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The Top Line

Fierce Life Scienceswww.fiercepharma.com

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. 

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Episodes

A closer look at Fierce Biotech's Fierce 15

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? See omnystudio.com/...

Aug 09, 202411 min

What 'The Next Berlin Patient' and a PrEP’s 100% efficacy mean for HIV drug development

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....

Aug 02, 202427 min

Fierce 15: Where are they now?

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 See omnystudio.com/listener for privacy information....

Jul 26, 202410 min

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

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 ...

Jul 19, 202417 min

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

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 insig...

Jul 15, 202414 min

A look at Big Pharma’s top-paid CEOs

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 ...

Jul 12, 202411 min

The best biopharma M&A deals

At Fierce Biotech, we love a big M&A deal, but valuation does not always equal the most exciting. In this week's episode of "The Top Line," Fierce Biotech’s Annalee Armstrong and James Waldron discuss what they think are the best and smartest acquisitions in recent years. From obesity to radiopharmaceuticals, they give you the Fierce Biotech team’s thoughts on who got the best deal. To learn more about the topics in this episode: Top 10 smartest deals in biopharma See omnystudio.com/listener...

Jun 28, 202415 min

A closer look at 'friend-shoring' and the drug shortage challenge

In this week’s episode of “The Top Line,” Fierce Pharma’s Zoey Becker sits down with Bobby Sheng, the CEO of Bora Pharmaceuticals, to discuss the concept of “friend-shoring” in drug manufacturing. "Friend-shoring" involves conducting manufacturing processes in countries considered friendly or allied. Sheng discusses the criteria for deeming a country “friendly” and explores whether this strategy could help address drug supply shortages. To learn more about the topics in this episode: Bora plants...

Jun 21, 202418 min

Inside this year’s ASCO: Biggest data drops, trends and the best exhibit booth

Each June, the American Society of Clinical Oncology (ASCO) hosts a conference that gathers physicians, researchers and the cancer community to share their latest research on treatments, technologies and more. The Fierce team is always on the ground at the ASCO meeting, and this year, Fierce Biotech’s Gabrielle Masson and Fierce Pharma’s Angus Liu covered the event. In this week's episode of "The Top Line," they discuss the most talked-about data drops at ASCO and share on-the-ground details, in...

Jun 14, 202414 min

A look at the top 10 pharma drug ad spenders

The Fierce Pharma Marketing team publishes a special report each year on the top pharmaceutical drug ad spenders. This year’s report, which includes numbers for 2023, was published on Monday. AbbVie was the standout in this edition, having spent heavily on ads for Skyrizi and Rinvoq. Overall spending on the top 10 ads also experienced a sizable increase compared to the previous year. In this week’s episode of “The Top Line,” Fierce Pharma Marketing Senior Editor Ben Adams and Deputy Editor Andre...

Jun 07, 202410 min

A cell therapy reckoning

The Fierce Biotech team published a four-part series this week exploring cell therapy, a modality that has faced clinical challenges, manufacturing constraints and multiple practice-changing events. In today’s episode, Fierce’s Annalee Armstrong and Gabrielle Masson discuss the series of special reports and key insights from their interviews with multiple experts. To learn more about the topics in this episode: Cell therapy reckoning: How a 'remarkable resolution of lupus' carried CAR-T from can...

May 31, 20247 min

Automation, decentralization and the future of CAR-Ts: Advancements in cell & gene therapy manufacturing (Part III)

This week’s episode of “The Top Line,” is the final part of a three-part series diving into the latest advancements in cell and gene therapy manufacturing. In this episode, Fierce Pharma’s Fraiser Kansteiner is joined by Bruce Levine, Ph.D., who is the co-inventor of Kymriah and the Barbara and Edward Netter Professor in Cancer Gene Therapy at the University of Pennsylvania. He’s also joined by executives from CGT technology provider ScaleReady and regenerative cell therapy developer CellProther...

May 24, 202440 min

[Sponsored] Opportunities & Challenges of Digital Pathology Adoption in CDx Development

In the fast-paced field of life sciences, digital pathology is poised to be a game-changer. In this episode, we sit down with Grace Lee and Douglas Clark of Agilent Technologies to explore the opportunities and challenges associated with companion diagnostics (CDx). Clark kicks off, shedding light on the current levels of digital pathology adoption in both clinical trials and practice. Thereafter, Lee outlines several opportunities and the associated regulatory hurdles, looking at areas such as ...

May 22, 202417 min

[Sponsored] Unlocking health equity: The promise of digital health technologies

What is the transformative potential of digital health technologies in advancing health equity? Rabin Martin, a global health consulting firm, explores those possibilities in this engaging episode. The conversation highlights the excitement surrounding digital tools and advanced analytics in achieving deeper insights, consistent care delivery, workforce support, and addressing social determinants of health. Listen in now. Host: Heath Clendenning, Fierce Life Sciences Producers: Matt Rickman and ...

May 20, 202415 min

Advancements in cell & gene therapy manufacturing (Part II)

This week’s episode of “The Top Line” is the second part of a three-part series exploring the latest advancements in cell and gene therapy manufacturing. In this episode, Fierce Pharma’s Fraiser Kansteiner interviews Delara Motlagh, head of cell therapy at Catalent; Becky Butler Cap, senior vice president of biotherapies at Vitalant; and Kevin Kyle, CEO of Germfree. The conversation covers cell collection, the critical first step in advanced therapy manufacturing. They also discuss the importanc...

