The Top Line

The leaders of this year’s list of the most anticipated drug launches will likely come as no surprise: Fierce’s annual report on the biggest potential launches of 2026 details how the next obesity meds from Novo Nordisk and Eli Lilly are expected to rake in a respective $17.2 billion and $11.8 billion in annual sales by 2032, so long as they score their expected approvals this year. Elsewhere in the report are candidates from the likes of Gilead Sciences, Johnson & Johnson, AstraZeneca and other biopharmas big and small, spanning a range of indications from breast cancer to essential tremor. All together, predicted 2032 sales for the year’s top 10 weigh in at nearly $46 billion. In this week’s episode of “The Top Line,” Fierce’s Andrea Park and Gabrielle Masson dive into the report, mapping out how it stacks up against last year’s edition and digging into the enormous sales potential of the top two drugs on the list.  To learn more about the topics in this episode:  Top 10 most anticipated drug launches of 2026 Novo Nordisk stock crashes after CagriSema misses phase 3 weight-loss goal Lilly's obesity pill largely maintains weight lost on injectable GLP-1s Top 10 most anticipated drug launches of 2025  See omnystudio.com/listener for privacy information.

Please see the following USPI, US ISI, EU SmPC and Canadian Product Monograph for complete LIVMARLI product information: US Important Safety Information (https://livmarli.com/important-safety-information/) US Prescribing Information (https://files.mirumpharma.com/livmarli/livmarli-prescribinginformation.pdf?_ga=2.264585739.54248471… EU SmPC (https://ec.europa.eu/health/documents/community-register/html/h1704.htm) Canadian Product Monograph (https://files.mirumpharma.com/livmarli/livmarli-product-monograph-en.pdf) Learn more about the latest research for Mirum’s investigational therapies: MRM-3379 (https://mirumpharma.com/wp-content/uploads/2025/09/FXS-NDD-2025-Mouse-Model-Poster_FINAL.pdf), volixibat in PSC (https://s29.q4cdn.com/633867992/files/doc_presentations/2024/Jun/Mirum-VISTAS-and-VANTAGE-Interim-Analysis-Results-Presentation.pdf)and PBC (https://mirumpharma.com/wp-content/uploads/2025/05/Heneghan-M-EASL-2025-VANTAGE-28-week-data-with-volixibat-in-PBC.pdf), and brelovitug (https://www.natap.org/2025/AASLD/AASLD_22.htm). LIVMARLI is also currently being evaluated in the Phase 3 EXPAND study (https://clinicaltrials.gov/study/NCT06553768) in additional settings of cholestatic pruritus. References What is hepatitis delta? Hepatitis B Foundation. Accessed January 14, 2026. https://www.hepb.org/research-and-programs/hepdeltaconnect/what-is-hepatitis-delta/ Agarwal K, Jucov A, Dobryanska M, et al. Brelovitug (BJT-778) monotherapy achieved 100% virologic response in patients with chronic hepatitis D: on treatment week 48 phase 2 study results. Presented at: AASLD 2025; November 7-11, 2025; Washington, D.C. Sagnelli C, Sagnelli E, Russo A, Pisaturo M, Occhiello L, Coppola N. HBV/HDV co-infection: epidemiological and clinical changes, recent knowledge and future challenges. Life (Basel). 2021;11(2):169. doi:10.3390/life11020169 Negro F, Lok AS. Hepatitis D: a review. JAMA. 2023;330(24):2376-2387. doi:10.1001/jama.2023.23242 Hunter J, Rivero-Arias O, Angelov A, Kim E, Fotheringham I, Leal J. Epidemiology of fragile X syndrome: A systematic review and meta‐analysis. doi:10.1002/ajmg.a.36511  See omnystudio.com/listener for privacy information.

Artificial intelligence is reshaping medical communications, but it is not a substitute for human judgment. In this episode of The Top Line, experts from RTI Health Solutions explore how AI is being used across scientific writing, editing and information discovery—and why guardrails are essential. The conversation examines practical applications of AI, including literature screening, early-stage drafting and editorial support, while addressing the limitations that can undermine quality and trust. Panelists share real-world examples showing how different tools can produce conflicting results and why expert review is required to ensure accuracy and relevance. Listen to the full interview to gain insight into how organizations can harness AI’s efficiency while keeping scientific rigor and the human perspective at the center of their work.See omnystudio.com/listener for privacy information.

