Episodes

1d ago

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.

Dec 8

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.

Dec 5

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.

Dec 1

In this episode of Health Matters, GCI Health’s Ryan Kuresman and Health@WPP’s 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. 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. 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.

Nov 21

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.

Nov 17

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.

Nov 17

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.

Nov 14

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.

Nov 7

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.

Nov 3

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.

Oct 31

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.

Oct 24

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.

Oct 20

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.

Oct 17

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.

Oct 10

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.

Oct 6

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.

Oct 3

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.

Sep 26

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.

Sep 19

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.

Sep 15

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.

Sep 12

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.

Sep 5

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.

Sep 1

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.

Aug 22

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.

Aug 15

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.

Aug 8

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.

Aug 4

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.

Aug 1

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.

Jul 25

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.

Jul 18

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.

Jul 11

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.

Jul 8

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.

Jun 27

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.

Jun 20

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.

Jun 13

Every year, the Fierce Medtech team highlights 15 standout companies that are pushing the boundaries of innovation in medical technology. From reinventing diagnostics and surgical tools to advancing AI and biological research, this year’s Fierce 15 is full of startups rethinking what care should look like—and improving on what came before. In this episode of "The Top Line," Fierce Medtech Senior Editor Conor Hale breaks down the themes and standout trends from this year’s list, offering a closer look at the ideas and technologies reshaping the healthcare landscape. To learn more about the topics in this episode: Introducing Fierce Medtech's Fierce 15 This episode is sponsored by Cencora . See omnystudio.com/listener for privacy information.

Jun 6

Each year, the American Society of Clinical Oncology annual meeting brings together the biggest names and brightest minds in cancer research, and this year was no exception. In this episode of "The Top Line," Fierce reporters take you inside the action at ASCO 2025. Zoey Becker shares the story behind Johnson & Johnson’s dramatic “Breathtaking” campaign, staged on the 99th floor of Chicago’s Willis Tower. Angus Liu breaks down phase 3 data on Enhertu from AstraZeneca and Daiichi Sankyo, while Gabrielle Masson overviews Bicara Therapeutics' investigational asset for head and neck squamous cell carcinoma. Plus, the team compares notes from the ASCO exhibit hall. To learn more about the topics in this episode: ASCO: AstraZeneca, Daiichi flex Enhertu's muscles in first-line breast cancer as they drop new phase 3 gastric cancer data 'Our data is resonating far more with the people that matter,' Bicara CEO says amid Merus race ASCO: J&J highlights Rybrevant-Lazcluze combo in 'Breathtaking Moments' lung cancer campaign high over Chicago skyline See omnystudio.com/listener for privacy information.

Jun 2

In this episode of The Top Line , Fierce Biotech’s Chris Hayden sat down with Dr. Juergen Eckhardt of Bayer and Dr. Seth Ettenberg of BlueRock Therapeutics to discuss an innovative partnership that’s reshaping how big pharma teams up with biotech startups. BlueRock, a wholly owned subsidiary of Bayer, operates with the independence of a small biotech while benefiting from Bayer’s global reach and infrastructure. The “arm’s-length” model gives BlueRock the agility to innovate while leveraging Bayer’s resources in manufacturing, clinical trials and commercialization. The collaboration has already led to major milestones, including the development of a promising cell therapy for Parkinson’s disease, which is expected to enter Phase 3 trials later this year. “This isn’t just a partnership—it’s a relationship,” Eckhardt said. “We’re combining the best of both worlds: biotech speed and pharma scale.” The episode also explores how Bayer’s experience in biologics manufacturing has helped BlueRock overcome one of regenerative medicine’s biggest challenges—scaling complex cell therapies. The model has proven so effective that Bayer has since replicated it with other companies, signaling a broader shift in how the company approaches innovation. To learn more about this unique partnership and what it means for the future of neurological disease treatment, listen to the full episode of The Top Line . See omnystudio.com/listener for privacy information.

Jun 2

In the latest episode of The Top Line podcast, host Heath Clendenning interviews Cheryl Lubbert, CEO of Reverba Global, to discuss how science-led storytelling is reshaping communications in the pharmaceutical industry. Lubbert, a veteran executive with experience at Amgen, Abbott and Bristol Myers Squibb, says authenticity, empathy and transparency are now critical to rebuilding public trust. She argues that scientific data, when paired with real patient and caregiver stories, becomes more impactful—helping both healthcare providers and patients better understand and engage with treatments. Lubbert also highlights the growing importance of breaking down silos between marketing and medical affairs. By integrating these functions, she says pharma companies can provide more consistent, credible messaging and support shared decision-making in clinical settings. With real-world examples—from peer mentorship programs to immersive educational initiatives—Lubbert makes a compelling case for treating storytelling as a strategic tool, not just a creative one. For more on how these approaches are driving better outcomes, listen to the full episode of The Top Line . See omnystudio.com/listener for privacy information.

May 30

Despite the long holiday weekend, news in biopharma never slows down. In this week’s episode of "The Top Line," the Fierce team breaks down some of the biggest stories from the past week. On the pharma side, Eric Sagonowsky and Kevin Dunleavy examine Big Pharma’s first-quarter 2025 performance. While most of the top 25 companies are still delivering strong sales growth despite emerging uncertainties in Washington, D.C., a few major players are starting to see a slowdown. Each company tells a different story, and Sagonowsky and Dunleavy dive into the nuances of the current commercial landscape. Later, Fierce Biotech's Gabrielle Masson and Darren Incorvaia highlight key data from the American Society of Gene & Cell Therapy conference and preview what the team is watching at this week’s American Society of Clinical Oncology annual meeting. To learn more about the topics in this episode: Seven top pharmas posted revenue declines in Q1. The common thread? All are US firms Atsena eye disease gene therapy hits safety goals, closes retinal splits in phase 1/2 ASGCT: Analysts see Rocket gene therapy setting 'a new bar' for efficacy in heart condition Rocket crashes as gene therapy patient dies, FDA imposes hold This episode is sponsored by Cencora . See omnystudio.com/listener for privacy information.

May 16

President Donald Trump put the pharmaceutical industry on notice early Monday with the signing of his "most favored nation" (MFN) executive order on drug prices. The order seeks to tie U.S. prices to significantly lower costs overseas. Many questions remain about how the measure will be implemented, and legal challenges are almost certain. To assess the seriousness of the threat, Fierce Pharma assembled a team of reporters and editors to break down the executive order and the industry’s response. After examining the MFN executive order, the group dives into other recent policy developments in Washington, D.C., and beyond, including tariffs, Medicare drug price negotiations and more. To learn more about the topics in this episode: Trump signs sweeping executive order to cut US drug prices by 'up to 90%' Sanofi, Novartis CEOs lambast EU price control as Trump reportedly weighs drug cost parity with other nations As Trump threatens tariffs on drugs, industry warns EU of $100B-plus pharma exodus to US US net drug spending surged 11.4% last year, boosted by obesity and oncology meds: IQVIA This episode is sponsored by Cencora . See omnystudio.com/listener for privacy information.

May 9

Angela Hwang spent nearly three decades at Pfizer before joining Flagship Pioneering in 2025 as a CEO-partner and the CEO of Metaphore Biotechnologies. In this week’s episode of "The Top Line," the former Pfizer chief commercial officer speaks with Fierce Pharma Deputy Editor Angus Liu about her transition from marketing drugs at a Big Pharma company to advancing novel technology at a young biotech startup. Hwang discusses how her upbringing in apartheid-era South Africa—and two key lessons from her career—shaped who she is today. A longtime champion of diverse talent, she emphasizes that regardless of the broader environment or the size of an organization, it’s essential to ensure “everybody has a chance of developing in their careers and that they have a level playing field.” To learn more about the topics in this episode: 'We have not seen anything similar': Novo Nordisk pens $600M obesity pact with Flagship's Metaphore 2022's Fiercest Women in Life Sciences — Angela Hwang Done deal: Pfizer completes $43B acquisition of Seagen, doubling its oncology pipeline See omnystudio.com/listener for privacy information.

