards precision medicine.On the regulatory front, there's been notable movement with significant updates affecting drug approvals and recommendations. The Centers for Disease Control and Prevention's decision to remove six vaccines from the recommended childhood immunization schedule has stirred controversy due to its opaque review process. Such decisions carry profound implications for public health policies and vaccine uptake, sparking debates about safety and transparency.Meanwhile, GlaxoSmithKline's Exdensur has gained approval in Japan for two new indications, showcasing efforts to expand existing drugs' therapeutic applications across different markets. However, Sanofi has faced hurdles with the FDA rejecting its multiple sclerosis drug due to serious safety concerns, including liver injury risks. This rejection underscores the delicate balance regulatory bodies must maintain between efficacy and safety when evaluating new therapeutics.Amgen's strategic acquisition of a UK biotech firm for up to $840 million exemplifies ongoing industry consolidation trends. By integrating preclinical blood cancer programs into its portfolio, Amgen aims to strengthen its oncology pipeline—a critical area in today's competitive cancer treatment landscape. Similarly, Roche has strategically invested $100 million in a licensing deal with Structure Therapeutics to secure its position within the GLP-1 therapeutics sphere for metabolic disorders.These strategic acquisitions and partnerships highlight an industry focused on bolstering pipelines through external collaborations—essential for maintaining competitive edges in high-stakes therapeutic areas like oncology and metabolic disorders. As companies endeavor to innovate while ensuring safety, their efforts promise to enhance patient care by addressing unmet mSupport the show
Host Dr. Emily Walsh Martin welcomes Dr. Niki Paulk, CEO and Founder of Siren Biotechnology, for a timely conversation on turning scientific promise into commercial success. Dr. Paulk offers perceptive insights into the complex world of biotech entrepreneurship, covering essential fundraising strategies from Seed and Series Rounds to Community Rounds and beyond. This episode is a must-listen for both industry professionals and academic innovators. Music: ‘Bright New Morning’ by Steven O’Brien – released under CC-BY 4.0. https://www.steven-obrien.net/Show your support for ASGCT!: https://asgct.org/membership/donateSee omnystudio.com/listener for privacy information.
Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Let's dive right into some of the latest breakthroughs and shifts shaping the industry landscape.In recent weeks, the pharmaceutical world has been abuzz with news of a groundbreaking new therapy that offers hope for patients with a rare genetic disorder. This novel treatment utilizes cutting-edge gene-editing technology, specifically CRISPR-Cas9, to target and correct genetic mutations at their source. By precisely editing the DNA within patient cells, this therapy promises not only to alleviate symptoms but potentially cure the disorder altogether. The implications of this development are profound, as it opens new avenues for treating a host of other genetic diseases that have long been considered incurable. Researchers are optimistic that this could herald a new era in personalized medicine.Meanwhile, on the regulatory front, significant progress has been made with the approval of a new cancer drug by the FDA. This drug, which has shown remarkable efficacy in clinical trials, targets a specific protein that is overexpressed in certain types of tumors. By inhibiting this protein, the drug effectively halts tumor growth and reduces metastasis. Such targeted therapies represent a shift towards more precise cancer treatments, minimizing damage to healthy cells and reducing side effects for patients. The FDA's decision underscores the importance of innovative approaches in oncology and sets a precedent for future approvals.In another exciting development, a recent phase III clinical trial has yielded promising results for a new Alzheimer's treatment. This monoclonal antibody targets amyloid-beta plaques in the brain, which are believed to be a key factor in the progression of Alzheimer's disease. The trial showed significant slowing of cognitive decline in patients who received the treatment compared to those on placebo. While there is still much to learn about the pathogenesis of Alzheimer's, these findings offer renewed hope for patients and their families and highlight the potential for antibody-based therapies in neurodegenerative diseases.Turning our attention to industry trends, there's a growing emphasis on sustainability within pharmaceutical manufacturing processes. Many companies are now investing in green chemistry, which focuses on designing products and processes that minimize environmental impact and reduce waste. This shift is not only driven by regulatory pressures but also by increasing consumer demand for eco-friendly products. By adopting sustainable practices, pharmaceutical companies are working to ensure that their contributions to global health do not come at the expense of planetary health.Finally, let's explore an intriguing trend within biotech: the rise of artificial intelligence (AI) and machine learning in drug discovery. These technologies are being harnessed to analyze vast datasets more efficiently than ever before, enabling researchers to identify potential drug candidates with greater speed and accuracy. AI-driven platforms can model complex biological interactions, predict molecular behavior, and even design novel compounds. As this field continues to evolve, it promises to revolutionize how new drugs are discovered and developed, potentially reducing time-to-market and bringing therapies to patients faster.These stories illustrate just how dynamic and innovative the pharmaceutical and biotech industries continue to be. With every breakthrough and development, there comes new hope for tackling some of humanity's most challenging health issues. Thank you for joining us today on Pharma Daily as we continue to explore these exciting advancements in science and medicine.Support the show
Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today, we're diving into some fascinating updates that are shaping the future of medicine and healthcare.Let's start with a groundbreaking development in cancer treatment. Researchers have announced significant progress in a novel therapy targeting a specific mutation often found in non-small cell lung cancer. This mutation, known as EGFR exon 20 insertion, has historically been resistant to standard treatments. The new therapy employs a targeted approach that precisely inhibits the mutant protein while sparing normal cells. Early-phase clinical trials have shown promising results, with substantial tumor shrinkage observed in participants. This could potentially redefine treatment protocols for patients who previously had limited options and improve their overall survival rates. As the study progresses into later phases, the industry is watching closely to see if these initial successes translate into long-term benefits.In another significant development, we're seeing advancements in gene therapy for inherited retinal diseases. A recent study has highlighted a novel gene-editing technique that promises to restore vision in patients with certain genetic forms of blindness. By utilizing CRISPR-Cas9 technology, scientists have been able to directly correct mutations in retinal cells. The preclinical models have shown restored function and improved visual responses, paving the way for human trials. This breakthrough is not just a beacon of hope for those affected by genetic blindness but also underscores the transformative potential of gene-editing technologies in treating complex diseases.Moving on to regulatory news, there's an update on new drug approvals that could have widespread implications for public health. The FDA has recently approved a first-in-class drug for the treatment of severe migraines. This medication represents a novel mechanism of action by targeting the calcitonin gene-related peptide (CGRP) pathway, which plays a crucial role in migraine pathophysiology. Clinical trials indicated that it significantly reduces the frequency and severity of migraine attacks compared to existing treatments. For millions of sufferers worldwide, this approval offers a new avenue for relief and highlights the importance of continued innovation in chronic pain management.Shifting gears to vaccine development, there's exciting progress in the fight against infectious diseases. A new vaccine candidate for malaria has shown an unprecedented level of efficacy in trial settings. This vaccine utilizes a protein-based approach that targets multiple stages of the parasite's lifecycle, thereby enhancing its protective effects. Given malaria's devastating impact globally, particularly in sub-Saharan Africa, this development is being hailed as a potential game-changer in global health efforts. As further studies and real-world evaluations unfold, this vaccine could become a cornerstone tool in reducing malaria's burden.Now turning our attention to industry trends, there's growing momentum around personalized medicine and its integration into mainstream healthcare systems. Personalized medicine tailors treatment strategies to individual patient profiles based on genetic, environmental, and lifestyle factors. Recent advances in genomics and data analytics have accelerated this shift, allowing for more precise and effective interventions. For healthcare providers and pharmaceutical companies alike, this trend necessitates rethinking traditional drug development models and embracing collaborative approaches to harness big data effectively.Finally, let's look at an intriguing development in neurodegenerative disease research. Scientists are exploring a new class of drugs designed to target protein misfolding—an underlying cause of conditions Support the show
In this visionary episode of Beauty Bytes, I am saying goodbye to the "filler fatigue" of 2025 and unveiling my Top 10 Aesthetic Predictions for 2026. This isn't just about trends; I'm mapping out a paradigm shift toward hyper-personalization and regenerative medicine that will change how we treat aging forever. I explain why the era of overfilling is dead and how I am pivoting to "undetectable" results using micro-tox, strategic lifting, and collagen biostimulators. I also explore the cutting-edge future of AI diagnostics, where digital avatars will allow me to simulate your aging trajectory and show you treatment outcomes years in advance . We dive deep into the science of skin senescence, targeting "zombie cells" to restore resilience rather than just treating wrinkles . From turning on your body's mTOR cycles for cellular repair to the rise of collagen banking for Gen Z, I'm sharing exactly where the world of aesthetics is heading next year.
Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today, we're diving into a series of fascinating stories that underscore the dynamic nature of our industry, where scientific innovation meets real-world application.Starting with a significant advancement in gene therapy, researchers have made remarkable progress in a novel approach to treating rare genetic disorders. This new methodology involves the use of CRISPR technology to edit genes directly within the human body, paving the way for potential cures once thought impossible. By targeting specific DNA sequences, scientists can now correct genetic mutations at their source. This breakthrough not only promises to transform the treatment landscape for rare diseases but also enhances our understanding of genetic disorders at a molecular level. The implications here extend beyond rare conditions, potentially offering new avenues for tackling more common genetic diseases in the future.Moving forward, let's discuss recent regulatory developments that have caught the industry's attention. The FDA has granted accelerated approval to a new oncology drug that shows promise in treating advanced forms of breast cancer. This decision was based on compelling clinical trial results demonstrating significant improvements in patient survival rates compared to existing therapies. The drug targets specific proteins involved in tumor growth, offering a more precise treatment option with potentially fewer side effects. This approval exemplifies how regulatory bodies are adapting to expedite access to life-saving treatments while ensuring rigorous safety and efficacy standards.In another noteworthy development, a Phase III clinical trial has yielded positive results for a novel Alzheimer's drug. The trial demonstrated that this drug significantly slows cognitive decline in patients with early-stage Alzheimer's disease. By targeting amyloid plaques in the brain, which are believed to contribute to neurodegeneration, this therapeutic approach represents a potential shift in how we treat this debilitating condition. These findings provide hope for millions affected by Alzheimer's and underscore the importance of continued investment in neuroscience research.Turning our attention to infectious diseases, there's exciting news from a biotech company focusing on vaccine development. They've announced encouraging preliminary data from trials of their new mRNA-based vaccine for respiratory syncytial virus (RSV). RSV is known for causing severe respiratory illness, particularly in infants and the elderly. The vaccine demonstrated robust immune responses and a favorable safety profile, suggesting it could become an important tool in preventing RSV infections globally. This development highlights the versatility of mRNA technology, which has already revolutionized COVID-19 vaccine design and holds promise for addressing various infectious diseases.In terms of industry trends, one cannot overlook the growing emphasis on personalized medicine. Recent advancements in biomarker research are enabling more tailored therapeutic approaches across multiple disease areas. By identifying specific genetic or molecular markers associated with diseases, healthcare providers can better predict patient responses to certain treatments. This shift towards precision medicine not only improves patient outcomes but also enhances healthcare efficiency by reducing trial-and-error prescribing.Lastly, we delve into an intriguing area of metabolic disorders where innovative therapeutic strategies are emerging. A biotech firm has developed a first-in-class oral medication for treating non-alcoholic steatohepatitis (NASH), a serious liver condition linked to obesity and metabolic syndrome. The drug works by modulating key metabolic pathways involved in liver inflammation and fibrSupport the show
Shunji Tomatsu, MD, PhD, Professor and Head, Nemours Children's Health, Delaware, USA; Alessandra d'Azzo, PhD, Emerita Faculty, Genetics, St. Jude Children's Research Hospital, Tennessee, USA; Merve Emecen Sanli, MD, Associate Professor, Department of Pediatrics, University of Texas Southwestern Medical Center, Texas, USA; and Ryan Colburn, patient with Pompe disease and president of Odimm Inc, discuss new and emerging gene therapies for lysosomal disorders.This continuing education activity is provided through collaboration between the Lysosomal and Rare Disorders Research and Treatment Center (LDRTC), CheckRare CE, and AffinityCE. This activity provides continuing education credit for physicians, physician assistants, nurses, nurse practitioners, and genetic counselors. A statement of participation is available to other attendees.To obtain CME/CE credit, please visit https://checkrare.com/learning/p-grids2025-session6-current-issues-in-gene-therapies-for-lysosomal-disorders/ Learning ObjectivesDescribe current and emerging gene therapy data in lysosomal disorders and its clinical relevanceDescribe role of patients in gene therapy developmentFacultyShunji Tomatsu, MD, PhD, Professor and Head, Nemours Children's HealthAlessandra d'Azzo, PhD, Emerita Faculty, Genetics, St. Jude Children's Research HospitalMerve Emecen Sanli, MD, Associate Professor, Department of Pediatrics, University of Texas Southwestern Medical CenterRyan Colburn. Odimm, Inc.DisclosuresAffinityCE staff, LDRTC staff, planners, and reviewers, have no relevant financial relationships with ineligible companies to disclose. Faculty disclosures, listed below, will also be disclosed at the beginning of the Program.Shunji Tomatsu, MD, PhD Dr. Tomatsu has received the following grants: Morquio Foundations and families: Scarlett Grifith, Bennett, A Cure for Roberts, and Morquio Conference; MPS Societies: Japanese, National, and Austrian; NIH grants: 1-R01-HD102545, NIH, NICHD, Tomatsu (PI), 1R01HD104814-01A1, NIH, NICHD, Langan, T.J. (PI), Role: Site-PI, R43HD114328-01, NIH, ACOSTA, WALTER (PI), Role: site PI, 1R43AR084638-01, NIH, MOUNZIH, KHALID (PI); Foundation of NIH: FNIH RFP NUMBER: 2022-BGTC-005 Tomatsu (PI). Alessandra d'Azzo, PhDDr. D'Azzo has no relevant financial relationships to disclose.Merve Emecen Sanli, MDDr. Sanli has no relevant financial relationships to disclose.Ryan ColburnMr. Colburn has an advisory, consulting and/or project based relationship or stock holding with: Abeona Therapeutics, Amicus Therapeutics, Astellas Gene Therapies, Avidity Biosciences, Bayer, Catalyst Pharmaceuticals, Denali Therapeutics, M6P Therapeutics, Sangamo Therapeutics, Sanofi, Solid Biosciences.Mitigation