The Top Line

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. In this week’s episode of "The Top Line," Fierce Pharma’s Angus Liu chats with Harpreet Singh, M.D., chief medical officer at Precision for Medicine and a former director of the FDA's Division of Oncology, about a recent article by FDA officials led by CBER Director Vinay Prasad, M.D., laying out the agency’s perspective on its regulation of autoimmune CAR-T therapies. Singh discusses how the agency’s "case-by-case" approach, as indicated in the article, could be similar to—and different from—CAR-T for oncology indications. She also talks about how drug developers should follow existing development experience, as well as prepare for specific requirements for long-term patient follow-up and potential new clinical endpoints from the agency. To learn more about the topics in this episode: FDA signals tailored approach to ‘carefully shepherd’ CAR-T therapy for autoimmune diseases Kyverna gains clear view to first CAR-T approval for autoimmune disease after 'truly remarkable' SPS readout Cabaletta CAR-T wipes out B cells without preconditioning in small autoimmune trial See omnystudio.com/listener for privacy information.

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, competition for specialized sterile fill expertise is intensifying. Johnson explains why segmentation and specialization are becoming critical differentiators in the CDMO space, particularly as biologics pipelines expand and product launches accelerate. He also shares how GRAM is investing in new facilities, high-volume syringe and cartridge capabilities, and workforce development to stay ahead of client demand while maintaining compliance and flexibility. For B2B healthcare professionals, marketers and payers seeking clarity on supply chain resilience and manufacturing strategy, this episode delivers timely insight. Listen now to explore how leading CDMOs are preparing for the next wave of sterile manufacturing demand.See omnystudio.com/listener for privacy information.

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 2026 and 2027, according to a recent outlook from Atradius. In this week’s episode of "The Top Line," Fierce Pharma’s Fraiser Kansteiner speaks with Brady McKinney, an underwriter for Atradius' pharmaceuticals sector focusing on the Americas, about the credit insurer's recent industry report. McKinney explains how tariff concerns drove last year’s manufacturing surge and why Atradius expects a period of stabilization ahead. He also discusses how companies are weighing the risk of future trade flare-ups and what that could mean for production, investment and credit conditions across the sector. To learn more about the topics in this episode: Global pharma manufacturing output surged in '25 in 'front-loading' response to US tariff threats: report FDA emphasizes drug ingredients, production pledges as it debuts PreCheck manufacturing program In quick reversal, Trump calls off tariff threat related to Greenland pursuit 3 biopharma CEOs explain why they are 'authentically optimistic' for 2026 See omnystudio.com/listener for privacy information.

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 pharmaceutical companies, health plans and government, including his time as a senior drug pricing advisor during the first Trump administration. He explains why prescription drugs remain a focal point in cost debates, what policymakers often misunderstand about value, and how middlemen and misaligned incentives affect what patients pay at the pharmacy counter. The conversation also examines emerging approaches such as direct-to-patient models, most-favored-nation pricing and the early effects of the Inflation Reduction Act, highlighting potential benefits as well as risks to access and future innovation. For healthcare professionals, payers and marketers seeking clarity in a complex policy environment, this episode offers a grounded perspective on how to ensure medical breakthroughs translate into meaningful patient benefit. Listen to the full interview.See omnystudio.com/listener for privacy information.

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 share of high-profile misses, reflecting the reality that many of the industry’s most ambitious late-stage programs now sit inside big pharma portfolios. On this episode of "The Top Line," Fierce Biotech's James Waldron and Fierce Pharma's Fraiser Kansteiner discuss the failures that stood out in 2025 and what they suggest about the challenges facing drug development. To learn more about the topics in this episode: 2025's top 10 clinical trial flops Sanofi ousts Paul Hudson after 'bumpy ride,' enlists Merck KGaA CEO to lead the French pharma See omnystudio.com/listener for privacy information.

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 patients, providers and the industry. Kaminsky explains how advances in cancer science have transformed many diagnoses into long-term conditions, increasing the need for accessible, high-quality care in local communities. He discusses the challenges community practices face as innovation accelerates, including evolving reimbursement models, operational pressures and the adoption of new technologies. The conversation also explores the role of community oncology in expanding access to clinical trials and accelerating research, as well as how artificial intelligence is being used to improve both clinical and administrative workflows. Kaminsky shares his outlook on the next five to 10 years of cancer care and why supporting community oncology will be critical to continued progress. Listen to the full interview to learn more.See omnystudio.com/listener for privacy information.

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 candidates from the likes of Gilead Sciences, Johnson & Johnson, AstraZeneca and other biopharmas big and small, spanning a range of indications from breast cancer to essential tremor. All together, predicted 2032 sales for the year’s top 10 weigh in at nearly $46 billion. In this week’s episode of “The Top Line,” Fierce’s Andrea Park and Gabrielle Masson dive into the report, mapping out how it stacks up against last year’s edition and digging into the enormous sales potential of the top two drugs on the list. To learn more about the topics in this episode: Top 10 most anticipated drug launches of 2026 Novo Nordisk stock crashes after CagriSema misses phase 3 weight-loss goal Lilly's obesity pill largely maintains weight lost on injectable GLP-1s Top 10 most anticipated drug launches of 2025 See omnystudio.com/listener for privacy information.