May 2

Although East Asians make up a significant share of entry-level roles in U.S. biopharma, few have risen to senior leadership positions. That disparity is what inspired the launch of ElevAAte—a new nonprofit founded this year to support and grow East Asian American leadership in the industry. In this week’s episode of "The Top Line," Fierce Pharma Deputy Editor Angus Liu speaks with two of ElevAAte’s co-founders: Architect Therapeutics CEO Angie You and Candid Therapeutics CEO Ken Song. The veteran biotech leaders discuss why a group like ElevAAte is needed and how East Asian Americans can harness their collective strength to build the next generation of biopharma executives. You and Song—who led Amunix’s $1.2 billion sale to Sanofi and RayzeBio’s $4.1 billion acquisition by Bristol Myers Squibb, respectively—also share insights from their dealmaking careers and offer advice for young professionals entering the field. To learn more about the topics in this episode: Though prevalent in the lab and middle management, East Asian Americans are underrepresented in biopharma C-suites: report Candid's T-cell engager shopping spree rolls on with WuXi Biologics pact worth up to $925M A reason to fight: Former FDA leader Janet Woodcock inspires 3rd Biotech Sisterhood summit Takeda taps Julie Kim to take over for retiring CEO Christophe Weber This episode is sponsored by Cencora . See omnystudio.com/listener for privacy information.

Apr 25

We’ve known for a while that there are two Anguses—both journalists covering oncology at health- and biopharma-focused news outlets. Now, for the first time, we’re bringing them together for a “Variety Studio: Actors on Actors”-style conversation. In this week’s episode of "The Top Line," Fierce Pharma Deputy Editor Angus Liu and STAT Cancer Reporter Angus Chen share insights into their work covering cancer and their thoughts on racial identity during a tumultuous time. They discuss what excites them most in the oncology field, how their reporting approaches differ and how they’ve often been mistaken for one another. To learn more about the topics in this episode: Judge permanently blocks NIH grant caps, prompting HHS appeal Cancer research, long protected, feels ‘devastating’ effects under Trump As Trump targets DEI practices, 4 pharmas reaffirm commitment to diversifying clinical trials For struggling cell and gene therapy field, Peter Marks' FDA exit adds even more uncertainty CAR-T cells can arm other immune cells with engineered proteins to fight cancer, study says See omnystudio.com/listener for privacy information.

Apr 18

After a batch of much-anticipated reciprocal tariffs spared pharmaceuticals in early April, drugmakers, medtech companies, manufacturers and other outfits across the life sciences spectrum are still scrambling to respond to mounting trade pressures. While many unknowns remain, biopharma companies should waste no time in starting to evaluate their options. In this week’s episode of “The Top Line,” we dig into the latest round of tariffs unveiled by the Trump administration and how they could impact multiple areas of the life sciences industry. Fierce Pharma’s Fraiser Kansteiner sits down with KPMG’s life sciences sector leader Kristin Pothier, who discusses how the current tariffs could pose challenges, how drugmakers and other life sciences companies should respond and whether additional sector-specific duties are on the horizon. To learn more about the topics in this episode: As Trump's 'Liberation Day' tariffs seem to spare pharmaceuticals, threat of industry-specific duties and loopholes persists Drugmakers fear Trump tariffs will drive up manufacturing costs, hurt medicine access: BIO survey Eli Lilly CEO on Trump's tariffs: 'It'll be hard to come back from here' Trump again threatens tariffs on pharmaceuticals in 'not too distant' future This episode is sponsored by Cencora . See omnystudio.com/listener for privacy information.

Apr 11

In this week’s episode of "The Top Line," Fierce Deputy Editor Andrea Park and Fierce Biotech Senior Editor Gabrielle Masson discuss how workforce reductions impacted the biopharma industry in the first quarter. The pair examine industry trends, company closures, developments in the cell and gene space—and the reductions in force happening at federal health agencies alongside them. To learn more about the topics in this episode: Biopharmas laid off staffers at least 63 times in Q1: Fierce Biotech analysis Fierce Biotech Layoff Tracker 2025: Pfizer sells site, cuts staff; Opthea reduces workforce by 65% See omnystudio.com/listener for privacy information.

Apr 4

In this week’s episode of "The Top Line," Fierce Biotech’s Gabrielle Masson and Darren Incorvaia sit down to discuss a recent special report from Fierce Biotech, ranking the top 10 R&D budgets from 2024. Did Merck hold on to its 2023 crown? And did any new faces crack this year’s list? Listen to find out! To learn more about the topics in this episode: The top 10 pharma R&D budgets for 2024 This week's episode is brought to you by Cencora . See omnystudio.com/listener for privacy information.

Mar 28

Since the first days of the new Trump administration, the White House has handed down orders to ban work focused on diversity, equity and inclusion (DEI) across the federal government. Some in the private sector—both inside and outside of healthcare—have followed the same path, eliminating DEI officer positions and ending initiatives that in some cases have been tied to millions of dollars in research funding. What does the field—and, ultimately, the patient—stand to lose from this effort? In this week’s episode of The Top Line, we hear from Nada Hanafi, co-founder of MedTech Color, a professional network aimed at building and supporting diverse leadership in the industry. Hanafi joins Fierce Medtech’s Conor Hale to discuss how studying diversity in a healthcare context has become integral to developing new medical breakthroughs and realizing the promise of precision medicine. To learn more about the topics in this episode: FDA issues draft guidance on ensuring pulse oximeter accuracy across skin tones How Trump's DEI executive orders could impact healthcare After White House transition, FDA’s diversity guidance for clinical trials no longer available As Trump targets DEI practices, 4 pharmas reaffirm commitment to diversifying clinical trials Amid Trump's push to abolish DEI, Roche and Novartis adjust hiring initiatives: reports See omnystudio.com/listener for privacy information.

Mar 24

In this episode of The Top Line , sponsored by PatientPoint, Andrew Schultz, President of PatientPoint Precision, discusses how hypertargeting and contextual relevance are redefining patient marketing. Traditional direct-to-consumer (DTC) campaigns often rely on educated guesses, but PatientPoint Precision blends EHR data and patient context to deliver hyper-personalized, high-impact messages. By engaging patients at critical touchpoints—like logging into a portal or checking in for an appointment—marketers can deliver tailored, valuable content that enhances patient experiences and drives better health outcomes. Schultz emphasizes the importance of trust, consent, and privacy in utilizing this treasure trove of data securely. With PatientPoint Precision’s ability to integrate data and context, brands can now create robust, personalized campaigns that truly resonate with their target audiences. Listen to the full episode to learn how this new DTC approach is transforming patient engagement. See omnystudio.com/listener for privacy information.