of Relevant Financial RelationshipsAffinityCE adheres to the ACCME's Standards for Integrity and Independence in Accredited Continuing Education. Any individuals in a position to control the content of a CME activity, including faculty, planners, reviewers, or others, are required to disclose all relevant financial relationships with ineligible entities (commercial interests). All relevant conflicts of interest have been mitigated prior to the commencement of the activity. Conflicts of interest for presenting faculty with relevant financial interests were resolved through peer review of content by a non-conflicted reviewer.Accreditation and Credit DesignationPhysiciansThis activity has been planned and implemented in accordance with the accreditation requirements and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint providership of AffinityCE and the LDRTC. AffinityCE is accredited by the ACCME to provide continuing medical education for physicians.AffinityCE designates this enduring activity for a maximum of 1 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.Physician AssistantsAffinityCE designates this enduring activity for a maximum of 1 AMA PRA Category 1 Credits™. Physician Assistants should claim only the credit commensurate with the extent of their participation in the activity.NursesAffinityCE is accredited as a provider of nursing continuing professional development by the American Nurses Credentialing Center's Commission on Accreditation (ANCC). This activity provides a maximum of 1 hours of continuing nursing education credit.Nurse PractitionersAffinityCE designates this enduring activity for a maximum of 1 AMA PRA Category 1 Credits™. Nurse practitioners should claim only the credit commensurate with the extent of their participation in the activity.Genetic CounselorsAffinityCE designates this enduring activity for a maximum of 1 AMA PRA Category 1 Credits™. Genetic Counselors should claim only the credit commensurate with the extent of their participation in the activity.Other ProfessionalsAll other health care professionals completing this continuing education activity will be issued a statement of participation indicating the number of hours of continuing education credit. This may be used for professional education CE credit. Please consult your accrediting organization or licensing board for their acceptance of this CE activity. Participation CostsThere is no cost to participate in this activity.CME InquiriesFor all CME policy-related inquiries, please contact us at ce@affinityced.comSend customer support requests to cds_support+ldrtc@affinityced.com
Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world.Today, we dive into the latest breakthroughs and innovations shaping our industry. We start with a remarkable advancement in Alzheimer's disease treatment. A recent clinical trial has demonstrated significant progress in slowing cognitive decline among patients suffering from this challenging condition. The study, which involved a novel monoclonal antibody, showed promise by targeting amyloid plaques, a hallmark of Alzheimer's pathology. This approach not only opens new avenues for treatment but also provides hope for millions of patients and their families. The scientific community is closely monitoring these developments as they could redefine therapeutic strategies for neurodegenerative diseases.Moving on to regulatory news, the FDA has recently granted approval to a groundbreaking gene therapy for hemophilia B. This therapy represents a significant milestone as it offers a potential one-time treatment to correct the genetic defect underlying the disorder. By delivering a functional copy of the gene necessary for clotting factor production, patients may experience reduced bleeding episodes and improved quality of life. This approval underscores the FDA's commitment to advancing personalized medicine and highlights the transformative potential of gene therapies in addressing rare genetic conditions.In oncology, we've seen exciting progress with a novel targeted therapy showing efficacy in treating advanced stages of lung cancer. The drug specifically inhibits a mutation found in non-small cell lung cancer, which is often resistant to conventional treatments. Clinical trials have reported improved survival rates and better tolerability compared to existing therapies, marking a significant step forward in precision oncology. As researchers continue to unravel the complexities of cancer genomics, targeted therapies like this one offer new hope for patients battling aggressive forms of cancer.The biotech industry is also witnessing a surge in collaborations aimed at expediting vaccine development. In light of recent global health challenges, several companies have entered strategic partnerships to leverage their combined expertise in mRNA technology. These collaborations aim to accelerate the production and distribution of vaccines for infectious diseases beyond COVID-19. By pooling resources and sharing technological advancements, these alliances have the potential to enhance our preparedness for future pandemics and improve global public health outcomes.Shifting focus to autoimmune diseases, a novel small molecule inhibitor has shown potential in managing rheumatoid arthritis symptoms more effectively than traditional treatments. This new drug targets specific pathways involved in inflammation without compromising immune function. Early clinical data suggests it could offer patients relief with fewer side effects, representing a promising addition to the therapeutic arsenal against chronic inflammatory conditions.In an intriguing development within regenerative medicine, researchers have made strides in bioengineered organs. A recent breakthrough involves creating functional liver tissue from stem cells, paving the way for future organ transplantation solutions. These lab-grown tissues have demonstrated essential liver functions in preclinical models, bringing us closer to addressing organ shortages and enhancing transplant success rates. The implications of such advancements extend far beyond liver disease, offering transformative possibilities for regenerative therapies across various medical fields.Turning our attention to antimicrobial resistance, an ever-pressing concern within global health, scientists have discovered a new class of antibiotics capable of combating multidrug-resistant bacteria. This discovery comes atSupport the show
Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today, we delve into some fascinating breakthroughs and regulatory updates that are shaping the future of healthcare.Starting with a pivotal advancement in Alzheimer's research, a new drug has shown promising results in slowing cognitive decline in patients with early-stage Alzheimer's disease. This innovative therapy targets amyloid plaques in the brain, which are believed to play a central role in the progression of Alzheimer's. Recent clinical trials have demonstrated that patients receiving this treatment experienced a significant reduction in the rate of cognitive deterioration compared to those on a placebo. The implications of this development are profound, offering hope for millions affected by this debilitating condition. As researchers continue to unravel the mysteries of Alzheimer's, this breakthrough marks a crucial step forward in understanding and potentially halting disease progression.Moving on to regulatory news, the FDA has recently granted accelerated approval to a novel gene therapy for a rare genetic disorder known as spinal muscular atrophy (SMA). This condition, which affects motor neurons and leads to muscle wasting and weakness, primarily impacts infants and young children. The newly approved therapy works by delivering a functional copy of the defective gene directly into the patient's cells. Early trials have shown remarkable improvements in motor function and survival rates among treated infants. This approval represents not only a lifeline for affected families but also underscores the growing potential of gene therapies to address previously untreatable genetic diseases.In another significant development, researchers have unveiled a groundbreaking study on an experimental cancer vaccine that has demonstrated efficacy in preventing tumor growth in preclinical models. Unlike traditional vaccines aimed at infectious diseases, this cancer vaccine is designed to harness the body's immune system to specifically target and destroy cancer cells. The study's results indicate that the vaccine was successful in generating a robust immune response, which significantly inhibited tumor progression. If these findings can be replicated in human trials, it could open new avenues for cancer prevention and treatment, particularly for cancers with limited therapeutic options.Shifting our focus to trends within the industry, there's an increasing emphasis on personalized medicine, reflecting a broader shift towards treatments tailored to individual patients' genetic profiles. This approach aims to optimize therapeutic efficacy while minimizing adverse effects by considering each patient's unique genetic makeup. Advances in genomic sequencing technologies and bioinformatics are driving this transformation, enabling more precise diagnostics and targeted therapies. As personalized medicine continues to evolve, it holds the promise of revolutionizing how diseases are treated and managed in clinical practice.On the topic of drug approvals, a new oral medication for type 2 diabetes has received regulatory clearance after demonstrating superior glycemic control compared to existing treatments. This drug belongs to a novel class of medications that enhance insulin sensitivity and reduce glucose production by targeting specific metabolic pathways. Clinical trials indicated significant improvements in blood sugar levels and overall metabolic health among participants. Given the global prevalence of type 2 diabetes and its associated health complications, such advancements are crucial for improving patient outcomes and reducing healthcare burdens.Lastly, focusing on collaborations within the industry, several prominent pharmaceutical companies have announced partnerships aimed at accelerating research in infectious diseases.Support the show
Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today, we are diving into a series of significant breakthroughs and updates that are shaping the industry landscape.Starting with a remarkable scientific advancement, researchers have made headway in the development of a new class of antibiotics that shows promise against drug-resistant bacteria. This comes as a beacon of hope in the ongoing battle against superbugs, a problem that has been escalating over the past few decades. The new antibiotics work by targeting bacterial cell walls in a novel way, which may bypass the resistance mechanisms that have rendered many traditional antibiotics ineffective. This innovation could potentially extend the lifespan of existing drugs and provide new treatment options for infections that are currently difficult to manage. It's crucial to monitor how these developments will proceed through clinical trials and regulatory scrutiny, as successful outcomes could revolutionize our approach to bacterial infections.Shifting focus to regulatory news, the FDA has recently approved a groundbreaking gene therapy for a rare genetic disorder affecting children. The therapy is designed to target and correct specific genetic mutations, offering hope for families affected by this debilitating condition. This approval not only marks a milestone for personalized medicine but also sets a precedent for future gene therapies targeting other rare diseases. The implications of such advancements are vast, as they open doors to tailored treatments that address the root causes of genetic disorders rather than just managing symptoms. As we continue to explore the potential of gene editing technologies like CRISPR, it's important to consider both the ethical and logistical challenges that accompany these scientific leaps.In clinical trial news, a late-stage study has shown promising results for a new cancer immunotherapy targeting non-small cell lung cancer. This therapy leverages the body's immune system to identify and destroy cancer cells more effectively than traditional treatments. The trial demonstrated significant improvements in patient survival rates and quality of life, underscoring the potential of immunotherapies to transform oncology care. These findings add to a growing body of evidence supporting immunotherapy as a cornerstone of future cancer treatment regimens. However, it is essential to continue researching how these therapies can be optimally combined with existing treatments to enhance outcomes and minimize side effects.Turning our attention to industry trends, there is an increasing emphasis on digital health solutions in drug development processes. Pharmaceutical companies are integrating artificial intelligence and machine learning