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 Product Monograph (https://files.mirumpharma.com/livmarli/livmarli-product-monograph-en.pdf) Learn more about the latest research for Mirum’s investigational therapies: MRM-3379 (https://mirumpharma.com/wp-content/uploads/2025/09/FXS-NDD-2025-Mouse-Model-Poster_FINAL.pdf), volixibat in PSC (https://s29.q4cdn.com/633867992/files/doc_presentations/2024/Jun/Mirum-VISTAS-and-VANTAGE-Interim-Analysis-Results-Presentation.pdf) and PBC (https://mirumpharma.com/wp-content/uploads/2025/05/Heneghan-M-EASL-2025-VANTAGE-28-week-data-with-volixibat-in-PBC.pdf), and brelovitug (https://www.natap.org/2025/AASLD/AASLD_22.htm). LIVMARLI is also currently being evaluated in the Phase 3 EXPAND study (https://clinicaltrials.gov/study/NCT06553768) in additional settings of cholestatic pruritus. References What is hepatitis delta? Hepatitis B Foundation. Accessed January 14, 2026. https://www.hepb.org/research-and-programs/hepdeltaconnect/what-is-hepatitis-delta/ Agarwal K, Jucov A, Dobryanska M, et al. Brelovitug (BJT-778) monotherapy achieved 100% virologic response in patients with chronic hepatitis D: on treatment week 48 phase 2 study results. Presented at: AASLD 2025; November 7-11, 2025; Washington, D.C. Sagnelli C, Sagnelli E, Russo A, Pisaturo M, Occhiello L, Coppola N. HBV/HDV co-infection: epidemiological and clinical changes, recent knowledge and future challenges. Life (Basel). 2021;11(2):169. doi:10.3390/life11020169 Negro F, Lok AS. Hepatitis D: a review. JAMA. 2023;330(24):2376-2387. doi:10.1001/jama.2023.23242 Hunter J, Rivero-Arias O, Angelov A, Kim E, Fotheringham I, Leal J. Epidemiology of fragile X syndrome: A systematic review and meta‐analysis. doi:10.1002/ajmg.a.36511 See omnystudio.com/listener for privacy information.

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, while addressing the limitations that can undermine quality and trust. Panelists share real-world examples showing how different tools can produce conflicting results and why expert review is required to ensure accuracy and relevance. Listen to the full interview to gain insight into how organizations can harness AI’s efficiency while keeping scientific rigor and the human perspective at the center of their work.See omnystudio.com/listener for privacy information.

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 well as global deal advisory and strategy leader for health and life sciences at KPMG, to discuss the firm’s latest industry outlook. Pothier also explains how drugmakers are cutting through the noise and reflects on the technology, indication and valuation factors shaping today’s dealmaking appetite. To learn more about the topics in this episode: 2026 forecast: After a surge of M&A in Q4, will the trend continue? Halozyme catches M&A wave to snap up Surf Bio in delivery tech deal worth up to $400M Global pharma manufacturing output surged in '25 in 'front-loading' response to US tariff threats: report In quick reversal, Trump calls off tariff threat related to Greenland pursuit See omnystudio.com/listener for privacy information.

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 in San Francisco. The conversation offers an early look at the themes and questions that could shape the year ahead. To learn more about the topics in this episode: All the meetings, none of the megadeals: Is JPM's purpose evolving? JPM26: What’s in a biopharma? CEO says Teva has the goods JPM26: Astellas CEO resists 'rescue BD' as $6B Xtandi patent cliff nears See omnystudio.com/listener for privacy information.

As payers focus on long-term outcomes and real-world performance, value matters more than ever. RTI Health Solutions experts discuss how clear evidence storytelling drives access decisions.See omnystudio.com/listener for privacy information.

In early 2025, the FDA was rocked by sweeping layoffs and leadership turnover, raising questions about whether the agency could maintain its pace in reviewing new drug applications. By the end of the year, the approval picture told a more complicated story, with momentum building after a slow start. This week on "The Top Line," we dig into what the numbers really show, which companies and therapies came out on top, and what the FDA’s performance over the course of 2025 signals for the drug review process going forward. To learn more about the topics in this episode: 2025 drug approvals: Despite FDA tumult and macro uncertainty, biopharma scored with 55 new products 2024 drug approvals: Small companies loom large with several key FDA nods 2023 drug approvals: After a down year, FDA signs off on a bounty of new meds, including 7 from Pfizer See omnystudio.com/listener for privacy information.

What does it really mean to put patients first in today’s life sciences landscape? In this sponsored episode of The Top Line, leaders from RTI Health Solutions explore how patient voices are transforming evidence generation, market access and medical communication. From patient-reported outcomes and advisory boards to inclusive value storytelling and trust-building across diverse communities, the discussion highlights why patient-centric strategies are no longer optional—and how they can influence approval, reimbursement and real-world impact.See omnystudio.com/listener for privacy information.

As artificial intelligence continues to dominate conversations across life sciences, many companies are reaching an inflection point between experimentation and real-world impact. In a recent episode of The Top Line, Mark Sullivan, president of regulated industries at Salesforce, said the industry is moving past broad promises toward a clearer divide between organizations that have laid the groundwork for AI and those still struggling to operationalize it. While early pilots have delivered mixed results, Sullivan said the next phase will be defined by how effectively companies use AI to augment their workforce, not replace it. Much like laptops or smartphones, AI proficiency is quickly becoming a baseline expectation for professionals, shaping productivity, decision-making and resilience across drug development, manufacturing and commercialization. Sullivan emphasized that success with AI agents hinges on trust, governance and high-quality data—particularly in an industry where accuracy and compliance are nonnegotiable. Life sciences organizations are beginning to see value in agents that support patient engagement, clinical trial matching and commercial execution, but only when those agents are grounded in enterprise data and clear guardrails. With as much as 80% of industry data unstructured, he said, the process of deploying agents often exposes deeper data and architecture challenges that must be addressed. Companies that solve for these issues can unlock both efficiency and growth, using AI not just to cut costs, but to strengthen patient relationships and drive innovation. The conversation offers a practical look at how life sciences leaders can move beyond the hype and build an agentic strategy that delivers measurable results—making it a must-listen for anyone navigating AI adoption in a regulated environment.See omnystudio.com/listener for privacy information.

China has moved from a fast-following biotech market to a source of globally competitive innovation, according to Josh Smiley, president and chief operating officer of Zai Lab. Speaking on The Top Line podcast, Smiley traces the country’s evolution over the past two decades, pointing to regulatory harmonization, expanded national insurance coverage and deepening R&D capabilities as key drivers. He said the most recent wave of Chinese biotechs is no longer focused solely on domestic opportunities but on first- or best-in-class medicines that can compete worldwide, particularly in oncology and immunology. Smiley also details how Zai Lab blends China’s patient access and development speed with global clinical and regulatory standards, a model he says has helped accelerate programs such as Zai’s DLL3-targeted antibody-drug conjugate for small cell lung cancer into late-stage trials. As China-sourced deals now account for a growing share of global biotech partnerships, Smiley argues companies that integrate China early — without treating it as a standalone market — will have a strategic edge. The conversation offers a candid look at what’s next for Zai Lab and why China’s expanding role in drug innovation is likely to reshape the global pipeline for years to come.See omnystudio.com/listener for privacy information.

