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

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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.

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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

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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.

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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.

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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.

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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

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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

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