technologies to streamline clinical trials and accelerate drug discovery. These digital tools enable more efficient data analysis, patient monitoring, and predictive modeling, which can significantly reduce development timelines and costs. As this trend gains momentum, it will be important to assess how these technologies can be best utilized without compromising data integrity or patient safety.Lastly, let's discuss an interesting development in sustainable biomanufacturing practices. Companies are investing in greener production methods that reduce environmental impact while maintaining high-quality standards for pharmaceuticals. This includes optimizing energy use, minimizing waste, and incorporating renewable resources into manufacturing processes. As regulatory bodies increasingly prioritize sustainability, we can expect these practices to become more widespread across the industry.These stories highlight how innovation continues to drive progress within pharmaceuticals and biotechnology, offering new possibilities for treatment and care. As always, it's eSupport the show
Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today, we delve into the significant events of 2025, a year marked by pivotal scientific breakthroughs, regulatory changes, and industry trends that have reshaped drug development and patient care.One of the standout advancements was Novo Nordisk gaining FDA approval for an oral version of Wegovy, a glucagon-like peptide-1 (GLP-1) receptor agonist for obesity management. This marks a notable shift in treatment accessibility, as it provides an easier alternative to injectables for those managing weight and cardiovascular risks. This development could significantly enhance patient adherence and broaden access to this critical therapy.However, not all news was positive. Pfizer faced a challenging situation when a patient death occurred in the extension of their Hympavzi hemophilia study. Such incidents highlight the intrinsic risks of clinical trials, especially within gene therapy realms where safety monitoring is paramount. These events remind us of the delicate balance between innovation and patient safety in advanced biologic therapies.In legal news, Johnson & Johnson was ordered by a Baltimore jury to pay $1.56 billion in a talc-related cancer case. This ruling underscores heightened scrutiny on product safety and consumer protection within the pharmaceutical industry, potentially influencing future litigation and regulatory measures.Clinical trial outcomes also presented mixed results. Neurocrine Biosciences' Ingrezza did not meet efficacy endpoints in its phase 3 trial for cerebral palsy-related dyskinesia. Although it is approved for other movement disorders, this setback reflects the complexities involved in expanding drug indications. Such challenges highlight ongoing hurdles in translating preclinical successes into clinical realities.Despite geopolitical tensions, particularly between China and the U.S., Chinese biotech firms thrived, maintaining robust deal activity. China's continued growth as an innovation hub is driven by strategic investments and collaborations that bolster global drug development efforts, underscoring its increasing influence in life sciences.Regulatory landscapes also shifted with proposals from the Center for Medicare & Medicaid Innovation to align U.S. drug prices with international rates under Medicare Parts B and D. These proposed models could significantly impact pricing strategies and market dynamics within the U.S., requiring pharmaceutical companies to adapt while ensuring equitable access to medications.Ethical challenges surfaced as six individuals were charged with insider trading involving biotech stocks. Such incidents highlight the necessity for stringent ethical standards and regulatory oversight to maintain investor confidence and market integrity.Meanwhile, AstraZeneca's extended partnership with Niowave for actinium-225 supply reflects an interest in radiopharmaceuticals as targeted cancer therapies. This collaboration highlights the potential of radiopharmaceuticals in oncology, opening promising avenues for precision medicine approaches.As 2025 closes, it's clear that this year has been one of both triumphs and trials for the pharmaceutical and biotech industries. Scientific innovations like Novo Nordisk's oral GLP-1 receptor agonist offer new hope for patients, yet challenges such as clinical trial setbacks and legal battles indicate ongoing hurdles in drug development and commercialization. These developments will likely influence industry strategies and regulatory policies as we advance into 2026.The sustained momentum of China's biotech industry amid global trade tensions remains notable. This trend reflects China's strategic investments in biotech capabilities and its growing role in global markets despite geopolitical frictions.In clinical research, Hope BioscienceSupport the show
In this episode, we sit down with Dr. Jean Bennett, Professor Emeritus of Ophthalmology at Penn Medicine and a true pioneer in gene therapy research. Dr. Bennett led the team that developed the first FDA-approved gene therapy to treat inherited blindness, transforming the lives of patients with retinitis pigmentosa and other retinal diseases. Her groundbreaking work spans over three decades and has opened doors for gene therapy applications far beyond ophthalmology. Dr. Bennett shares her remarkable journey from a curious child in New Haven, Connecticut—who chose seeds over candy at age four—to becoming a world-renowned scientist. She opens up about the challenges she faced as a woman in science, including being advised to leave her field entirely when seeking tenure at Penn. With candor and humor, she discusses how mentorship from previous Girl Power Gurus guest, Dr. Virginia Lee, helped her persevere, the emotional eureka moment when blind dogs first regained their sight, and what it felt like to witness blind children see for the first time. Dr. Bennett also offers invaluable advice for young women pursuing STEM careers, emphasizing the importance of finding work you love, building collaborative teams, and never giving up on your dreams despite the obstacles. This is a must-listen for anyone interested in science, medicine, or the power of determination.
In this episode, we discuss promising results of gene therapy, administered suprachoroidally, for the treatment of nonproliferation diabetic retinopathy without macular edema with Charles Wykoff, MD, Ph.D., Retina Consultants of Houston.
