The Top Line

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.

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% See omnystudio.com/listener for privacy information.

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.

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.

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.

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.

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.

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.See omnystudio.com/listener for privacy information.

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.

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.

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.

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.

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.

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.

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.

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.

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 See omnystudio.com/listener for privacy information.

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.

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.

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.

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.

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.

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.

 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 findsSee omnystudio.com/listener for privacy information.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.