Mar 21

Johnson & Johnson’s Stelara, Regeneron’s Eylea and Amgen’s Prolia are just some of the drugs facing off against new biosimilars or generics in 2025, as featured in the latest edition of Fierce Pharma’s annual special report documenting the 10 biggest losses of U.S. exclusivity expected throughout the year. In this week’s episode of The Top Line, we dig into the report, which details the stories behind 10 key medicines that are set to face off against new generic or biosimilar competitors this year as their patents expire. Fierce’s Eric Sagonowsky and Angus Liu recap the report, sharing their perspectives on several of the drugs and discussing the industry effects of 2025’s sizable patent cliff. To learn more about the topics in this episode: The top 10 drugs losing US exclusivity in 2025 After patent settlement, Amgen scores FDA nod for its biosimilar version of J&J's Stelara Amgen grabs FDA thumbs-up for Soliris biosim, eyes 2025 launch Novartis wins 11th-hour bid to block generic version of blockbuster heart med Entresto Amgen settles Prolia patent suit with Celltrion, teeing up potential biosimilar launch in June See omnystudio.com/listener for privacy information.

Mar 17

Agenus Chief Medical Officer Dr. Steven O'Day joined Fierce's Chris Hayden on a recent sponsored episode of The Top Line podcast to discuss the evolving landscape of cancer immunotherapy. O'Day, a medical oncologist with 30 years of experience, explained the fundamental differences between immunotherapy and traditional cancer treatments like chemotherapy, surgery, and radiation. He emphasized immunotherapy's potential for durable responses and even cures by activating the body's own T-cells to fight cancer. The conversation addressed the challenges of treating "cold" tumors, such as colorectal cancer, which are less visible to the immune system. O'Day highlighted Agenus's pipeline of antibodies, botensilimab (BOT) and balstilimab (BAL), designed to trigger T-cell recognition of these colder cancers. O'Day expressed his excitement about a potential "2.0 revolution" of immuno-oncology, expanding the benefits of immunotherapy to a wider range of cancers. He described BOT and BAL as a "one-two punch," with BOT priming T-cells and BAL preventing their exhaustion. Listen to the full conversation on the latest episode of The Top Line. See omnystudio.com/listener for privacy information.

Mar 14

Despite a rocky start for many drugmakers at the start of last year, 2024’s fourth quarter saw just two of the top 25 global pharma companies record sales declines. But that growth may be short-lived, as many of those same companies forecast more muted revenue increases in 2025. In this week’s episode of The Top Line, we dissect the unprecedented revenue growth enjoyed by many of the world’s top pharma companies by sales in the fourth quarter of last year. Fierce Pharma’s Kevin Dunleavy and Fraiser Kansteiner discuss the period’s results, examine the companies’ performance expectations going into 2025 and consider whether the momentum seen in Q4 is repeatable or more of an anomaly. To learn more about the topics in this episode: Eli Lilly, Novo Nordisk lead revenue boom in the 'always tricky' Q4 Eli Lilly logs massive Q4 revenue jump—but it's not just thanks to Mounjaro and Zepbound Pfizer harnesses COVID fluctuations to clinch Q4 gains as RSV vaccine sales plummet Astellas takes $760M charge, reveals slowdown for eye drug Izervay after regulatory stumbles This episode is brought to you by Cencora . See omnystudio.com/listener for privacy information.

Mar 10

In the latest episode of The Top Line , Chris Hayden of Fierce Pharma sits down with Mary Lou Glotzbach, senior manager of drug delivery partnerships at Grand River Aseptic Manufacturing (GRAM). They explore the evolving landscape of biologics, the increasing importance of cold chain management, and how contract development and manufacturing organizations (CDMOs) are adapting to industry shifts. Glotzbach highlights a growing trend in biotech: transitioning patient treatments from infusion centers to home delivery. This shift demands innovative drug delivery solutions, including wearable devices and auto-injectors, capable of handling high-viscosity biologics. She also emphasizes the industry's push for smaller batch sizes due to the high cost and complexity of producing biologics, which challenges traditional manufacturing processes. Another key discussion point is the rising demand for transparency and early collaboration between pharmaceutical companies, CDMOs, and device manufacturers. Glotzbach notes that CDMOs are now being brought into the development process earlier than ever, allowing for better alignment on formulation, container design, and regulatory compliance. The conversation also touches on Annex 1 compliance and the need for standardization in primary containers like syringes and cartridges. Glotzbach envisions a future where standardized components streamline production, making drug development more efficient. For anyone interested in the intersection of biologics, manufacturing, and drug delivery innovation, this episode offers valuable insights into how GRAM is helping shape the future of the industry. Tune in to learn more about the latest advancements and challenges in aseptic manufacturing. See omnystudio.com/listener for privacy information.

Mar 10

The latest episode of The Top Line, sponsored by ViiV Healthcare, features Dr. Luis Buzón, an infectious disease specialist, discussing the critical role of real-world evidence in HIV treatment and prevention. While clinical trials establish the safety and efficacy of new therapies, real-world data help bridge the gap between these highly controlled environments and patient care in the real world. Buzón explains that collecting long-term data is essential, especially for lifelong conditions like HIV. Not only do real-world studies track how medicines perform over longer periods of time than clinical trials, they include a broader range of people, revealing potential side effects not seen in trials and ensuring long-term effectiveness for the different people who can be impacted by HIV. Beyond the science, Buzón shares how his father was a pioneer in Spain’s early response to the HIV epidemic, and why, inspired by his father’s dedication, he continues to advocate for compassionate, evidence-based care. For those interested in the evolving landscape of HIV treatment and prevention and the power of real-world data in shaping better health outcomes, this episode is a must-listen. Tune in to The Top Line to hear Buzón’s expert insights and personal perspective. See omnystudio.com/listener for privacy information.

Mar 7

For the biotech industry, 2024 meant the return of the venture capital megaround. And one startup, Xaira Therapeutics, took it a step further, expanding the industry’s definition of a megaround by reeling in a rarely seen $1 billion financing early in the year. In this week’s episode of The Top Line, we dive into a recently published report from Fierce Biotech highlighting the industry’s top 10 money raisers in 2024, led by none other than Xaira. Fierce’s Gabrielle Masson and Andrea Park talk about some of the year’s biggest financing rounds, how 2024’s list compares to 2023 and what indications are changing the fundraising scene. To learn more about the topics in this episode: Biotech's top money raisers of 2024 Fierce Biotech Fundraising Tracker '24 Biotech's top money raisers of 2023 See omnystudio.com/listener for privacy information.

Feb 28

Huntington’s disease was long thought to be caused by the slow buildup of a toxic protein, but new research has revealed that it’s actually driven by the expansion of a gene that, at a certain length, triggers quick neuron death. In this week’s episode of The Top Line, we hear from Steven McCarroll, Ph.D., a Huntington’s disease researcher at the Broad Institute of MIT and Harvard, whose team recently published that research in the journal Cell. McCarroll joins Fierce Biotech’s Darren Incorvaia to dig into the findings, which not only change our understanding of the disease itself, but also open up new avenues for potential treatments. To learn more about the topics in this episode: New findings shed light on cause of Huntington's disease progression Scientists look to survival secrets of plants for Huntington's treatments Scientists use long-approved GSK HIV drug to stave off dementia, Huntington's proteins in mice Sage drops dalzanemdor as Huntington's failure completes clean sweep of midphase flops See omnystudio.com/listener for privacy information.

Feb 21

Clinical-stage drug development offers big rewards—and big risks. To that end, Fierce Biotech recently published its annual roundup of several of the most eye-catching trial failures of the preceding year. The 2024 list includes trial flops from the likes of AbbVie, Novo Nordisk, Pfizer and more, with reports of disappointing results in many tough-to-treat indications, including schizophrenia and Alzheimer's disease. In this week’s episode of The Top Line, we dive into the report. Fierce Biotech’s James Waldron and Gabrielle Masson discuss the entries that stood out for them and ask what lessons the biopharma industry can learn from these setbacks going forward. To learn more about the topics in this episode: 2024's top 10 clinical trial flops AbbVie's $9B schizophrenia prospect flunks phase 2 trials, handing advantage to BMS GSK surrenders HSV vaccine hopes after phase 2 fail, ceding race to Moderna, BioNTech Merck halts phase 3 TIGIT trial after immune-mediated adverse events prompt discontinuations Pfizer's phase 3 gene therapy trial fails to improve function for boys with Duchenne muscular dystrophy See omnystudio.com/listener for privacy information.