The company has also fully enrolled the Phase 2/3 VISTA clinical trial for its XLRP gene therapy.
In Part 2 of the 2026 pipeline series, host Carolyn Liptak welcomes Dr. Amanda Frick, Senior Clinical Manager, Strategic Clinical Intelligence at Vizient, to explore the advanced therapies pipeline: cell therapies, gene therapies, tissue-engineered products, and combination advanced therapy products. The discussion explores major pipeline trends, six leading products to watch, and the growing innovation expected to shape clinical practice in 2026. Guest speakers: Amanda Frick, PharmD, BCPS Senior Clinical Manager, Strategic Clinical Intelligence Spend Management Vizient Host: Carolyn Liptak, MBA, BS Pharm Pharmacy Executive Director Center for Pharmacy Practice Excellence (CPPE) Vizient Show Notes: [00:05] — Introduction Announcer opens the episode. Host Carolyn Liptak introduces the focus on advanced therapies: cell & gene therapies, tissue-engineered products, and combination products. Guest: Dr. Amanda Frick, Senior Clinical Manager, Strategic Clinical Intelligence at Vizient. [01:07] — Defining Advanced Therapies FDA groups cell and gene therapies within advanced therapies. Total FDA-approved advanced therapies: 46. Amanda monitors 29 drug-like therapies within that group. [02:01] — Pipeline Size and Approval Activity S. pipeline: 264 agents in development. About 10 agents approach FDA decision annually. Actual approvals: 5–7 per year on average. [02:56] — Big-Picture Trends in Cell & Gene Therapy Oncology dominates 40–50% of all CGTs in development. Expanding into autoimmune, neurology, and earlier-phase therapies for diabetes, angina, osteoarthritis. Movement toward allogeneic ("off-the-shelf") therapies Designed to overcome limits of autologous cell manufacturing. Reduces wait time and manufacturing failures. Resurgence of therapeutic vaccines Currently 3 approved (Sipuleucel-T, Talimogene, Papzimeos ). 20+ vaccines in the pipeline, largely targeted to cancer. CE program coming Jan 29. [06:13] — Therapy #1: Tabelecleucel or Tab-cel (Allogeneic EBV-Specific T-Cell Therapy) First allogeneic T-cell therapy expected in the U.S. For EBV-positive post-transplant lymphoproliferative disorder (PTLD). “Off-the-shelf” and donor-derived. [07:07] — Clinical Need & Outcomes Currentstandard of care: rituximab. After relapse, survival
It Happened To Me: A Rare Disease and Medical Challenges Podcast
In this uplifting episode, hosts Beth Glassman and Cathy Gildenhorn sit down with Leanna Scaglione, a powerhouse rare disease advocate and marathon runner living with NF2-Related Schwannomatosis (NF2-SWN), formerly known as neurofibromatosis type 2. Diagnosed at just 16 years old, Leanna's life changed dramatically when tumors were discovered in her nervous system, a hallmark of NF2-SWN. Many would have slowed down. Instead, Leanna sped up. Today, she has: Completed multiple marathons, including Berlin and New York City Participated in clinical trials Become an advocate and 2025 Ambassador for the Children's Tumor Foundation Set her sights on becoming the first person with NF2 to complete all 7 Abbott World Marathon Majors Her message is powerful: a diagnosis doesn't define the finish line. In This Episode, We Discuss: What NF2-SWN is and how it impacts the nervous system The emotional toll of receiving a life-altering diagnosis as a teenager Losing a dream — and finding a new one Running marathons through surgeries, treatments, and uncertainty How advocacy and visibility can change the rare disease landscape Building a life rooted in resilience, purpose, and possibility About Our Guest: Leanna Scaglione is 34 years old living with NF2-Related Schwannomatosis (NF2-SWN). Ever since being diagnosed at 16 years old, she has refused to live defined by her diagnosis. From relearning to walk, participating in immunotherapy drug trials, and going through numerous surgeries she has defied the odds against her. Most recently she has undergone surgery to remove her right acoustic neuroma. She continues to live her best life as an endurance runner, sharing her story and experiences living with NF2 in hopes to spread awareness, motivate her community and rally for a cure. Resources: Children's Tumor Foundation NF2 Accelerator: A Strategic Portfolio Approach to End NF2 Articles Explaining NF2 MedlinePlus GeneReviews National Organization for Rare Disorders (NORD) Research from China that Leanna reference for a gene therapy for NF2 Yuan R, Wang B, Wang Y, Liu P. Gene Therapy for Neurofibromatosis Type 2-Related Schwannomatosis: Recent Progress, Challenges, and Future Directions. Oncol Ther. 2024 Jun;12(2):257-276. doi: 10.1007/s40487-024-00279-2. Epub 2024 May 17. PMID: 38760612; PMCID: PMC11187037. Additional Research Articles Alexandra K. O'Donohue, Samantha L. Ginn, Gaetan Burgio, Yemima Berman, Gabriel Dabscheck, Aaron Schindeler, The evolving landscape of NF gene therapy: Hurdles and opportunities, Molecular Therapy Nucleic Acids, Volume 36, Issue 1, 2025, 102475 ,ISSN 2162-2531, https://doi.org/10.1016/j.omtn.2025.102475. Connect With Us: Stay tuned for the next new episode of “It Happened To Me”! In the meantime, you can listen to our previous episodes on Apple Podcasts, Spotify, streaming on the website, or any other podcast player by searching, “It Happened To Me”. “It Happened To Me” is created and hosted by Cathy Gildenhorn and Beth Glassman. DNA Today's Kira Dineen is our executive producer and marketing lead. Amanda Andreoli is our associate producer. Ashlyn Enokian is our graphic designer. See what else we are up to on Twitter, Instagram, Facebook, YouTube and our website, ItHappenedToMePod.com. Questions/inquiries can be sent to ItHappenedToMePod@gmail.com.