After a turbulent 2025, the biopharma industry is heading into the new year with major questions still unresolved. A tough biotech investing environment, aggressive direct-to-consumer drug marketing and sweeping U.S. policy changes reshaped the landscape last year. Many of those pressures are expected to persist into 2026, even as early signs point to a thaw in venture capital. At the same time, the industry is testing whether DTC drug sales can meaningfully affect pricing for patients and whether broad manufacturing onshoring goals can realistically apply to advanced therapies like cell and gene treatments and radiopharmaceuticals. In this week’s episode of "The Top Line," Fierce Pharma’s Fraiser Kansteiner sits down with three biopharma CEOs to unpack what defined 2025 and what comes next. He’s joined by Thijs Spoor, CEO of Perspective Therapeutics; Brian Culley, CEO of Lineage Cell Therapeutics; and Rich Daly, CEO of Catalyst Pharmaceuticals. Together, they tackle issues from DTC sales and onshore manufacturing to drug pricing, regulatory uncertainty at the FDA and the broader innovations the leaders are most excited about this year. To learn more about the topics in this episode: 2026 forecast: After a surge of M&A in Q4, will the trend continue? Editor's Corner: Fierce Biotech's 10 most-read stories of 2025 What a year: Here are the stories that captivated our audience in 2025 Editor's Corner: The top 10 Fierce Pharma Marketing stories of 2025 2026 forecast: Pharma clicks with patients as direct sales model shifts marketing strategies See omnystudio.com/listener for privacy information.

As 2025 closes, biopharma and healthcare are learning to live on shifting ground. In this special year-end episode of "The Top Line," Fierce reporters take stock of a year defined by federal research cuts, vaccine policy fights and leadership churn at the FDA, then push the conversation forward into the questions that will shape 2026. The through line is that uncertainty has become an operating environment, and the industry is recalibrating in real time. Fierce Biotech’s Gabrielle Masson, joined by Darren Incorvia, traces how funding decisions can narrow the pipeline years before the consequences are visible. Fierce Pharma’s Fraiser Kansteiner sits down with Angus Liu and Eric Sagonowsky to unpack the new center of gravity inside federal agencies, where vaccine recommendations, review norms and new FDA pilots are colliding with questions about capacity and outside influence. From there, Ben Adams and James Waldron bring the lens to Europe, where Jefferies in London captured a cautiously optimistic market still wrestling with tariffs, pricing pressure and investment hesitation. The episode closes with Fierce Healthcare’s Heather Landi and Paige Minemyer sharing their outlook on 2026, from the fight over ACA subsidies and Medicaid headwinds to the next phase of AI adoption, where the promise is real but the payoff may be slower, messier and more uneven than the hype suggests. To learn more about the topics in this episode: 'Unprecedented turmoil' engulfing FDA threatens public health: mRNA coalition speaks out FDA names Tracy Beth Høeg, fresh from vaccine safety probe, as acting head of drug center A dozen former FDA commissioners blast Prasad's proposed vaccine policy changes In letter to Makary, biotech CEOs push for FDA stability and say volatility threatens US innovation NIH grant cuts have disrupted hundreds of clinical trials, study finds 'Alternative history' of the NIH shows how a 40% budget cut may thwart new medicines House passes healthcare affordability bill without subsidy extension AMA: A look at concentration in commercial insurance, MA markets 2025 Outlook: Hospital finances show signs of stability, but rising costs will be a major headwind See omnystudio.com/listener for privacy information.

Walgreens is emerging as a real-world evidence partner for the biopharma industry, according to a new episode of The Top Line, sponsored by Walgreens. In the conversation, Deepak Kuletha, who leads data management and analytics for the company’s biopharma services division, explains how Walgreens’ 9 million daily interactions and nationwide footprint generate rich insights into patient behavior, access barriers and therapy performance in the real world. Kuletha shares examples of how Walgreens helps pharma partners optimize drug launches, identify early adoption patterns, uncover affordability challenges and improve patient support programs—ultimately enabling faster, evidence-based decision-making. As real-world evidence grows more complex, Kuletha highlights how Walgreens’ advanced data management, privacy safeguards and emerging analytics tools—including machine learning and AI—help cut through the noise. These capabilities allow the pharmacy chain to synthesize de-identified data into actionable insights that reveal adherence risks, surface gaps in treatment understanding, and support earlier interventions. For life sciences professionals looking to understand how retail pharmacies are shaping the future of evidence generation, the episode offers a compelling inside look at the collaboration opportunities ahead. Listen to the full conversation to hear how Walgreens is turning scale into smarter, proactive patient care.See omnystudio.com/listener for privacy information.

Uncertainty reigned early this year with the inauguration of President Donald Trump and his threats to impose tariffs and slash prescription drug prices. But as players in the biopharma industry have gotten a better handle on the impact of these measures and the overall investment landscape, valuations have become more predictable and dealmakers have focused on larger, lower-risk acquisitions. The recent trends bode well for the business development landscape in 2026 and beyond. In this week’s episode of “The Top Line,” Arda Ural, EY Americas life sciences sector leader, joins Fierce Pharma’s Kevin Dunleavy to discuss the dealmaking landscape in the biopharma industry. They dig into the Federal Trade Commission’s scrutiny of M&A transactions, revitalized therapeutic areas, artificial intelligence investment and the emergence of China as an innovation powerhouse. To learn more about the topics in this episode: 2025 M&A up in value and deal count after year of 'conservatism and recovery': Leerink Partners After a 'reset' year for M&A, expect bigger deals in 2025: reports See omnystudio.com/listener for privacy information.