Feb 14

Valentine’s Day represents a perfect opportunity to highlight news and updates from across biopharma that have hearts all aflutter. In this week’s episode of “The Top Line,” we do just that, fueled by heart puns and holiday candy. Fierce’s Gabrielle Masson and Andrea Park discuss a new heart-focused biotech that recently emerged with $300 million and a cardiovascular drug that’s been named one of the most anticipated launches of 2025, as well as several other stories they’ve loved covering this year. To learn more about the topics in this episode: Kardigan launches with cozy $300M series A and collection of late-stage cardio assets Top 10 most anticipated drug launches of 2025 Cumberland's Duchenne drug improves blood flow from heart in phase 2 trial Novartis' first Super Bowl ad aims to 'create a movement' with breast cancer awareness blitz Don't call it a comeback: Pfizer returns to Super Bowl with ad pledging to 'knock out' cancer Takeda tightens reins on early-stage investments, looks to expand option deals: R&D head See omnystudio.com/listener for privacy information.

Feb 7

If Fierce Pharma Marketing’s annual list of the top 10 biggest potential drug launches of the coming year is any indication, biopharma may soon be in for a blockbuster boom. All together, the 10 meds that made the 2025 list stand to generate a whopping $29 billion in annual sales by the end of the decade. In this week’s episode of The Top Line, we dig into the report’s predictions. Fierce’s Andrea Park and Eric Sagonowsky take a deep dive into the top three drugs on the list—all of which had already snagged their first FDA approvals by this episode’s release—and highlight some of the prevailing trends from past years’ reports, including repeat entries, popular indications and drugs that never had the chance to meet their predicted potential. To learn more about the topics in this episode: Top 10 most anticipated drug launches of 2025 Vertex snags FDA nod for once-daily cystic fibrosis triplet Alyftrek as switch from Trikafta kicks off Datroway, 2nd ADC from AstraZeneca-Daiichi collab, wins first FDA nod in breast cancer Vertex scores FDA nod for long-awaited non-opioid pain reliever Journavx This episode is brought to you by Cencora. Learn more at cencora.com/breakthrough . See omnystudio.com/listener for privacy information.

Jan 31

During a panel discussion at this year’s Fierce JPM Week—which took place alongside the annual J.P. Morgan Healthcare Conference in San Francisco—industry experts broke down what it takes to pull off a successful biotech IPO in the current market. This week’s episode of The Top Line dives into the discussion, featuring Fierce Biotech’s Gabrielle Masson as moderator, joined by Septerna CEO and co-founder Jeffrey Finer, M.D., Ph.D.; Rapport Therapeutics Chief Financial Officer Troy Ignelzi; Sofinnova Investments General Partner Maha Katabi, Ph.D.; and Morgan Stanley Executive Director Chirag Surti. In their wide-ranging conversation, the industry leaders spoke about the types of biotechs that debuted on the public market in 2024, the keys to success for an effective IPO and what to expect from the market heading into 2025. To learn more about the topics in this episode: ‘A really rational IPO environment’: What does it takes for a biotech to go public now? 'Own JP Morgan, don't let JP Morgan own you': Biopharma—and Jill Biden—show up for JPM25 Septerna's $288M IPO is another sign of the market warming to biotech investment Third Rock's Rapport reveals upsized $154M IPO This episode is brought to you by Cencora. Learn more at cencora.com/breakthrough . See omnystudio.com/listener for privacy information.

Jan 24

This year’s edition of the annual J.P. Morgan Healthcare Conference has come to a close, with attendees enjoying sunny skies and a heavy police presence throughout the San Francisco-set event. In this week’s episode of The Top Line, Fierce Pharma’s Zoey Becker and Angus Liu join Fierce Biotech’s Darren Incorvaia to break down the biggest news stories out of the conference. From Johnson & Johnson’s blockbuster acquisition of Intra-Cellular Therapies to former First Lady Jill Biden’s appearance at Fierce JPM Week just days before she left the White House, this year’s conference set the stage for what will surely be an eventful 2025. To learn more about the topics in this episode: ‘Own JP Morgan, don't let JP Morgan own you’: Biopharma—and Jill Biden—show up for JPM25 JPM25: Johnson & Johnson makes a splash, buying out Intra-Cellular Therapies for $14.6B JPM25: First Lady Jill Biden committed to improving women's health as White House tenure winds down JPM25: Strategist GSK acquires IDRx for $1B in hopes of bringing GIST patients new standard of care GSK-backed Ouro Medicines launches into T-cell engager space with $120M and a clinical-stage asset This episode is brought to you by Cencora. Learn more at cencora.com/breakthrough . See omnystudio.com/listener for privacy information.

Jan 17

Following the strange year for the biopharma industry that was 2024, insiders and analysts alike are waiting expectantly to see how trends in layoffs, drug shortages, clinical trials and more play out in 2025. Meanwhile, a second Trump term and a spree of related health agency nominations raise serious questions about how health policy could shift over the next 12 months and beyond. In this week’s episode of “The Top Line,” we explore the trends that defined the industry in 2024 and tackle predictions about how 2025 could shake out for biopharmas big and small. Fierce Pharma’s Fraiser Kansteiner and Fierce Biotech’s Gabrielle Masson discuss 2024’s layoff count, the state of GLP-1 supplies, the future of clinical trial research, potential policy shakeups and more. To learn more about the topics in this episode: Analysts predict M&A, IPO uptick in 2025 but don't expect 'floodgates to suddenly open' Big Pharma layoff rounds jump 281% in '24, but overall industry rates similar to '23 2025 forecast: After Novo, Lilly expansion sprees, 'positive signals' emerge around future supply of GLP-1 drugs From AI and layoffs to supply chains and political unknowns, Deloitte outlines key areas for biopharma to watch in 2025 This episode is brought to you by Cencora. Learn more at cencora.com/breakthrough . See omnystudio.com/listener for privacy information.

Jan 10

Arun Krishna, Vice President and franchise head for an AstraZeneca US OBU, shares details of a treatment option with TAGRISSO® (osimertinib). AstraZeneca is focused on the development of new treatments, prioritizing researching options in eligible patients. Listen to the full podcast episode to learn more. Please see Important Safety Information for TAGRISSO. Please see complete Prescribing Information , including Patient Information for TAGRISSO. See omnystudio.com/listener for privacy information.

Jan 10

A review of the FDA’s drug approvals of 2024 shows that small companies loomed large—both in the sheer number of nods gained and the significance of the new drugs and biologics that these firms are bringing to the market. In this week’s episode of “The Top Line,” we take a deep dive into the FDA’s list of drugs that were approved in 2024. Fierce Pharma’s Kevin Dunleavy and Eric Sagonowsky discuss why biotechs emerged with more approvals than large drugmakers and which new drugs figure to have the most impact for patients. To learn more about the topics in this episode: 2024 drug approvals: Small companies loom large with several key FDA nods For Bristol Myers Squibb's newly approved schizophrenia drug, what a long, strange trip it's been 2023 drug approvals: After a down year, FDA signs off on a bounty of new meds, including 7 from Pfizer This episode is brought to you by Cencora. Learn more at cencora.com/breakthrough . See omnystudio.com/listener for privacy information.

