The Top Line

In this week's episode of "The Top Line," we're looking at two companies building on recent successes and pursuing new opportunities in the pharmaceutical industry. From Teva's growing portfolio of innovative medicines to Novo's expanding reach in the GLP-1 market, both companies are looking to build on their momentum as they prepare for the next phase of growth. First, Fierce Pharma's Fraiser Kansteiner speaks with Christine Fox, Teva's executive vice president of U.S. commercial and head of its innovative medicines franchise, and Eric Hughes, M.D., Ph.D., executive vice president of global R&D and chief medical officer. They discuss the FDA's recent approval of Weltruza, a once-monthly injectable treatment for schizophrenia, lessons learned from the company's earlier rollout of Uzedy and how its growing portfolio of innovative medicines fits into its broader strategy. They also explain how Weltruza's formulation could help address unmet needs in schizophrenia treatment. Then, we turn to Novo and the…

Clinical AI is moving from systems that predict and summarize toward agents that can help execute parts of a workflow. In this sponsored episode of The Top Line, Will Hurth speaks with Saama’s Ari Srinivasan, chief customer success and growth officer, and Yatesh Midha, associate vice president of product management, about what that evolution could mean for clinical development. The conversation places AgentOS, Saama’s orchestration and governance layer, within a broader shift from disconnected AI tools to coordinated clinical workflows. A practical example explores how an agentic data manager could support SAE reconciliation by retrieving records from EDC and safety systems, comparing fields and presenting important mismatches with supporting evidence. The interview also considers what trusted use requires in a regulated environment: task-appropriate models, grounding, provenance, permission controls, transparency, auditability and human oversight. The central argument is not that agents replace clinical…

What if clinical development teams could evaluate potential trial outcomes before a study reaches patients? In this sponsored episode of The Top Line, host Irena Luo speaks with Raja Shankar, vice president for machine learning within AI and technology solutions at IQVIA, about a foundation model designed specifically for life sciences. Shankar explains why general-purpose models may overlook important relationships in patient and clinical trial data and how post-training on life sciences data can make AI more relevant to predictive decision-making. He explores how the model represents patients, diseases, treatments and endpoints, then applies those relationships to anticipate events across a patient journey. The conversation also examines the strategic role of study simulation, including how teams can compare scenarios, challenge assumptions and refine protocol decisions before a trial begins. Shankar addresses the evidence, transparency and expert oversight needed to build confidence in model outputs.…

What does it mean to be a Fierce 15 biotech in 2026? With this year’s list unveiled, the Fierce Biotech team gets together to discuss what the winners tell us about the state of the sector. In this week’s episode of "The Top Line," the Fierce Biotech editorial team reflects on the process of distilling more than 150 high-quality entries into the final Fierce 15 list. The team discusses how the ambitions of these companies are higher than ever and looks back on some of its conversations with the winners, covering everything from cutting-edge antibody research and novel fertility treatments to innovative ways to source radioisotopes. To learn more about the topics in this episode: Introducing Fierce Biotech's 2026 Fierce 15 Regeneron backs $75M series A for antibody upstart Infinimmune Sanofi-backed Expedition uses $115M series B to advance COPD drug on phase 2 journey Beacon lights path to FDA approval with pivotal trial win for rare vision loss gene therapy Fierce Biotech at London Life Sciences Week: Learn…

With GLP-1s paving the way, a consumer shift is happening across markets for certain branded pharmaceuticals. Now, the CEO of a buzzy pattern-hair-loss biotech is eyeing opportunities in an evolving market that could expand well beyond his own company. In this week’s episode of "The Top Line," Fierce’s Fraiser Kansteiner chats with Reid Waldman, co-founder and CEO of hair loss-focused biotech Veradermics. With impressive data on its reformulated minoxidil candidate and an upsized IPO earlier this year, Veradermics has generated significant interest in its approach. The company now hopes to tap into an increasingly consumer-minded market for certain drugs, a shift Waldman says could carry over to a range of indications and products. To learn more about the topics in this episode: A cut above: Veradermics locks in $256M IPO and shares spike Buzzy Veradermics shows its oral minoxidil can tackle female pattern hair loss, too Contraline and its male birth control candidate rally $92.5M amid push into 'massive…