In this week’s episode of “The Top Line,” Fierce checks in with professional services juggernaut KPMG on the biopharma rebound many industry watchers predicted in the closing months of 2025. Fierce Pharma’s Fraiser Kansteiner sits down with Kristin Cirello Pothier, principal and U.S. and Americas region life sciences sector leader, as well as global deal advisory and strategy leader for health and life sciences at KPMG, to discuss the firm’s latest industry outlook. Pothier also explains how drugmakers are cutting through the noise and reflects on the technology, indication and valuation factors shaping today’s dealmaking appetite. To learn more about the topics in this episode:  2026 forecast: After a surge of M&A in Q4, will the trend continue? Halozyme catches M&A wave to snap up Surf Bio in delivery tech deal worth up to $400M Global pharma manufacturing output surged in '25 in 'front-loading' response to US tariff threats: report In quick reversal, Trump calls off tariff threat related to Greenland pursuit See omnystudio.com/listener for privacy information.

With this year’s iteration of the J.P. Morgan Healthcare Conference in the rearview mirror, the biopharma industry has officially closed the door on 2025 as it heads into what is sure to be another eventful year. In this week’s episode of "The Top Line," Fierce Pharma's Zoey Becker sits down with Angus Liu and Fierce Biotech's Gabrielle Masson to unpack the key topics and trends that stood out at this year's conference in San Francisco. The conversation offers an early look at the themes and questions that could shape the year ahead. To learn more about the topics in this episode:  All the meetings, none of the megadeals: Is JPM's purpose evolving? JPM26: What’s in a biopharma? CEO says Teva has the goods JPM26: Astellas CEO resists 'rescue BD' as $6B Xtandi patent cliff nears  See omnystudio.com/listener for privacy information.

As payers focus on long-term outcomes and real-world performance, value matters more than ever. RTI Health Solutions experts discuss how clear evidence storytelling drives access decisions.See omnystudio.com/listener for privacy information.

In early 2025, the FDA was rocked by sweeping layoffs and leadership turnover, raising questions about whether the agency could maintain its pace in reviewing new drug applications. By the end of the year, the approval picture told a more complicated story, with momentum building after a slow start. This week on "The Top Line," we dig into what the numbers really show, which companies and therapies came out on top, and what the FDA’s performance over the course of 2025 signals for the drug review process going forward. To learn more about the topics in this episode:  2025 drug approvals: Despite FDA tumult and macro uncertainty, biopharma scored with 55 new products 2024 drug approvals: Small companies loom large with several key FDA nods 2023 drug approvals: After a down year, FDA signs off on a bounty of new meds, including 7 from Pfizer See omnystudio.com/listener for privacy information.

What does it really mean to put patients first in today’s life sciences landscape? In this sponsored episode of The Top Line, leaders from RTI Health Solutions explore how patient voices are transforming evidence generation, market access and medical communication. From patient-reported outcomes and advisory boards to inclusive value storytelling and trust-building across diverse communities, the discussion highlights why patient-centric strategies are no longer optional—and how they can influence approval, reimbursement and real-world impact.See omnystudio.com/listener for privacy information.

As artificial intelligence continues to dominate conversations across life sciences, many companies are reaching an inflection point between experimentation and real-world impact. In a recent episode of The Top Line, Mark Sullivan, president of regulated industries at Salesforce, said the industry is moving past broad promises toward a clearer divide between organizations that have laid the groundwork for AI and those still struggling to operationalize it. While early pilots have delivered mixed results, Sullivan said the next phase will be defined by how effectively companies use AI to augment their workforce, not replace it. Much like laptops or smartphones, AI proficiency is quickly becoming a baseline expectation for professionals, shaping productivity, decision-making and resilience across drug development, manufacturing and commercialization. Sullivan emphasized that success with AI agents hinges on trust, governance and high-quality data—particularly in an industry where accuracy and compliance are nonnegotiable. Life sciences organizations are beginning to see value in agents that support patient engagement, clinical trial matching and commercial execution, but only when those agents are grounded in enterprise data and clear guardrails. With as much as 80% of industry data unstructured, he said, the process of deploying agents often exposes deeper data and architecture challenges that must be addressed. Companies that solve for these issues can unlock both efficiency and growth, using AI not just to cut costs, but to strengthen patient relationships and drive innovation. The conversation offers a practical look at how life sciences leaders can move beyond the hype and build an agentic strategy that delivers measurable results—making it a must-listen for anyone navigating AI adoption in a regulated environment.See omnystudio.com/listener for privacy information.