Dec 20, 2024

In this week’s episode of "The Top Line," we bring you a special conversation from earlier this month at our New York City gala, where we celebrated this year’s Fierce 50 honorees. On stage, five extraordinary leaders shared their insights, experiences, and bold ideas shaping the future of healthcare and beyond. These honorees represent the five categories of this year’s Fierce 50: health equity, innovation, social impact, breakthroughs and patient advocacy. Each honoree brings powerful insights and inspiring stories to the table. From reimagining maternal healthcare and addressing antibiotic resistance to translating public health science, transforming healthcare with AI, and tackling rural health challenges, this panel highlights innovation and disruption at its finest. To learn more about the topics in this episode: Fierce 50 of 2024 Fierce 50 of 2024 - Innovation Honorees Fierce 50 of 2024 - Health Equity Honorees Fierce 50 of 2024 - Social Impact Honorees Fierce 50 of 2024 - Breakthroughs Honorees Fierce 50 of 2024 - Patient Advocacy Honorees See omnystudio.com/listener for privacy information.

Dec 13, 2024

GLP-1 agonists have taken the pharma world by storm, and Novo Nordisk has been at the forefront of it all with its blockbuster drug semaglutide, which it sells as Ozempic, Wegovy and Rybelsus. Semaglutide and other GLP-1s have gained widespread popularity as treatments for Type 2 diabetes and obesity, and it doesn’t stop there—they’re currently being tested in a wide variety of additional therapeutic areas and in new dosages and forms. In this week’s episode of “The Top Line,” Fierce’s James Waldron talked to Marcus Schindler, Novo’s chief scientific officer and executive VP of research and early development, about what’s next for GLP-1s and what else is top of mind at the Danish pharma. To learn more about the topics in this episode: Novo Nordisk hails ‘remarkable’ weight loss result for dual-acting oral drug in early trial Novo obesity prospect linked to ‘mild to moderate neuropsychiatric side effects’ in phase 2 Novo Nordisk axes once-monthly GLP-1/GIP agonist and MASH prospect Another day, another win for Novo in obesity, as early oral med appears to beat Wegovy See omnystudio.com/listener for privacy information.

Dec 6, 2024

After a promising start to the year, the biotech IPO market picked up steam again late this summer, with notable offerings from companies like Upstream, Septerna and BioAge. But what does this mean for the sector? Is market enthusiasm truly returning, or are we just seeing a temporary rebound? To unpack these questions and look ahead to 2025, Fierce Biotech’s James Waldron chatted with Adam Farlow, Global Chair of Baker McKenzie’s Capital Markets Practice Group. To learn more about the topics in this episode: Septerna's $288M IPO is another sign of the market warming to biotech investment BioAge brings in almost $200M from IPO as obesity biotech joins Nasdaq Upstream swells IPO to $255M as it prepares to join Nasdaq along with CAMP4 Kairos goes public with $6M IPO to fund trials of lead cancer drug See omnystudio.com/listener for privacy information.

Nov 22, 2024

Every year, Fierce’s pharma, biotech, and medtech teams come together to spotlight some of the fiercest women in life sciences—leaders who are transforming the industry with their innovation and impact. This year, our special report celebrates 10 women driving change in clinical research, business development, venture capital, and beyond. In this week's episode of "The Top Line," Fierce’s Andrea Park and Gabrielle Masson share the stories that stood out, the breakthroughs these women are championing, and why recognizing their achievements is more crucial than ever. To learn more about the topics in this episode: 2024's Fiercest Women in Life Sciences Big Pharma's 10 highest-paid CEOs of 2023 See omnystudio.com/listener for privacy information.

Nov 15, 2024

Last month, the NIH announced that it had found evidence of research misconduct by Eliezer Masliah, M.D., the head of the neuroscience division at the National Institute on Aging. The NIH announcement coincided with the Sept. 26 publication of an investigation by Science, finding that 132 papers published by Masliah appear to contain manipulated images. In this week’s episode of “The Top Line,” Fierce Biotech’s Darren Incorvaia dives into this issue with Matthew Schrag, M.D., Ph.D., a neuroscientist who contributed to the dossier outlining Masliah’s misconduct. To learn more about the topics in this episode: NIH neuroscience leader committed research misconduct, agency investigation finds See omnystudio.com/listener for privacy information.

Nov 8, 2024

Each year, we dive into the world of biotech closures and layoffs, tracking the industry’s pulse as companies navigate high risks and harsh realities. In this week's episode of "The Top Line," Fierce editors Gabrielle Masson and Andrea Park take a closer look at this year’s biotech graveyard, which tracks biotechs that have shuttered or are in the process of winding down. They also discuss how we identify these closures, the trends we’re seeing and what might be in store as the year wraps up. To learn more about the topics in this episode: The 2024 Biotech Graveyard Fierce Biotech Layoff Tracker 2024 See omnystudio.com/listener for privacy information.

Nov 1, 2024

As the 2024 U.S. presidential election nears, the choice between Democratic nominee Vice President Kamala Harris and Republican nominee former President Donald Trump will shape the future of drug pricing policy. While both candidates have pledged to reduce drug costs, their approaches are likely to differ significantly. In this week's episode of "The Top Line," Fierce Pharma's Zoey Becker chats with John Barkett, managing director of BRG’s healthcare transactions and strategy practice and former senior policy advisor for healthcare delivery system reform on the White House Domestic Policy Council, about what we can expect from each candidate's potential presidency and how the Inflation Reduction Act could play a pivotal role. To learn more about the topics in this episode: With election nearing, BMO analysts don't expect major pharma shake-ups from either candidate Biden touts drug pricing achievements as he steps down from reelection campaign 2024 forecast: Biden admin efforts show there's no pricing relief on the horizon for pharma See omnystudio.com/listener for privacy information.

Oct 28, 2024

Discover how Turbine Simulated Cell Technologies is transforming drug development by addressing biases in training data. Guests Bence Szalai, MD, PhD, and Istvan Taisz, MD, PhD, share insights on the challenges of biased AI models in biology and introduce their groundbreaking framework, EFFECT (Evaluation Framework for Predicting Efficacy of Cancer Treatment). Learn how Turbine's innovative bias detector ensures meaningful predictions, enhancing the accuracy of drug response models. Explore their tailored in silico biomarker discovery process, including a collaboration with Cancer Research Horizons to identify the right patient populations for new cancer drugs. By integrating recent patient samples, Turbine achieves remarkable predictive capabilities, significantly improving model accuracy. This episode is essential for anyone interested in the future of biotechnology and precision medicine. Don’t miss this opportunity to understand how Turbine is shaping the landscape of drug development. Listen now and be part of the conversation that’s paving the way for more effective cancer treatments. See omnystudio.com/listener for privacy information.

Oct 25, 2024

EY recently published their 18th annual Pulse of the MedTech Industry report, highlighting how—despite steadily rising profits year-over-year—devicemakers large and small are still being squeezed by the cost of doing business and waning investor enthusiasm. During AdvaMed’s MedTech Conference this month in Toronto, John Babbitt, partner on the life sciences team at EY, chatted with Fierce Medtech’s Conor Hale about the team's findings and shared what he heard from other executive attendees on the pace of M&A, venture capital funding and recent IPOs. Babbitt also discussed how the industry is expanding over-the-counter, to stock shelves with consumer-focused products—as well as how a record number of AI approvals from the FDA may be counted on to help address the ever-growing demand for healthcare, amid provider burnout and staff shortages. To learn more about the topics in this episode: Ceribell CEO Jane Chao explains why now was the time for its upsized IPO Stryker strikes again, acquiring brain surgery device maker Nico How will regulators adapt to adaptive AI? Medtech VC investment held steady in Q2 with $3.3B of deal value: PitchBook EY's Pulse of the MedTech Industry report 2024 See omnystudio.com/listener for privacy information.