GCI Health, Fersen and Fierce Pharma, hosts Ryan Kurzman and Wendy Lund explore the fast-shifting landscape of cancer care with Pam Traxel of the American Cancer Society Cancer Action Network. Traxel outlines the growing complexity facing patients—from navigating an expanding range of treatment options to managing rising costs—and explains why access to reliable insurance remains one of the most urgent challenges. As she notes, even with groundbreaking innovation, patients still struggle with affordability, systemic barriers and an overwhelming amount of information that is not always credible or tailored to their specific diagnosis. The conversation also examines the evolving role of patient advocacy and the partnerships needed to drive meaningful change. Traxel emphasizes the importance of integrating lived experiences into policy, improving the credibility of patient-facing communication and strengthening early, ongoing collaboration between biopharma, policymakers and advocacy organizations. She also highlights two top priorities for U.S. cancer policy by 2030: reducing out-of-pocket costs and improving nationwide screening rates. For healthcare and life sciences professionals seeking deeper insight into how access, innovation and policy must intersect to improve patient outcomes, this is a must-listen episode.See omnystudio.com/listener for privacy information.

Research shows that women remain woefully underrepresented at the highest levels of leadership in the life sciences industry. Those who have broken through that glass ceiling, however, are not only doing groundbreaking work in pharma, biotech, medtech and beyond but also reframing what it means to be a leader in the sector—as evidenced by the often-unconventional career paths and management philosophies of the 10 women featured in this year’s Fiercest Women in Life Sciences report. In this week’s episode of “The Top Line,” Fierce’s Andrea Park and Gabrielle Masson dive into the report, highlighting several honorees’ paradigm-busting approaches to leadership, mentorship and building inclusive teams. To learn more about the topics in this episode: 2025's Fiercest Women in Life Sciences 4 reasons life sciences still fail women at the top, despite a female-majority workforce: report GSK's Emma Walmsley to step down as CEO in shock move, giving way to commercial lead Luke Miels Merck KGaA, grappling with geopolitical tensions, ⁠reveals CEO transition Takeda taps Julie Kim to take over for retiring CEO Christophe Weber See omnystudio.com/listener for privacy information.

Bayer is reshaping its pharmaceutical business with a new operating model designed to enhance collaboration and bring research & development and commercialization closer together. In a recent episode of The Top Line podcast, Bayer executives Christine Roth, Executive Vice President and Head of Global Product Strategy and Commercialization, and Dr. Yesmean Wahdan, Head of Medical Affairs for the United States and North America, discussed how the company’s Dynamic Shared Ownership framework is driving faster innovation and helping accelerate the development of new therapies for patients. The model removes traditional hierarchies, empowers cross-functional teams and encourages real-time collaboration across departments. Roth and Wahdan said the approach has already shortened regulatory timelines, reduced resource use and helped deliver treatments to patients sooner. By embedding commercial insights early in the research process, Bayer teams can anticipate market needs and focus on the greatest areas of unmet medical demand. The leaders said the company’s collaborative culture keeps patient benefit at the center of decision-making. To learn more about how Bayer’s model is transforming its pipeline, listen to the full episode of The Top Line. See more from Bayer’s Christine Roth and Dr. Yesmean Wahdan on their LinkedIn profiles below: Christine: https://www.linkedin.com/in/christine-roth-34b07b18/ Yesmean: https://www.linkedin.com/in/yesmean-h-wahdan-md-71409b199/ See omnystudio.com/listener for privacy information.

In this episode of The Top Line, Fierce’s Chris Hayden speaks with Foresight Diagnostics co-founders Dr. Jake Chabon and Dr. Max Diehn about how their company is delivering the next generation of minimal residual disease (MRD) detection in cancer care. Born from research at Stanford University, Foresight’s PhasED-Seq technology delivers ultra-sensitive detection—down to parts per ten million—enabling clinicians to identify microscopic traces of cancer that traditional imaging misses. The discussion explores how Foresight’s MRD platform, CLARITY, can have the ability to support more confident decision-making, from determining curative success in early-stage cancers to guiding consolidation treatment in lymphoma. Chabon and Diehn highlight the company’s biopharma collaborations, clinical trial integration, and evidence-driven approach to guideline inclusion. They also look ahead to a future where MRD testing becomes central to oncology surveillance, accelerating therapy approvals and complementing genomic and digital pathology tools to advance precision medicine.See omnystudio.com/listener for privacy information.

In this week’s episode of "The Top Line," we take a deep dive into the top-line performance of the biopharma industry in the third quarter. After a slow start to the year, U.S. drugmakers in particular have recovered, led by Eli Lilly. We examine which companies are hot and which are not. We also look at trends that emerged in the third quarter, such as the shortfall in vaccine sales, especially in the U.S., and companies’ sales projections for the rest of the year. Fierce Pharma’s Kevin Dunleavy and Eric Sagonowsky discuss their observations from the third quarter and put the industry’s performance in perspective compared with previous quarters. They also examine the biopharma outlook for the fourth quarter. To learn more about the topics in this episode: Q1 biopharma layoff trends, plus expectations for Q2 7 top pharmas posted revenue declines in Q1. The common thread? All are US firms Several US pharma giants stage Q2 sales turnaround after subpar results earlier in year See omnystudio.com/listener for privacy information.

As the prospect of import tariffs and drug price reform marshals billions of biopharma investment dollars into the U.S., the feasibility of rapid domestic manufacturing buildouts could hinge on a new program cooking at the FDA. How that program, dubbed PreCheck, will work in practice—and on what timeline—are key questions as the U.S. looks to bolster its local pharmaceutical production base. This week on “The Top Line,” we dive into comments from a recent public meeting on the industry’s hopes for PreCheck, which is being designed to streamline the process by which new biopharma manufacturing facilities are built in the U.S. Fierce Pharma’s Fraiser Kansteiner sits down with Christopher Shilling, chief regulatory officer at gene therapy CDMO Forge Biologics—who attended the meeting—to offer an on-the-ground perspective and explore the aspects of the plan that could have the biggest impact on manufacturers. Shilling also outlines what he sees as FDA’s next steps, plus regulatory considerations that could most benefit CDMOs and the broader industry. To learn more about the topics in this episode: Amid tariff-fueled onshoring push, Trump signs order to boost US stockpiling of certain drug ingredients FDA launches generics pilot program, advances facility PreCheck proposal in bid to incentivize US drug manufacturing Amid pharma's US investment spree, FDA unveils new program to streamline domestic plant build-outs Trump signs executive order to boost US drug manufacturing amid threat of tariffs See omnystudio.com/listener for privacy information.