Fierce Pharma Week brought thousands of people to Philadelphia for four days of conversations about pharma marketing, commercialization, medical affairs and communications. In this episode of "The Top Line," Fierce editors share the conversations, trends and moments that stood out from the event. Topics include Genentech’s use of humor and celebrity storytelling to raise awareness of diabetic macular edema, how Novo is navigating the extraordinary attention around GLP-1 drugs, and the growing role of AI in pharma marketing. The team also looks at some of the campaigns honored at the Fierce Pharma Marketing Awards and the creative approaches companies are using to reach patients and healthcare professionals. To learn more about the topics in this episode: ‘People like the sincerity of it’: comedian Damon Wayans on humor, relatability and DME awareness in… Standout pharma marketing takes the stage at the 2026 Fierce Pharma Marketing Awards Panthers and zebras and meerkats, oh my: A peek behind the curtain at…

Prediction markets are opening up new ways to bet on biopharma events, from clinical trial readouts to FDA approvals. But they also create a new set of risks for an industry where employees, researchers, contractors and others may have access to confidential information that could give them an edge. In this episode of “The Top Line,” Fierce Biotech’s Will Maddox talks with David Oliwenstein, a partner at Pillsbury Winthrop Shaw Pittman and former SEC enforcement attorney, about how regulators may approach misuse of nonpublic information in prediction markets, why biopharma could face heightened scrutiny and what companies should be doing now to reduce their risk. To learn more about the topics in this episode: Betting on biotech: Prediction markets set sights on clinical trials See omnystudio.com/listener for privacy information.

Clinical development organizations are facing mounting pressure to do more with increasingly complex protocols, larger data sets and tighter timelines. While automation has improved individual processes, many of the industry's most persistent delays continue to occur between tasks, systems and teams. In this sponsored episode of The Top Line, host Lauren Ledger sits down with Greg Lever, director of AI and Technology Solutions at IQVIA, to discuss why agentic AI is gaining attention across clinical operations. Lever explains how the conversation is shifting from task automation to workflow orchestration, with AI systems designed to coordinate activities, connect information and help reduce operational bottlenecks. The episode explores where sponsors can find the greatest opportunities for improvement, what it takes to move from pilots to enterprise-scale adoption, and how clinical roles may evolve as routine work becomes increasingly automated. The discussion also addresses the importance of data…

The promise of precision medicine depends on more than scientific innovation. It also depends on whether eligible patients can be identified, tested and connected to the most appropriate treatment. In this episode of The Top Line, host Kelly Hogan is joined by Susanne Munksted, chief growth officer at Diaceutics, and Jordan Clark, chief customer officer, to discuss why many diagnostic-driven therapies still fail to reach their full potential. Drawing on findings from Diaceutics' practice gap studies, the conversation explores where patients are being lost across the diagnostic pathway and why improvements in testing have not always translated into better treatment decisions. The guests discuss increasing healthcare complexity, expanding biomarker requirements and the challenges clinicians face when making treatment decisions under time pressure. See omnystudio.com/listener for privacy information.

Revolution Medicines recently made history with the approval of its RAS inhibitor Rasonque for advanced pancreatic cancer. But behind RevMed is an entire field of biotechs working to broaden the reach of RAS-targeting drugs. In this week’s episode of “The Top Line,” Fierce Biotech’s Darren Incorvaia sits down with Verastem Oncology CEO Dan Paterson and Chief Scientific Officer Jonathan Pachter, Ph.D., to discuss the significance of Revolution Medicines’ recent pancreatic cancer approval, Verastem’s work in the RAS-targeting space and how the company is trying to improve on existing approaches. To learn more about the topics in this episode: FDA greenlights Revolution Medicines' pancreatic cancer gamechanger As RevMed preps for ‘historic’ pancreatic cancer launch, questions linger on the ground ASCO: Revolution Medicines confident in RAS leadership as rivals square up AACR: Revolution sees pancreatic cancer win as 'tip of the iceberg' as RAS wave rises Fierce 50 of 2026: Breakthrough honoree Verastem Oncology…