Oct 18, 2024

At this year’s Fierce Biotech Summit in Boston, we caught up with leaders in the biotech industry who have been recognized as past Fierce 15 honorees. These private biotechs have made significant contributions to their field, and their groundbreaking work is shaping the industry's future. Fierce Biotech’s Gabrielle Masson sat down with Liang Schweizer, Ph.D. founder, chairperson and CEO of HiFiBiO Therapeutics; Adam Friedman, M.D., Ph.D., CEO of Scorpion Therapeutics; and Debanjan Ray CEO of Synthekine. In this week’s episode of “The Top Line,” these leaders share their insights, experiences, and visions for the evolving biotech landscape. To learn more about the topics in this episode: Introducing Fierce Biotech's 2024 Fierce 15 Scorpion snaps up $150M in series C funds to widen clinical plans for cancer pipeline Synthekine hopes new IL-2 will be the high-alpha in a beta class See omnystudio.com/listener for privacy information.

Oct 14, 2024

In this episode, we dive into the world of gene therapy logistics with Cryoport Systems' innovative Elite Ultra Cold shipping system. Mike Dybicz and Khoa Tran are in the hotseat to discuss how their solution addresses critical challenges in transporting temperature-sensitive gene therapies. The pair explain how Cryoport Elite offers extended hold times, exceeding industry standards to ensure therapy viability during unexpected delays. Here, its unique payload holding system provides consistent cooling without direct dry ice contact, maintaining product integrity throughout transit. Security is paramount for these high-value therapies. The system allows for re-icing without accessing the payload, reducing tampering risks. Meanwhile, real-time monitoring tracks key metrics such as temperature, pressure and humidity, providing comprehensive visibility during shipping. Dybicz and Tran also emphasize their collaborative product development approach, working with clients to meet current needs and anticipate future challenges. In addition, they discuss their commitment to sustainability and share insights on upcoming innovations, including the SafePak system and plans to expand the Elite product line. Catch the full episode for more insights! See omnystudio.com/listener for privacy information.

Oct 11, 2024

The neuroscience sector has seen a surge in investment over the past year, leading to breakthroughs and high-stakes deals, especially in the closing months of 2023. This momentum shows no signs of slowing, as companies continue to push boundaries in neuroscience and psychiatric disease research. At this year's Fierce Biotech Summit on Oct. 1, pharma staff writer, Fraiser Kansteiner, sat down with a panel of industry leaders to explore the latest trends, groundbreaking discoveries and the next big targets in neuropharmaceuticals. Joining the conversation were Camille Bendrosian, M.D., chief medical officer at Amylyx; Craig Thompson, CEO of Cerevance; Sara Kenkare-Mitra, Ph.D., president and head of R&D at Alector; and Blake Mandell, co-founder and CEO of Transcend Therapeutics. To learn more about the topics in this episode: Bristol Myers Squibb's Karuna buyout pays off with FDA approval for novel schizophrenia med Cobenfy PTSD treatment is on the cusp of a paradigm shift. This biotech hopes to Transcend the competition After 'clearing the decks,' Alkermes ready to roll as pure-play neuroscience company Merck is back in Alzheimer's saddle with $1B-plus Cerevance pact, years after dropping the BACE See omnystudio.com/listener for privacy information.

Oct 4, 2024

Since the introduction of the BIOSECURE Act in January, named companies and U.S.-based biopharmas alike have speculated on what the legislation could mean for the life sciences industry. In this week's episode of "The Top Line," Fierce Pharma staff writer Fraiser Kansteiner sits down with Arnold & Porter’s Life Sciences practice chair Dan Kracov to discuss the broader implications of the bill, and what the likely next steps are for the legislation to become law. Kracov also breaks down what measures life sciences companies are already taking in light of the bill and concessions that may need to be made to appease lawmakers on both sides of the aisle. To learn more about the topics in this episode: After BIOSECURE Act passes in House, targeted Chinese companies say they're 'deeply' concerned Despite looming BIOSECURE threat, pharma contracting giant WuXi Bio scoops up new projects Lawmakers urge FDA to investigate clinical trials run in tandem with China's military See omnystudio.com/listener for privacy information.

Sep 27, 2024

At the recent World Conference on Lung Cancer and European Society for Medical Oncology annual meetings, two packages of lung cancer data from a partnership between Akeso and Summit Therapeutics and another collaboration between iTeos Therapeutics and GSK showed much promise of disrupting the current standard of care. But they also drew some questions and debate. In this week's episode of “The Top Line,” Angus Liu from Fierce Pharma and Gabrielle Masson from Fierce Biotech discuss the key issues behind those two readouts. To learn more about the topic in this episode: iTeos-GSK's TIGIT combo shows 30% more tumor shrinkage than Jemperli, but safety signals scare investors Akeso, Summit's PD-1 bispecific crushes Merck's Keytruda in study, signaling potential new standard in lung cancer 'Cooking with gas': Regeneron sees its Opdualag rival as next big thing for treating solid tumors ESMO: Bristol Myers moves Opdualag into phase 3 trials in competitive first-line lung cancer field See omnystudio.com/listener for privacy information.

Sep 20, 2024

In this week's episode of "The Top Line," we’re recapping and discussing the major trends from Digitial Pharma East, which took place in Philadelphia last week. The event brought together marketing experts from across the life sciences industry. Fierce Pharma Marketing's Andrea Park and Ben Adams talk about major trends from the event that came up in conversations, including the complicated current attitudes toward artificial intelligence in this space. They also highlight some winners of the annual Fierce Pharma Marketing Awards, held on the final night of Digital Pharma East. To learn more about the topics in this episode: Navigating the AI 'hype cycle': Bayer, Daiichi Sankyo and argenx leaders on implementing AI in biopharma marketing Pfizer, Sanofi, GSK among the winners of the 2024 Fierce Pharma Marketing Awards Two-thirds of top 20 pharmas have banned ChatGPT—and many in life sci call AI 'overrated,' survey finds See omnystudio.com/listener for privacy information.

Sep 13, 2024

In this week's episode of "The Top Line," we will dive into the annual Fierce 50 special report. We share the stories of a select few 2024 Fierce 50 honorees and interesting highlights from this year's special report. To learn more about the topics in this episode: Fierce 50 of 2024 Innovation Honorees Health Equity Honorees Social Impact Honorees Breakthroughs Honorees Patient Advocacy Honorees See omnystudio.com/listener for privacy information.

Sep 6, 2024

In this week's episode of "The Top Line," we’re looking at what goes into manufacturing and supply of flu vaccines. Fierce Pharma’s Zoey Becker chats with Stefan Merlo, vice president of commercial operations, North America at CSL Seqirus. He discusses the company's differentiated flu vaccine portfolio and how its manufacturing process has evolved over the decades to create and distribute vaccines offering targeted protection each year. To learn more about the topics in this episode: Driving flu vaccine uptake in the post-pandemic era Flu vaccine makers CSL Seqirus, Sanofi and GSK kick off initial shipments ahead of upcoming season See omnystudio.com/listener for privacy information.

Aug 29, 2024

In this week's episode of "The Top Line," we look at factors driving the continuing decline of flu vaccination rates in the U.S. and beyond. Fierce Pharma’s Zoey Becker chats with Gregg Sylvester, M.D., Chief Health Officer at CSL Seqirus, to get insight on what we might expect to see from this upcoming flu season. He also explains efforts to increase vaccine uptake through awareness and education campaigns. To learn more about the topics in this episode: Flu vaccine makers CSL Seqirus, Sanofi and GSK kick off initial shipments ahead of upcoming season CDC starts 'Wild to Mild' campaign to reverse falling flu vaccine use in key groups American Lung Association, Sanofi urge high-risk communities to grab their flu shots in 'United Against Flu' campaign See omnystudio.com/listener for privacy information.