The healthcare marketing landscape is evolving fast — shaped by regulatory shifts, patient empowerment, and the rise of digital health marketplaces. In this episode of The Top Line, sponsored by Havas Media Network, host Chris Hayden sits down with Holly Dunn, Managing Partner of Performance at Havas Media Network, to explore how pharma brands can redefine patient engagement for a more connected, equitable future. Dunn explains how first-party data, AI-driven intent signals, and curated health marketplaces are enabling more compliant, transparent, and human-centered campaigns. She also discusses the growing role of healthcare creators, the fight against misinformation, and strategies to ensure high-quality, privacy-safe engagement across the patient journey. If you’re in pharma or biotech marketing, this conversation offers critical insight into how leading brands are building trust and equity in an increasingly complex environment.See omnystudio.com/listener for privacy information.

Welcome to the Fierce Biotech Graveyard, our annual ritual remembering the biotechs we lost in 2025 and those on the brink. In this episode, Fierce Biotech’s Darren Incorvaia and Gabrielle Masson came together to chat about themes from this year’s graveyard, including a cell therapy mausoleum, some mad science, and Darren’s incredibly dated reference to a novelty song from 1958. To learn more about the topics in this episode: The 2025 Biotech Graveyard See omnystudio.com/listener for privacy information.

This week's episode of "The Top Line" features a discussion about what’s working now in biotech and what isn't. Recorded Oct. 7 at Fierce Biotech Week, this panel featuring leaders from past Fierce 15 winners digs into timelines, partnerships, what's hype, what's signal and how teams are pressure-testing their models in today's market. You'll hear from Generate Biomedicines CEO Mike Nally, Arbor Biotechnologies Chief Scientific Officer John Murphy, Epicrispr Biotechnologies CEO Amber Salzman, Ph.D., and Parabilis Medicines Chief Business Officer Greg Miller. The conversation was moderated by Fierce Biotech's Gabrielle Masson. To learn more about the topics in this episode: Fierce Biotech's 2022 Fierce 15 Fierce Biotech's 2023 Fierce 15 See omnystudio.com/listener for privacy information.

Life sciences organizations are facing both intense pressure and extraordinary opportunity, according to Mark Sullivan, president of regulated industries at Salesforce. In a conversation with The Top Line’s Chris Hayden, Sullivan said companies too often operate in “survival mode,” focused on defending margins rather than leading innovation. But with the rise of AI and agentic technologies, he said, the industry is poised for a transformation that could reshape how drugs are developed, trials conducted and patient data used — all at greater speed and lower cost. Sullivan emphasized that this new era requires rethinking how companies engage with stakeholders. Instead of distant, one-way interactions, he said, agentic AI enables dynamic, conversational relationships that improve satisfaction and generate actionable insights. Salesforce, he noted, is expanding beyond its CRM roots to help life science enterprises become “agentic” organizations — integrating secure, compliant AI systems across finance, HR and supply chains. With data security and trust at the core, Sullivan called on leaders to look beyond software replacement and pursue true digital transformation for the good of patients and the industry alike.See omnystudio.com/listener for privacy information.

The FDA made waves in early September when it announced a plan to publicly release complete response letters (CRLs) at the same time they are issued to sponsoring companies, part of what the agency calls a push toward “radical transparency.” At the same time, the FDA released 89 new CRLs, adding to the more than 200 that were previously made public in July and shedding more light on the agency’s often opaque review process. That earlier document dump, though, only included rejection letters for drugs that were eventually approved. Now, for the first time, the agency is releasing CRLs for unapproved drug candidates—including recent high-profile rejections such as Ultragenyx’s gene therapy for Sanfilippo syndrome type A, Capricor Therapeutics’ Duchenne muscular dystrophy cell therapy and Replimune’s melanoma drug. Publicly airing the rationale for rejecting drug candidates is a significant shift for the FDA and a potential cause for concern for the biopharma industry. To unpack what the new policy means for drug developers, Fierce Biotech’s Darren Incorvaia sat down with Torrey Cope, a lawyer with Sidley Austin who represents and advises life sciences companies on issues related to the FDA. To learn more about the topics in this episode: FDA releases ‘initial batch’ of more than 200 drug rejection letters FDA moves to publish drug rejection letters in real time, releases new batch including Replimune's high-profile snub FDA misinterpreted efficacy data that prompted DMD rejection, Capricor claims ‘Weak’ evidence and an ‘unpleasant’ odor: FDA sheds light on drug refusal process 'Several concerning observations': FDA sheds more light on reasons it rejected drugs See omnystudio.com/listener for privacy information.

With a new president of U.S. pharma at the helm—and two key FDA approvals now in the books—Boehringer Ingelheim is sharpening its focus on the lucrative American market. In this week’s episode of “The Top Line,” we dive into Boehringer Ingelheim’s latest regulatory successes, two crucial launches, and the German company’s expanding commercialization push in the U.S. Fierce Pharma’s Fraiser Kansteiner sits down with Brian Hilberdink—who joined Boehringer as president of U.S. human pharma in February—to discuss his game plan to further unlock the American market and capitalize on key BI green lights in idiopathic pulmonary fibrosis and lung cancer. To learn more about the topics in this episode: Boehringer Ingelheim breaks into oncology with FDA approval for lung cancer med Hernexeos Boehringer Ingelheim breathes new life into lung fibrosis field with FDA approval for Jascayd 'Crossing fingers': Boehringer awaits key FDA decisions to spearhead 'maturing' pipeline Chutes & Ladders—Boehringer snatches up LEO exec for US pharma team See omnystudio.com/listener for privacy information.