China has moved from a fast-following biotech market to a source of globally competitive innovation, according to Josh Smiley, president and chief operating officer of Zai Lab. Speaking on The Top Line podcast, Smiley traces the country’s evolution over the past two decades, pointing to regulatory harmonization, expanded national insurance coverage and deepening R&D capabilities as key drivers. He said the most recent wave of Chinese biotechs is no longer focused solely on domestic opportunities but on first- or best-in-class medicines that can compete worldwide, particularly in oncology and immunology. Smiley also details how Zai Lab blends China’s patient access and development speed with global clinical and regulatory standards, a model he says has helped accelerate programs such as Zai’s DLL3-targeted antibody-drug conjugate for small cell lung cancer into late-stage trials. As China-sourced deals now account for a growing share of global biotech partnerships, Smiley argues companies that integrate China early — without treating it as a standalone market — will have a strategic edge. The conversation offers a candid look at what’s next for Zai Lab and why China’s expanding role in drug innovation is likely to reshape the global pipeline for years to come.See omnystudio.com/listener for privacy information.

After a turbulent 2025, the biopharma industry is heading into the new year with major questions still unresolved. A tough biotech investing environment, aggressive direct-to-consumer drug marketing and sweeping U.S. policy changes reshaped the landscape last year. Many of those pressures are expected to persist into 2026, even as early signs point to a thaw in venture capital. At the same time, the industry is testing whether DTC drug sales can meaningfully affect pricing for patients and whether broad manufacturing onshoring goals can realistically apply to advanced therapies like cell and gene treatments and radiopharmaceuticals. In this week’s episode of "The Top Line," Fierce Pharma’s Fraiser Kansteiner sits down with three biopharma CEOs to unpack what defined 2025 and what comes next. He’s joined by Thijs Spoor, CEO of Perspective Therapeutics; Brian Culley, CEO of Lineage Cell Therapeutics; and Rich Daly, CEO of Catalyst Pharmaceuticals. Together, they tackle issues from DTC sales and onshore manufacturing to drug pricing, regulatory uncertainty at the FDA and the broader innovations the leaders are most excited about this year. To learn more about the topics in this episode:  2026 forecast: After a surge of M&A in Q4, will the trend continue? Editor's Corner: Fierce Biotech's 10 most-read stories of 2025 What a year: Here are the stories that captivated our audience in 2025 Editor's Corner: The top 10 Fierce Pharma Marketing stories of 2025 2026 forecast: Pharma clicks with patients as direct sales model shifts marketing strategies See omnystudio.com/listener for privacy information.

As 2025 closes, biopharma and healthcare are learning to live on shifting ground. In this special year-end episode of "The Top Line," Fierce reporters take stock of a year defined by federal research cuts, vaccine policy fights and leadership churn at the FDA, then push the conversation forward into the questions that will shape 2026. The through line is that uncertainty has become an operating environment, and the industry is recalibrating in real time. Fierce Biotech’s Gabrielle Masson, joined by Darren Incorvia, traces how funding decisions can narrow the pipeline years before the consequences are visible. Fierce Pharma’s Fraiser Kansteiner sits down with Angus Liu and Eric Sagonowsky to unpack the new center of gravity inside federal agencies, where vaccine recommendations, review norms and new FDA pilots are colliding with questions about capacity and outside influence. From there, Ben Adams and James Waldron bring the lens to Europe, where Jefferies in London captured a cautiously optimistic market still wrestling with tariffs, pricing pressure and investment hesitation. The episode closes with Fierce Healthcare’s Heather Landi and Paige Minemyer sharing their outlook on 2026, from the fight over ACA subsidies and Medicaid headwinds to the next phase of AI adoption, where the promise is real but the payoff may be slower, messier and more uneven than the hype suggests. To learn more about the topics in this episode:  'Unprecedented turmoil' engulfing FDA threatens public health: mRNA coalition speaks out FDA names Tracy Beth Høeg, fresh from vaccine safety probe, as acting head of drug center A dozen former FDA commissioners blast Prasad's proposed vaccine policy changes In letter to Makary, biotech CEOs push for FDA stability and say volatility threatens US innovation NIH grant cuts have disrupted hundreds of clinical trials, study finds 'Alternative history' of the NIH shows how a 40% budget cut may thwart new medicines House passes healthcare affordability bill without subsidy extension AMA: A look at concentration in commercial insurance, MA markets 2025 Outlook: Hospital finances show signs of stability, but rising costs will be a major headwind See omnystudio.com/listener for privacy information.

