The Top Line

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.See omnystudio.com/listener for privacy information.

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 stumbles This episode is brought to you by Cencora.See omnystudio.com/listener for privacy information.

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.See omnystudio.com/listener for privacy information.

Dr. Luis Buzón, an infectious disease specialist and spokesman for the Spanish Society of Infectious Diseases, sheds light on the vital role of real-world evidence in HIV care. He emphasizes how long-term data reveal treatment effectiveness and side effects often missed in clinical trials. Buzón shares a personal connection to HIV advocacy, inspired by his father's pioneering work in Spain. The discussion highlights the importance of inclusive research to improve health outcomes and the ongoing journey towards compassionate, evidence-based care.

The biotech sector is buzzing with excitement over massive fundraising achievements in 2024. Xaira Therapeutics made headlines by securing a staggering $1 billion, reshaping industry norms. The conversation unfolds around key players like Treeline Biosciences, Kylara Therapeutics, and Mirador Therapeutics, each raising impressive sums. Innovations in precision medicine and obesity treatments are spotlighted, revealing how these trends are driving investment strategies and shifting the biotech landscape. It's a thrilling time for biotech as money pours in!

Recent research shifts the understanding of Huntington's disease from toxic protein buildup to a 'ticking DNA clock' that causes rapid neuron death. Innovative technologies like Droplet Single Cell Genomics reveal cell-specific toxicity, providing insights into the disease's fatal effects on brain neurons. The importance of human brain tissue analysis uncovers mechanisms behind selective cell death. New therapies focusing on genetic aspects may pave the way for effective treatments, drawing inspiration from genetics of resilient individuals.

James Waldron, a journalist from Fierce Biotech, brings insights on the biggest clinical trial failures of 2024. He highlights the disappointing results from major companies like AbbVie and Pfizer, particularly in trials for schizophrenia and Duchenne muscular dystrophy. The discussion delves into lessons learned from these setbacks and the human impact of failed trials. Waldron and Gabrielle Masson also explore the ongoing challenges the industry faces and the crucial need for innovative treatments to improve patient outcomes.

Celebrate cardiovascular advancements as a new biotech emerges with a whopping $300 million! Discover the top 10 anticipated drug launches of 2025, including a breakthrough for obstructive hypertrophic cardiomyopathy. Learn about a phase 2 trial improving heart function in Duchenne muscular dystrophy. Get the lowdown on innovative Super Bowl ads from Novartis and Pfizer aimed at health awareness. Enjoy playful banter on Valentine’s Day and the quirky connections between heart health and candy!

2025 is gearing up to be a blockbuster year in biopharma, with anticipated drug launches projected to net $29 billion by the decade's end. The spotlight shines on Aliftrek, a game-changing treatment for cystic fibrosis, rich with historical context and competitive insights. Vertex Pharmaceuticals stands out with its FDA approvals, including a pioneering non-opioid pain reliever. However, trends reveal challenges in meeting sales expectations, showcasing the unpredictable nature of drug market predictions.

Jeffrey Finer, CEO of Septerna, shares insights from their recent successful IPO. Troy Ignelzi, CFO of Rapport Therapeutics, discusses strategies that led to their upsized IPO. Chirag Surti from Morgan Stanley highlights market trends and investor engagement. The panel emphasizes the evolution of the biotech IPO landscape, focusing on strategic planning, disciplined valuation, and the importance of compelling narratives. They predict a hopeful outlook for 2025, with anticipated breakthroughs and a stronger emphasis on quality therapeutic areas in this revitalized market.