Afleveringen
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Johnson & Johnson’s Stelara, Regeneron’s Eylea and Amgen’s Prolia are just some of the drugs facing off against new biosimilars or generics in 2025, as featured in the latest edition of Fierce Pharma’s annual special report documenting the 10 biggest losses of U.S. exclusivity expected throughout the year.
In this week’s episode of The Top Line, we dig into the report, which details the stories behind 10 key medicines that are set to face off against new generic or biosimilar competitors this year as their patents expire. Fierce’s Eric Sagonowsky and Angus Liu recap the report, sharing their perspectives on several of the drugs and discussing the industry effects of 2025’s sizable patent cliff.
To learn more about the topics in this episode:
The top 10 drugs losing US exclusivity in 2025
After patent settlement, Amgen scores FDA nod for its biosimilar version of J&J's Stelara
Amgen grabs FDA thumbs-up for Soliris biosim, eyes 2025 launch
Novartis wins 11th-hour bid to block generic version of blockbuster heart med Entresto
Amgen settles Prolia patent suit with Celltrion, teeing up potential biosimilar launch in June
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Agenus Chief Medical Officer Dr. Steven O'Day joined Fierce's Chris Hayden on a recent sponsored episode of The Top Line podcast to discuss the evolving landscape of cancer immunotherapy.
O'Day, a medical oncologist with 30 years of experience, explained the fundamental differences between immunotherapy and traditional cancer treatments like chemotherapy, surgery, and radiation. He emphasized immunotherapy's potential for durable responses and even cures by activating the body's own T-cells to fight cancer.
The conversation addressed the challenges of treating "cold" tumors, such as colorectal cancer, which are less visible to the immune system. O'Day highlighted Agenus's pipeline of antibodies, botensilimab (BOT) and balstilimab (BAL), designed to trigger T-cell recognition of these colder cancers.
O'Day expressed his excitement about a potential "2.0 revolution" of immuno-oncology, expanding the benefits of immunotherapy to a wider range of cancers. He described BOT and BAL as a "one-two punch," with BOT priming T-cells and BAL preventing their exhaustion.
Listen to the full conversation on the latest episode of The Top Line.
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Despite a rocky start for many drugmakers at the start of last year, 2024’s fourth quarter saw just two of the top 25 global pharma companies record sales declines. But that growth may be short-lived, as many of those same companies forecast more muted revenue increases in 2025.
In this week’s episode of The Top Line, we dissect the unprecedented revenue growth enjoyed by many of the world’s top pharma companies by sales in the fourth quarter of last year. Fierce Pharma’s Kevin Dunleavy and Fraiser Kansteiner discuss the period’s results, examine the companies’ performance expectations going into 2025 and consider whether the momentum seen in Q4 is repeatable or more of an anomaly.
To learn more about the topics in this episode:
Eli Lilly, Novo Nordisk lead revenue boom in the 'always tricky' Q4 Eli Lilly logs massive Q4 revenue jump—but it's not just thanks to Mounjaro and Zepbound Pfizer harnesses COVID fluctuations to clinch Q4 gains as RSV vaccine sales plummet Astellas takes $760M charge, reveals slowdown for eye drug Izervay after regulatory stumblesThis episode is brought to you by Cencora.
See omnystudio.com/listener for privacy information.
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In the latest episode of The Top Line, Chris Hayden of Fierce Pharma sits down with Mary Lou Glotzbach, senior manager of drug delivery partnerships at Grand River Aseptic Manufacturing (GRAM). They explore the evolving landscape of biologics, the increasing importance of cold chain management, and how contract development and manufacturing organizations (CDMOs) are adapting to industry shifts.
Glotzbach highlights a growing trend in biotech: transitioning patient treatments from infusion centers to home delivery. This shift demands innovative drug delivery solutions, including wearable devices and auto-injectors, capable of handling high-viscosity biologics. She also emphasizes the industry's push for smaller batch sizes due to the high cost and complexity of producing biologics, which challenges traditional manufacturing processes.