Walgreens is emerging as a real-world evidence partner for the biopharma industry, according to a new episode of The Top Line, sponsored by Walgreens. In the conversation, Deepak Kuletha, who leads data management and analytics for the company’s biopharma services division, explains how Walgreens’ 9 million daily interactions and nationwide footprint generate rich insights into patient behavior, access barriers and therapy performance in the real world. Kuletha shares examples of how Walgreens helps pharma partners optimize drug launches, identify early adoption patterns, uncover affordability challenges and improve patient support programs—ultimately enabling faster, evidence-based decision-making. As real-world evidence grows more complex, Kuletha highlights how Walgreens’ advanced data management, privacy safeguards and emerging analytics tools—including machine learning and AI—help cut through the noise. These capabilities allow the pharmacy chain to synthesize de-identified data into actionable insights that reveal adherence risks, surface gaps in treatment understanding, and support earlier interventions. For life sciences professionals looking to understand how retail pharmacies are shaping the future of evidence generation, the episode offers a compelling inside look at the collaboration opportunities ahead. Listen to the full conversation to hear how Walgreens is turning scale into smarter, proactive patient care.See omnystudio.com/listener for privacy information.

Uncertainty reigned early this year with the inauguration of President Donald Trump and his threats to impose tariffs and slash prescription drug prices. But as players in the biopharma industry have gotten a better handle on the impact of these measures and the overall investment landscape, valuations have become more predictable and dealmakers have focused on larger, lower-risk acquisitions. The recent trends bode well for the business development landscape in 2026 and beyond. In this week’s episode of “The Top Line,” Arda Ural, EY Americas life sciences sector leader, joins Fierce Pharma’s Kevin Dunleavy to discuss the dealmaking landscape in the biopharma industry. They dig into the Federal Trade Commission’s scrutiny of M&A transactions, revitalized therapeutic areas, artificial intelligence investment and the emergence of China as an innovation powerhouse. To learn more about the topics in this episode:  2025 M&A up in value and deal count after year of 'conservatism and recovery': Leerink Partners After a 'reset' year for M&A, expect bigger deals in 2025: reports See omnystudio.com/listener for privacy information.

In this episode of Health Matters, GCI Health’s Ryan Kuresman and Health@WPP’s Wendy Lund explore the fast-shifting landscape of cancer care with Pam Traxel of the American Cancer Society Cancer Action Network. Traxel outlines the growing complexity facing patients—from navigating an expanding range of treatment options to managing rising costs. The conversation also examines the evolving role of patient advocacy and the partnerships needed to drive meaningful change. Traxel emphasizes the importance of integrating lived experiences into policy, improving the credibility of patient-facing communication and strengthening early, ongoing collaboration between biopharma, policymakers and advocacy organizations. For healthcare and life sciences professionals seeking deeper insight into how access, innovation and policy must intersect to improve patient outcomes, this is a must-listen episode.See omnystudio.com/listener for privacy information.

Research shows that women remain woefully underrepresented at the highest levels of leadership in the life sciences industry. Those who have broken through that glass ceiling, however, are not only doing groundbreaking work in pharma, biotech, medtech and beyond but also reframing what it means to be a leader in the sector—as evidenced by the often-unconventional career paths and management philosophies of the 10 women featured in this year’s Fiercest Women in Life Sciences report. In this week’s episode of “The Top Line,” Fierce’s Andrea Park and Gabrielle Masson dive into the report, highlighting several honorees’ paradigm-busting approaches to leadership, mentorship and building inclusive teams. To learn more about the topics in this episode: 2025's Fiercest Women in Life Sciences 4 reasons life sciences still fail women at the top, despite a female-majority workforce: report GSK's Emma Walmsley to step down as CEO in shock move, giving way to commercial lead Luke Miels Merck KGaA, grappling with geopolitical tensions, ⁠reveals CEO transition Takeda taps Julie Kim to take over for retiring CEO Christophe Weber  See omnystudio.com/listener for privacy information.