Aug 26, 2024

Biotherapeutics are transforming healthcare for over 350 million patients globally, tackling everything from cancer and diabetes to rare diseases. Human embryonic kidney (HEK) 293 cells play a key role in the manufacturing of many of these life-changing products. However, they are not without their challenges. In this episode of The Top Line, sponsored by Bio-Rad, Dipika Gurnani, Global Product Manager at Digital Biology Group, discusses the critical need to accurately quantify HEK293 DNA in biotherapeutics to ensure patient safety and regulatory compliance. Gurnani highlights the risks of residual DNA integrating into a patient's genome, potentially causing cancer or genetic abnormalities. She also addresses the limitations of traditional quantification methods like qPCR, which can be time-consuming and prone to errors. We also look at some key innovations in the field, such as Bio-Rad’s Vericheck ddPCR HEK293 Residual DNA Quantification Kit that can minimize false positives by specifically targeting HEK293 DNA. For deeper insights into these challenges and innovations, listen to the full episode. See omnystudio.com/listener for privacy information.

Aug 23, 2024

For the last 40 years, when federal legislation was ambiguous or left an administrative gap, courts were required to defer to the interpretation of agencies. This stipulation, called the Chevron deference, gave agencies room to advance their regulatory priorities. The Supreme Court overturned the doctrine in June, bringing significant implications for the healthcare industry and federal regulators like the FDA. In this week's episode of "The Top Line," Fierce Pharma’s Kevin Dunleavy chats with Project Farma President Anshul Mangal about the potential impact on the biopharma industry. To learn more about the topics in this episode: Supreme Court overrules Chevron deference, dealing blow to federal healthcare agencies The Supreme Court just limited federal power. Healthcare is feeling the shock waves How Chevron's demise could impact employers, purchasers and health payers See omnystudio.com/listener for privacy information.

Aug 16, 2024

The TROP2 antibody-drug conjugate race has heated up among three Big Pharma companies: Gilead Sciences, AstraZeneca and Merck. Fierce Pharma’s Angus Liu recently took a deep dive into the three TROP2 front-runners. In a feature article, he examined the strengths and potential challenges facing each candidate, as well as the considerations behind their extensive phase 3 programs and their various development strategies. In this week’s episode of “The Top Line,” Fierce executive editor Eric Sagonowsky chats with Liu about his feature story on the three TROP2 front-runners. To learn more about the topics in this episode: 3 Big Pharma companies, 33 phase 3 trials: The race for supremacy in an ADC field ASCO: Gilead looks for silver lining in Trodelvy’s failed lung cancer trial. But will the FDA play ball? AstraZeneca-Daiichi's Enhertu follow-up Dato-DXd unable to prove overall survival benefit in phase 3 See omnystudio.com/listener for privacy information.

Aug 9, 2024

In this week's episode of "The Top Line," we’re diving into Fierce Biotech’s annual Fierce 15 special report. Fierce Biotech's Annalee Armstrong and Gabrielle Masson take you behind the scenes to explore the meticulous selection process and share interesting highlights from this year’s honorees. To learn more about the topics in this episode: Introducing Fierce Biotech's 2024 Fierce 15 Fierce Biotech's Gabrielle Masson presents Fierce 15 at NYSE Fierce 15: Where are they now? See omnystudio.com/listener for privacy information.

Aug 2, 2024

This week on “The Top Line,” we discuss two studies in HIV research that were presented at the 25th International AIDS Conference in Germany. One of them is the report of a 7th person who has likely been cured of HIV. And there’s something unique about this case that has sparked excitement among scientists. The other one is the report of a long-acting injection that showed 100% efficacy in preventing HIV infection in a phase 3 trial. Some experts have hailed the PrEP candidate as a game-changer. To dive deeper into these studies, Fierce Pharma’s Angus Liu interviews Jared Baeten, M.D., Ph.D., senior vice president and head of clinical development of the virology therapeutic area at Gilead Sciences. To learn more about the topics in this episode: With seventh person seemingly cured of HIV, signs of hope for a broader cure Watch out, GSK. Gilead’s twice-yearly PrEP drug shows 100% efficacy for HIV prevention See omnystudio.com/listener for privacy information.

Jul 26, 2024

In this week’s episode of "The Top Line," Fierce Biotech’s Annalee Armstrong highlights some of the most promising companies that made our prestigious Fierce 15 list back in 2014. A decade later, she revisits these trailblazers to see how they’ve navigated the biotech landscape. To learn more about the topics in this episode: Fierce Biotech's Fierce 15 of 2014 See omnystudio.com/listener for privacy information.

Jul 19, 2024

Back in February, Novo Holdings laid out a $16.5 billion deal to snap up contract manufacturing giant Catalent. In this week's episode of "The Top Line," we dive into the current state and implications of the proposed buyout. Fierce Pharma’s Fraiser Kansteiner is joined by former FTC policy director David Balto. They discuss the likelihood of the deal going through, potential regulatory hurdles and what the transaction could mean for the greater CDMO landscape. To learn more about the topics in this episode: Another day, another delay for Novo's Catalent acquisition as FTC imposes 'Second Request' Novo antes up $16.5B to poach CDMO giant Catalent amid Wegovy surge See omnystudio.com/listener for privacy information.

Jul 15, 2024

In this episode of The Top Line, sponsored by the Parenteral Drug Association (PDA), we explore the upcoming PDA/FDA Joint Regulatory Conference, happening September 9-11 in Washington, D.C. Our guest, Janeen Skutnik-Wilkinson, Director of Global Quality Regulatory Surveillance and External Engagement for Moderna and Co-Chair of the 33rd annual event, shares why this conference is the essential annual CGMP event to attend. Janeen notes the direct access to federal regulators and the unique insights from FDA colleagues as standout features. The FDA co-sponsored conference is known for fostering collaboration among scientific minds to create practical solutions and best practices, with this year's focus on improving quality culture, shifting to proactive approaches, and evolving quality maturity. Key sessions will cover de-risking quality control environments by utilizing case studies on OOS and OOT results, and enhancing lab systems with QRM. The conference's focus on Current Good Manufacturing Practices (CGMP) makes it a must attend for quality assurance and operations professionals. Additionally, discussions will delve into the role of AI in manufacturing and data integrity. For a comprehensive look at this year's PDA/FDA Joint Regulatory Conference, listen to the full episode and register at pda.org/PDAFDA2024 . See omnystudio.com/listener for privacy information.

Jul 12, 2024

Pharmaceutical CEOs often earn pay packages worth tens of millions of dollars for leading the top drugmaking companies in the industry. Every year, some new faces enter the rankings while others leave. In this week's episode of "The Top Line," Fierce Pharma’s Eric Sagonowsky and Fraiser Kansteiner discuss Fierce’s annual special report, “Big Pharma's 10 highest-paid CEOs.” Aside from digging into the specific numbers surrounding CEO pay packages, the discussion also touches on CEO-to-worker pay ratios for 2023 and more. To learn more about the topics in this episode: Big Pharma's 10 highest-paid CEOs of 2023 See omnystudio.com/listener for privacy information.