Another key discussion point is the rising demand for transparency and early collaboration between pharmaceutical companies, CDMOs, and device manufacturers. Glotzbach notes that CDMOs are now being brought into the development process earlier than ever, allowing for better alignment on formulation, container design, and regulatory compliance.
The conversation also touches on Annex 1 compliance and the need for standardization in primary containers like syringes and cartridges. Glotzbach envisions a future where standardized components streamline production, making drug development more efficient.
For anyone interested in the intersection of biologics, manufacturing, and drug delivery innovation, this episode offers valuable insights into how GRAM is helping shape the future of the industry. Tune in to learn more about the latest advancements and challenges in aseptic manufacturing.
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The latest episode of The Top Line, sponsored by ViiV Healthcare, features Dr. Luis Buzón, an infectious disease specialist, discussing the critical role of real-world evidence in HIV treatment and prevention. While clinical trials establish the safety and efficacy of new therapies, real-world data help bridge the gap between these highly controlled environments and patient care in the real world.
Buzón explains that collecting long-term data is essential, especially for lifelong conditions like HIV. Not only do real-world studies track how medicines perform over longer periods of time than clinical trials, they include a broader range of people, revealing potential side effects not seen in trials and ensuring long-term effectiveness for the different people who can be impacted by HIV.
Beyond the science, Buzón shares how his father was a pioneer in Spain’s early response to the HIV epidemic, and why, inspired by his father’s dedication, he continues to advocate for compassionate, evidence-based care.
For those interested in the evolving landscape of HIV treatment and prevention and the power of real-world data in shaping better health outcomes, this episode is a must-listen. Tune in to The Top Line to hear Buzón’s expert insights and personal perspective.
See omnystudio.com/listener for privacy information.
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For the biotech industry, 2024 meant the return of the venture capital megaround. And one startup, Xaira Therapeutics, took it a step further, expanding the industry’s definition of a megaround by reeling in a rarely seen $1 billion financing early in the year.
In this week’s episode of The Top Line, we dive into a recently published report from Fierce Biotech highlighting the industry’s top 10 money raisers in 2024, led by none other than Xaira. Fierce’s Gabrielle Masson and Andrea Park talk about some of the year’s biggest financing rounds, how 2024’s list compares to 2023 and what indications are changing the fundraising scene.
To learn more about the topics in this episode:
Biotech's top money raisers of 2024
Fierce Biotech Fundraising Tracker '24
Biotech's top money raisers of 2023
See omnystudio.com/listener for privacy information.
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Huntington’s disease was long thought to be caused by the slow buildup of a toxic protein, but new research has revealed that it’s actually driven by the expansion of a gene that, at a certain length, triggers quick neuron death.
In this week’s episode of The Top Line, we hear from Steven McCarroll, Ph.D., a Huntington’s disease researcher at the Broad Institute of MIT and Harvard, whose team recently published that research in the journal Cell. McCarroll joins Fierce Biotech’s Darren Incorvaia to dig into the findings, which not only change our understanding of the disease itself, but also open up new avenues for potential treatments.
To learn more about the topics in this episode:
New findings shed light on cause of Huntington's disease progression
Scientists look to survival secrets of plants for Huntington's treatments
Scientists use long-approved GSK HIV drug to stave off dementia, Huntington's proteins in mice
Sage drops dalzanemdor as Huntington's failure completes clean sweep of midphase flops
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Clinical-stage drug development offers big rewards—and big risks. To that end, Fierce Biotech recently published its annual roundup of several of the most eye-catching trial failures of the preceding year. The 2024 list includes trial flops from the likes of AbbVie, Novo Nordisk, Pfizer and more, with reports of disappointing results in many tough-to-treat indications, including schizophrenia and Alzheimer's disease.
In this week’s episode of The Top Line, we dive into the report. Fierce Biotech’s James Waldron and Gabrielle Masson discuss the entries that stood out for them and ask what lessons the biopharma industry can learn from these setbacks going forward.
