The Top Line

It’s a pivotal year for RNA therapeutics pioneer Ionis Pharmaceuticals. 

After transitioning from a partnering model to a full-ownership strategy following the 2024 approval of Tryngolza, the company is expecting an FDA decision to expand the drug into severe hypertriglyceridemia as its first non-rare-disease indication for a wholly owned product. Meanwhile, potentially game-changing phase 3 readouts are expected from Io...

Speed, precision, and visibility are critical to clinical trial success, and logistics plays a central role in delivering all three. In this interview, Manishaa O’Brien, director of commercial operations at Marken UPS Healthcare Precision Logistics, shares how the Laboratory Advantage service line is helping central labs and sponsors accelerate timelines while maintaining sample integrity and compliance.

O’Brien ...

President Donald Trump has struck a deal with the UK that exempts prescription drugs imported to the United States from tariffs for three years. In exchange, Britain’s National Health Service will pay 25% more for new drugs. The question now is: Can the U.S. negotiate similar deals with other countries?

In this wee...

Biomarkers are playing an increasingly critical role in shaping the future of oncology trials—and the pace of innovation is accelerating. In this sponsored episode of The Top Line, host Stephanie Butler sits down with Dr. Danielly Vicente, Associate Medical Director of Oncology and Hematology at Allucent, to explore how advanced biomarker strategies are transforming clinical development.

From improving patient selection in ea...

Artificial intelligence is increasingly shaping how pharma companies approach content strategy and decision-making. In this episode of The Top Line, Kristen Pilkiewicz, EVP and executive creative director at Sound Healthcare Communications, examines how AI is being applied in real-world marketing workflows.

Rather than positioning AI as a standalone solution, Sound has integrated it into core processes to support faster content dev...

Spray-dried dispersions are widely used, but they do not always deliver expected results. In this sponsored episode of The Top Line, host Stephanie Butler speaks with AustinPx Chief Scientific Officer Dr. Dave Miller about how drug developers can recover from suboptimal formulations and manufacturing challenges.

Miller outlines common issues, including poor bioperformance, inefficient scale-up, intellectual property limitations and...

China’s biotech rise has been a persistent concern for federal health leaders, Congress, and many biopharma executives. But to Roivant CEO Matt Gline, the country is nothing more than a red herring. 

In this week’s episode of "The Top Line," Fierce Biotech’s Darren Incorvaia chats with Gline about China, artificial intelligence and the exciting year ahead for Roivant’s lead asset brepocitinib. 

To ...

The wait is over. Fierce Biotech has released its annual ranking of the top 10 pharma R&D budgets of 2025—offering a clear look at which companies are spending the most on innovation and how those investments are shifting year over year.

In this week’s episode of "The Top Line," Darren Incorvaia and Eric Sagonowsky break down the new report, digging...

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...