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In this episode of Mind the Meds, Erica Marini, PharmD, highlights information from the European Stroke Organization Conference include encouraging data on asundexian(Bayer), a factor XIa inhibitor showing reduced recurrent ischemic stroke risk without increased bleeding, as well as positive results from three trials of tirofiban in acute ischemic stroke settings. On the multiple sclerosis (MS) front, Marini covers the FDA approval of ocrelizumab (Ocrevus; Genentech) for pediatric relapsing-remitting MS in children 10 and older, a new study supporting early use of high-efficacy agents in pediatric MS, and 2 Lancet publications on ocrelizumab — one examining higher weight-adjusted dosing (which did not improve disability progression) and one confirming benefit in a broader primary progressive MS population. She also briefly discusses PADOVA (NCT04777331), a phase 2b trial of prasinezumab in early Parkinson's disease, which failed to meet its primary end point.The bulk of the episode is a discussion with guest Millad Sobhanian, PharmD, BCPS, clinical pharmacy specialist in neurology at the University of Maryland, focused on Alzheimer disease. They cover dextromethorphan/bupropion (Auvelity; Axsome Therapeutics), newly approved in April 2026 for agitation associated with Alzheimer dementia. Sobhanian walks through key safety considerations—including additive NMDA antagonism if combined with memantine, cardiovascular risks from the bupropion component, and the ever-present black box warning on antipsychotics in dementia patients—while both note that the efficacy data, though statistically significant, shows modest clinical effect sizes compared to the threshold for meaningful within-patient change.The conversation then turns to lecanemab's subcutaneous initiation formulation (Leqembi Iqlik; Eisai, Biogen), whose FDA decision has been delayed to about August 2026 as regulators seek more data on bioavailability and ARIA monitoring in the at-home setting. Sobhanian shares his real-world perspective on anti-amyloid therapy, describing a patient population that is typically early-stage, high-functioning, and has a mean age of about 60 to 70 years, and emphasizing the pharmacist's role in expectation-setting around the modest but potentially cumulative slowing of cognitive decline. The episode closes with a thorough discussion of the April 2026 Cochrane review on amyloid-targeting monoclonal antibodies, which both Marini and Sobhanian find overly broad in its conclusions. They note limitations such as the inclusion of withdrawn agents like aducanumab (Aduhelm; Biogen), heterogeneous inclusion criteria across trials, and an 18-month study horizon that may be too short to capture the full benefit suggested by longer-term open-label extension data.Key Takeaways:1. New options for Alzheimer's agitation exist, but fit carefully into the treatment algorithm. Dextromethorphan/bupropion offers a novel NMDA-based mechanism for treating agitation in Alzheimer dementia, but its clinical effect size is modest, and it carries meaningful safety considerations—particularly around the bupropion component in elderly patients. Like all pharmacologic options in this space, it remains a later-line choice after nonpharmacologic interventions have been exhausted, and medication reconciliation is critical given its interaction potential with memantine and CYP2D6 inhibitors.2. Anti-amyloid therapies are imperfect but not ready to be written off. The April 2026 Cochrane review drew significant attention with its conclusion that anti-amyloid monoclonal antibodies produce only trivial cognitive benefits, but its findings are limited by the inclusion of older, withdrawn agents, heterogeneous trial populations, and an 18-month time horizon that may be too short to capture the full trajectory of benefit.3. The pharmacist's role in anti-amyloid therapy goes well beyond dispensing. As illustrated by Sobhanian's practice at the University of Maryland, clinical pharmacists embedded in neurology clinics play a critical role in patient selection, expectation-setting, ARIA counseling, and informed decision-making for patients considering anti-amyloid therapy—a complex, high-stakes treatment decision that these patients and their caregivers should never be navigating alone.
What if the future of multiple sclerosis treatment could go beyond suppressing inflammation - and actually help protect the brain? In this episode of Rx for Biotech, host Chris Leidli sits down with Jason Tardio, President & COO of Immunic Therapeutics, to discuss the evolving future of treatment for Multiple Sclerosis (MS), one of the most complex autoimmune and neurodegenerative diseases affecting millions worldwide. Jason shares his deep experience leading major MS franchises at Biogen and Novartis, explains how MS attacks the brain and spinal cord, and breaks down why many current therapies focus primarily on inflammation but may not fully address the neurodegeneration driving long-term disability. The conversation also explores Immunic's lead investigational therapy, vidofludimus calcium, an oral once-daily treatment being studied in Phase 3 clinical trials for relapsing multiple sclerosis. The company believes the therapy may offer a unique dual approach by targeting both neuroinflammation and neurodegeneration. Topics discussed include: • What causes multiple sclerosis • Early symptoms and diagnosis of MS • How MRI imaging transformed MS care • Why MS remains difficult to treat • The difference between inflammation and neurodegeneration • Oral therapies vs infusions and injectables • Progressive multiple sclerosis and unmet patient needs • The future of neuroscience, immunotherapy, and personalized medicine For patients, caregivers, healthcare providers, and anyone interested in the future of neurology and autoimmune disease treatment, this episode offers an accessible and hopeful look at where MS care may be headed next.
Ted Turner built CNN from scratch and changed how America consumes media — but what happened to him in his final years is something almost nobody talks about. Drug companies like Biogen spent $18 billion trying to crack the condition that took Turner down, and the FDA rejected their best shot twice. The answer might be simpler and cheaper than anyone expected. Kimchi One from Brightcore – Health Starts in the Gut Get 25% Off – Use Code: LARRY at https://www.brightcore.com/larry Or call (888) 462-4779 for up to 50% OFF your order and Free Shipping! Purchase only directly from Brightcore Nutrition to ensure product integrity – We do not authorize resellers. SHOP OUR MERCH: https://store.townhallmedia.com/ BUY A LARRY MUG: https://store.townhallmedia.com/products/larry-mug Watch LARRY with Larry O'Connor LIVE — Monday-Thursday at 12PM Eastern on YouTube, Facebook, & Rumble! Find LARRY with Larry O'Connor wherever you get your podcasts! SPOTIFY: https://open.spotify.com/show/7i8F7K4fqIDmqZSIHJNhMh?si=814ce2f8478944c0&nd=1&dlsi=e799ca22e81b456f APPLE: https://podcasts.apple.com/us/podcast/larry/id1730596733 Become a Townhall VIP Member today and use promo code LARRY for 50% off: https://townhall.com/subscribe?tpcc=poddescription https://townhall.com/ https://rumble.com/c/c-5769468 https://www.facebook.com/townhallcom/ https://www.instagram.com/townhallmedia/ https://twitter.com/townhallcomBecome a Townhall VIP member with promo code "LARRY": https://townhall.com/subscribeSee omnystudio.com/listener for privacy information.
She came to the US with her first year's tuition and figured the rest out from there. What followed is one of the most grounded quality leadership journeys I have heard - and one we felt was worth bringing back.Swetha Krishnan on Building a Quality Mindset from the Ground UpThis is a rerelease of one of our favourite episodes from two years ago. In today's episode I was joined by Swetha Krishnan. I really wanted to bring this conversation back because Swetha's route into quality was entirely unplanned - and the way she has turned that unplanned start into a clear leadership philosophy is something every quality professional should hear.Swetha came to the US from India to complete a master's in bioengineering at the University of Toledo. She needed work, she needed a visa sponsor, and she found her way into a contractor role at Pfizer in Connecticut doing technical writing and validation. It was not the destination she had mapped out, but two years of being moved from role to role - quality management systems, regulatory content authoring, client-facing support - gave her a cross-functional view of how a pharma company actually operates. From there she moved through roles at Biogen, Sanofi Genzyme, and Alkermes before taking on her current position leading quality across all GXPs at Mural Oncology, a clinical-stage biotech focused on cytokine-based immunotherapies for cancer.Swetha leads with a combination of strategic clarity and genuine warmth. She is honest about the things she struggled with early on - particularly the belief that credibility required having all the answers - and equally clear about what changed that. She talks about the boss at Alkermes who told her she would one day be head of quality before she believed it herself, the nine-month Women Unlimited LEAD program that gave her two external mentors, and the MIT LeadershipSignature course that asked her to examine what in her personal history shapes how she shows up every day.We talk about the following:• How a bioengineering thesis on non-invasive glucose measurement for diabetics led to an unexpected start in quality• Starting as a contractor at Pfizer and what wearing so many hats in two years taught her about the whole product life cycle• Why validation gave her a quality mindset before she had ever formally joined a quality team• The shift from individual contributor to manager to leader of teams - and why it forced her to rethink everything she thought she knew about credibility• The nine-month Women Unlimited LEAD program at Alkermes and the boss who saw her potential before she saw it herself• Quality by design in practice - being involved in CRO selection from the start, not after the contract is signed• How she manages prioritisation, managing up, and keeping her team grounded in a lean, fast-moving clinical-stage biotech• Her 4C model for aspiring quality leaders: challenge, curiosity, collaboration, and compassionSwetha is a thoughtful, pragmatic quality leader who understands how to balance compliance, collaboration and business reality in complex development environments. If you are a quality professional working in an early-stage biotech and trying to build the right systems with limited resources, then this episode is for you. You can watch on LinkedIn Live at 12pm EST today or listen via Apple or Spotify. Thank you Swetha for sharing your incredible journey. Hope everyone enjoys the show.Who This Episode Is For• Quality managers and directors in clinical-stage biotech who are building systems and leading teams without large headcounts or unlimited budgets• Aspiring heads of quality who are in the transition from individual contributor to people leader and finding that shift harder than they expected• Quality professionals who came into the function from validation, technical writing, or another non-traditional route and are still making sense of how it all connects• Senior quality leaders who want a practical framework for developing the next generation on their team• Anyone in pharma or biotech who has ever felt like asking for help put their credibility at riskTimestamps:(00:00) Introduction to Swetha Krishnan and Mural Oncology(05:08) The Importance of Quality in Biotech(11:00) The Role of Quality in Driving Strategy(16:39) Managing Stress and Prioritization(21:55) Self-Development and Continuous Learning(26:44) Advice for Aspiring Quality Leaders
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 noteworthy advancements and challenges that are shifting the landscape of drug development and patient care. Starting with AstraZeneca and Daiichi Sankyo, their Trop2-directed antibody-drug conjugate, Datroway, has secured FDA approval for first-line treatment in triple-negative breast cancer. This form of cancer is notoriously aggressive and offers limited treatment options, making this approval a significant milestone. It positions Datroway as a key player in the ADC market targeting TNBC, highlighting the increasing role of antibody-drug conjugates in oncology. This advancement not only expands therapeutic options for patients but also emphasizes the growing importance of ADCs in effectively targeting cancer cells while sparing healthy tissues. In another exciting development, Merck and Kelun Biotech have reported on their SAC-TMT ADC, which when paired with Keytruda, shows a profound impact on PD-L1-positive non-small cell lung cancer patients. Their combination therapy demonstrated a remarkable 65% reduction in disease progression or death compared to Keytruda alone. Presented at the ASCO annual meeting, these findings could potentially revolutionize first-line treatments for NSCLC, further underscoring the promising therapeutic potential of combining ADCs with immunotherapies. However, AstraZeneca faced a setback with a novel breast cancer drug as an FDA advisory committee recommended against its approval. Interestingly, the European Medicines Agency provided a favorable opinion, illustrating the divergent regulatory landscapes across continents. Such discrepancies highlight the complex regulatory environment pharmaceutical companies must navigate and could influence strategic decisions regarding market focus. On the legal front, Eli Lilly is embroiled in controversy over an alleged $200 million rebate fraud scheme involving its diabetes drug, Trulicity. This situation sheds light on ongoing issues within pharmaceutical distribution channels and raises questions about compliance and oversight mechanisms necessary to prevent such financial misconduct. Meanwhile, industry dynamics continue to evolve as AbbVie announced workforce reductions in its Allergan Aesthetics unit. This move reflects broader trends where companies streamline operations to prioritize core competencies and promising therapeutic areas. From a regulatory perspective, Maat Pharma's decision to seek re-examination for its graft-versus-host disease medication underscores the iterative nature of drug approval processes. Persistence in addressing regulatory feedback