Artificial intelligence is reshaping drug safety, but governance is just as critical as innovation, according to Marie Flanagan of IQVIA Safety Technologies. Speaking on The Top Line podcast, Flanagan said responsibility for AI in healthcare must be shared across compliance, technology, business teams and regulators. Strong governance, she said, ensures AI systems are ethically designed, technically validated, transparent and adaptable to continuous oversight. Organizations can prepare by grounding their strategies in guiding principles such as human oversight, fairness and accountability, Flanagan said. She emphasized the need to embed governance in AI design from the start, rather than adding controls later. Compliance teams, she added, can shift from being seen as barriers to acting as enablers of safe innovation. From constant monitoring to feedback loops, the conversation highlights practical steps for managing AI in life sciences. Hear the full episode of The Top Line for a deeper look at how companies can balance innovation and responsibility.See omnystudio.com/listener for privacy information.

Tariffs, drug pricing reform, a government shutdown and a major turnover at one of the world’s largest drugmakers all converged this week, leaving plenty to unpack for the industry as it heads into fall. Greater clarity on President Donald Trump’s tariff and pricing strategies has likely come as something of a relief for those companies operating in the U.S., but that news was tempered by a shutdown of the federal government on Wednesday. Meanwhile, big changes are likely on the way at GSK, whose longtime CEO Emma Walmsley is headed for the exit. In this week’s episode of "The Top Line," we break down some of the biggest stories across Fierce Pharma for the week—which may very well be some of the biggest stories of the year—touching on critical policy updates in the U.S., the furloughing of federal employees at agencies like the FDA and NIH and the imminent departure of GSK’s chief executive. Fierce Life Sciences’ Ben Adams sits down with Fierce Pharma's Fraiser Kansteiner to discuss the latest headlines and go over the key points from each major development that has played out. To learn more about the topics in this episode: FDA avoids the worst amid government shutdown, but new applications put on hold NIH research grinds to a halt as government shuts down Pfizer offers price concessions, $70B US outlay in Trump's 'most favored nation' push Trump's pharma tariffs on hold amid administration's effort to secure pricing concessions, industry investment: Stat GSK's Emma Walmsley to step down as CEO in shock move, giving way to commercial lead Luke Miels See omnystudio.com/listener for privacy information.

Despite a challenging year, the biotech industry has continued to push boundaries, taking bold risks in pursuit of groundbreaking science. If anything, this year has only strengthened our conviction in the rising stars leading the next wave of innovation. Fierce Biotech’s Fierce 15 class of 2025 is defined by their resilience, diversity in both strategy and leadership, and treatments that hold life-changing potential for underserved patients around the world. In this week’s episode of "The Top Line," Fierce Biotech’s Gabrielle Masson and Fierce Pharma’s Andrea Park discuss what went into picking this year’s winners and some highlights from the special report. To learn more about the topics in this episode: Introducing Fierce Biotech's 2025 Fierce 15 See omnystudio.com/listener for privacy information.

Trust in pharma has always been fragile, and the rise of misinformation has made it even more precarious. In this episode of "The Top Line," recorded at Fierce Pharma Week in Philadelphia, Freda Lewis-Hall, M.D., joins us to share how she has worked to put a human face on the industry. A psychiatrist, longtime patient advocate and former Pfizer chief medical officer, she explains why listening must come before messaging, how AI and omnichannel outreach can help or harm patient trust and why rebuilding credibility starts one conversation at a time. To learn more about the topics in this episode: TV ads close to overtaking doctors as consumers' primary source for learning about new meds: survey Pharma's reputation is stable-ish. Will that survive Trump 2.0? ABPI finds familiarity breeds trust, supporting push for industry-healthcare collaborations Doctor Mike calls on healthcare, pharma leaders to lean into social media to rebuild trust with patients See omnystudio.com/listener for privacy information.

Robert Abel, chief scientific officer at Schrödinger, says advanced computational tools are changing the pace and accuracy of drug discovery. In a recent episode of The Top Line podcast, Abel outlined three areas where AI and machine learning are making the greatest impact: understanding disease biology, predicting protein structures and designing drug molecules. Schrödinger’s platform uses physics-based simulations alongside AI to evaluate millions of molecules in days, compared with the thousands traditionally synthesized in a year. Abel pointed to real-world results, including a program that reached a clinical trial candidate in just 10 months — far faster than industry averages. He said the technology also helps overcome challenges such as improving drug selectivity and reducing the need for animal testing, aligning with FDA priorities. Abel will share more insights during his upcoming talk at AAPS PharmSci 360 in San Antonio this November. His session abstract is available here. To hear more about Schrödinger’s work in computational drug discovery, listen to the full interview.See omnystudio.com/listener for privacy information.

With Pfizer discontinuing Beqvez and BioMarin scaling back the commercial focus of Roctavian, the curative promise of hemophilia gene therapies is tempered by significant barriers that discourage widespread adoption. In this week’s episode of “The Top Line,” Fierce Pharma’s Zoey Becker speaks with Glenn Pierce, M.D., Ph.D., vice president of medical at the World Federation of Hemophilia, about the complexities behind these innovative therapies and the multifaceted reasons for their slow uptake. Pierce discusses the competitiveness of the current hemophilia gene therapy market, why Pfizer’s product couldn’t keep up, and the patient populations that risk being left behind. To learn more about the topics in this episode: As Pfizer backs out of hemophilia gene therapy space, CSL hopes Hemgenix is here to stay Pfizer discontinues hemophilia treatment Beqvez, emptying its gene therapy portfolio BioMarin downsizes Roctavian efforts but keeps hemophilia gene therapy for 3 markets See omnystudio.com/listener for privacy information.

Hope, when applied with purpose and action, can be a powerful force for driving change in healthcare. That’s the philosophy of Eugene Woods, CEO of Advocate Health and a 2025 Fierce 50 honoree, who joins Ayla Ellison, Editor-in-Chief of Fierce Life Sciences & Healthcare, to share how he puts “Applied Hope” into practice. Woods explains how this approach combines optimism with action and why it’s become a guiding strategy for one of the nation’s largest nonprofit health systems. In their conversation, Woods discusses leading through massive organizational change, cultural transformation and the rapid adoption of new technologies. He offers insights on improving quality and affordability, investing in both rural communities and urban neighborhoods and preparing for a future shaped by AI and more human-centered healthcare delivery. To learn more about the topics in this episode: Fierce 50 of 2025 Eugene A. Woods—Fierce 50 Leadership Honoree See omnystudio.com/listener for privacy information.