The 2026 Fierce 50 includes people and organizations working on very different problems across biopharma and healthcare, from designing new proteins and developing cancer medicines to protecting vaccine science, improving health literacy and expanding representation in medicine. In this episode of “The Top Line,” Fierce Editor-in-Chief Ayla Ellison looks at the stories behind several of this year’s honorees, including Revolution Medicines’ work targeting RAS, the protein-design research of David Baker, Ph.D., and Michael Osterholm, Ph.D.’s, decision to put plans to step back from public health on hold. The episode also explores the work of Lisa Fitzpatrick, M.D., Hip Hop Public Health, Eric Topol, M.D., and Mary Owen, M.D., and the problems they have chosen to keep working on. See omnystudio.com/listener for privacy information.

As Fierce Pharma Week approaches, the Fierce Pharma Marketing team is taking stock of some of the biggest trends reshaping how drugmakers and healthcare agencies reach audiences. In this week’s episode of “The Top Line,” Fierce’s Ben Adams and Zoey Becker discuss how pharma marketing is evolving across social media, creative work and agency strategy. They dig into the changing approach to HIV marketing, pharma’s experiments with platforms including Snapchat, and what a collaboration with MrBeast says about the industry’s efforts to reach new audiences. They also examine how healthcare agencies are putting AI to work, pharma’s return to the winner’s circle at Cannes and why Novo Nordisk built a maze along the River Thames in London this summer. The conversation comes as Fierce Pharma Week approaches Sept. 14-17 in Philadelphia. To learn more about the topics in this episode: YouTuber MrBeast welcomes Amgen to the channel, kicking off pediatric cancer funding effort Inside agency view: Real Chemistry’s Frank…

Earnings calls are a chance to catch up with the latest developments across Big Pharma and beyond, and last quarter was no different. From the rollout of AI to the oral GLP-1 battle between Novo Nordisk and Eli Lilly and new leadership at Sarepta and Sanofi, it feels like the opportunities and challenges for biopharma have never been greater. In this week’s episode of "The Top Line," Fierce Pharma Senior Editor Fraiser Kansteiner and Fierce Biotech Senior Editor James Waldron share their takeaways from another whirlwind season of earnings calls. Alongside a Q2 scorecard breakdown, the Fierce editors discuss how several new CEOs are finding their footing, which drugs appear poised to cross the $1 billion sales threshold in 2026 and more. To learn more about the topics in this episode: Biopharma saw a Q2 sales boom led by Lilly, Sanofi, Regeneron and Astellas Sanofi’s new CEO ‘looking deeply’ at late-stage pipeline as clinical clearout continues Novo CEO has 'no doubt' on eventual share price recovery as…

Consumerization is changing how patients engage with healthcare, and pharma companies may need to rethink how they approach awareness, diagnosis and commercialization. In this sponsored episode of The Top Line, host Irena Luo is joined by Rachel Stoll, Managing Partner, Growth & Innovation at Princeton10, and Kevin Nalty, Vice President of Strategy at Princeton10, to discuss how evolving patient behaviors are reshaping the healthcare journey. Together, they explore the impact of GLP-1s, telemedicine, AI, wellness technologies and other low-friction healthcare experiences that are raising expectations for convenience and accessibility. The conversation examines emerging gaps between health awareness and clinical diagnosis, the role of wellness tools and health data, and why some patients delay or avoid care altogether. The guests also discuss opportunities for pharma brands to rethink disease awareness, improve navigation to diagnosis and treatment, and borrow engagement strategies from successful consumer…