remains crucial as companies strive for successful market entry. In obesity management, Novo Nordisk's oral GLP-1 receptor agonist, Wegovy, gains traction as a convenient treatment option. The shift towards oral medications could significantly improve patient adherence and outcomes by offering an easier alternative to injections. Biogen's decision to terminate its collaboration with Denali Therapeutics after unsuccessful phase 2 trials for a Parkinson's disease candidate highlights the inherent risks in neurological drug development. Rigorous clinical evaluation remains essential to ensure efficacy before advancing therapies further. Despite these advancements, challenges persist as Biogen and Denali's BIIB122 failed in phase 2b trials for idiopathic Parkinson's disease. This underscores the complexity of neurological disorders and emphasizes the need for continued innovation targeting LRRK2 kinase inhibitors. In the realm of CAR-T therapies, Novartis' T-Charge platform faces competition from emerging in vivo technologies. This competitive landscape demonstrates rapid evolution within cell therapy domains, aiming to enhance efficacy and accessibility for patients. Meanwhile, strategic mergers and acquisitions continue as Liminatus Pharma acquires CAR-T biotech Innocsai for $320 million, underscoring sustained interest in oncology cell therapies. Switching gears to Eli Lilly's recent Phase 3 TRIUMPH-1 trial results for retatrutide, they reveal promising weight loss outcomes comparable to bariatric surgery. As a triple hormone receptor agonist targeting GLP-1, retatrutide holds significant potential in addressing obesity—a condition with profound public health implications. Medtronic's acquisition of SPR Therapeutics to enhance its chronic pain portfolio reflects a focus on minimally invasive treatments. Financially, Research Alliance III raised $75 million through a SPAC IPO targeting mergers with China-based biotech firms, signaling increased global collaboration within the sector. Dandelion Health's $14 million Series A funding aims to advance clinical intelligence platforms that could transform drug development through data analytics. Finally, Moderna's mRNA-based flu vaccine is set for review by the FDA's vaccine advisory committee after overcoming initial regulatory hurdles. This scrutiny highlights ongoing challenges faced by novel vaccine technologies within rigorous regulatory environments. In summary, these developments illustrate an industry at the forefront of scientific innovation while grappling with regulatory complexities and operational challenges. From antibody-drug conjugates and immunotherapy combinations to gene editing and advanced cell therapies, there's a clear commitment to improving patient outcomes through novel scientific approaches. As these trends evolve, they promise to redefine treatment landscapes across various therapeutic areas—offering new opportunities for scientific advancements and enhanced patient care worldwide.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 explore a series of transformative events shaping the industry landscape, from scientific breakthroughs to regulatory shifts and strategic realignments. Eisai's progress with its Alzheimer's treatment, Leqembi, marks a significant milestone in addressing one of the most challenging neurological disorders. With a sales forecast of $900 million, this development underscores the growing demand for effective Alzheimer's treatments. Eisai's partnership with Biogen plays a crucial role in this context, aiming to provide a solution to a disease that has long eluded effective therapeutic intervention. This collaboration highlights the intricate interplay between scientific innovation and strategic alliances in tackling complex health challenges. Biogen's recent data on Alzheimer's disease advances our understanding of neurodegenerative disorders by reinforcing the tau hypothesis alongside longstanding amyloid-beta research. This insight opens new avenues for therapeutic interventions targeting tau proteins—a potentially pivotal shift given prior limited success with amyloid-centric approaches. Denali Therapeutics may benefit from this paradigm shift thanks to its proprietary technology that enhances central nervous system drug delivery—a crucial factor for effective tau-targeting therapies. Concurrently, organizational restructuring at Novartis reflects broader industry trends. As companies increasingly focus on optimizing operations and honing in on core therapeutic areas, Novartis's strategy to streamline its biomedical research arm could potentially impact innovation timelines and resource allocation. This move is indicative of a wider industry shift aimed at enhancing research efficiency and maintaining competitive edges in a rapidly evolving market. Regulatory updates continue to be pivotal, as seen with the U.S. Supreme Court's decision to temporarily restore telehealth access to the abortion pill mifepristone. This ruling not only underscores the intersection between healthcare access and legal frameworks but also highlights potential implications for patient accessibility to medications across the U.S. Meanwhile, AstraZeneca's Imfinzi received swift regulatory endorsement from NICE for perioperative use in stomach cancer just 17 days post UK approval. Such rapid endorsements are crucial in expanding treatment options and improving patient outcomes, particularly in oncology where timely interventions can be life-saving. In market dynamics, Novo Nordisk's Wegovy pill has experienced its first decline in total prescriptions, as tracked by Fierce Pharma through their new oral GLP-1 tracker. This development suggests shifting preferences among clinicians and patients within the competitive landscape of weight management therapies. It points to an environment where continuous innovation and adaptation are necessary to maintain market presence. Biopharmaceutical pipelines are increasingly dominated by biologics, presenting both opportunities and challenges. A report highlights manufacturing complexities that pose hurdles for new product launches, emphasizing the industry's shift from small molecules to biologically-derived therapies. As demand grows, advancements in manufacturing technologies and processes become essential to meeting these needs effectively. Aardvark Therapeutics' decision to unblind its phase 3 Prader-Willi syndrome study data following an FDA-imposed hold illustrates the regulatory hurdles that can occur during drug development. These holds often delay critical data analyses but also present opportunities for reevaluating trial strategies, ensuring that patient safety remains paramount. Aardvark Therapeutics faces regulatory challenges as its Prader-Willi syndrome trials encounter an FDA-imposed hold due to cardiac safety concerns. These developments highlight both scientific promise and the stringent safety standards essential within drug development processes. Technological innovation is reshaping drug discovery efforts through targeted protein degradation—a method allowing researchers to address previously "undruggable" targets. This approach signifies a potential revolution in developing novel therapeutic modalities across various diseases, highlighting the industry's capacity for groundbreaking advancements. On the policy front, bipartisan lawmakers have reintroduced legislation aimed at preventing pharmacy benefit managers from owning retail pharmacies. This legislation seeks to address conflicts of interest that could impact drug pricing and access, underscoring the ongoing scrutiny on practices affecting healthcare costs. In oncology, Genmab's recalibration of its antibody-drug conjugate pipeline signals competitive pressures within this innovative space where differentiation is key to maintaining market leadership. Similarly, Create Medicines' entry into CAR T-cell therapies—backed by substantial funding—reflects ongoing investment in breakthrough cancer treatments while balancing immediate clinical opportunities with strategic long-term goals. Amidst these transformative developments are broader industry trends involving employment shifts and funding dynamics. Despite workforce reductions like those at Takeda as part of its transformation strategy, there remains strong momentum within sectors such as California's vibrant biotech scene—illustrating resilience amid economic pressures. These stories exemplify an industry characterized by transformation driven by scientific insights into disease mechanisms coupled with regulatory vigilance ensuring patient safety remains paramount throughout all stages—from discovery through commercialization—ultimately striving towards improved patient care outcomes addressing various unmet medical needs worldwide.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 of the latest news shaping the industry, from breakthroughs in cancer therapies to advancements in AI-driven drug discovery. Starting with regulatory updates, the potential appointment of Richard Pazdur, M.D., as the new FDA Commissioner is causing quite a stir. Following Marty Makary's resignation, Pazdur has emerged as a prominent candidate due to his extensive background in oncology drug regulation. Known for his commitment to accelerating cancer therapy approvals, his potential leadership could maintain or even amplify the focus on expediting innovative treatments for cancer patients. In a significant regulatory achievement, Beone Medicines celebrated the FDA's approval of Beqalzi, marking it as the first BCL-2 inhibitor approved for mantle cell lymphoma. This approval challenges AbbVie's Venclexta and underscores a growing trend towards targeted cancer therapies that offer new treatment avenues for patients. The oncology space continues to be fiercely competitive, with companies striving to deliver more precise and effective cancer treatments. Turning to clinical trials, AstraZeneca's Imfinzi has shown promising results in a phase 3 trial focused on bladder cancer patients who are not eligible for cisplatin-based chemotherapy. These findings position Imfinzi as a strong competitor to Merck's Keytruda and reinforce AstraZeneca's strategic focus on expanding its oncology portfolio through novel combinations and indications. In the realm of genetic therapies, Regenxbio has achieved a milestone with its gene therapy for Duchenne muscular dystrophy. This therapy met its primary endpoint in pivotal trials, highlighting the potential of gene therapies to address rare diseases with limited treatment options. Such successes are likely to encourage further investment in gene editing technologies, which hold significant promise for tackling conditions once deemed untreatable. The FDA is also exploring frameworks to repurpose existing drugs for new uses by leveraging existing safety data. This could streamline drug development processes and offer cost-effective solutions for patients with complex conditions. However, this approach will need rigorous validation of efficacy in new indications to ensure patient safety and therapeutic effectiveness. Despite setbacks in its Alzheimer's research, Biogen remains steadfast in its efforts. While their tau-targeting candidate did not meet primary endpoints in a phase 2 trial, reductions in tau pathology and cognitive benefits were observed. This perseverance showcases Biogen's commitment to finding innovative approaches to tackle Alzheimer's disease despite ongoing challenges. On the operational front, Taiwan's Bora Group is acquiring Macrogenics' CDMO operations for up to $127.5 million. This move reflects a broader trend of consolidation within the CDMO space as companies aim to enhance their production capabilities and streamline operations. Quality control remains a critical concern as evidenced by Sun Pharma's recent recall of a chemotherapy batch due to glass particle contamination. Incidents like these underline the importance of stringent quality assurance measures throughout the manufacturing process to ensure patient safety. Moreover, Viz.ai has launched an AI-powered pulmonary care platform aimed at integrating acute and chronic care workflows. This development signals an increasing adoption of artificial intelligence in healthcare, promising improvements in diagnostics and patient management efficiency. AI continues to gain traction as Isomorphic Labs recently secured $2.1 billion in Series B funding aimed at enhancing AI-driven drug design models. Similarly, Charles River has introduced an AI-powered digital pathology platform poised to Support the show
On this week's episode, Sam Fazeli, Josh Schimmer, Eric Schmidt, and Tess Cameron kickoff with deals, highlighting the up to $15.2B Hengrui–BMS partnership and the broader trend of outsourcing early-stage drug development to China. The discussion continues with the co-hosts noting China's edge in speed, quality, and cost-efficiency, while underscoring that the strength of U.S. capital markets remains a key advantage. This week also saw a significant raise, with Isomorphic Labs announcing a $2.1B Series B. In regulatory news, the group described the departure of FDA Commissioner Dr. Marty Makary as creating fresh uncertainty around FDA leadership and direction as they speculated on his exit and who will replace him. On the data front, Regenxbio met the primary endpoint inits Phase 3 trial for Duchenne, though the hosts flagged potential investor skepticism around the side effects, limited data, and FDA uncertainty. Next, they discuss that Biogen and Ionis are advancing their Alzheimer's tau program despite mixed results. The co-hosts also mention Inhibrx's Phase 2 data in head and neck squamous cell carcinoma, as well as Moderna's Hantavirus vaccine research following the recent cruise ship outbreak. The episode concludes with a look ahead to upcoming conferences, including ASCO, ADA, and ATS. *This episode aired on May 15, 2026.
Shares of AI chipmaker Cerebras surging in its Nasdaq debut, topping $100 billion in market cap after a blockbuster IPO. How the rest of tech fared in today's rally, and how the Fast Money traders are positioning in the group. Plus Applied Materials reports results, Biogen pushes ahead despite disappointing drug data, and the latest out of President Trump's China trip. The CEOs and companies able to leave the mainland with a deal. Fast Money Disclaimer Hosted by Simplecast, an AdsWizz company. See pcm.adswizz.com for information about our collection and use of personal data for advertising.
