The Top Line

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

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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

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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

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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.

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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

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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

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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?

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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 

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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

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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.