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 fibrosis. We also cover growing scrutiny from U.S. lawmakers over the industry’s use of clinical trials in China.

Then, Fierce Pharma Senior Editor Fraiser Kansteiner recounts his recent trip to New Orleans for the American Diabetes Association’s 2026 Scientific Sessions with Fierce Pharma Marketing’s Zoey Becker. For years, ADA has focused heavily on its eponymous indication, but this year’s meeting made clear how much the conversation is evolving, with obesity data from drugmakers of all stripes taking up more of the spotlight. Topics include the biggest data sets from the meeting, what it was like to sit down with Novo Nordisk’s new CEO for the first time and the latest from Insulet’s Marvel collaboration on a line of comics about an Omnipod-wearing superheroine.

To learn more about the topics in this episode:

• Vertex, in its largest-ever deal, acquires endocrine disease specialist Crinetics for $10B
• As US lawmakers increase scrutiny of Chinese trials, industry fears ‘huge distraction and expense’
• ‘I’m a lot more optimistic today’: Mike Doustdar tells Fierce about pivotal first year as Novo Nordisk CEO
• ADA: Lilly pulls back curtain on impressive triple-G efficacy in patients with obesity, diabetes
• ADA: Amgen highlights Repatha perks, GLP-1 pitfalls in push to boost cardiometabolic pedigree
• With ADA in the books, analyst says Lilly is ‘widening its lead’ in the obesity race
• ADA: Novo's Wegovy pill reaches new GLP-1 patients with impressive 3M prescription milestone
• ADA: Tolerability ‘not to be underappreciated’ in Roche, Zealand’s amylin obesity prospect
• ADA: Boehringer execs claim survodutide tolerability 'consistent' with class despite phase 3 update
• ADA: Lilly posts oral semaglutide-topping data as Foundayo speeds toward 2nd potential nod in diabetes

See omnystudio.com/listener for privacy information.

AI is reshaping how organizations compete, but more data and more tools do not automatically lead to better decisions. In this episode of The Top Line, Justin Masterson, senior vice president of human sciences at The Directions Group, challenges leaders to look beyond AI adoption and focus on the discipline required to act on intelligence.

Masterson argues that the defining issue for many organizations is not a data problem, but a decision readiness problem. As information ecosystems become more complex, the ability to translate insight into timely, confident action is emerging as a critical business differentiator.

With more than 20 years of experience in healthcare and human sciences, Masterson shares perspective on how companies can align teams, processes and strategies to unlock AI’s value without becoming overwhelmed by the volume of available information.

For leaders navigating new technologies, competing priorities and higher expectations for speed, this conversation offers a practical reframing of where AI value is created. Learn why decision readiness may be the next true advantage.

See omnystudio.com/listener for privacy information.

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 transactions at Merck; and Abbas Kazemi, CEO of Nimbus Therapeutics.

The panel digs into the realities behind the headlines, from investor scrutiny and platform company pressure to China’s growing role in licensing and the long relationship-building that often happens before a deal gets done.

To learn more about the topics in this episode:

• March M&A surge triggers high expectations for 2026
• 'Biopharma ecosystem is back to full health,' fueled by M&A: PwC
• Facing mounting China licensing costs, biopharma buyers turn to AI and local know-how to keep up
• After 230% deal size explosion, China is no longer the 'bargain basement' for biopharma licensing: analyst
• Was Big Pharma’s ‘unusually aggressive’ M&A spree to blame for March IPO drought?

This week's episode is sponsored by IQVIA Biotech.

Built for biotech innovators, IQVIA Biotech is a full-service CRO, designed for agility, fast decisions, and the urgency needed for emerging biopharma. With dedicated teams and deep therapeutic expertise, we help move programs forward with focus and confidence. Visit IQVIABiotech.com

See omnystudio.com/listener for privacy information.

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, noting that Breakthrough Therapy requires evidence of substantial improvement over existing treatments, while RMAT is available for regenerative medicine therapies and centers on preliminary clinical evidence indicating the potential to address unmet medical needs.

The conversation also explores the strategic choices that determine whether sponsors are ready to pursue these designations, from building a credible data package to designing trials with clinically meaningful endpoints and keeping manufacturing readiness aligned with development timelines.

Once a designation is granted, closer collaboration with the FDA can help sponsors navigate development with more dynamic feedback. But as Plant emphasizes, these pathways deliver the greatest value when they are part of a disciplined regulatory strategy.

Listen now to learn how sponsors can approach expedited pathways with greater clarity and position oncology programs for meaningful acceleration.

See omnystudio.com/listener for privacy information.

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 partnering, describing the company as an “accelerator” that helps move promising science from academic labs and biotech partners toward patients. She also discusses how Ipsen evaluates which programs move forward, why transparency with partners is essential from the start and what the company is watching as it heads into a year with several key clinical and regulatory milestones.

To learn more about the topics in this episode:

• Ipsen unveils data for Botox rival that drove long-acting anti-wrinkle jab into phase 3
• Ipsen scuttles liver disease candidates from $952M Albireo acquisition

This week's episode is sponsored by IQVIA Biotech.

Built for biotech innovators, IQVIA Biotech is a full-service CRO, designed for agility, fast decisions, and the urgency needed for emerging biopharma. With dedicated teams and deep therapeutic expertise, we help move programs forward with focus and confidence. Visit IQVIABiotech.com

See omnystudio.com/listener for privacy information.

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 foundational to smarter development strategy.

The discussion looks at how ultrasensitive, tumor-informed MRD assays can help track response over time, potentially surface deeper signals earlier and inform decisions that shape trial design, patient selection and regulatory direction. It also considers why these capabilities may become more important as oncology programs face growing pressure to balance speed, flexibility and evidence generation.

Listeners will hear why early diagnostic strategy is increasingly seen as a competitive differentiator, how MRD can help teams make better decisions sooner and why its role in oncology development is expected to continue to evolve and expand.

See omnystudio.com/listener for privacy information.

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 takeaways from their weekend of reporting live from the Windy City. From “nutty” in vivo CAR-T data to a historic first for a Chinese biotech asset, ASCO 2026 reflected new and continuing trends within the evolving state of cancer care today.

To learn more about the topics in this episode:

• ASCO: Revolution Medicines confident in RAS leadership as rivals square up

• ASCO: Lilly exec points to ‘nutty’ 100% response rate for in vivo CAR-T as justifying Kelonia buyout

• ASCO preview: With expectations jacked up, Akeso's ivonescimab to face scrutiny in high-stakes plenary

This week's episode is sponsored by IQVIA Biotech.

Built for biotech innovators, IQVIA Biotech is a full-service CRO, designed for agility, fast decisions, and the urgency needed for emerging biopharma. With dedicated teams and deep therapeutic expertise, we help move programs forward with focus and confidence. Visit IQVIABiotech.com

See omnystudio.com/listener for privacy information.

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 discussion focuses on mesutoclax, a novel oral BCL‑2 inhibitor evaluated in combination with azacitidine. Dr. Zeidan breaks down early findings showing a 100% objective response rate with CR rate of 40% per IWG 2006 criteria and 90% composite complete response with CR in 60% in treatment‑naïve high‑risk MDS, along with strong efficacy and encouraging safety signals in AML, with over 80% composite CR, and with potent activity in TP53 mutant, as well as zero death within 30 or 60 days and rapid cytopenia recovery.

Listeners will hear how mesutoclax’s potency, selectivity, and pharmacokinetic profile may overcome key limitations of existing BCL‑2 inhibitors, and what these results could mean for future frontline treatment strategies.

See omnystudio.com/listener for privacy information.