In the latest episode of the Health Matters podcast, former Food and Drug Administration Commissioner Scott Gottlieb joins WPP’s Wendy Lund, GCI Health’s Ryan Kuresman and Burson’s Judy Stecker to discuss the forces reshaping U.S. health policy. Gottlieb warns that while new laws such as the Inflation Reduction Act may lower government spending on drugs, consumers are unlikely to see significant relief at the pharmacy counter. Insurers’ tighter formularies and higher cost-sharing requirements, he said, could continue to drive affordability challenges for patients. The discussion also covers the future of direct-to-consumer advertising, FDA’s role in combating health misinformation and the promise of cell and gene therapies. Gottlieb shares both caution and optimism — noting the risk of consumer frustration if policy changes fail to deliver savings, while pointing to breakthroughs that are transforming treatment and outcomes. To hear his full take on the challenges and opportunities facing health care leaders, listen to the full Health Matters episode.See omnystudio.com/listener for privacy information.

After many U.S. biopharma companies posted sales declines in the first quarter, the domestic pharma industry largely bounced back to growth in the second quarter. In this episode of "The Top Line," Fierce Pharma's Eric Sagonowsky and Kevin Dunleavy break down the numbers behind the industry’s second-quarter performance. Among U.S. pharma heavyweights, J&J, AbbVie, Pfizer, Regeneron, Bristol Myers Squibb and Biogen each eked out gains this past quarter. Their results varied, with individual stories worth highlighting at each of these major companies. Beyond earnings, Sagonowsky and Dunleavy also discuss the growing competition in diabetes and obesity treatments between Eli Lilly and Novo Nordisk, as well as Merck’s rising financial reliance on its blockbuster cancer drug Keytruda, among other topics. To learn more about the topics in this episode: Several US pharma giants stage Q2 sales turnaround after subpar results earlier in year The battle of the obesity drug heavyweights 7 top pharmas posted revenue declines in Q1. The common thread? All are US firms Biopharma briefing: Q1 trends, gene therapy updates and ASCO preview See omnystudio.com/listener for privacy information.

While it’s been easy to grow a bit desensitized to the seemingly unstoppable sales growth of Novo Nordisk and Eli Lilly’s GLP-1s quarter after quarter, this most recent earnings season delivered a few surprises. It’s a good moment to jump back in and assess where the two rivals stand in the market and where their pipelines are headed in the near term. In this week’s episode of "The Top Line," we break down the recent commercial performances of Novo’s and Lilly’s drugs for diabetes and obesity, plus the status of their oral obesity med prospects. Fierce Biotech’s James Waldron sits down with Fierce Pharma’s Fraiser Kansteiner to discuss the latest in the companies’ ongoing obesity duel, as well as some recent pitfalls that seem common to GLP-1 development and commercialization more broadly. To learn more about the topics in this episode: Novo's outgoing CEO prepares to hand off business as sales threats from Lilly, GLP-1 compounders persist Amid MFN talks, Lilly chief warns US adoption of international drug prices could bring 'worst of two worlds' Novo Nordisk drops 2 obesity drugs as part of major pipeline clearout Lilly's oral GLP-1 data 'as good as it gets' at 12% weight loss, exec says Pfizer's embattled obesity program loses another GLP-1 over poor data and strong competition See omnystudio.com/listener for privacy information.

Following a barrage of letters from President Donald Trump urging 17 large pharmaceutical companies to implement Most Favored Nation drug pricing reforms in the U.S., analysts and industry watchers are questioning how far the president’s authority extends, while several drugmakers have signaled a willingness to negotiate. In this week’s episode of "The Top Line," we break down the latest Most Favored Nation pricing pressures in the U.S., how companies are responding and which facets of the proposal might fall short of Trump’s goals. Fierce Pharma’s Eric Sagonowsky and Fraiser Kansteiner discuss the current state of those reform efforts and past attempts to rein in U.S. drug costs, followed by a brief discussion on tariffs. To learn more about the topics in this episode: Pfizer CEO touts 'extremely productive' talks with Trump administration as MFN pricing, tariff threats close in White House threatens to 'deploy every tool in our arsenal' to implement most-favored-nation drug pricing All branded drugs not facing generic, biosimilar competition must abide by MFN order in 'all markets,' HHS tells pharma Trump ups the ante on pharma tariffs, saying they will reach 250% See omnystudio.com/listener for privacy information.

In the latest episode of Health Matters, vaccine expert Dr. Paul Offit joins host Wendy Lund to discuss the growing crisis of vaccine hesitancy and what can be done to rebuild trust. Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia, points to the COVID-19 pandemic as a turning point, citing perceived government overreach and widespread misinformation as key drivers of public distrust. He emphasizes that vaccine hesitancy is often rooted in reasonable concerns and calls on health care professionals to respond with empathy, not judgment. Offit also outlines steps the industry can take to regain credibility, including amplifying trusted community voices, improving science communication, and putting a human face on pharmaceutical innovation. He shares moving stories from the field, including one about Dr. Penny Heaton’s work to develop a rotavirus vaccine and bring it to children in need. “We all want the same thing,” Offit says. “Healthy children, protected from preventable diseases.” Listen to the full episode for more insights on how the health care sector can meet this moment with clarity and compassion. Disclaimer: All information provided on this podcast is for informational purposes only and does not constitute medical advice. You should consult with qualified healthcare professionals before making any decisions related to your health. Any opinions expressed are those of the individuals expressing them and do not represent the views of the podcast or its affiliates.See omnystudio.com/listener for privacy information.