Bayer is reshaping its pharmaceutical business with a new operating model designed to enhance collaboration and bring research & development and commercialization closer together. In a recent episode of The Top Line podcast, Bayer executives Christine Roth, Executive Vice President and Head of Global Product Strategy and Commercialization, and Dr. Yesmean Wahdan, Head of Medical Affairs for the United States and North America, discussed how the company’s Dynamic Shared Ownership framework is driving faster innovation and helping accelerate the development of new therapies for patients. The model removes traditional hierarchies, empowers cross-functional teams and encourages real-time collaboration across departments.  Roth and Wahdan said the approach has already shortened regulatory timelines, reduced resource use and helped deliver treatments to patients sooner. By embedding commercial insights early in the research process, Bayer teams can anticipate market needs and focus on the greatest areas of unmet medical demand. The leaders said the company’s collaborative culture keeps patient benefit at the center of decision-making. To learn more about how Bayer’s model is transforming its pipeline, listen to the full episode of The Top Line.  See more from Bayer’s Christine Roth and Dr. Yesmean Wahdan on their LinkedIn profiles below:  Christine: https://www.linkedin.com/in/christine-roth-34b07b18/  Yesmean: https://www.linkedin.com/in/yesmean-h-wahdan-md-71409b199/ See omnystudio.com/listener for privacy information.

In this episode of The Top Line, Fierce’s Chris Hayden speaks with Foresight Diagnostics co-founders Dr. Jake Chabon and Dr. Max Diehn about how their company is delivering the next generation of minimal residual disease (MRD) detection in cancer care. Born from research at Stanford University, Foresight’s PhasED-Seq technology delivers ultra-sensitive detection—down to parts per ten million—enabling clinicians to identify microscopic traces of cancer that traditional imaging misses. The discussion explores how Foresight’s MRD platform, CLARITY, can have the ability to support more confident decision-making, from determining curative success in early-stage cancers to guiding consolidation treatment in lymphoma. Chabon and Diehn highlight the company’s biopharma collaborations, clinical trial integration, and evidence-driven approach to guideline inclusion. They also look ahead to a future where MRD testing becomes central to oncology surveillance, accelerating therapy approvals and complementing genomic and digital pathology tools to advance precision medicine.See omnystudio.com/listener for privacy information.

In this week’s episode of "The Top Line," we take a deep dive into the top-line performance of the biopharma industry in the third quarter.  After a slow start to the year, U.S. drugmakers in particular have recovered, led by Eli Lilly. We examine which companies are hot and which are not. We also look at trends that emerged in the third quarter, such as the shortfall in vaccine sales, especially in the U.S., and companies’ sales projections for the rest of the year. Fierce Pharma’s Kevin Dunleavy and Eric Sagonowsky discuss their observations from the third quarter and put the industry’s performance in perspective compared with previous quarters. They also examine the biopharma outlook for the fourth quarter.  To learn more about the topics in this episode:  Q1 biopharma layoff trends, plus expectations for Q2 7 top pharmas posted revenue declines in Q1. The common thread? All are US firms Several US pharma giants stage Q2 sales turnaround after subpar results earlier in year   See omnystudio.com/listener for privacy information.

As the prospect of import tariffs and drug price reform marshals billions of biopharma investment dollars into the U.S., the feasibility of rapid domestic manufacturing buildouts could hinge on a new program cooking at the FDA. How that program, dubbed PreCheck, will work in practice—and on what timeline—are key questions as the U.S. looks to bolster its local pharmaceutical production base. This week on “The Top Line,” we dive into comments from a recent public meeting on the industry’s hopes for PreCheck, which is being designed to streamline the process by which new biopharma manufacturing facilities are built in the U.S. Fierce Pharma’s Fraiser Kansteiner sits down with Christopher Shilling, chief regulatory officer at gene therapy CDMO Forge Biologics—who attended the meeting—to offer an on-the-ground perspective and explore the aspects of the plan that could have the biggest impact on manufacturers. Shilling also outlines what he sees as FDA’s next steps, plus regulatory considerations that could most benefit CDMOs and the broader industry. To learn more about the topics in this episode:  Amid tariff-fueled onshoring push, Trump signs order to boost US stockpiling of certain drug ingredients FDA launches generics pilot program, advances facility PreCheck proposal in bid to incentivize US drug manufacturing Amid pharma's US investment spree, FDA unveils new program to streamline domestic plant build-outs Trump signs executive order to boost US drug manufacturing amid threat of tariffs See omnystudio.com/listener for privacy information.