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

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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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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

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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

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 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

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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

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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

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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.

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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

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