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The Top Line

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Rating
★★★★☆
4.1
from
12 reviews
This podcast has
100 episodes
Language
English
Explicit
No
Date created
2023/07/20
Latest episode
2026/02/06
Average duration
24 min.
Release period
5 days

Description

Biopharma and medtech explained. Every week, journalists from Fierce Biotech, Fierce Medtech, and Fierce Pharma recount the latest industry trends and why they matter. We'll analyze the week's biggest business news, from mergers and marketing to drug R&D and device development. Available every Friday morning. 

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The biggest potential drug launches of 2026
2026/02/06
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.
How Mirum is Advancing Rare Disease Care Through Strategic M&A (Sponsored)
2026/02/03
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.
Why human expertise still matters in AI-driven med comms (Sponsored)
2026/02/02
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.
Biopharma's rebound keeping pace so far
2026/01/30
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.
JPM26: Sunshine, AI and the deals that weren't
2026/01/23
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.
From approval to value: Why evidence storytelling now matters (Sponsored)
2026/01/19
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.
Drug approvals went from crawl to sprint in 2025
2026/01/16
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.
Putting patients first: from buzzword to business imperative (Sponsored)
2026/01/12
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.
Beyond the AI hype: How life sciences can turn agents into a competitive advantage (Sponsored)
2026/01/12
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’s biotech moment goes global, Zai Lab exec says (Sponsored)
2026/01/12
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.
Biopharma CEOs assess the road ahead in 2026
2026/01/09
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.
A year in review and what 2026 holds for biopharma and healthcare
2025/12/19
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.
From data to decisions: how Walgreens is powering smarter pharma strategies (Sponsored)
2025/12/08
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.
The biopharma dealmaking landscape and what to expect in 2026
2025/12/05
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.
Advocacy, access and the future of cancer care take center stage in new Health Matters episode (Sponsored)
2025/12/01
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.

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