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  • 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.

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  • 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. 

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  • 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. 

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  • 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

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  • 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. 

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  • 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

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  • 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.

  • 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%

     

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  • 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.

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  • 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 

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  • 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.

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  • 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 

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  • 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.

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  • 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.

  • 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.

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  • 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.

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  • 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 

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  • 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 

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  • 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 

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  • 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  

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