Happy Thanksgiving… Thursday, November 27, 2025. Week 48. Continued from #S10e189… And the AAV Paper (https://pubmed.ncbi.nlm.nih.gov/40988338/) from #S10e187… https://curesyngap1.org/podcasts/syngap10/clinical-research-ai-dx-nl47-survey-autism-press-6-days-to-register-for-syngap1conf-s10e187/ https://curesyngap1.org/blog/ Issac's story, Transmitter reprint, Scramble 4 write up and JK on #Autism, #MustRead https://curesyngap1.org/resources/webinars/ 119 - 112 Register for livestream of the conference, AAV from Allen Inst., dos en espanol, Missense, Unlock and Rare-X for ProMMiS. https://curesyngap1.org/podcasts/syngap1-stories/ A gold mine have you listened to #38, the Virginie Pod, really must listen, she is our leader. https://www.linkedin.com/posts/graglia_syngap1stories-syngap1-syngap1storiesty-activity-7387203351907708928-liNL CLINICAL TRIAL & GENETIC MEDICINE CORNER Example of Ultragenyx FAST Angelman follow on trial to look at other ages and genotypes, key message, never give up. https://www.linkedin.com/posts/cureangelman_the-global-aurora-study-will-enroll-approximately-activity-7389647402690957312-Bihi Congrats to Novartis on approval of the first Gene Therapy to Cure SMA! https://www.linkedin.com/posts/graglia_sma-fdaapproval-rarediseaseinnovation-activity-7398939783005347840-Ocd_ Remember Spinraza was approved in December 2019. TODOS Sign up for Citizen Health: https://www.citizen.health/partners/srf USE YOUR ICD-10 F78.A1 #S10e185 https://www.youtube.com/watch?v=dale0NbxDpU Go to CURE SYNGAP1 Conference 2025 Atlanta: https://curesyngap1.org/events/conferences/cure-syngap1-conference-2025-hosted-by-srf/ SOCIAL MATTERS 4,468 LinkedIn. https://www.linkedin.com/company/curesyngap1/ 1,480 YouTube. https://www.youtube.com/@CureSYNGAP1 11.2k Twitter https://twitter.com/cureSYNGAP1 45k Insta https://www.instagram.com/curesyngap1/ $CAMP stock is at $3.62 on 26 Nov. ‘25 https://www.google.com/finance/beta/quote/CAMP:NASDAQ Episode 190 of #Syngap10 #CureSYNGAP1
This week, a world first gene therapy treats rare Hunter syndrome. Could these personalised medicines be used more widely? We speak to Claire Booth, professor in Gene Therapy at Great Ormond Street Hospital. And high in the Chilean desert, the last bit of 13 billion year old light has hit the mirror of the Atacama Cosmology Telescope for the last time. Dr Jenifer Millard, a science communicator and host of the Awesome Astronomy podcast, tells us what it's been up to for the past 20 years.And Penny Sarchet, managing editor at New Scientist brings her pick of the latest new discoveries.Think you know space? Head to bbc.co.uk, search for BBC Inside Science, and follow the links to the Open University to try The Open University Space Quiz. Presenter: Tom Whipple Producers: Alex Mansfield, Ella Hubber, Jonathan Blackwell, Tim Dodd and Clare Salisbury Editor: Martin Smith Production Co-ordinator: Jana Bennett-Holesworth
New Crash Test Dummies for women… Freddie Mercury old boyfriend writes book… I Wool Survive… Email: Chewingthefat@theblaze.com www.blazetv.com/jeffy $20 off annual plan right now ( limited time ) New Years Eve hosts on ABC… Chelsea Handler to host Critics Choice again… All Reality AMC+ thru Prime… Social Media usage.. .Gene Therapy breakthrough… Who Died Today: Jimmy Cliff 81 / Udo Kier 81 / John Eimen 76 / Dharmendra 89… Joke(s) of The Day… Learn more about your ad choices. Visit megaphone.fm/adchoices
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