To learn more about the topics in this episode:
2024's top 10 clinical trial flops AbbVie's $9B schizophrenia prospect flunks phase 2 trials, handing advantage to BMS GSK surrenders HSV vaccine hopes after phase 2 fail, ceding race to Moderna, BioNTech Merck halts phase 3 TIGIT trial after immune-mediated adverse events prompt discontinuations Pfizer's phase 3 gene therapy trial fails to improve function for boys with Duchenne muscular dystrophySee omnystudio.com/listener for privacy information.
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Valentine’s Day represents a perfect opportunity to highlight news and updates from across biopharma that have hearts all aflutter.
In this week’s episode of “The Top Line,” we do just that, fueled by heart puns and holiday candy. Fierce’s Gabrielle Masson and Andrea Park discuss a new heart-focused biotech that recently emerged with $300 million and a cardiovascular drug that’s been named one of the most anticipated launches of 2025, as well as several other stories they’ve loved covering this year.
To learn more about the topics in this episode:
Kardigan launches with cozy $300M series A and collection of late-stage cardio assets
Top 10 most anticipated drug launches of 2025
Cumberland's Duchenne drug improves blood flow from heart in phase 2 trial
Novartis' first Super Bowl ad aims to 'create a movement' with breast cancer awareness blitz
Don't call it a comeback: Pfizer returns to Super Bowl with ad pledging to 'knock out' cancer
Takeda tightens reins on early-stage investments, looks to expand option deals: R&D head
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If Fierce Pharma Marketing’s annual list of the top 10 biggest potential drug launches of the coming year is any indication, biopharma may soon be in for a blockbuster boom. All together, the 10 meds that made the 2025 list stand to generate a whopping $29 billion in annual sales by the end of the decade.
In this week’s episode of The Top Line, we dig into the report’s predictions. Fierce’s Andrea Park and Eric Sagonowsky take a deep dive into the top three drugs on the list—all of which had already snagged their first FDA approvals by this episode’s release—and highlight some of the prevailing trends from past years’ reports, including repeat entries, popular indications and drugs that never had the chance to meet their predicted potential.
To learn more about the topics in this episode:
Top 10 most anticipated drug launches of 2025 Vertex snags FDA nod for once-daily cystic fibrosis triplet Alyftrek as switch from Trikafta kicks off Datroway, 2nd ADC from AstraZeneca-Daiichi collab, wins first FDA nod in breast cancer Vertex scores FDA nod for long-awaited non-opioid pain reliever JournavxThis episode is brought to you by Cencora. Learn more at cencora.com/breakthrough.
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During a panel discussion at this year’s Fierce JPM Week—which took place alongside the annual J.P. Morgan Healthcare Conference in San Francisco—industry experts broke down what it takes to pull off a successful biotech IPO in the current market.
This week’s episode of The Top Line dives into the discussion, featuring Fierce Biotech’s Gabrielle Masson as moderator, joined by Septerna CEO and co-founder Jeffrey Finer, M.D., Ph.D.; Rapport Therapeutics Chief Financial Officer Troy Ignelzi; Sofinnova Investments General Partner Maha Katabi, Ph.D.; and Morgan Stanley Executive Director Chirag Surti. In their wide-ranging conversation, the industry leaders spoke about the types of biotechs that debuted on the public market in 2024, the keys to success for an effective IPO and what to expect from the market heading into 2025.
To learn more about the topics in this episode:
‘A really rational IPO environment’: What does it takes for a biotech to go public now?
'Own JP Morgan, don't let JP Morgan own you': Biopharma—and Jill Biden—show up for JPM25
Septerna's $288M IPO is another sign of the market warming to biotech investment
Third Rock's Rapport reveals upsized $154M IPO
This episode is brought to you by Cencora. Learn more at cencora.com/breakthrough.
See omnystudio.com/listener for privacy information.
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This year’s edition of the annual J.P. Morgan Healthcare Conference has come to a close, with attendees enjoying sunny skies and a heavy police presence throughout the San Francisco-set event.