Having spent 14 years building out its capacity, Regeneron Genetics Center—the genomic research branch of the Tarrytown, New York-based pharma—is a pro when it comes to the sort of target validation work central to the field today. Now, as RGC continues the massive expansion of its genetic database, the center’s unique ability to interpret that trove of data could give it an edge in the age of AI-powered drug development. In this week’s episode of "The Top Line," Fierce’s Fraiser Kansteiner sits down with Andy Deubler, chief business and administrative officer at Regeneron Genetics Center, to discuss the role RGC plays in the larger Regeneron model, as well as where the center could be headed as drug development pushes into new technological frontiers. Aside from the data interpretation advantage RGC believes it holds in the AI era, Deubler also discusses how the unit’s ongoing genetic research has helped deliver recent breakthroughs like the hearing loss gene therapy Otarmeni. To learn more about the topics…

Novo Nordisk’s second-quarter earnings results this week were closely watched by analysts and investors eager to see whether the rollout of oral Wegovy could neutralize concerns about the pharma’s pipeline. Fierce spoke to Novo’s chief financial officer, Karsten Munk Knudsen, to dig into the figures, including the reasons behind the company’s decision to raise its full-year guidance and the launch of oral Wegovy across Europe. In the candid conversation, Knudsen also reflected on Novo’s “rollercoaster” journey in obesity, his approach to pursuing long-term growth for the company and why he’s “still optimistic” about CagriSema despite recent setbacks. To learn more about the topics in this episode: Novo CEO accepts ‘couple of setbacks’ in R&D as CagriSema posts more mixed data Novo CEO has 'no doubt' on eventual share price recovery as Wegovy pill continues to wow ‘I’m a lot more optimistic today’: Mike Doustdar tells Fierce about pivotal first year as Novo Nordisk CEO See omnystudio.com/listener for privacy…

The future of patient support may depend less on how much data organizations collect and more on how effectively they connect, govern and activate it. In this sponsored episode of The Top Line, host Stephanie Butler speaks with ZS principals Asheesh Shukla and Kirti Prakash about the changing role of patient data in life sciences and what it will take to support more personalized engagement at scale. The conversation examines several shifts reshaping the industry, including the move from reactive care to proactive intervention, the growing role of AI-powered experiences and the increasing importance of trust, consent and compliance in patient engagement. As organizations invest in new technologies, the speakers contend that success will depend on creating connected data foundations that can deliver timely, actionable insights across the patient journey. Listeners will hear practical guidance on structuring data for actionability, building AI-ready capabilities and designing governance models that support…

The continued shift toward self-administered therapies is changing how pharmaceutical companies think about patient support. While access and affordability remain priorities, a growing share of industry attention is focused on the patient experience itself, particularly during the critical transition from prescription to successful treatment initiation. In this episode of The Top Line, Adam Shain, Vice President and Head of Business Transformation and Growth and Government Affairs Lead at Noble, an Aptar Pharma company, examines why patient onboarding, device training, and engagement strategies are increasingly being viewed as interconnected components of a broader patient experience. Drawing from Noble's work in self-administration support, Shain discusses the importance of incorporating patient insights into program design, the evolving complexity of at-home treatment models, and the industry's growing focus on adherence and long-term treatment success. See omnystudio.com/listener for privacy information.

Is biotech taking a trip to the world of psychedelic drugs? Why is Novo Nordisk going after Eli Lilly’s Zepbound ads? And what are peptides? This week on "The Top Line," Fierce's Zoey Becker, Will Maddox and Kevin Dunleavy chat about some of the biggest recent stories. From a psychedelics acquisition that could spark more movement in the emerging field to an advisory committee meeting on peptides shrouded in political controversy to a lawsuit between the two major obesity drugmakers, we’ll catch you up on the latest developments shaking up the biopharma world. To learn more about the topics in this episode: ‘A rising tide scenario’: Why other Big Pharmas could follow Lilly into psychedelics UPDATE: Peptides favored on 1st day of closely watched FDA compounding adcomm Peptide adcomm Day 2: Emideltide voted down in panel's 1st pushback Novo Nordisk files lawsuit accusing rival Eli Lilly of running ‘false and misleading’ GLP-1 ads Novo escalates Lilly false advertising suit with planned bid to halt comparative…