Markets climb and investors turn their attention to the next major AI IPO: Cerebras. Eric Vishria of Benchmark and a Cerebras board member joins to discuss why the company's debut matters for markets and what it could mean for the broader AI ecosystem. Keith Lerner of Truist explains what it means for the Dow to reclaim 50,000 and whether momentum can continue. Our Angelica Peebles reports on a key Alzheimer's trial from Biogen and what it could mean for biotech and drug development. Our Eamon Javers reports from China on the latest developments surrounding President Trump's meetings while Michael Froman of the Council on Foreign Relations analyzes what the U.S. may have gained and the implications for Taiwan and global trade. Hosted by Simplecast, an AdsWizz company. See pcm.adswizz.com for information about our collection and use of personal data for advertising.
In about five weeks, adland will take over a small resort city in the south of France for a weeklong industry bonanza. The 2026 Cannes Lions International Festival of Creativity is on the horizon, slated for the last full week of June and rest assured, the medical marketing community will be there in force. Nearly one month ago, the juries for Health & Wellness Lions and the Pharma Lions were announced, featuring a few North American-based creatives, including Chris Charles, executive creative director of Real Chemistry subsidiary 21Grams. You might remember Chris and his team for their Gold Pharma Lions-winning work on behalf of Biogen for Friedreich's Back, a darkly humorous campaign focused on the often terminal, rare condition Friedreich's ataxia. For this week's episode, Chris joins executive editor Jack O'Brien for a conversation about the early stages of the sizable task undertaken by the Cannes pharma jury and what trends he's keeping an eye on as they analyze the nominated work. He also reflects on the success of Frederich's Back and why Cannes is important to pharma marketers. For our Trends segment, we're talking about the frustrating, mixed public health messaging surrounding the hantavirus cruise ship outbreak. Check us out at: mmm-online.com Follow us: YouTube: @MMM-onlineTikTok: @MMMnewsInstagram: @MMMnewsonlineTwitter/X: @MMMnewsLinkedIn: MM+M To read more of the most timely, balanced and original reporting in medical marketing, subscribe here.Music: “Deep Reflection” by DP and Triple Scoop Music. Hosted by Simplecast, an AdsWizz company. See pcm.adswizz.com for information about our collection and use of personal data for advertising.
From the lab bench to the C-Suite - and every crisis in between.In today's episode I was joined by Kimberly Garko, former Senior Vice President and Chief Technical Officer at Akebia Therapeutics.I really wanted to speak to Kim because her career trajectory is unlike almost anyone else I have interviewed on this show. She is a PhD virologist who began her career in the QC lab at Biogen, and over the following two decades built herself into one of the most accomplished quality and technical operations executives in the industry. She has led through warning letters, product recalls, complete response letters, workforce reductions, and commercial drug launches - often all at the same organisation. Her story is one of relentless curiosity, self-belief, and a genuine commitment to the patient at every stage.Kim talks about the pivotal moment early in her Biogen career when she was pulled out of the lab to help lead the effort to return Tysabri to market following its voluntary withdrawal. She discusses how that experience raised her ceiling permanently, and why she has never been able to go back to a smaller version of herself since. She shares how she thinks about building quality culture, identifying real leaders within an organisation, and what it actually takes to lead a team through a product recall at 3am on a Tuesday.We talk about the following:• How a JC virus safety crisis at Biogen changed the entire direction of Kim's career• What she looks for when she joins a new organisation and how she scales quality teams without losing culture• Her philosophy on 'creative compliance' and why the answer in quality is never just no• How to lead through warning letters, product recalls, and complete response letters without losing the team• The knowledge management crisis that follows every reduction in force and why most organisations are not prepared• What the Vafseo launch felt like after everything Akebia had been through• Her advice to quality leaders who want to reach the C-SuiteKimberly Garko is a thoughtful, pragmatic quality leader who understands how to balance compliance, collaboration and business reality in the most complex development environments imaginable. She has done this across biologics, oral solid dose, devices, and combination products at every stage from early clinical through to commercial launch.If you are a quality professional at any stage of your career - whether you are building your first team or trying to figure out what comes after VP - this episode is for you.Thank you Kim for sharing your incredible journey.Hope everyone enjoys the show.WHO THIS EPISODE IS FOR:• Quality leaders at director and VP level who are navigating high-pressure compliance situations and want a practical framework for crisis response• Aspiring quality executives who want to understand what it actually takes to move from functional leader to Chief Technical Officer• Quality managers in biologics, pharma, and biotech who want to build stronger, more resilient teams• Anyone who has ever had to manage a recall, a warning letter, or a workforce reduction and wants to hear from someone who has been through all three• Early-career scientists and QC professionals wondering whether there is a path to leadership from the lab bench
Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today's episode delves into a range of significant industry updates, spotlighting scientific advancements, regulatory challenges, and strategic movements that are shaping the future of drug development and patient care. The pharmaceutical landscape is often marked by rapid changes, as evidenced by recent reports indicating President Donald Trump's plan to dismiss FDA Commissioner Marty Makary. This potential leadership change is set against a backdrop of controversies during Makary's tenure, including the rejection of Replimune's advanced melanoma therapy, RP1. This therapy was designed as an oncolytic immunotherapy using a genetically modified herpes simplex virus to target and destroy cancer cells. The FDA's rejection of RP1 ignited debate over the agency's decision-making processes, which some critics view as inconsistent and lacking transparency. Such decisions can have profound implications—delaying patient access to critical treatments and affecting company financials and market dynamics. Furthermore, internal discord at the FDA during Makary's leadership period underscores the importance of stable leadership in maintaining efficiency and fostering scientific rigor. Turning to corporate developments, Gilead Sciences has revised its first-year sales forecast for YezTugo, its long-acting PrEP injection for HIV prevention. The company now projects revenues to reach $1 billion, reflecting strong market uptake. This adjustment highlights the growing demand for innovative PrEP solutions as part of broader HIV prevention strategies. Meanwhile, Daiichi Sankyo is grappling with a $610 million profit setback due to an overextension in their manufacturing capabilities for antibody-drug conjugates (ADCs). This situation illustrates the financial risks inherent in scaling production within rapidly evolving therapeutic areas like ADCs, where balancing supply and demand remains critical. In legal news, Capricor Therapeutics has initiated a lawsuit against NS Pharma concerning a breach-of-contract over Deramiocel, a Duchenne muscular dystrophy treatment. With an FDA decision pending, this legal battle underscores the complexities of partnerships and contract compliance in advancing neuromuscular therapies. On the regulatory front, Biogen and Eisai are experiencing delays from the FDA regarding their Alzheimer's drug Leqembi. These regulatory hurdles highlight the complex processes that can impact drug rollout timelines significantly. Odyssey Therapeutics' successful $304 million IPO aims to bolster its autoimmune and inflammatory disease pipeline. This reflects robust investor interest in biotech firms with promising therapeutic candidates addressing high-need areas. In terms of market dynamics, the competition between Novo Nordisk's Wegovy pill and Eli Lilly's Foundayo is reshaping the oral GLP-1 receptor agonist market. A newly launched weekly tracker will monitor prescription trends to provide insights into how these weight-loss solutions are impacting obesity management. Additionally, Johnson & Johnson's efforts to enhance awareness around depression treatment through public health campaigns illustrate how companies are addressing mental health challenges. Advancements in digital health continue with Tether's rollout of medical AI for mobile devices and MedAptus' operational 'command center,' highlighting ongoing innovations poised to transform healthcare delivery by enhancing efficiency and patient engagement. Strategic acquisitions remain a key theme as Angelini Pharma acquires Catalyst Pharmaceuticals for $4.1 billion—a move that expands Angelini's footprint into the U.S. rare neurological drug market. Similarly, Blackstone's $250 million investment in Anagram Therapeutics for cystic fibrosis enzyme replacement therapySupport the show
On this week's episode, Josh Schimmer, Paul Matteis, Eric Schmidt, Yaron Werber, and special guest STAT's Allison DeAngelis open with what they describe as “a bananas week for biotech,” highlighting strong substantial secondary offerings, including Cytokinetics and Avalo Therapeutics. The conversation then turns to M&A, with multiple new deals announced in Q1 and continued activity this week, including UCB's acquisition of Candid Therapeutics for up to $2.2B, Angelini's $4.1B purchase of Catalyst Pharmaceuticals, and Bayer's acquisition of Perfuse for up to $2.45B. The group also reflects on what feels like the year of developmental-stage biotech, highlighting investor focus on companies with pipeline events such as Vertex and Biogen, while commercial-stage companies have lagged. In regulatory news, the co-hosts discuss Sanofi's decision to withdraw diabetes drug, teplizumab, from the Commissioner's National Priority Review program, broader concerns about shifting goalposts and political influence, and contradicting outcomes including Replimune's rejection versus Atara's reversal. On the data front, the hosts discuss Cytokinetics' Phase 3 results and subsequent $650M raise, as well as encouraging autoimmune data from Artiva Biotherapeutics. They also overview neurofilament as a biomarker following Clene's data, and J&J's decision to advance its DUET program despite failing to meet its primary endpoint in IBD. *This episode aired on May 8, 2026.
Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today, we delve into an array of dynamic changes and strategic maneuvers within the industry, showcasing how these transformations are shaping the future of healthcare and patient treatment. Starting with regulatory innovation, the FDA's new initiative to facilitate real-time review of clinical trial data is a potential game-changer for drug development timelines. With AstraZeneca and Amgen participating in this pilot program, the industry anticipates a more efficient approval process that addresses issues during trials rather than post-completion. This could significantly reduce the time it takes for patients to access cutting-edge therapies, marking a pivotal shift towards more agile regulatory frameworks. Such initiatives reflect a broader move towards streamlining drug approvals without sacrificing safety and efficacy. Turning to strategic investments, AstraZeneca's renewed commitment to a £300 million investment in the UK, following earlier disputes over drug pricing, signals confidence in resolving these issues favorably. This decision underscores AstraZeneca's dedication to fostering innovation within the UK's life sciences sector. Similarly, Teva Pharmaceuticals' $700 million acquisition of Emalex Biosciences positions it to introduce a new therapy for Tourette syndrome, highlighting efforts to address conditions with limited treatment options. In oncology, GSK is aligning its strategy with industry trends by focusing on cancer therapies. Despite withdrawing from a partnership with Mersana Therapeutics and pausing its mRNA bird flu shot program, GSK aims to channel resources into more promising ventures. This reflects a broader industry focus on oncology due to its high unmet needs and market potential, which companies are eager to capitalize on through innovative treatments. Additionally, Kite Pharma is preparing for potential approval of its next-generation CAR-T therapy for multiple myeloma, representing ongoing progress in personalized medicine approaches aimed at complex diseases like cancer. Furthermore, Pfizer's Elrexfio has shown promising results in multiple myeloma trials, potentially expanding treatment options and reinforcing Pfizer's oncology market position. The competitive dynamics in Alzheimer's treatments are also noteworthy as Biogen and Eli Lilly vie for market share with Leqembi and Kisunla, respectively. This competition highlights complexities in chronic disease management where dosing differences may influence patient decisions. The biotech sector remains robust in fundraising activities despite challenges. Noteworthy is Vivacta's $50 million Series A round and Coultreon's $125 million fundraising effort, indicating strong investor confidence in biotech innovations. These financial injections are vital for advancing ambitious projects that promise transformative impacts on patient care. Strategic acquisitions continue to shape the industry landscape. Chiesi Group's $1.9 billion acquisition of KalVista Pharmaceuticals exemplifies this trend, focusing on expanding rare disease offerings—a niche market with significant unmet needs but fewer competitors. Meanwhile, AbbVie's acquisition option for Kestrel Therapeutics underscores its strategic expansion into targeted cancer therapies, particularly through Kestrel's promising oral pan-KRAS inhibitor. In regulatory scrutiny news, AstraZeneca's camizestrant faces intense evaluation ahead of advisory committee meetings. Such scrutiny ensures that only effective treatments reach the market while emphasizing the rigorous standards required during drug development processes. Lastly, technological integration within pharmaceutical operations is becoming increasingly crucial as companies leverage AI to enhance R&D efficiency and accelerate value crSupport the show
Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today, we explore some of the pivotal shifts and breakthroughs shaping the industry and their implications for drug development and patient care. In oncology, Merck & Co.'s Welireg triplet therapy faced a setback in its Phase 3 trial for first-line treatment of kidney cancer. Despite previous successes, this outcome underscores the complexity of developing oncology treatments and illustrates the ongoing need for innovative approaches to meet diverse patient needs. Meanwhile, Roche has reported promising results for Enspryng in its Phase 3 trial, demonstrating a 68% reduction in relapse risk for a rare neuroinflammatory disorder. This success highlights Roche's commitment to addressing unmet needs in rare diseases and paves the way for potential FDA approval. AstraZeneca continues to advance with Ultomiris, which showed significant results in reducing protein levels in urine for IgA nephropathy patients. This success not only expands Ultomiris' indications but also underscores AstraZeneca's focus on rare diseases, positioning them as leaders in this specialized market. Additionally, AstraZeneca's Tozorakimab met primary endpoints in COPD trials, showcasing new possibilities for managing this prevalent respiratory disease. On another front, Zai Lab's strategic evolution from licensing major pharma drugs to developing its own pipeline marks a significant maturation of China's biotech capabilities. This reflects a broader trend of Chinese firms seeking global footprints while navigating regulatory challenges to gain international credibility. Regulatory and strategic news also has its highlights: Pfizer is undergoing changes as its Chief Strategy and Innovation Officer steps down, possibly signaling a shift in strategic direction. Replimune's drastic workforce reduction following an FDA rejection exemplifies the harsh realities biotech companies face in regulatory pathways. Meanwhile, Gilead's retraction from a collaboration with Arcus Biosciences after a Phase 3 failure underscores the risks associated with antibody-based therapies. In other collaborations, Roche's Foundation Medicine is deepening ties with Bristol Myers Squibb to develop new diagnostic targets, illustrating how partnerships can drive innovation by leveraging combined expertise. In industry trends, there's a growing integration of medical affairs with commercial operations to optimize scientific exchange and product launches—this alignment is critical for ensuring new therapies reach patients efficiently. Eli Lilly's acquisition of Kelonia Therapeutics for up to $7 billion signals an increased focus on in vivo CAR-T capabilities. This acquisition could streamline cancer treatments by engineering T-cells directly within patients' bodies, offering potentially more effective therapeutic approaches. Globally, Biogen has expanded its partnership with TJ Biopharma for Felzartamab rights in China, reflecting strategic moves to penetrate Asian markets. GSK's Blenrep received Chinese approval for treating multiple myeloma, marking a significant advancement with this antibody-drug conjugate targeting BCMA. In Canada, ClearPoint Neuro gained approval for its neuro navigation system, highlighting precision medicine's role in enhancing therapeutic outcomes. The technological landscape is also evolving with Serif pioneering DNA-based therapeutics. Supported by Flagship Pioneering's $50 million investment, these innovations could revolutionize personalized medicine by offering tailored solutions. Ray Therapeutics' $125 million funding advancement in gene therapy candidates targeting retinal degeneration further underscores interest in genetic therapies as viable treatment options. In regulatory landscapes, there's a push for designing neurodegenerative trials that 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 delve into a series of dynamic changes and strategic shifts reshaping these industries, driven by scientific advancements and regulatory updates. Let's start with Biogen, which recently resolved an investor lawsuit concerning its Alzheimer's drug, Aduhelm. Approved under controversial circumstances by the FDA, Aduhelm faced scrutiny for its efficacy and costs. This settlement is a critical reminder of the importance of transparent communication with investors, especially when navigating high-stakes therapeutic areas like Alzheimer's. The broader implication for pharmaceutical companies is the need to balance innovation with accountability and transparency—a challenge that resonates across the industry. Meanwhile, Pfizer's decision to vacate office space in South San Francisco exemplifies a significant trend toward remote work, accelerated by the COVID-19 pandemic. This shift suggests that traditional workplace models are being reassessed in favor of flexibility and cost efficiency, a change likely to influence real estate investments and organizational structures across biotech firms. Amgen stands out with its notable financial growth highlighted by CEO Robert Bradway's $24.7 million compensation package in 2025. This success underscores Amgen's strategic prowess in maintaining robust performance amidst competitive pressures. Their approach could serve as a blueprint for other firms aiming to achieve sustained growth through innovation and strategic management. On the clinical trial front, Insmed's decision to halt development of Brinsupri after underwhelming mid-stage results illustrates the inherent risks in drug development. This highlights the need for rigorous trial designs and adaptive strategies within development pipelines to address potential setbacks efficiently. Turning to Gilead Sciences, there's a strategic pivot from mergers and acquisitions towards strengthening its internal research pipeline, now described as stronger than ever. This shift away from external acquisitions reflects an industry trend prioritizing internal R&D capabilities, potentially leading to breakthrough therapies that enhance patient care while ensuring sustained business growth. In regulatory developments, GSK's Exdensur received new approval in China, showcasing the ongoing globalization of pharmaceutical markets. Navigating diverse regulatory environments becomes crucial for maximizing drug accessibility worldwide. Another trend is seen through Invivyd's “Antibodies for Any Body” campaign featuring Olympic skier Lindsey Vonn. Leveraging public figures can significantly raise awareness about innovative treatments, playing a crucial role in educating the public about medical advancements. There's also significant financial movement within the sector as Jeito Capital announced a record $1.2 billion fundraising for an independent biopharma-focused European fund. This capital influx is poised to accelerate research and development activities across Europe, potentially leading to new therapeutic breakthroughs. Vivtex Therapeutics' $2.1 billion deal with Novo Nordisk illustrates the power of strategic collaborations in advancing therapeutic solutions and enhancing drug delivery systems—key components for improving patient outcomes. Sidewinder Therapeutics is making strides with a $137 million funding round to develop antibody-drug conjugates (ADCs), highlighting investor confidence in technologies that integrate precision medicine approaches to offer potent cancer treatments with reduced side effects. Astellas Pharma's collaboration with Dyno Therapeutics marks another milestone in gene therapy advancements. A $15 million agreement aims at utilizing engineered adeno-associated virus (AAV) capsids for muscle disorders, proSupport the show
From designing drugs with a simple text prompt to running experiments guided by extended reality, a new wave of agentic AI is transforming the modern lab. Our editors discuss the latest autonomous systems accelerating biological discovery. In business deals, Gilead Sciences has acquired Tubulis in a transaction worth up to $5 billion, strengthening the buyer's position in antibody–drug conjugates for cancer. Correspondingly, Eli Lilly and Biogen are each making billion-dollar-plus bets, acquiring Centessa, a sleep disorder drug developer, and Apellis, known for its work in immunology and rare diseases. Our episode rounds out by unpacking the dynamic obesity drug market, where intensifying competition from Novo Nordisk's Wegovy pill is prompting Lilly to temper the 2026 sales outlook for its oral obesity drug, Foundayo.Join GEN editors Corinna Singleman, PhD, Fay Lin, PhD and Alex Philippidis for a discussion of the latest biotech and biopharma news. Listed below are links to the GEN stories referenced in this episode of Touching Base: Can AI Agents Automate Scientific Discovery? By Fay Lin, PhD, GEN Edge, April 1, 2026Gilead to Acquire Tubulis for Up to $5B, Expanding Cancer ADC Capabilities By Alex Philippidis, GEN Edge, April 7, 2026Lilly Acquires Centessa for Up to $7.8B; Biogen Buys Apellis for Up to $6.1B By Alex Philippidis, GEN Edge, March 31, 2026StockWatch: Price War Dampens Lilly Surge After Oral GLP-1 Wins FDA Nod By Alex Philippidis, GEN Edge, April 5, 2026Touching Base Podcast Hosted by Corinna Singleman, PhD Behind the Breakthroughs Hosted by Jonathan D. Grinstein, PhD Hosted on Acast. See acast.com/privacy for more information.
Biotech has been resilient as the financial markets teeter under global volatility. For now, M&A and financings, if not IPOs, are continuing, but will the Mideast conflict halt biotech's recovery? On the latest BioCentury This Week podcast, BioCentury's Stephen Hansen breaks down the near-term and long-term outlook for a biotech industry hoping to continue the growth of 2H25.BioCentury's analysts also discuss the impact of the Trump administration's tariffs on the biopharma industry and last week's biggest deals: the pending $6.3 billion takeout of Centessa by Eli Lilly and the proposed $5.6 billion acquisition of Apellis by Biogen. This episode of the BioCentury This Week podcast was brought to you by IQVIA Biotech.Register now as a delegate or apply to join the 2026 Presenting Company Class before the 26th Bio€quity Europe May 4-6 in Prague sells out.View full story: https://www.biocentury.com/article/659040#BiotechMarkets #BiotechMA #GlobalVolatility #DrugPricingPolicy #BiopharmaStrategy00:01 - Sponsor Message: IQVIA Biotech05:09 - 2Q26 Preview17:09 - Pharma Tariffs24:04 - C-Path Initiative26:32 - Lilly Deal32:19 - Biogen DealTo submit a question to BioCentury's editors, email the BioCentury This Week team at podcasts@biocentury.com.Reach us by sending a text
On this week's episode, Graig Suvannavejh, Mike Yee, and Eric Schmidt kick off with a look back at biotech deal activity through the first quarter, highlighting a solid, but not overheated, M&A environment. The group discusses recent transactions, including large, commercially focused deals designed to drive near‑term revenue growth rather than pipeline speculation, particularly Biogen's $5.6 billion acquisition of Apellis. While total Q1 deal value was roughly in line with historical averages, they note that meaningful capital continues to be recycled back into the sector. In other deals, Lilly's $6.3 billion upfront acquisition of Contessa is also noted as an opportunity for Lilly diversify its pipeline beyond obesity. Next, the co-hosts highlight growing interest in blood–brain barrier drugs following Korsana's merger with Cyclerion. The conversation shifts to regulatory news, including the FDA approval of Lilly's oral GLP‑1, alongside signs of increasing regulatory flexibility in rare disease, such as Scholar Rock's SMA BLA resubmission, and an upcoming decision for Replimune. The episode concludes with data updates, including Viridian's Phase 3 thyroid eye disease results and discussion on NLRP3 inhibitors as a potential next wave cardiometabolic and obesity drugs beyond GLP 1s. *This episode aired on April 3, 2026.