In this week’s episode of The Top Line, Fierce Pharma’s Zoey Becker and Angus Liu join Fierce Biotech’s Darren Incorvaia to break down the biggest news stories out of the conference. From Johnson & Johnson’s blockbuster acquisition of Intra-Cellular Therapies to former First Lady Jill Biden’s appearance at Fierce JPM Week just days before she left the White House, this year’s conference set the stage for what will surely be an eventful 2025.
To learn more about the topics in this episode:
‘Own JP Morgan, don't let JP Morgan own you’: Biopharma—and Jill Biden—show up for JPM25 JPM25: Johnson & Johnson makes a splash, buying out Intra-Cellular Therapies for $14.6B JPM25: First Lady Jill Biden committed to improving women's health as White House tenure winds down JPM25: Strategist GSK acquires IDRx for $1B in hopes of bringing GIST patients new standard of care GSK-backed Ouro Medicines launches into T-cell engager space with $120M and a clinical-stage assetThis episode is brought to you by Cencora. Learn more at cencora.com/breakthrough.
See omnystudio.com/listener for privacy information.
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Following the strange year for the biopharma industry that was 2024, insiders and analysts alike are waiting expectantly to see how trends in layoffs, drug shortages, clinical trials and more play out in 2025. Meanwhile, a second Trump term and a spree of related health agency nominations raise serious questions about how health policy could shift over the next 12 months and beyond.
In this week’s episode of “The Top Line,” we explore the trends that defined the industry in 2024 and tackle predictions about how 2025 could shake out for biopharmas big and small. Fierce Pharma’s Fraiser Kansteiner and Fierce Biotech’s Gabrielle Masson discuss 2024’s layoff count, the state of GLP-1 supplies, the future of clinical trial research, potential policy shakeups and more.
To learn more about the topics in this episode:
Analysts predict M&A, IPO uptick in 2025 but don't expect 'floodgates to suddenly open'
Big Pharma layoff rounds jump 281% in '24, but overall industry rates similar to '23
2025 forecast: After Novo, Lilly expansion sprees, 'positive signals' emerge around future supply of GLP-1 drugs
From AI and layoffs to supply chains and political unknowns, Deloitte outlines key areas for biopharma to watch in 2025
This episode is brought to you by Cencora. Learn more at cencora.com/breakthrough.
See omnystudio.com/listener for privacy information.
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Arun Krishna, Vice President and franchise head for an AstraZeneca US OBU, shares details of a treatment option with TAGRISSO® (osimertinib). AstraZeneca is focused on the development of new treatments, prioritizing researching options in eligible patients.
Listen to the full podcast episode to learn more.
Please see Important Safety Information for TAGRISSO.
Please see complete Prescribing Information, including Patient Information for TAGRISSO.
See omnystudio.com/listener for privacy information.
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A review of the FDA’s drug approvals of 2024 shows that small companies loomed large—both in the sheer number of nods gained and the significance of the new drugs and biologics that these firms are bringing to the market.
In this week’s episode of “The Top Line,” we take a deep dive into the FDA’s list of drugs that were approved in 2024. Fierce Pharma’s Kevin Dunleavy and Eric Sagonowsky discuss why biotechs emerged with more approvals than large drugmakers and which new drugs figure to have the most impact for patients.
To learn more about the topics in this episode:
2024 drug approvals: Small companies loom large with several key FDA nods
For Bristol Myers Squibb's newly approved schizophrenia drug, what a long, strange trip it's been
2023 drug approvals: After a down year, FDA signs off on a bounty of new meds, including 7 from Pfizer
This episode is brought to you by Cencora. Learn more at cencora.com/breakthrough.
See omnystudio.com/listener for privacy information.
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In this week’s episode of "The Top Line," we bring you a special conversation from earlier this month at our New York City gala, where we celebrated this year’s Fierce 50 honorees.
