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

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: 
<ul>
<li><a href="https://www.fiercepharma.com/pharma/another-day-another-30-day-waiting-period-novo-holdings-catalent-acquisition-ftc-imposes" data-cke-saved-href="https://www.fiercepharma.com/pharma/another-day-another-30-day-waiting-period-novo-holdings-catalent-acquisition-ftc-imposes">Another day, another delay for Novo's Catalent acquisition as FTC imposes 'Second Request'</a></li>
<li><a href="https://www.fiercepharma.com/pharma/novo-holdings-antes-165b-poach-catalent-selling-three-fill-finish-sites-novo-nordisk" data-cke-saved-href="https://www.fiercepharma.com/pharma/novo-holdings-antes-165b-poach-catalent-selling-three-fill-finish-sites-novo-nordisk">Novo antes up $16.5B to poach CDMO giant Catalent amid Wegovy surge</a></li>
</ul>

Biopharma and medtech explained. Every week, journalists from Fierce Biotech, Fierce Medtech, and Fierce Pharma recount the latest industry trends and why they matter. We'll analyze the week's biggest business news, from mergers and marketing to drug R&D and device development. Available every Friday morning. 

Biopharma and medtech explained. Every week, journalists from Fierce Biotech, Fierce Medtech, and Fierce Pharma recount the latest industry trends and why they matter. We'll analyze the week's biggest business news, from mergers and marketing to drug R&amp;D and device development. Available every Friday morning.&nbsp;

The Top Line

Biopharma and medtech explained. Every week, journalists from Fierce Biotech, Fierce Medtech and Fierce Pharma recount the latest industry trends and why they matter. We’ll analyze the week’s biggest business news—from mergers and marketing to drug R&D and device development. Available every Friday morning.

 

Biopharma and medtech explained. Every week, journalists from Fierce Biotech, Fierce Medtech and Fierce Pharma recount the latest industry trends and why they matter. We&rsquo;ll analyze the week&rsquo;s biggest business news&mdash;from mergers and marketing to drug R&amp;D and device development. Available every Friday morning.
&nbsp;

Former FTC director weighs in on Novo's $16.5B deal with Catalent

In early 2025, the FDA was rocked by sweeping layoffs and leadership turnover, raising questions about whether the agency could maintain its pace in reviewing new drug applications.

By the end of the year, the approval picture told a more complicated story, with momentum building after a slow start.

This week on "The Top Line," we dig into what the numbers really show, which companies and therapies came out on top, and what the FDA’s performance over the course of 2025 signals for the drug review process going forward.

To learn more about the topics in this episode: 
2025 drug approvals: Despite FDA tumult and macro uncertainty, biopharma scored with 55 new products
2024 drug approvals: Small companies loom large with several key FDA nods
2023 drug approvals: After a down year, FDA signs off on a bounty of new meds, including 7 from Pfizer

In early 2025, the FDA was rocked by sweeping layoffs and leadership turnover, raising questions about whether the agency could maintain its pace in reviewing new drug applications.
By the end of the year, the approval picture told a more complicated story, with momentum building after a slow start.
This week on "The Top Line," we dig into what the numbers really show, which companies and therapies came out on top, and what the FDA&rsquo;s performance over the course of 2025 signals for the drug review process going forward.
To learn more about the topics in this episode:&nbsp;
<ul>
<li><a href="https://www.fiercepharma.com/pharma/2025-drug-approvals">2025 drug approvals: Despite FDA tumult and macro uncertainty, biopharma scored with 55 new products</a></li>
<li><a href="https://www.fiercepharma.com/pharma/2024-drug-approvals">2024 drug approvals: Small companies loom large with several key FDA nods</a></li>
<li><a href="https://www.fiercepharma.com/special-reports/2023-drug-approvals-after-down-year-fda-signs-bounty-new-medicines">2023 drug approvals: After a down year, FDA signs off on a bounty of new meds, including 7 from Pfizer</a></li>
</ul>

Drug approvals went from crawl to sprint in 2025

What does it really mean to put patients first in today’s life sciences landscape? In this sponsored episode of The Top Line, leaders from RTI Health Solutions explore how patient voices are transforming evidence generation, market access and medical communication. From patient-reported outcomes and advisory boards to inclusive value storytelling and trust-building across diverse communities, the discussion highlights why patient-centric strategies are no longer optional—and how they can influence approval, reimbursement and real-world impact.