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 shaping the industry, from groundbreaking drug approvals to strategic corporate maneuvers.Recently, the U.S. Food and Drug Administration (FDA) granted approval for Eli Lilly's new GLP-1 receptor agonist pill, Foundayoby, marking a significant milestone as it's the first new molecular entity to be cleared under the FDA's Commissioners National Priority Voucher Program. This program is designed to expedite the review process for drugs addressing critical needs or representing substantial advancements in treatment. Foundayoby's entry into the market provides a competitive edge against Novo Nordisk's products, offering a convenient oral alternative in the management of type 2 diabetes and obesity. Clinical trials have shown that this oral formulation maintains efficacy comparable to injectable peptides while improving patient adherence due to its ease of use. This development not only broadens therapeutic options but also emphasizes the growing trend towards patient-centric formulations in diabetes management.In related news, Eli Lilly has also received FDA approval for its oral obesity medication, Orforglipron, marketed as Foundayo. This approval further intensifies the rivalry with Novo Nordisk, which launched its oral therapy Wegovy earlier. Orforglipron's clinical trials demonstrated significant weight reduction in patients, highlighting pharmacotherapy's rising importance as an option for individuals struggling with obesity despite lifestyle modifications. The convenience of an oral formulation is expected to enhance patient compliance and long-term success, addressing a key challenge in obesity management.In strategic corporate news, Korsana Biosciences is making waves by entering public markets through a reverse merger with Cyclerion. This move highlights ongoing interest and investment in neurodegenerative diseases like Alzheimer's. In contrast, KBP Biosciences faces legal challenges as it seeks to reclaim ownership of heart drug Ocedurenone from Novo Nordisk after a failed billion-dollar deal. Such cases underscore the complexities inherent in pharmaceutical collaborations.Regulatory scrutiny continues to play a crucial role in shaping industry dynamics. The FDA extended its review period for Orca Bio's novel cell therapy for blood cancers by three months. This delay reflects rigorous regulatory requirements for innovative treatments poised to transform oncology care paradigms. Meanwhile, Iterum Therapeutics is winding down operations following unsuccessful sales of its antibiotic Orlynvah, highlighting financial sustainability challenges within the antibiotic market.Safety remains paramount as evidenced by concerns over Amgen's Tavneos after reports of serious liver injuries linked to its use. The FDA has identified 76 cases, including fatalities, underscoring the importance of post-market surveillance and risk management in ensuring patient safety.In terms of mergers and acquisitions, Eli Lilly's strategic acquisition of Centessa Pharmaceuticals for $6.3 billion signifies its entry into the sleep disorder market. Biogen followed suit by acquiring Apellis Pharmaceuticals for $5.6 billion to strengthen its kidney disease expertise. These moves reflect a broader trend where pharmaceutical giants are diversifying portfolios through acquisitions targeting niche therapeutic areas.On the technological front, partnerships leveraging artificial intelligence (AI) are gaining traction. Bristol Myers Squibb's collaboration with Faro Technologies aims to refine clinical trials using AI, while Merck & Co.'s partnership with Infinimmune focuses on antibody discovery innovations.Financially, Blackstone's record-breaking $6.3 billion life sciences fund highlights robust invSupport the show
Erfahre hier mehr über unseren Partner Scalable Capital - dem Broker mit einem der besten YouTube-Kanäle zu Aktien & Investments. https://www.youtube.com/@scalable.capital/videos Buffett ist doch nicht in Rente und will Apple günstiger nachkaufen. Allbirds für 39 Mio. $ verkauft. NVIDIA investiert 2 Mrd. $ in Marvell. Biogen kauft Apellis, Eli Lilly kauft Centessa. Snap-Investor will Smart-Glasses-Verkauf. Iran-Hoffnung beflügelt Börsen. Shenzhou International (WKN: A0HL4U) produziert für Nike, Adidas & Uniqlo. KGV von 11, 5% Dividende, 2 Mrd. $ Cash. Wenn Nike und Adidas wieder mehr verkaufen, landet ein Großteil davon hier. McCormick (WKN: 858250) kauft Unilevers Food-Sparte mit Knorr und Hellmann's. Unilever (WKN: A0JMZB) fokussiert sich danach auf Beauty und Pflege, mit Indien und USA als Wachstumskerne. McCormick bleibt Food. Mit hohen Schulden. Diesen Podcast vom 01.04.2026, 3:00 Uhr stellt dir die Podstars GmbH (Noah Leidinger) zur Verfügung. Learn more about your ad choices. Visit megaphone.fm/adchoices
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 noteworthy advancements and strategic movements shaping the future of drug development and patient care.The pharmaceutical industry is seeing a flurry of mergers and acquisitions, reflecting a strategic push to enhance therapeutic portfolios. Biogen's $5.6 billion acquisition of Apellis Pharmaceuticals emphasizes its ambition to expand its immunology offerings and venture into kidney disease therapeutics. This move aligns with a broader industry trend where major players are investing heavily in acquisitions to bolster their pipelines and market positions. Similarly, Eli Lilly's $6.3 billion investment in Centessa Pharmaceuticals highlights its focus on diversifying its neuroscience portfolio, particularly in sleep disorder treatments. These strategic acquisitions underscore the high stakes and potential rewards associated with advancing treatments for neurological conditions.On the clinical front, United Therapeutics is making strides with its idiopathic pulmonary fibrosis program. A successful Phase 3 trial for Tyvaso positions it as a potential new standard in IPF treatment, paving the way for an FDA filing. This development underscores the company's ambition to secure blockbuster sales and expand its therapeutic footprint. However, AstraZeneca faced a setback when its Strensiq successor missed primary endpoints in a Phase 3 trial for treating rare metabolic diseases. This outcome illustrates the inherent risks in drug development, especially when expanding indications beyond existing pediatric uses.Regulatory scrutiny remains intense, with the FDA's Center for Biologics Evaluation and Research issuing untitled letters to several companies over promotional practices. This action highlights the importance of compliance in marketing biologics and emphasizes ethical promotional strategies that align with regulatory standards. Meanwhile, GSK's Exdensur secured regulatory approval in China for asthma treatment, marking a strategic expansion into a key geographical market.Economic pressures are also influencing the industry, as seen with BASF Pharma Solutions announcing price increases for excipients and some active pharmaceutical ingredients due to rising energy and raw material costs. Such moves reflect broader economic challenges impacting the pharmaceutical supply chain, emphasizing the ongoing need for cost-effective solutions in drug manufacturing.In obesity treatment innovation, Ambrosia Biosciences has raised $100 million to advance its oral small-molecule GLP-1 therapy into clinical trials. This funding round highlights growing investor interest in next-generation obesity treatments that move beyond traditional peptide-based approaches.Moreover, artificial intelligence is increasingly being harnessed to enhance clinical trial design efficiency. Bristol-Myers Squibb's collaboration with Faro exemplifies how AI technologies are streamlining clinical research processes to improve patient outcomes and accelerate drug development timelines.In other developments, Merck has presented compelling phase 3 results for its PCSK9 inhibitor, showcasing superiority over other oral non-statin therapies for cardiovascular diseases. This positions Merck strategically within the cardiovascular market by offering promising alternatives for patients intolerant to statins.Despite these advancements, some companies face challenges. Astellas Pharma discontinued an early-stage trial for Sjogren's syndrome treatment due to developmental hurdles, while Lipella Pharmaceuticals and Io Biotech filed for bankruptcy after struggling to advance their pipelines past regulatory obstacles.On the financial side, Blackstone's closure of a $6.3 billion life sciences fund underscores robust investor confidence in biotecSupport the show
Biogen, Eli Lilly and Merck spent more than $20 billion in the past week to swallow biotechs with approved products or promising drug candidates—representing three of this year's four biggest takeovers. First, Merck picked up Terns Pharmaceuticals and its mid-stage leukemia drug for $6.7 billion. Then, on Tuesday, Lilly and Biogen struck, acquiring Centessa Pharmaceuticals and Apellis Pharmaceuticals respectively.Those big-ticket deals aren't the only recent transactions, however. Others include Novartis' up to $2 billion pick up of Excellergy and Gilead's $2.1 billion purchase of Ouro Medicines. Meanwhile, Kevin Tang—the newly minted CEO of Aurinia Pharmaceuticals—again has his sights set on Kezar Life Sciences, which he previously targeted in 2024. This time, biopharma's “clean-up” man is offering $50 million for the chronic disease–focused biotech.Last week also saw nods for Denali Therapeutics' Avlayah, the first treatment for Hunter syndrome to target the disease's neurological complications, and Rocket Pharmaceuticals' Kresladi for leukocyte adhesion deficiency-I. And it's been a big week for Biogen, which besides moving on Apellis, won approval of a high-dose formulation of spinal muscular atrophy drug Spinraza and scored a Phase 2 win for lupus candidate litifilimab in cutaneous lupus erythematosus.On the weight loss front, Wave Life Sciences' stock was cut in half after its obesity candidate WVE-007 failed to impress investors in a Phase 1 trial.
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 developments that underscore the continual evolution of this dynamic industry.First, let's explore the latest strategic move from Takeda Pharmaceuticals, which has embarked on a $1.3 billion restructuring plan in the United States. This has resulted in layoffs affecting 634 employees, a decision aimed at streamlining operations and cutting annual costs by over $1.26 billion. Such significant restructuring efforts are likely to alter market dynamics, as Takeda reallocates resources to focus on its core competencies and innovation-driven growth. The industry may witness shifts as Takeda aims to bolster its competitive edge amid a rapidly evolving market landscape.In a significant regulatory development, Biogen has successfully secured FDA approval for a high-dose version of Spinraza, designed to treat spinal muscular atrophy (SMA). This approval, following the resolution of prior manufacturing concerns, is a strategic effort to enhance therapeutic efficacy and maintain Biogen's competitive positioning against newer market players. The high-dose formulation of Spinraza promises improved patient outcomes, reinforcing Biogen's dedication to addressing unmet medical needs in SMA and offering hope to patients and families affected by this debilitating condition.Meanwhile, Samsung Biologics faces internal challenges as its labor union votes in favor of striking over unresolved governance issues and rigid labor policies. This potential strike highlights growing tensions within the company and raises concerns about operational continuity, which could affect production timelines and contractual obligations with partners. It's a reminder of the delicate balance between corporate governance and employee relations within major organizations.On the innovation front, Idorsia's investigational drug Quviviq has shown promise in treating pediatric insomnia following successful Phase 2 trials. If approved, Quviviq could be a pioneering treatment for children with insomnia, setting a new standard of care for this underserved patient population. This development highlights the importance of addressing specific medical needs across different demographics within the broader field of sleep disorders.Financial investments in research and development continue to shape the industry, with Eli Lilly embracing insilico medicine's AI technology through a $2.75 billion collaboration. This partnership aims to leverage AI-driven insights for drug discovery, reflecting an industry-wide trend toward integrating digital technologies into R&D processes. By adopting AI, companies like Eli Lilly are poised to accelerate drug discovery timelines and enhance precision in identifying potential therapeutic candidates. Additionally, Eli Lilly is spearheading research efforts into GLP-1 receptor agonists for treating substance use disorders, based on emerging scientific evidence suggesting these compounds could play a role in managing addiction by modulating reward pathways linked to addictive behaviors.In cardiovascular health advancements, Boston Scientific's Watchman heart implant has demonstrated substantial clinical benefits by reducing bleeding risks compared to traditional anticoagulants while maintaining non-inferiority in stroke prevention and mortality outcomes among atrial fibrillation patients. This advancement is likely to influence future clinical practice guidelines by offering safer long-term management options for atrial fibrillation.Moreover, Advocate Health's ambitious hospital drone delivery program, in partnership with Zipline, seeks to revolutionize logistics within healthcare delivery systems across major U.S. cities. By enhancing supply chain efficiencies and ensuring timely access to critical Support the show
