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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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.

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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.

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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.

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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.

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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.

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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.

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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 

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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

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