Jun 28, 2024

At Fierce Biotech, we love a big M&A deal, but valuation does not always equal the most exciting. In this week's episode of "The Top Line," Fierce Biotech’s Annalee Armstrong and James Waldron discuss what they think are the best and smartest acquisitions in recent years. From obesity to radiopharmaceuticals, they give you the Fierce Biotech team’s thoughts on who got the best deal. To learn more about the topics in this episode: Top 10 smartest deals in biopharma See omnystudio.com/listener for privacy information.

Jun 21, 2024

In this week’s episode of “The Top Line,” Fierce Pharma’s Zoey Becker sits down with Bobby Sheng, the CEO of Bora Pharmaceuticals, to discuss the concept of “friend-shoring” in drug manufacturing. "Friend-shoring" involves conducting manufacturing processes in countries considered friendly or allied. Sheng discusses the criteria for deeming a country “friendly” and explores whether this strategy could help address drug supply shortages. To learn more about the topics in this episode: Bora plants its flag in the US with $210M acquisition of generics manufacturer Upsher-Smith Emergent, pivoting away from CDMO business, sells Baltimore plant to acquisitive Bora for $30M See omnystudio.com/listener for privacy information.

Jun 14, 2024

Each June, the American Society of Clinical Oncology (ASCO) hosts a conference that gathers physicians, researchers and the cancer community to share their latest research on treatments, technologies and more. The Fierce team is always on the ground at the ASCO meeting, and this year, Fierce Biotech’s Gabrielle Masson and Fierce Pharma’s Angus Liu covered the event. In this week's episode of "The Top Line," they discuss the most talked-about data drops at ASCO and share on-the-ground details, including their experience with Gilead’s virtual reality Trodelvy ride. To learn more about the topics in this episode: Akeso, Summit's Keytruda win draws 'explosive' interest at ASCO. But what does Merck think? ASCO: After Keytruda, Merck builds 3-pronged cancer strategy starring Moderna-partnered vaccine ASCO: Cautious Big Pharmas double down on past wins—steering clear of radioligands and cell therapy See omnystudio.com/listener for privacy information.

Jun 7, 2024

The Fierce Pharma Marketing team publishes a special report each year on the top pharmaceutical drug ad spenders. This year’s report, which includes numbers for 2023, was published on Monday. AbbVie was the standout in this edition, having spent heavily on ads for Skyrizi and Rinvoq. Overall spending on the top 10 ads also experienced a sizable increase compared to the previous year. In this week’s episode of “The Top Line,” Fierce Pharma Marketing Senior Editor Ben Adams and Deputy Editor Andrea Park discuss the report, providing key insights and takeaways. To learn more about the topics in this episode: The top 10 pharma drug ad spenders for 2023 See omnystudio.com/listener for privacy information.

May 31, 2024

The Fierce Biotech team published a four-part series this week exploring cell therapy, a modality that has faced clinical challenges, manufacturing constraints and multiple practice-changing events. In today’s episode, Fierce’s Annalee Armstrong and Gabrielle Masson discuss the series of special reports and key insights from their interviews with multiple experts. To learn more about the topics in this episode: Cell therapy reckoning: How a 'remarkable resolution of lupus' carried CAR-T from cancer to immunology Cell therapy reckoning: Pivot to autoimmune leaves unmet need in oncology Biotech faces a reckoning: 'We've lost our luster in cell therapies' Fulfilling the promise of cell & gene therapies through manufacturing (Part I) From cell collection to commercial contracting: Advancements in cell & gene therapy manufacturing (Part II) Automation, decentralization and the future of CAR-Ts: Advancements in cell & gene therapy manufacturing (Part III) See omnystudio.com/listener for privacy information.

May 24, 2024

This week’s episode of “The Top Line,” is the final part of a three-part series diving into the latest advancements in cell and gene therapy manufacturing. In this episode, Fierce Pharma’s Fraiser Kansteiner is joined by Bruce Levine, Ph.D., who is the co-inventor of Kymriah and the Barbara and Edward Netter Professor in Cancer Gene Therapy at the University of Pennsylvania. He’s also joined by executives from CGT technology provider ScaleReady and regenerative cell therapy developer CellProthera. They dive into novel production approaches discussed earlier in this series, with a special focus on CAR-T therapies. To learn more about the topics in this episode: CAR-T hype faces infrastructure reality check CAR-T boxed warnings: What comes next? See omnystudio.com/listener for privacy information.

May 22, 2024

In the fast-paced field of life sciences, digital pathology is poised to be a game-changer. In this episode, we sit down with Grace Lee and Douglas Clark of Agilent Technologies to explore the opportunities and challenges associated with companion diagnostics (CDx). Clark kicks off, shedding light on the current levels of digital pathology adoption in both clinical trials and practice. Thereafter, Lee outlines several opportunities and the associated regulatory hurdles, looking at areas such as the utilization of whole slide images for companion diagnostic interpretation. Pointing to the amplified scrutiny on Laboratory Developed Tests (LDTs) and the emerging CDx guidelines in the EU and China, she emphasizes the importance of aligning with agencies: “Oftentimes we are trying to manage changes in the CDx world by providing regulators with evidence that assay performance has not changed.” Clark echoes these sentiments, first highlighting the challenges posed by image variability and the resultant disparities in CDx interpretation and scoring, and then offering an optimistic outlook on the transformative potential of AI in the realm of multiplexing assays. For a deep dive into the opportunities presented by digital pathology and CDx development, tune into the full episode. See omnystudio.com/listener for privacy information.

May 20, 2024

What is the transformative potential of digital health technologies in advancing health equity? Rabin Martin, a global health consulting firm, explores those possibilities in this engaging episode. The conversation highlights the excitement surrounding digital tools and advanced analytics in achieving deeper insights, consistent care delivery, workforce support, and addressing social determinants of health. Listen in now. Host: Heath Clendenning, Fierce Life Sciences Producers: Matt Rickman and Samantha Mazzotta See omnystudio.com/listener for privacy information.

May 17, 2024

This week’s episode of “The Top Line” is the second part of a three-part series exploring the latest advancements in cell and gene therapy manufacturing. In this episode, Fierce Pharma’s Fraiser Kansteiner interviews Delara Motlagh, head of cell therapy at Catalent; Becky Butler Cap, senior vice president of biotherapies at Vitalant; and Kevin Kyle, CEO of Germfree. The conversation covers cell collection, the critical first step in advanced therapy manufacturing. They also discuss the importance of locking in process decisions early and how to effectively scale projects from the lab to the clinic and eventually to the market. Additionally, they talk about Germfree’s recent asset acquisition from Orgenesis, which will allow the company to expand its mission of decentralized manufacturing. To learn more about the topics in this episode: Fulfilling the promise of cell & gene therapies through manufacturing (Part I) With new partnership, Galapagos takes decentralized CAR-T manufacturing quest nationwide Catalent opens cell therapy production site at Belgian 'center of excellence' After recent troubles, Catalent expands its biologics services platform See omnystudio.com/listener for privacy information.

May 10, 2024

This week’s episode of “The Top Line,” kicks off a series diving into the latest advancements in cell and gene therapy manufacturing. In this episode, Fierce Pharma’s Fraiser Kansteiner sits down with Ori Biotech CEO Jason Foster and the Cell Therapy Manufacturing Center's CEO, Jason Bock. They delve into the current state of cell and gene therapy manufacturing and consider if the existing production methods can keep up with the potential of personalized medicines. They also dive into past hurdles in the space and highlight the varied approaches—including their own—that a new generation of cell and gene therapy manufacturing companies have been pioneering. To learn more about the topics in this episode: Ori Biotech taps MD Anderson, National Resilience joint venture to put its automated cell and gene therapy manufacturing tech to the test See omnystudio.com/listener for privacy information.