The Top Line

For more than a decade, CAR-T therapy has been the miracle of oncology, turning end-stage blood cancers into curable diseases. But the application of these engineered cell therapies is expanding to reset the immune system for patients living with lupus, stiff person syndrome and other autoimmune conditions. And with new frontiers come new rules.

What does the future hold for sterile fill-finish CDMOs in a rapidly evolving market?

In this sponsored episode of The Top Line, Denis Johnson, CEO of Grand River Aseptic Manufacturing, discusses the capacity crunch facing U.S. sterile manufacturing and what it means for healthcare stakeholders. As acquisitions reduce available capacity, Annex 1 drives preference for isolator technology, and companies reshore production, competitio...

Though uncertainty still surrounds the Trump administration’s pharmaceutical import tariffs, the trade rhetoric set off a clear response across the industry in 2025. Drugmakers accelerated U.S. manufacturing plans, pushing production higher as companies looked to insulate their supply chains. Now, with many of those moves already underway, that breakneck pace is expected to level off through 2...

Biopharmaceutical innovation is advancing at an unprecedented pace, yet many patients still face barriers to accessing new medicines. In this episode of Health Matters, John O’Brien, president and CEO of the National Pharmaceutical Council, speaks with Kristin Cahill about why policy, pricing and benefit design are increasingly shaping whether innovation reaches patients.

O’Brien shares insights from his career spanning...

Every clinical setback carries lessons. That’s why Fierce revisits major trial failures each year: not to dwell on disappointment, but to understand what went wrong and what it signals for the road ahead.

The 2025 edition of Fierce Biotech’s clinical trial flops report highlights a familiar pattern. Large drugmakers account for a disproportionate shar...

Community oncology is playing an increasingly important role in how cancer care is delivered across the United States, with a growing share of patients treated outside large academic medical centers. In this sponsored episode of The Top Line, host Chris Hayden sits down with Kirk Kaminsky, executive vice president and group president of North American Pharmaceutical Services for McKesson, to examine what this shift means for patien...

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 candidate...

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 Pr...

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...

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 we...

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 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 ...

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 pat...

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 struggl...

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 wav...

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 v...

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 envi...

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 ther...