On stage, five extraordinary leaders shared their insights, experiences, and bold ideas shaping the future of healthcare and beyond. These honorees represent the five categories of this year’s Fierce 50: health equity, innovation, social impact, breakthroughs and patient advocacy.
Each honoree brings powerful insights and inspiring stories to the table. From reimagining maternal healthcare and addressing antibiotic resistance to translating public health science, transforming healthcare with AI, and tackling rural health challenges, this panel highlights innovation and disruption at its finest.
To learn more about the topics in this episode:
Fierce 50 of 2024 Fierce 50 of 2024 - Innovation Honorees Fierce 50 of 2024 - Health Equity Honorees Fierce 50 of 2024 - Social Impact Honorees Fierce 50 of 2024 - Breakthroughs Honorees Fierce 50 of 2024 - Patient Advocacy HonoreesSee omnystudio.com/listener for privacy information.
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GLP-1 agonists have taken the pharma world by storm, and Novo Nordisk has been at the forefront of it all with its blockbuster drug semaglutide, which it sells as Ozempic, Wegovy and Rybelsus. Semaglutide and other GLP-1s have gained widespread popularity as treatments for Type 2 diabetes and obesity, and it doesn’t stop there—they’re currently being tested in a wide variety of additional therapeutic areas and in new dosages and forms.
In this week’s episode of “The Top Line,” Fierce’s James Waldron talked to Marcus Schindler, Novo’s chief scientific officer and executive VP of research and early development, about what’s next for GLP-1s and what else is top of mind at the Danish pharma.
To learn more about the topics in this episode:
Novo Nordisk hails ‘remarkable’ weight loss result for dual-acting oral drug in early trial Novo obesity prospect linked to ‘mild to moderate neuropsychiatric side effects’ in phase 2 Novo Nordisk axes once-monthly GLP-1/GIP agonist and MASH prospect Another day, another win for Novo in obesity, as early oral med appears to beat WegovySee omnystudio.com/listener for privacy information.
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After a promising start to the year, the biotech IPO market picked up steam again late this summer, with notable offerings from companies like Upstream, Septerna and BioAge. But what does this mean for the sector? Is market enthusiasm truly returning, or are we just seeing a temporary rebound?
To unpack these questions and look ahead to 2025, Fierce Biotech’s James Waldron chatted with Adam Farlow, Global Chair of Baker McKenzie’s Capital Markets Practice Group.
To learn more about the topics in this episode:
Septerna's $288M IPO is another sign of the market warming to biotech investment BioAge brings in almost $200M from IPO as obesity biotech joins Nasdaq Upstream swells IPO to $255M as it prepares to join Nasdaq along with CAMP4 Kairos goes public with $6M IPO to fund trials of lead cancer drugSee omnystudio.com/listener for privacy information.
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Every year, Fierce’s pharma, biotech, and medtech teams come together to spotlight some of the fiercest women in life sciences—leaders who are transforming the industry with their innovation and impact. This year, our special report celebrates 10 women driving change in clinical research, business development, venture capital, and beyond.
In this week's episode of "The Top Line," Fierce’s Andrea Park and Gabrielle Masson share the stories that stood out, the breakthroughs these women are championing, and why recognizing their achievements is more crucial than ever.
To learn more about the topics in this episode:
2024's Fiercest Women in Life Sciences Big Pharma's 10 highest-paid CEOs of 2023See omnystudio.com/listener for privacy information.
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Last month, the NIH announced that it had found evidence of research misconduct by Eliezer Masliah, M.D., the head of the neuroscience division at the National Institute on Aging. The NIH announcement coincided with the Sept. 26 publication of an investigation by Science, finding that 132 papers published by Masliah appear to contain manipulated images.
In this week’s episode of “The Top Line,” Fierce Biotech’s Darren Incorvaia dives into this issue with Matthew Schrag, M.D., Ph.D., a neuroscientist who contributed to the dossier outlining Masliah’s misconduct.
To learn more about the topics in this episode:
NIH neuroscience leader committed research misconduct, agency investigation finds
See omnystudio.com/listener for privacy information.
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