Summary In this episode of the Med City Pivot Podcast, host Arundhati Parmar speaks with Lars Petersen about one of the most remarkable corporate transformations in modern business history. Facing a catastrophic collapse of its core film business in the mid-2000s due to the rise of digital photography, Fujifilm executed a bold and strategic pivot into healthcare and life sciences. The company diversified aggressively, leveraging its deep expertise in materials science, imaging, and innovation to build a thriving biotechnology and medical technology ecosystem. Today, Fujifilm operates as a global Contract Development and Manufacturing Organization (CDMO), partnering with leading pharmaceutical companies and startups alike. The conversation explores how strategic investment, diversification, long-term thinking, and innovation—including AI—enabled Fujifilm not just to survive, but to lead in a completely new industry. Links & Resources Connect with Arundhati Parmar aparmar@medcitynews.com https://twitter.com/aparmarbb?lang=en https://medcitynews.com/ Keywords Fujifilm Pivot Healthcare CDMO Biotechnology Biologics digital transformation business strategy Innovation AI in healthcare Pharma Manufacturing monoclonal antibodies gene therapy cell therapy Diversification corporate strategy MedTech Episode Highlights 00:00–00:23 – Introduction to the concept of "pivot" and Fujifilm's survival story 00:00–00:47 – The collapse of the film industry and existential crisis 00:00–01:15 – Fujifilm's transformation into a healthcare company 00:02:39–00:03:28 – 2006: the pivotal year and 60% revenue loss 00:03:28–00:03:45 – Strategic decision to diversify long-term 00:04:22–00:05:08 – Why Fujifilm succeeded while competitors failed 00:05:35–00:06:26 – Key investments and acquisitions (including Biogen assets) 00:06:52–00:07:30 – Why healthcare is a stable, long-term growth industry 00:07:53–00:08:29 – Expansion into medical devices and imaging technologies 00:09:42–00:10:34 – Core therapeutic focus: biologics, gene therapy, cell therapy 00:10:49–00:11:22 – Serving both startups and global pharma giants 00:12:39–00:13:40 – Competitive positioning vs. Samsung Biologics & Lonza 00:15:08–00:15:44 – "Partners for life" philosophy and long-term trust 00:17:52–00:18:49 – AI integration across manufacturing ecosystems 00:18:54–00:19:42 – Final takeaway: building shared ecosystems for the future of medicine
Send us Fan MailPreventing transplant loss doesn't just save organs—it could eliminate hospitalizations, reduce lifelong medications, and transform millions of lives.Dr. Janine Gaiha-Rohrbach, Ph.D. is a globally recognized leader in immunology and medical strategy, currently serving as Head of Global Medical Immunology at Biogen ( https://www.biogen.com/ ). With a PhD in Immunology and Virology from the University Hospital of Berne and extensive postdoctoral research at the Ragon Institute of Mass General Brigham, MIT, and Harvard, Dr. Gaiha-Rohrbach has dedicated her career to translating complex scientific advances into high-impact patient care.Throughout her career, Dr. Gaiha-Rohrbach has driven innovation across diverse therapeutic areas, including HIV, hepatitis, NASH, and specialized immunology, leading multiple new product launches and shaping global strategies to expand patient access.At Biogen, Dr. Gaiha-Rohrbach now focuses on advancing therapies in immunology with an emphasis on areas of high unmet need, including the evolving field of kidney transplantation.On today's episode, we'll explore the future of kidney transplant care, the limitations of current treatments for antibody-mediated rejection, and how emerging therapies targeting the immune system are poised to transform patient outcomes.#KidneyTransplant #TransplantInnovation #Biogen #Immunology #AntibodyMediatedRejection #AMR #CD38 #Felzartamab #OrganTransplant #HealthcareInnovation #Biotech #DrugDevelopment #PrecisionMedicine #Nephrology #ChronicKidneyDisease #MedicalBreakthrough #FutureOfMedicine #Immunotherapy #TransplantMedicine #LifeSavingScience #Podcast #HealthcarePodcast #BiotechPodcast #SciencePodcastSupport 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 delving into a series of transformative events that underscore the dynamic nature of our industry.First on our radar is Merck's acquisition of Terns Pharmaceuticals for a staggering $6.7 billion. This strategic move is rooted in the looming patent expiration of Keytruda, Merck's blockbuster drug. By acquiring Terns, Merck gains access to a promising chronic myeloid leukemia asset, potentially diversifying its oncology portfolio and offsetting anticipated revenue losses. This acquisition is part of a broader industry trend where companies consolidate and acquire to maintain competitive advantages and ensure pipeline robustness amidst patent challenges.In the diabetes arena, Novo Nordisk is making waves with its triple-G candidate in China, which has shown positive mid-phase trial results. This success could position Novo Nordisk as a formidable player in diabetes treatment, even as it faces competition from Eli Lilly. The development not only strengthens Novo Nordisk's global market position but also exemplifies the growing importance of international collaborations and localized clinical trials in accessing emerging markets.Sarepta Therapeutics' investment in Arrowhead Pharmaceuticals' siRNA assets is beginning to show promise with preliminary data from two siRNA candidates. This indicates a significant shift towards RNA-based therapies in addressing untreatable genetic conditions, emphasizing an innovative pivot towards precision medicine and personalized treatment approaches.Maze Therapeutics has released promising phase 2 data for its lead kidney disease candidate, described by analysts as having "best-in-class potential." Despite this clinical promise, the market's negative reaction resulted in a significant drop in Maze's stock value, highlighting the volatile nature of biotech investments where scientific potential often clashes with financial realities.In obesity treatment research, BrightGene's early-stage data shows an 8% weight loss at eight weeks with its oral dual agonist. This adds to evidence supporting multi-target therapies for complex metabolic disorders like obesity. Meanwhile, Takeda's plan to realize $1.3 billion in cost savings through restructuring aims to streamline operations and fund late-stage drug development, reflecting an industry-wide focus on operational efficiency.The partnership between ICON and Advarra seeks to optimize clinical trial efficiency through a network of connected sites, aligning with broader industry efforts to leverage technology and improve drug development timelines.Turning to UCB's substantial $2 billion investment in a biologics manufacturing facility near its US headquarters in Atlanta, Georgia, this move marks UCB's first major manufacturing footprint in the United States, underscoring its commitment to expanding biologics production capabilities. Biologics are increasingly important due to their potential for treating chronic and genetic conditions, highlighting why UCB's investment is pivotal as it strengthens its position in the US market.Biogen's collaboration with Alteogen involves a $20 million investment to utilize Alteogen's subcutaneous delivery technology for two unnamed biologics. Subcutaneous administration offers improved patient convenience and potentially better therapeutic outcomes compared to traditional intravenous methods.On the regulatory front, ImmunityBio received an FDA warning over promotional claims for Anktiva, their cancer drug. This underscores the critical need for accurate communication in drug marketing. Additionally, CSL updated its Flucelvax label at the FDA's request to include a febrile seizure warning, reflecting ongoing vigilance in post-marketing surveillance.The integration of AI into pharmaceutical operations is accelSupport the show
What actually changes for regulatory leaders when they move between large pharma and small biotech, and what stays the same? Tammy Sarnelli draws on over 35 years of experience across organizations of every size to break down the real differences in workload, risk tolerance, resource access, and culture.Tammy discusses how organizational silos create friction in large companies, why limited resources at small companies can actually accelerate decision-making, and how risk tolerance shapes not just strategy but the speed at which products move forward, especially in rare disease.A few of Tammy's key takeaways:Regulatory expectations are the same regardless of company size — it's the day-to-day experience and workload distribution that differSilos in large organizations restrict collaboration and can fragment how a company approaches health authority interactionsSmall companies benefit from "all-in thinking" — fewer programs mean faster alignment, but leaders must fill multiple roles simultaneouslyRisk tolerance is cultural, not organizational — when people aren't punished for good-faith decisions, they move fasterRegulatory "failure" can mean not taking a chance when you had one, especially in rare disease where patients can't waitAI is shifting medical writing from structured formatting toward strategy and interpretation — but adoption speed depends on resourcesAbout Tammy SarnelliTammy Sarnelli is Senior Vice President and Global Head of Regulatory Affairs and Clinical Quality at Amylyx Pharmaceuticals. She has over 35 years of regulatory experience spanning Biogen (27 years), Bioverativ, EMD Serono (Merck KGaA), and Amylyx, working across therapeutic areas and organization sizes with a sustained focus on rare disease. She holds a Master's degree in Public Administration from Suffolk University and a Bachelor's degree in Biology from Saint Anselm College.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/
Com avanço de cerca de 35% nos preços da ureia e tensões no Oriente Médio, importadores buscam alternativas mais econômicas, aponta consultoria. Instabilidade climática e praga que ataca as raízes podem pressionar a produtividade do tomate em 2026. Biogenética, inteligência artificial e agricultura digital ajudam produtores a reduzir riscos e aumentar a produtividade, analisa especialista. Mercado rural é responsável por três a cada dez vagas formais no país, segundo CNM. Tempo: frente fria avança e leva instabilidade a todos país.
El gobierno de Sánchez vigila a los jueces tras diez feminicidios en 2026, destacando un apuñalamiento en Navarra frente a un menor. El Ministerio de Igualdad elude fallos del sistema Biogen, y la ministra Ana Redondo insta a jueces a ampliar el alejamiento a más de 350 metros. La Policía Nacional afronta críticas tras una denuncia de presunta violación donde la víctima evitó los protocolos internos, acudiendo a un punto violeta y tribunales. Sindicatos alegan fallos si el acusado pertenece a la cúpula, señalando al DAO y sus encubridores. La izquierda radical se reúne en Madrid buscando refundación política, con SUMAR, IU, Comunes y Más Madrid presentes. Notable la ausencia de Yolanda Díaz, Gabriel Rufián y Podemos, este último apostando por perfil propio y criticando priorizar personas sobre proyectos. Donald Trump rediseña su estrategia económica con un gravamen global del 10%, tras la ilegalidad de sus aranceles por el Supremo de EE.UU. Trump critica a los magistrados y ...
Guest Full Name: Dr. R. Stacy Lindborg, PhDGuest Title: President, Chief Executive Officer, and Board DirectorCompany: IMUNONTicker: IMNNWebsite: https://imunon.com/Guest Bio:Stacy R. Lindborg, PhD, was appointed President and Chief Executive Officer of IMUNON in May 2024. Dr. Lindborg has served on IMUNON's Board of Directors since June 2021. She has nearly 30 years of experience in the pharmaceutical and biotech industries, with a particular focus on R&D, regulatory affairs, executive management, and strategy development. She has designed, hired, and led global teams, guiding long-term visions for growth through analytics and stimulating innovative development platforms to increase productivity.Prior to joining IMUNON, Dr. Lindborg was Executive Vice President and Co-Chief Executive Officer at BrainStorm Cell Therapeutics, where she remains a member of the company's Board of Directors. At BrainStorm, she was accountable for creating and executing clinical development strategies through registration and launch and progressed its novel cell therapy for ALS through a positive Phase 3 Special Protocol Assessment (SPA) study with the U.S. Food and Drug Administration. She frequently interacted with investors and analysts, represented the company in the scientific community and with the media, and played an active role in discussions with potential business partners.Dr. Lindborg previously was Vice President and Head of Global Analytics and Data Sciences, responsible for R&D and marketed products at Biogen. She began her biopharmaceutical career at Eli Lilly and Company, where, over the course of 16 years, she assumed positions of increasing responsibility, including Head of R&D strategy.Dr. Lindborg received an MA and PhD in statistics, and a BA in psychology and math from Baylor University. She has authored more than 200 presentations and 90 manuscripts that have been published in peer-reviewed journals, including 20 first-authored. She has held numerous positions within the International Biometric Society and American Statistical Association and was elected Fellow in 2008.Company Bio:IMUNON is a clinical-stage biotechnology company focused on advancing a portfolio of innovative treatments that harness the body's natural mechanisms to generate safe, effective, and durable responses across a broad array of diseases. IMUNON is developing its non-viral DNA technology across its modalities. The first modality, TheraPlas®, is developed for the gene-based delivery of cytokines and other therapeutic proteins in the treatment of solid tumors where an immunological approach is deemed promising. The second modality, PlaCCine®, is developed for the gene delivery of viral antigens that can elicit a strong immunological response.IMUNON's lead clinical program, IMNN-001, is a DNA-based immunotherapy for the localized treatment of advanced ovarian cancer. IMNN-001 is the first therapy to achieve a clinically effective response in advanced (stage IIIC/IV) ovarian cancer including benefits in both progression-free survival (PFS) and overall survival (OS) in a first-line treatment setting when used with standard of care chemotherapy. IMUNON has completed multiple clinical trials evaluating the potential of IMNN-001, including one Phase 2 clinical trial (OVATION 2), and is currently conducting a Phase 3 clinical trial (OVATION 3). The first patient was dosed in the Phase 3 study in the third quarter of 2025. IMNN-001 works by instructing the body to produce safe and durable levels of powerful cancer-fighting molecules, such as IL-12 and interferon gamma, at the tumor site. Additionally, the Company has completed dosing in a first-in-human study of its COVID-19 booster vaccine (IMNN-101).
