The Top Line

After a wave of high-profile pledges to bring pharmaceutical manufacturing back to the United States, a clearer picture of what reshoring actually looks like is starting to emerge. Tens of billions of dollars have been committed to new U.S. plants, but those investments are unlikely to translate into immediate gains in domestic production.

In this week’s ep...

While Lilly’s position in the obesity market and wider GLP-1 space has remained largely unshakeable in recent months, a crack in the company’s armor may be forming, according to at least one analyst. As that assessment dealt a blow to the company’s stock price in recent weeks, Lilly is plowing forward all the same with more details on its next wave of potential incretin drugs.  

In this week’s epis...

In this episode of The Top Line, host Chris Hayden speaks with Olive McCormick, Head of Quality and Qualified Person at Almac Clinical Services about why late‑breaking issues in clinical trials pose such significant risk — and what teams can do to prevent them. McCormick explains that operational misalignment, delayed communication, overlooked regulatory steps or misinterpretation of requirements under the new UK Clinical Tri...

Since Xaira’s eye-popping $1 billion fundraise in 2024, the company has said relatively little in public. That’s made it one of biotech’s more closely watched black boxes: a company with enormous backing, enormous ambition and, until recently, few clues about what it has actually been building.

In this week’s episode of “The Top Line,...

In this week’s episode of “The Top Line,” we take a deep dive into the fourth-quarter performance of the biopharma industry and how the sector fared in 2025 overall.

As the world’s 25 largest biopharma companies reported earnings, attention quickly shifted to their outlook for 2026. Only five drugmakers expect faster growth than in 2025, a...

The design of the modern R&D lab may be due for a rethink.

Artificial intelligence and automation are reshaping how science gets done, yet many of the physical spaces where research happens were built around assumptions that date back decades.

In this episode of “The Top Line,” Fierce Life Sciences & Healthca...

Physiology connects genes and molecules to whole-body function, shaping every stage of drug discovery and development. In this sponsored episode of The Top Line, Sue Bodine, president-elect of the American Physiological Society and a professor at the Oklahoma Medical Research Foundation, explains why physiology remains central to biomedical innovation.

Bodine details how physiology strengthens biotech and pharmaceutical research by...

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 ...