Medical affairs is at an inflection point. As science advances and healthcare professionals gain access to information in real time, medical teams face a mandate to deliver insight with greater speed, relevance and impact. In this episode of The Top Line, Josh Schwartz, Vice President of Medical Affairs, North America at BeOne Medicines, and Jalpa Shah, who leads the medical and evidence practice at ZS Pharma discuss what a modern medical affairs model requires. The conversation explores how the function is becoming a more strategic business driver and why traditional measures of activity are no longer enough to demonstrate value. The episode examines the structural challenges that continue to hold organizations back, including fragmented data systems, limited visibility into insights and the difficulty of translating engagement into measurable outcomes. It also looks at how artificial intelligence (AI) is reshaping workflows by helping teams generate insights faster, identify trends and inform next best…

This week on "The Top Line," Fierce Healthcare and Life Sciences' editor-in-chief steps behind the microphone for a solo episode highlighting several of the biggest stories in biopharma. The episode covers GSK’s first lung cancer approval following its acquisition of Nuvalent, Axiom Biosciences’ unusual plan to list first in Hong Kong before pursuing a Nasdaq co-listing amid a resurgent biotech IPO market, and the U.S. House’s passage of legislation directing the FDA to update its animal testing rules. The episode also includes an update from the Fierce newsroom, including the arrival of a new Fierce Biotech staff writer, and a reflection on why human judgment, curiosity and original reporting matter more than ever. To learn more about the topics in this episode: GSK secures first lung cancer approval as FDA clears Jideytro in quick payoff from Nuvalent deal ‘There is always a first’: Why US biotech Axiom will begin its IPO journey in Hong Kong House passes bill directing FDA to update animal testing rules…

Clinical trial success depends on more than scientific rigor and operational execution. It also depends on the financial systems that support every stage of a study. In this episode of The Top Line, Zahiah “Zee Zee” Gueddar, senior director of commercial strategy for the Clinical Trial Financial Suite at IQVIA Technologies, discusses why modernizing clinical trial finance has become a strategic priority for sponsors. As trials become more complex, fragmented systems and manual workflows are creating bottlenecks that limit visibility, delay payments and introduce unnecessary risk. Gueddar explains how these challenges affect site relationships, operational efficiency and study performance, and why organizations can no longer afford to treat finance as a disconnected administrative process. The conversation also highlights key indicators of readiness for transformation, from cross-functional alignment to executive sponsorship, and outlines the common pain points study teams face today. Ultimately, success…

Boston. San Francisco. Beijing? The global biotech industry has long been concentrated in a handful of cities. But which emerging hubs could become dominant forces in biotech in the decades ahead? In this week’s episode of “The Top Line,” Fierce Biotech’s Darren Incorvaia and Will Maddox discuss a new Fierce special report identifying five cities with the potential to become major forces in the global biotech industry. Did your favorite city make the cut? Listen to find out. To learn more about the topics in this episode: Top emerging biotech hubs in 2026 As US lawmakers increase scrutiny of Chinese trials, industry fears ‘huge distraction and expense’ British biotech VC funding shows ‘signs of recovery,’ but IPO rebound yet to materialize Could Basel be the next Boston? How the Swiss biotech hub is quietly raising its game 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…

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…

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…

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…

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…

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…

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…

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…

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…

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 specialty pharmacy and explains where the traditional model breaks down for patients and providers. He addresses common misconceptions about DTP, including the belief that it only works for cash-pay or consumer-driven drugs, and outlines how a single, seamless platform can support medications across therapeutic areas and price points. With experience guiding more than 7 million patients through their prescription journeys, Richardson discusses what manufacturers truly need from a DTP partner, how technology can accelerate time to therapy and why ease and transparency are becoming nonnegotiable expectations. He also…