This INSIGHTS episode revisits a core topic from Neurocritical Care ON CALL®, originally released in August 2023. Listen to the fourth episode of the NCS INSIGHTS series on acute ischemic stroke (part 2 of 2). The INSIGHTS series is hosted by Casey Albin, MD, and Salia Farrokh, PharmD, and covers topics from Neurocritical Care ON CALL®, the only up-to-date, comprehensive resource dedicated exclusively to the practice of neurocritical care. Learn more about ON CALL®. This episode is sponsored by Biogen. Science that transforms patient lives. Science that seeks to solve societal problems. Science that acts with purpose. Science that is inspired by the diversity and passion of our people. Discover where science meets humanity at Biogen. The NCS Podcast is the official podcast of the Neurocritical Care Society. The views expressed on the NCS Podcast are solely those of the hosts and guests and do not necessarily reflect the opinions or official positions of the Neurocritical Care Society.
Host: Yuval Zabar, MD Guest: Michelle Mielke, PhD Guest: Henrik Zetterberg, MD, PhD For the latest insights on tau and neurodegeneration biomarkers in Alzheimer's disease (AD), tune in to this recorded presentation featuring Doctor Michelle Mielke and Professor Henrik Zetterberg. Together, they delve into the role of tau in AD, exploring the ‘tau cascade', the current use of tau and neurodegeneration biomarkers in tracking disease progression, and how the AD biomarker landscape may evolve over time. Doctor Mielke is a Professor of Epidemiology and Neurology at the Wake Forest University School of Medicine, and Professor Zetterberg is a Professor of Neurochemistry at the University of Gothenburg. To learn more about tau in Alzheimer's disease, explore the Know Tau medical education platform. Know Tau is created and funded by Biogen and is intended for healthcare professionals only.
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 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
APAC stocks were ultimately mixed after the global market rout rolled over into the region following the continued tech woes stateside and weak US labour market data.US equity futures were lower but off worst levels with headwinds seen after Amazon shares dropped 10% post-earnings.European equity futures indicate an uneventful cash market open with Euro Stoxx 50 futures up 0.1% after the cash market closed with losses of 0.8% on Thursday.RBI maintained its Repurchase Rate at 5.25%, as expected, via a unanimous decision and voted to maintain its neutral policy stance; Banxico held rates at 7.00%, as expected, in a unanimous decision.Looking ahead, highlights include German Trade Balance (Dec), Swedish CPIF prelim. (Jan), Swiss Unemployment (Jan), Canadian Jobs Report (Jan), US Prelim. Michigan (Feb), ECB Survey of Professional Forecasters. Speakers include ECB's Cipollone, BoE's Pill & Fed's Jefferson.Earnings from Biogen, Under Armour, Carlyle Group, Philip Morris International, SocGen & Sabadell.Read the full report covering Equities, Forex, Fixed Income, Commodites and more on Newsquawk
Javier Aledo, analista de AFI, sigue de cerca los escenarios de Amazon, Intel, Molina Healthcare, Biogen y Carlyle.
This INSIGHTS episode revisits a core topic from Neurocritical Care ON CALL®, originally released in August 2023. Listen to the third episode of the NCS INSIGHTS series on acute ischemic stroke (part 1 of 2). The INSIGHTS series is hosted by Casey Albin, MD, and Salia Farrokh, PharmD, and covers topics from Neurocritical Care ON CALL®, the only up-to-date, comprehensive resource dedicated exclusively to the practice of neurocritical care. Learn more about ON CALL®. This episode is sponsored by Biogen. Science that transforms patient lives. Science that seeks to solve societal problems. Science that acts with purpose. Science that is inspired by the diversity and passion of our people. Discover where science meets humanity at Biogen. The NCS Podcast is the official podcast of the Neurocritical Care Society. The views expressed on the NCS Podcast are solely those of the hosts and guests and do not necessarily reflect the opinions or official positions of the Neurocritical Care Society.
Host: Holly M. Brothers, PhD Guest: Niklas Mattsson-Carlgren, MD, PhD The prevalence of dementia is projected to almost double every 20 years.1 Alzheimer's disease (AD) is the most common cause of dementia,2 making early diagnosis and management increasingly important. Based on our current understanding of its pathology, AD is an amyloid driven tauopathy3 with biomarker changes occurring years before clinical symptoms appear.4 Learn more with this webinar featuring Dr Niklas Mattsson-Carlgren, Associate Professor at Lund University as he explores the relationship between amyloid beta and tau, the correlation between pathology and clinical symptoms, and biomarker progression across the AD continuum. To learn more about tau in Alzheimer's disease, explore the Know Tau medical education platform. Know Tau is created and funded by Biogen and is intended for healthcare professionals only. References: Alzheimer's Disease International. Numbers of people with dementia worldwide. Available from: https://www.alzint.org/resource/numbers-of-people-with-dementia-worldwide/ (Accessed June 2025) Alzheimer's Association. Alzheimer's disease facts and figures. Available from: https://www.alz.org/alzheimers-dementia/facts-figures (Accessed June 2025) Aksman LM, et al. Brain 2023;146:4935–4948 Jack CR Jr, et al. Alzheimers Dement 2018;14:535–562
Dr. Christina Rahm has worked as a medical, clinical, and research scientist in the pharmaceutical, nutraceutical, and biotechnology industries for Janssen, Johnson & Johnson, Biogen Idec/Biogen, UCB, Bristol Meyers Squibb, and Alexion. Additionally, she worked on the corporate side for Pfizer, Biogen, and Janssen and is currently the Chairman of International Science Nutrition Society and Chief Science Officer for ROOT Wellness. Dr. Rahm has also served as a formulator for several companies and manufacturing labs, including her own. She has created multiple provisional patents, proprietary formulas, and trade secrets in addition to authoring her first book, Cure the Causes: Live the Life you Want, Not the One Prescribed. Through years of laboratory research and ethical observations, she has developed a personalized and predictive consulting company working on everything from the environment to DNA and detox wellness plans in which Dr. Rahm helps clients reset their bodies and minds to be spiritually, mentally, emotionally, and physically balanced.
In der heutigen Folge sprechen die Finanzjournalisten Nando Sommerfeldt und Holger Zschäpitz über einen Sam Altman im Attacke-Modus, die prominenten MDax-Aufsteiger und 7 Bücher, die Euch helfen, das globale Chaos besser zu verstehen. Außerdem geht es um Alphabet, Nvidia, Tencent, Softbank, T-Mobile, Nvidia, Arm, Biogen, Lululemon, ON Semiconductor, GlobalFoundries, CDW, The Trade Desk, Alnylam Pharmaceuticals, Seagate, Western Digital, Insmed, Monolithic, Ferrovial, Meta, Tesla, Apple, Microsoft, Broadcom, T-Mobile, Applovin, Palantir, Aumovio, TKMS, Hellofresh, Gerresheimer, Teamviewer, Ottobock, Tonies, Verbio, PSI Software, LPKF, Stratec, Thyssenkrupp Nucera, Formycon, Procredit, Amadeus Fire, iShares MSCI EM SRI ETF (WKN: A2AFCZ), Xtrackers MSCI World Health Care ETF (WKN: A113FD), L&G Cyber Security ETF (WKN: A14WU5), iShares STOXX Europe 600 Construction & Materials ETF (WKN: A0H08F), iShares Core MSCI World ETF (WKN: A0RPWH), (Xtrackers MSCI Emerging Market ETF (WKN: A12GVR), Amundi Core MSCI Japan ETF (WKN: LYX0YC), iShares Core MSCI Europe ETF (WKN: A0RPWG), Xtrackers MSCI USA ETF (WKN: A1XB5V), NASDAQ-100 ETF (WKN: A0F5UF), JPMorgan US Research Enhanced ETF (WKN: A2DWM7), Xetra-Gold (WKN: A0S9GB, Euwax Gold II (WKN: EWG2LD), iShares Global Corporate Bond EUR (WKN: A1W02Q), Xtrackers II EUR Overnight Rate ETF (WKN: DBX0AN). Die aktuelle "Alles auf Aktien"-Umfrage findet Ihr unter: https://www.umfrageonline.com/c/mh9uebwm Wir freuen uns an Feedback über aaa@welt.de. Noch mehr "Alles auf Aktien" findet Ihr bei WELTplus und Apple Podcasts – inklusive aller Artikel der Hosts und AAA-Newsletter.[ Hier bei WELT.](https://www.welt.de/podcasts/alles-auf-aktien/plus247399208/Boersen-Podcast-AAA-Bonus-Folgen-Jede-Woche-noch-mehr-Antworten-auf-Eure-Boersen-Fragen.html.) [Hier] (https://open.spotify.com/playlist/6zxjyJpTMunyYCY6F7vHK1?si=8f6cTnkEQnmSrlMU8Vo6uQ) findest Du die Samstagsfolgen Klassiker-Playlist auf Spotify! Disclaimer: Die im Podcast besprochenen Aktien und Fonds stellen keine spezifischen Kauf- oder Anlage-Empfehlungen dar. Die Moderatoren und der Verlag haften nicht für etwaige Verluste, die aufgrund der Umsetzung der Gedanken oder Ideen entstehen. Hörtipps: Für alle, die noch mehr wissen wollen: Holger Zschäpitz können Sie jede Woche im Finanz- und Wirtschaftspodcast "Deffner&Zschäpitz" hören. +++ Werbung +++ Du möchtest mehr über unsere Werbepartner erfahren? [**Hier findest du alle Infos & Rabatte!**](https://linktr.ee/alles_auf_aktien) Impressum: https://www.welt.de/services/article7893735/Impressum.html Datenschutz: https://www.welt.de/services/article157550705/Datenschutzerklaerung-WELT-DIGITAL.html
Vinay Prasad's memo, leaked over the weekend, has sent vaccine makers' stocks slipping and experts clamoring for more evidence to support the CBER director's claim that COVID vaccines have led to the deaths of at least 10 children. It's the latest insult to the vaccine sector from the healthcare administration this year, with other challenges coming on the CDC side, where the recently revamped advisory committee is heading into its next meeting with a brand new chair. Elsewhere at the FDA, newly promoted Center for Drug Evaluation and Research Director Richard Pazdur has filed the paperwork to retire from the agency just weeks after reportedly reluctantly accepting the position. Meanwhile, the Alzheimer's space is buzzing as the 2025 Clinical Trials on Alzheimer's Disease (CTAD) conference continues in San Diego. Last week saw a mid-stage flop for Johnson & Johnson's anti-tau candidate and the “definitive” failure of Novo's GLP-1 semaglutide—which analysts say may actually help uptake of anti-amyloid therapies from Biogen and Eli Lilly. Meanwhile, Roche announced positive results for its latest antibody, putting the pharma back in the game it had once stepped back from in the tumultuous days of Aduhelm. In the weight loss space, Novo Nordisk revealed ‘competitive' mid-stage data for its next-gen amycretin, which showed no weight-loss plateau over 36 weeks in patients with type 2 diabetes. Meanwhile, the pricing war for approved and future GLP-1s from Novo and obesity rival Eli Lilly rages on, with Lilly this week announcing another price drop for Zepbound through its LillyDirect self-pay platform. In BioPharm Executive this week, we review the top venture capital rounds for female-founded biotechs and examine the 2026 biotech market outlook.