What does it really mean to put patients first in today&rsquo;s life sciences landscape? In this sponsored episode of The Top Line, leaders from RTI Health Solutions explore how patient voices are transforming evidence generation, market access and medical communication. From patient-reported outcomes and advisory boards to inclusive value storytelling and trust-building across diverse communities, the discussion highlights why patient-centric strategies are no longer optional&mdash;and how they can influence approval, reimbursement and real-world impact.

RTI Health Solutions leaders explain how patient voices are reshaping evidence generation, access and value communication

Putting patients first: from buzzword to business imperative (Sponsored)

As artificial intelligence continues to dominate conversations across life sciences, many companies are reaching an inflection point between experimentation and real-world impact. In a recent episode of The Top Line, Mark Sullivan, president of regulated industries at Salesforce, said the industry is moving past broad promises toward a clearer divide between organizations that have laid the groundwork for AI and those still struggling to operationalize it. While early pilots have delivered mixed results, Sullivan said the next phase will be defined by how effectively companies use AI to augment their workforce, not replace it. Much like laptops or smartphones, AI proficiency is quickly becoming a baseline expectation for professionals, shaping productivity, decision-making and resilience across drug development, manufacturing and commercialization.

Sullivan emphasized that success with AI agents hinges on trust, governance and high-quality data—particularly in an industry where accuracy and compliance are nonnegotiable. Life sciences organizations are beginning to see value in agents that support patient engagement, clinical trial matching and commercial execution, but only when those agents are grounded in enterprise data and clear guardrails. With as much as 80% of industry data unstructured, he said, the process of deploying agents often exposes deeper data and architecture challenges that must be addressed. Companies that solve for these issues can unlock both efficiency and growth, using AI not just to cut costs, but to strengthen patient relationships and drive innovation. The conversation offers a practical look at how life sciences leaders can move beyond the hype and build an agentic strategy that delivers measurable results—making it a must-listen for anyone navigating AI adoption in a regulated environment.

As artificial intelligence continues to dominate conversations across life sciences, many companies are reaching an inflection point between experimentation and real-world impact. In a recent episode of The Top Line, Mark Sullivan, president of regulated industries at Salesforce, said the industry is moving past broad promises toward a clearer divide between organizations that have laid the groundwork for AI and those still struggling to operationalize it. While early pilots have delivered mixed results, Sullivan said the next phase will be defined by how effectively companies use AI to augment their workforce, not replace it. Much like laptops or smartphones, AI proficiency is quickly becoming a baseline expectation for professionals, shaping productivity, decision-making and resilience across drug development, manufacturing and commercialization.
Sullivan emphasized that success with AI agents hinges on trust, governance and high-quality data&mdash;particularly in an industry where accuracy and compliance are nonnegotiable. Life sciences organizations are beginning to see value in agents that support patient engagement, clinical trial matching and commercial execution, but only when those agents are grounded in enterprise data and clear guardrails. With as much as 80% of industry data unstructured, he said, the process of deploying agents often exposes deeper data and architecture challenges that must be addressed. Companies that solve for these issues can unlock both efficiency and growth, using AI not just to cut costs, but to strengthen patient relationships and drive innovation. The conversation offers a practical look at how life sciences leaders can move beyond the hype and build an agentic strategy that delivers measurable results&mdash;making it a must-listen for anyone navigating AI adoption in a regulated environment.

Salesforce’s Mark Sullivan explains why trust, data discipline and human oversight will determine who wins in an agent-driven future.

Former FTC director weighs in on Novo's $16.5B deal with Catalent

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