The Top Line

This week on "The Top Line," we’re covering some of the biggest stories across biopharma before turning to one of the industry’s major scientific meetings of the summer. First, we discuss Vertex’s $10 billion acquisition of Crinetics Pharmaceuticals, the company’s largest deal to date, and what it says about Vertex’s push beyond its historic strength in cystic fibrosi...

Big Pharma dealmaking has picked up, but the biotech path to a signed agreement is still anything but simple. In this episode, recorded at Fierce Biotech Week, Senior Editor James Waldron leads a discussion on the evolving BD&L landscape across pharma and biotech. He is joined by Kaleem Chowdhury, Ph. D., CEO of Haiku Biosciences; Liz Leveille, who leads the Boston Innovation Hub and discovery...

In this sponsored episode of The Top Line, host Stephanie Butler is joined by Sheila Plant, vice president of regulatory affairs at Allucent, to examine how FDA Breakthrough Therapy and RMAT designations can support more strategic oncology development.  Although both pathways are intended to speed development, they are not interchangeable. Plant outlines the key distinctions, n...

In this episode of “The Top Line,” recorded on site at Fierce Biotech Week in Boston, Fierce’s Ayla Ellison sits down with Christelle Huguet, Ph. D., executive vice president and head of R&D at Ipsen, to discuss how the company is building its pipeline through external innovation while maintaining internal scientific accountability. Huguet explains Ipsen’s approach to p...

In this sponsored episode of The Top Line , experts from Myriad Genetics join host Stephanie Butler to examine how tumor-informed molecular residual disease, or MRD, testing is beginning to redefine what early insight can mean in oncology drug development. As biomarker-driven therapies become more precise, the ability to understand response earlier and more clearly is increasingly being viewed as...

Each year, the global oncology community flocks to Chicago to convene at the American Society of Clinical Oncology’s annual meeting for a weekend of buzzy data drops, practice-changing posters and insightful sessions.   In this week’s episode of "The Top Line," Fierce Biotech and Fierce Pharma’s Darren Incorvaia, Zoey Becker and Angus Liu break down the biggest takeaway...

High‑risk MDS and AML continue to challenge clinicians, with limited durable responses and few options for older or treatment‑refractory patients. In this sponsored episode of The Top Line, host Stephanie Butler is joined by Dr. Amer Zeidan, Professor of Internal Medicine at Yale School of Medicine, to unpack new ASCO 2026 data that are drawing attention across the myeloid malignancies field. The...

Boston remains biotech's most influential hub, but the questions facing the region are increasingly global. Recorded live at Fierce Biotech Week in Boston, this panel discussion brings together Uli Stilz, senior advisor at Flagship Pioneering; Bruce Beutel, CEO and co-founder of PassKey; and Ben Bradford, head of external affairs at MassBio, for a conversation about the future of biotech innovatio...

Direct-to-patient models are no longer an experiment - they're becoming a critical part of the modern prescription journey. In this sponsored episode of The Top Line , host Kelly Hogan talks with Jeremy Richardson, chief commercial officer at GiftHealth, about how DTP is redefining access, transparency and speed in pharma commercialization. Richardson shares insights from more than a decade in spe...

Recorded last week at Fierce Biotech Week in Boston, this episode of “The Top Line” features a conversation with Kristen Fortney, Ph. D., co-founder and CEO of BioAge Labs. In a conversation with Ayla Ellison, editor-in-chief of Fierce Healthcare and Life Sciences, Fortney discusses the company’s decade-long effort to use human aging data to identify drug targets tied to longevit...

Emerging pharma organizations face unique technology challenges as they prepare for launch. Expectations for AI-enabled decision-making continue to rise, even as teams remain small and operate in highly regulated environments. In this sponsored episode of The Top Line, Fierce Biotech host Kelly Hogan speaks with JR Raelin, executive director of analytics and insight at SynOx Therapeutics and Krish...

Despite a prolonged period of policy uncertainty in the U.S.—and the ripple effects across the global life sciences and healthcare industries—executives at health companies are still seeing opportunities amid the tumult. In many cases, they’re finding that the resilient business models they built through disruptions like the pandemic have positioned their companies not just to su...

After months of mixed messaging from the White House, the pharmaceutical industry has gained more clarity on the second Trump administration’s import tariff policy for drugs. While many of the industry’s biggest firms have navigated the trade threat through investment pledges and drug pricing deals, the current landscape remains murkier for small- and mid-sized drugmakers. In this epis...

In this sponsored episode of The Top Line, host Kelly Hogan speaks with Dr. Bettine Boltres, director of scientific affairs, integrated systems at West Pharmaceutical Services, about the development of the West Synchrony prefillable syringe system. As drug pipelines grow and regulatory expectations increase, pharma and biotech companies face mounting pressure to reduce complexity while a...

Theranostics is transforming cancer care, but scaling these treatments requires overcoming operational and workforce challenges. In this episode of The Top Line, Curium’s Mike Patterson discusses how access, safety and trust are shaping the next phase of growth for targeted radiopharmaceutical therapies.   Patterson explains why strong coordination across ordering, manufacturing and dis...

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 ph...

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 an...

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 week’s episode of "The Top Line," we examine the drug pricing agreement bet...

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 Lin e, 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. Fr...

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 proc...

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, in...

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...

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 into who claimed the top spot, w...

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 episode of "The Top Line," Fierce&rsq...

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.&nb...