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

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: 
<ul>
<li><a href="https://www.fiercebiotech.com/special-report/fiercebiotech-s-2014-fierce-15">Fierce Biotech's Fierce 15 of 2014</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;

Fierce 15: Where are they now?

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>

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

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.

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 <a href="https://www.pda.org/global-event-calendar/conferences/pda-fda-joint-regulatory-conference-2024">pda.org/PDAFDA2024</a>.

Co-Chair Janeen Skutnik-Wilkinson gives us an exclusive behind-the-scenes look at what’s in store for this essential CGMP event.

Find out what to expect from the PDA/FDA Joint Regulatory Conference (Sponsored by Parenteral Drug Association)

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

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: 
<ul>
<li><a href="https://www.fiercepharma.com/pharma/big-pharmas-top-10-highest-paid-ceos-2023" data-cke-saved-href="https://www.fiercepharma.com/pharma/big-pharmas-top-10-highest-paid-ceos-2023">Big Pharma's 10 highest-paid CEOs of 2023</a></li>
</ul>

Fierce 15: Where are they now?

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