Send us a textGood morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today, we dive into a series of significant stories shaping the future of healthcare, from innovative financing strategies to groundbreaking scientific advancements.The biotech industry in 2025 has experienced a notable shift in funding strategies, particularly through the rising trend of royalty financing. This approach, involving the exchange of future drug revenue for immediate capital, has surged to approximately $3.5 billion in disclosed upfront volume in just the first half of the year. According to health economist Julien Willard, this represents a transformative shift from a niche option to a mainstream strategy amid challenging equity and credit markets. Royalty financing provides biotech companies with a lifeline, allowing them to avoid the pitfalls of equity dilution or high-interest debt while retaining control over their clinical developments. Firms like Royalty Pharma and Healthcare Royalty Partners are at the forefront, offering upfront cash for future sales royalties, typically ranging from 2.5% to 7.5%.This trend has accelerated due to economic pressures like low stock valuations and rising interest rates, making traditional funding routes less viable. A closer look at this year's deals reveals a cautious approach among investors, who are focusing on phase 3 trials or candidates awaiting FDA approval rather than early-stage assets. Oncology takes center stage as the leading therapeutic area, accounting for about 70% of total disclosed funding, thanks to its potential for large revenue streams. Other areas like rare genetic diseases and immunology also attract significant attention.Interestingly, even large pharmaceutical companies such as Biogen have ventured into royalty financing—an unconventional move for well-capitalized firms. Biogen's collaboration with Royalty Pharma for lupus drug development illustrates innovative financial engineering by transferring clinical trial risk through milestone-tied payments. As this strategy gains traction globally, especially in cash-strapped regions like Asia, it serves as a crucial tool for companies prioritizing survival and continued innovation amidst financial uncertainties.Turning now to regulatory dynamics and strategic shifts within the industry. The legal controversy between GSK's subsidiary Tesaro and AnaptysBio over Jemperli highlights complexities in collaborative agreements within drug development. Such disputes could reshape how companies negotiate intellectual property rights and revenue sharing in future co-development deals.The FDA's investigation into Takeda's Adzynma following a pediatric patient's death underscores the critical role of post-market surveillance in drug safety. This incident could potentially impact Takeda's market position while emphasizing the need for robust adverse event monitoring systems across biopharmaceutical firms.In Australia, the government's decision to block Cosette's proposed $430 million acquisition of Mayne Pharma reflects increasing scrutiny on foreign investments in healthcare companies, prioritizing national interest. This move signals a growing trend that could reshape global M&A strategies within the sector.Meanwhile, Moderna's strategic financial maneuvering is noteworthy. By securing a $1.5 billion loan aimed at supporting its commercial and R&D endeavors with an eye on breaking even by 2028, Moderna demonstrates its commitment to diversifying its mRNA technology applications beyond COVID-19 vaccines—a move likely to influence innovation trajectories across biotech landscapes. Additionally, Moderna's decision to discontinue three clinical mRNA programs showcases strategic pipeline management amidSupport the show
This episode, hosts Heather and Matthew sit down with Nicole Murphy, Executive Vice President and Head of Pharmaceutical Operations and Technology at Biogen. Nicole shares why Biogen is growing in North Carolina with a $2 billion investment in Research Triangle Park, how the region's talent and infrastructure have fueled decades of innovation, and what's next for the company's late-stage clinical pipeline. We also explore how Biogen is using AI to accelerate drug development, the impact of federal price control policies, and why workforce development partnerships are key to the company's future. Tune in now!
This episode of the Scope of Things features an exclusive panel at SCOPE Europe 2025 covering regulatory requirements for AI literacy training, featuring industry executives Jonathan Crowther, head of the operational design center at Merck KGaA; Janie Hansen, global development information management, business systems transformation at Daiichi Sankyo; Francis Kendall, head of statistical programming, digital and data sciences at Biogen; and James Weatherall, vice president and chief data scientist of biopharmaceuticals R&D at AstraZeneca. Plus, host Deborah Borfitz gives the latest news on efforts to reduce excess data collection in studies, whole genome sequencing of breast cancer, a virus cocktail to combat superbugs, and more. Show Notes News Roundup Collaborative study on data collection in trials News posted on the TransCelerate website Heart benefits of semaglutide Study in The Lancet Whole genome sequencing of breast cancers Study in The Lancet Oncology Pan-cancer immunotherapy heads to trials Research article in Cell Article in Bio-IT World Promising NAD+ “youth molecule” Review article in Nature Aging Virus cocktail to combat superbugs Article in Nature Microbiology AI annotates medical images News posted on the MIT website Fitbits aid precision health American Life in Realtime study in PNAS Nexus Latest from the Human Epilepsy Project Study in JAMA Neurology Imposter study participants Editorial in The BMJ Guests Jonathan Crowther, Ph.D., Head, Operational Design Center, Merck KGaA, Darmstadt, Germany Janie Hansen, Global Development Information Management, Business Systems Transformation, Daiichi Sankyo Francis Kendall, Head of Statistical Programming, Digital and Data Sciences, Biogen James Weatherall, Ph.D., Vice President & Chief Data Scientist, BioPharmaceuticals R&D, AstraZeneca The Scope of Things podcast explores clinical research and its possibilities, promise, and pitfalls. Clinical Research News senior writer, Deborah Borfitz, welcomes guests who are visionaries closest to the topics, but who can still see past their piece of the puzzle. Focusing on game-changing trends and out-of-the-box operational approaches in the clinical research field, the Scope of Things podcast is your no-nonsense, insider's look at clinical research today.
For TriloTalk episode 38, Lisa Chamberlain James, Senior Partner at Trilogy, and Sudipta Chakraborty, Head of Literacy & Plain Language Center of Excellence at Biogen, talk about how to use AI in the creation of lay summaries of clinical trial results. Scalability, change management, prompting, biases, realistic attitudes, and human involvement are all touched on so listen up!
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 advancements and strategic movements that are shaping the landscape of drug development and patient care.Starting with a significant milestone in precision oncology, China has approved its first EGFR-targeted antibody-drug conjugate. This approval marks a pivotal moment in the industry's shift towards targeted therapies, which promise more precise treatment options with potentially fewer side effects than traditional chemotherapy. Targeted therapies are at the forefront of personalized medicine, where treatments are tailored to individual genetic profiles, offering hope for more effective cancer care.In the realm of HIV prevention, Gilead Sciences has reported impressive sales for its new long-acting pre-exposure prophylaxis medication, Yetztugo. Since its launch in June 2025, Yetztugo has generated $54 million in U.S. sales, underscoring the demand for long-term HIV prevention solutions. This development is part of Gilead's broader strategy to strengthen its HIV franchise as it advances its pipeline with promising candidates like GS-3242 alongside lenacapavir. The aim is to develop treatments that require less frequent dosing, which could significantly improve patient adherence and outcomes. Despite challenges within its HIV portfolio and declining Veklury sales, Gilead Sciences is actively seeking growth opportunities through strategic partnerships and pipeline advancements—an essential approach for navigating patent cliffs while sustaining long-term growth.On the financial front, AbbVie has increased its revenue forecast by $400 million to a staggering $60.9 billion, driven by robust sales from its immunology drugs Skyrizi and Rinvoq. These treatments address chronic inflammatory conditions like psoriasis and rheumatoid arthritis, reflecting AbbVie's strong positioning in this therapeutic area despite competitive pressures. AbbVie continues to report strong earnings from Skyrizi and Rinvoq, reinforcing its dominance in the immunology market and highlighting the profitable nature of successful biologics in treating chronic inflammatory diseases.Biogen continues to bolster its multiple sclerosis franchise by focusing on both legacy treatments and new product launches. This strategy highlights the importance of balancing innovation with lifecycle management to maintain market strength against generic competition—a common challenge in the industry.Meanwhile, the American Academy of Pediatrics has taken a cautious stance by not endorsing leucovorin for autism treatment due to insufficient evidence. This decision emphasizes the critical need for rigorous, evidence-based practices in developing clinical guidelines for complex disorders like autism.Internationally, CSL Seqirus has partnered with Saudi Arabia to supply cell-based influenza vaccines and support local production capabilities. This move aligns with global efforts to enhance pandemic preparedness and healthcare resilience through local manufacturing initiatives.The volatile nature of the biotech sector is evident with reports of 16 companies ceasing operations in 2025 due to high R&D costs and regulatory challenges. Despite these closures, such volatility opens doors for new innovations that could address unmet medical needs.Turning our attention to obesity treatment, Eli Lilly stands at a crucial juncture with its novel obesity medication, orforglipron. The company aims to make this weight loss pill accessible while maintaining financial viability for future R&D—a balancing act faced by many pharmaceutical companies as they strive to deliver affordable yet innovative treatments amid growing global health concerns. However, not all R&D efforts reach fruition. Eli Lilly has decided to discontinue its mid-stage program Support the show
In this episode of Molecule to Market, you'll go inside the outsourcing space of the global drug development sector with Lars Petersen, President & Chief Executive Officer at FUJIFILM Biotechnologies. Your host, Raman Sehgal, discusses the pharmaceutical and biotechnology supply chain with Lars, covering: The difficult decision to leave Novo Nordisk and make the jump from one great company to another in Genentech/Roche. How leaving a Biogen site led him to step away from big pharma after 25 years and transition to the CDMO side. How Fujifilm's culture of innovation, technology, quality, and people runs through the Biotechnologies division — and why empowerment and culture should never be compromised. Why the duplication of its CDMO sites globally, all running on the same kojoX platform, is truly differentiating. Why he believes the need to standardise, scale, and globalise drug production in a consistent, efficient, and traceable way is key to the future of the supply chain. Molecule to Market is also sponsored by Bora Pharma (boracdmo.com) and Charles River (www.criver.com), and supported by Lead Candidate. Lars Petersen, CEO of FUJIFILM Biotechnologies, is recognized as a visionary leader in the life science sector, commanding a global contract development and manufacturing organization (CDMO) with nearly 5,000 employees spread across Denmark, UK, USA, and Japan. Distinguished for his strategic vision and a "people first" philosophy, Lars has profoundly impacted the company and the industry. His leadership journey saw him rise from Chief Operational Officer & Senior Vice President at the Danish site, where he established an empowering culture, to CEO, promoting transparency across all operations. Since his global leadership appointment in June 2023, Lars has been instrumental in cultural transformation, integrating a "people first" approach across FUJIFILM Biotechnologies' global facilities regardless of geographical differences. Prior to his appointment as CEO, Lars was responsible for the Global Large Scale Commercial operation including full profit and loss accountability as well as the responsibility for over $6.2 Billion global expansions both in Hillerød, Denmark, and Holly Springs, North Carolina, USA. Previously, Lars has held leadership positions with Biogen, Genentech/Roche, Novo Nordisk, Novozymes and NNE, and he has successfully executed projects in Europe, China and the US. Lars holds a master's degree from the Technical University of Denmark. Please subscribe, tell your industry colleagues and join us in celebrating and promoting the value and importance of the global life science outsourcing space. We'd also appreciate a positive rating!
Greg and Matias interview Brendon Boot of Skin2Neuron. Brendon is a neurologist at Harvard and Mayo Clinic with prior experience as Medical Director at Biogen overseeing their Phase 1b Alzheimer's trials.In this episode, we discuss:How skin-derived cells can be turned into neurons to repair the brain.Why replacing lost neurons may succeed where drugs have failed in Alzheimer's.What makes autologous (self-derived) cell therapy safer and more effective.How testing in dogs brought stronger proof than traditional mouse models.Why this approach could shift Alzheimer's treatment from slowing decline to restoring memory.Credits:Created by Greg Kubin and Matias SerebrinskyHost: Matias Serebrinsky & Greg KubinProduced by Caitlin Ner & Nico V. Rey Find us at businesstrip.fm and psymed.venturesFollow us on Instagram and Twitter!Theme music by Dorian LoveAdditional Music: Distant Daze by Zack Frank