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 innovation. Moderated by Senior Writer Darren Incorvaia, the discussion explores everything from funding pressures and talent trends to AI, clinical development and growing competition from biotech ecosystems around the world. Along the way, the panelists debate what the industry can learn from China's rapid innovation model, why investors and pharma companies have shifted toward clinically validated assets and whether biotech needs a fundamentally new operating model to accelerate drug development and bring breakthrough science to patients. To learn more about the topics in this episode: After 230% deal size explosion,…

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 Krishna GS, business technology solutions manager at ZS, about how first-launch and emerging companies can design an agentic future-ready technology road map. The conversation examines common pitfalls, including chasing new technology and AI trends before establishing data readiness, underinvesting in integration, and relying on fragmented point solutions. Raelin and Krishna explain why strong data foundations, governance, and interoperability are prerequisites for. and how agentic AI—when built on that foundation—can close the gap between insight and action in real commercial workflows. Listeners will also hear a…

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 longevity and age-related disease. She also breaks down BioAge’s oral NLRP3 inhibitor, BGE-102, which the company believes could have applications across cardiovascular, ocular and CNS diseases by targeting inflammation linked to aging biology. The conversation also explores why pharma companies are paying closer attention to aging and exercise biology, how GLP-1 drugs are reshaping conversations around prevention and what the future of aging-related medicine could look like. To learn more about the topics in this episode: BioAge CEO has big plans for 'multi-disease impact' of NLRP3 drug across cardio, ocular and CNS Novartis, BioAge take on…

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 survive, but to thrive in a new normal for the industry. In this episode of “The Top Line,” Fierce Pharma’s Fraiser Kansteiner chats with Glenn Hunzinger, PwC’s U.S. health industries leader, about results from the firm’s recent survey on investor sentiment. Focusing on health companies, Hunzinger explains how many innovative drugmakers have managed to capitalize on the shifting environment. Still, he warns that a more uncertain landscape for U.S. innovation and continued tariff pressures on sectors such as medtech could pose challenges down the line. To learn more about the topics in this episode: AstraZeneca CEO's conservative MFN…

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 accelerating development timelines. Dr. Boltres explains how West Synchrony addresses these challenges by offering a fully integrated system rather than a collection of individual components. By providing complete design verification data, system level specifications and a single global regulatory package, West enables developers to eliminate redundant testing, streamline submissions and move more quickly into clinical fill. The discussion highlights the benefits of single supplier accountability, improved supply security and reduced risk across development and commercialization. Designed for biologics and modern vaccines,…

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 episode of “The Top Line,” Fierce Pharma’s Fraiser Kansteiner sits down with Chris Young, a principal in KPMG’s trade and customs practice, to discuss the pharma tariff landscape following President Donald Trump’s announcement in early April of a potential 100% tariff on imported drugs. Young explains how the policy could affect smaller drugmakers that haven’t inked high-profile pricing deals with the government and shares best practices for navigating the rapidly evolving U.S. trade environment. To learn more about the topics in this episode: An update on the pharma industry’s reshoring effort Trump eyes 100% tariff rate for…

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 distribution is essential to delivering therapies on time. He also explores how building trust with physicians, care teams and patients requires education, consistent communication and reliable support at every stage of the treatment process. As theranostics expands into community settings, new challenges are emerging. Workforce shortages, training needs and the importance of standardized practices are key considerations for scaling safely. Patterson shares how industry collaboration can help address these gaps while maintaining high standards of care. He also outlines a future defined by greater access, reduced travel burdens and…

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 Ionis’ Novartis-partnered lipoprotein(a) candidate and AstraZeneca-partnered ATTR cardiomyopathy program. In this week’s episode of "The Top Line," Fierce’s Angus Liu interviews Ionis CEO Brett Monia, Ph.D. He discusses the science of antisense oligonucleotides, the significance of the two closely watched upcoming clinical readouts, and what it takes to turn a 30-year-old discovery platform into a full-fledged commercial biotech. To learn more about the topics in this episode: Ionis slashes Tryngolza's price tag by 93% ahead of anticipated label expansion 'It’s going to be huge': The…