Over a whirlwind three weeks, Sarepta Therapeutics has faced tough safety questions around its commercial gene therapy Elevidys and growing scrutiny over the company’s transparency following multiple patient deaths. In this week’s episode of "The Top Line," we explore Sarepta’s brief standoff with the FDA over Elevidys, a short-lived marketing pause, and the regulator’s surprise reversal on the treatment. Fierce Pharma’s Fraiser Kansteiner and Angus Liu sit down with Fierce Biotech’s Gabrielle Masson to recap the story and discuss the broader implications the Elevidys saga may have for gene therapy, the FDA and the pharmaceutical industry. To learn more about the topics in this episode: Sarepta pivots to siRNA and lays off 500 staffers as Elevidys gets box warning Sarepta LGMD trials all hit by FDA hold amid newly surfaced safety concerns over gene therapy Sarepta, bowing to FDA pressure, pauses shipments of Duchenne gene therapy Elevidys FDA takes U-turn on Sarepta's Elevidys, backing Duchenne gene therapy again in ambulatory patients Analysts demand transparency after Sarepta's roundabout disclosure of 3rd patient death Roche won't throw in the towel after DMD gene therapy Elevidys' rebuff in Europe See omnystudio.com/listener for privacy information.

With an uptick in licensing deals and promising data emerging from China-based biopharmas, especially in oncology, it’s clear the country is poised to play a major role in life sciences for the foreseeable future. In this week’s episode of "The Top Line," we trace China’s ascent in R&D and drug discovery and examine how U.S. and European drugmakers are capitalizing on the momentum through a surge in licensing activity. Fierce Pharma’s Fraiser Kansteiner sits down with Mark Lansdell, director at Evaluate, to break down the policies fueling China’s growth, how global companies are engaging with Chinese assets and which modalities and indications are commanding the most attention. To learn more about the topics in this episode: China approves 4 new drugs, including a global first-in-class medicine With China approval, Lilly and Innovent's mazdutide breaks into new class for GLP-1 obesity drugs China biotechs ‘reshaping’ US biopharma as outlicensing deals rise 11%: Jefferies report China proposes shorter clinical trial reviews in efforts to accelerate drug development See omnystudio.com/listener for privacy information.

In this episode of "The Top Line," Ayla Ellison, Editor-in-Chief of Fierce Life Sciences and Healthcare, sits down with two longtime industry leaders to talk about what it takes to stand out and grow in today’s pharma marketing landscape. Zoe Dunn, president and CEO of Hale Advisors, and Paul Murasko, head of digital innovation and marketing operations at Azurity Pharmaceuticals, reflect on how the industry has evolved—from print to digital to AI—and what early-career professionals need to know to thrive. As co-chairs of the Rising Stars program at this year’s Fierce Pharma Week, Dunn and Murasko share their insights on mentorship, innovation and how the next generation can navigate a highly regulated field while staying grounded in the fundamentals. To learn more about the topics in this episode: Fierce Pharma Week Information and Agenda Fierce Pharma Week Registration Rising Stars Program at Fierce Pharma Week See omnystudio.com/listener for privacy information.

Layoffs in biopharma show no signs of slowing, with workforce reductions holding steady across the first two quarters of 2025. In this week’s episode of "The Top Line," Fierce Deputy Editor Andrea Park and Fierce Biotech Senior Editor Gabrielle Masson break down the latest layoff trends and how they compare to last year. Tune in for a look at the numbers so far, the pace of biotech closures and how federal policy shifts are affecting the industry. To learn more about the topics in this episode: Biopharma layoffs for first half of the year jump 32% YOY Fierce Biotech Layoff Tracker 2025 See omnystudio.com/listener for privacy information.

In the latest episode of the Health Matters podcast, Wendy Lund sits down with Peter Pitts, former FDA associate commissioner and current president of the Center for Medicine in the Public Interest, to discuss the state of regulatory science and communication in health care. Pitts shares a cautiously optimistic outlook for the FDA under Commissioner Makary, noting the agency's renewed focus on innovation, patient engagement and modernization. He also stresses the importance of alignment among marketing, legal and regulatory teams—what he calls “regulatory therapy”—to ensure health communications serve the public good. The conversation spans high-stakes topics such as direct-to-consumer advertising, misinformation, and missed PDUFA dates, with Pitts urging both regulators and industry leaders to improve transparency and collaboration. He calls on pharmaceutical companies to put patients first in communications and avoid blaming the FDA when approvals stall. Pitts also encourages the agency to learn from industry on how to better engage the public. For more insights—and a candid look at where the health care conversation needs to go—tune in to the full episode.See omnystudio.com/listener for privacy information.

Two and a half years into his tenure as Teva’s CEO, Richard Francis is breaking down the strategy that’s powered the company through nine consecutive quarters of growth. On this week’s episode of "The Top Line," Fierce Pharma’s Fraiser Kansteiner sits down with Francis to talk about the progress made so far on Teva’s “Pivot to Growth” strategy and what comes next. They dig into the strategies behind the company’s chief commercial medicines, its pipeline darlings and the way Teva’s generic and biosimilar backbone is expected to evolve through the end of the decade. To learn more about the topics in this episode: As Austedo, Ajovy and Uzedy gain steam, Teva banks on $5B-plus in 2030 innovative drug sales Teva plots thousands of job cuts as restructuring drive enters 'acceleration' phase Teva taps Matthew Shields to oversee manufacturing and supply division amid company revamp This week's episode is sponsored by Cencora. See omnystudio.com/listener for privacy information.

Antibody drug conjugates, or ADCs, are still holding on to their spot as one of the hottest areas in cancer care—and AbbVie, like many of its peers, has embraced the trend head-on. In this week’s episode of "The Top Line," Fierce Pharma’s Zoey Becker speaks with Daejin Abidoye, M.D., AbbVie’s vice president and therapeutic area head for solid tumor oncology. They discuss the company’s evolution, trends from this year’s American Society of Clinical Oncology meeting and what’s ahead for ADCs in oncology. AbbVie, a newer player in the ADC space, recently earned FDA approval for Emrelis in adults with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who have previously received systemic therapy. With a robust pipeline of ADCs in development, Abidoye envisions a bright future for the class—one that could herald “a new era” of cancer treatment beyond traditional chemotherapy. To learn more about the topics in this episode: AbbVie advances solid tumor agenda with FDA nod for lung cancer ADC Emrelis AbbVie pays $10B to acquire ImmunoGen, doubling down on red-hot ADC cancer field Replacing chemotherapy with ADCs? AbbVie rebuilds next-gen assets after Rova-T flop See omnystudio.com/listener for privacy information.