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 discusses how Marken’s global network, combined with its air and ground fleet, connects clinical sites worldwide and expands access to diverse patient populations. She explains how enhanced tracking, integrated data systems and a 99.5% on-time performance rate support reliable, end-to-end visibility for lab partners. Dedicated account management and tailored logistics solutions further strengthen collaboration and help ensure regulatory requirements are met. The conversation also explores key trends shaping the future of clinical trial logistics, including increasing complexity, the rise of AI-driven…

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 between the UK and the U.S. Fierce Pharma’s Kevin Dunleavy explores the issue with Jeffrey Gerrish, who served as deputy U.S. trade representative for Asia, Europe and the Middle East during the first Trump administration. They break down the specifics of the UK-U.S. partnership and whether the deal could be applied to other countries to bring drug prices more in line with those in the U.S. They also discuss Trump’s other attempts to use America’s economic power to secure drug pricing agreements. To learn more about the topics in this episode: UK signs off on US pharma deal, ensuring tariff reprieve as Britain aims to reattract…

A closer look at how AI is helping pharma teams sharpen messaging, reduce bias and improve research outcomes.

Learn how to rescue suboptimal formulations, improve bioavailability and scale efficiently with next-generation ASD approaches.

Discover how biomarker strategies are transforming oncology trials and accelerating precision medicine breakthroughs.

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 learn more about the topics in this episode: After 230% deal size explosion, China is no longer the 'bargain basement' for biopharma licensing: analyst NIH grant cuts hit women, early-career scientists the hardest: analysis Roche pumps $480M into South Korea biopharma industry to establish global trial 'ecosystem' Lilly pledges $500M to South Korea biopharma industry, following Roche’s lead Pfizer-backed Priovant scores again with fast-rising brepocitinib in midstage study See omnystudio.com/listener for privacy information.

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, which companies moved up or down the rankings and whether any newcomers broke into the top 10. The conversation also explores the broader trends behind the budgets—what increased R&D investment signals about pipeline priorities, where companies may be pulling back and whether this year’s list reflects continued momentum or a plateau after several years of elevated spending. Listen to the full episode for a closer look at how the industry’s biggest players are allocating their R&D budgets—and what it could mean for the next wave of drug development. To learn more about the topics in this episode: The top 10 pharma R&D budgets of 2025…

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’s Eric Sagonowsky sits down with Rosemary Coates, executive director of the Reshoring Institute, to unpack where the trend stands today and what comes next. Coates explains why the pharma industry is uniquely positioned to bring supply chains back to the U.S., and the challenges companies face as they try to do it. To learn more about the topics in this episode: UCB unveils plan to build $2B biologics plant near its US headquarters in Atlanta Pharmas have promised $370B in US investments amid 2025's onshoring boom: DPR Global pharma manufacturing output surged in '25 in 'front-loading' response to US tariff threats: report…

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 episode of "The Top Line," the Fierce Pharma team breaks down Lilly’s recent HSBC downgrade, what it signals for the GLP-1 and obesity markets, and the data shaping the company’s next wave of diabetes and weight loss products. Fierce’s Eric Sagonowsky is joined by Kevin Dunleavy and Fraiser Kansteiner to unpack the latest and assess the commercial narrative around GLP-1s so far. To learn more about the topics in this episode: With downgrade, HSBC casts doubt about Lilly's 'stairway to heaven' trajectory Lilly's triple-G bet lowers blood sugar, prompts 16.8% weight loss in phase 3 diabetes trial Lilly's obesity triple…

Proactive coordination is essential to protect patients, sponsors and trial integrity, especially as teams navigate the new UK Clinical Trial Regulation. Hear why alignment matters more than ever.