May 17, 202431 min

Fulfilling the promise of cell & gene therapies through manufacturing (Part I)

This week’s episode of “The Top Line,” kicks off a series diving into the latest advancements in cell and gene therapy manufacturing. In this episode, Fierce Pharma’s Fraiser Kansteiner sits down with Ori Biotech CEO Jason Foster and the Cell Therapy Manufacturing Center's CEO, Jason Bock. They delve into the current state of cell and gene therapy manufacturing and consider if the existing production methods can keep up with the potential of personalized medicines. They also dive into past hurdl...

May 10, 202429 min

A closer look at 2023's top biopharma deals and what lies ahead

This week on "The Top Line," we're diving into the details of the spree of big-money biopharma deals in 2023 and examining what that means for this year. Fierce Pharma Senior Writer Kevin Dunleavy sits down with Cody Powers, a consultant who advises companies on business development and franchise growth strategy, to discuss the reasons behind the numerous high-value deals in 2023, which companies are primed to make major moves this year, and whether the trend of acquiring ADCs and obesity treatm...

May 03, 202418 min

A look at pharma revenue rankings

Fierce Pharma publishes a yearly special report highlighting the top 20 pharmas based on their revenue. The most recent edition, published this month, ranks each pharma based on their total revenues for 2023. This week on "The Top Line," Fierce Pharma Senior Editor Eric Sagonowsky and Senior Writer Kevin Dunleavy break down the numbers, highlight key trends and share some of the biggest changes at the top and bottom of the rankings year over year. To learn more about the topics in this episode: ...

Apr 26, 202410 min

Winning formulas for the best biotech and drug names

This week on “The Top Line,” we're joined by Fierce Biotech Senior Editor Annalee Armstrong and Fierce Pharma Marketing Senior Editor Ben Adams. We're diving into our recent spin on March Madness at Fierce. This time around, Fierce Biotech kicked off its inaugural Best Biotech Name tournament, while over at Fierce Pharma Marketing, we held our biannual Drug Names tournament. The editors discuss what makes a company or drug name tick, what to steer clear of, and how the entire competition played ...

Apr 19, 202415 min

[Sponsored] What does the future of specialist distribution look like?

Jeff Beck of BioCare is in the hotseat for this edition of The Top Line. Beck is the Chief Development Officer at the company, which stands tall as a pioneer in specialty product distribution with over 40 years of experience dating back to hemophilia therapies. During the conversation, Beck provides an inside look at the rapidly evolving specialty distribution landscape. He outlines how the patient-centric model is working well and is supported by efficient supply chains. However, the future wil...

Apr 15, 202412 min

Deep dive: Biopharma layoffs in Q1

This week on "The Top Line," we explore biopharma layoffs in the first quarter of 2024. Using data from Fierce Biotech's layoff tracker, Gabrielle Masson and Max Bayer analyze the trends of layoffs in the first quarter of 2024, comparing them to previous years. With a notable number of layoff rounds marking the start of the year, they examine the factors behind this ongoing challenge while also highlighting positive industry developments. To learn more about the topics in this episode: No reprie...

Apr 12, 202418 min

The unrecognized threat of PAD

This week on “The Top Line,” we explore peripheral arterial disease, a serious health issue that is often overlooked and undermanaged. Join Editor-in-Chief of Fierce Life Sciences and Healthcare Ayla Ellison as she sits down with Kumar Madassery, M.D., Director of the Peripheral Vascular Intervention & CLI Program at Rush University Medical Center. They discuss the hidden dangers of PAD, and Dr. Madassery emphasizes the importance of early detection. He also discusses the launch of the PAD P...

Apr 05, 202414 min

The top money raisers in biotech

This week on "The Top Line," we explore our annual special report on the top money raisers in the biotech industry. Which company raised the most funding in 2023? What does the biotech financing landscape look like for this year? Fierce Biotech's Annalee Armstrong and Max Bayer answer those questions and many more in today's episode. They also discuss the details of the special report and share some of the stories behind the numbers. To learn more about the topics in this episode: Biotech's top ...

Mar 29, 202419 min

A closer look at European biotech investment in 2024

This week on “The Top Line,” we explore the European biotech investment landscape. Fierce Biotech’s James Waldron sits down with Maina Bhaman, a Partner at Sofinnova Capital Strategy, who provides insights into how investors are approaching the European biotech sector. To learn more about the topics in this episode: 'The fundamentals are really strong': Why investors are staying loyal to European biotech in 2023 'Optimism' at Jefferies conference, but don't expect biotech IPO boost soon, says So...

Mar 22, 202418 min

Inclusivity in psoriasis trials with Takeda

This week on “The Top Line,” we’re diving into the topic of diversity in clinical trials, examining both the progress made and the ongoing work needed to ensure inclusivity. In this episode, Fierce Biotech Senior Editor Annalee Armstrong engages in a conversation with Karen Correa, Ph.D., Head of Global Clinical Operations at Takeda and Executive Sponsor of Trial Diversity. Correa shares her insights into why it's imperative for pharmaceutical companies to adapt and prioritize diversity in their...

Mar 15, 202415 min

Fierce Medtech's Fierce 15

In this week's episode of "The Top Line," join Conor Hale, Senior Editor of Fierce Medtech, and Andrea Park, Deputy Editor of Fierce Life Sciences, as they share the highlights of this year's Fierce Medtech Fierce 15. To learn more about the topics in this episode: Fierce Medtech's Fierce 15 of 2023 See omnystudio.com/listener for privacy information....

Mar 08, 202416 min

[Sponsored] A Person-Centered Approach to Achieving Long-Term Success

This week on “The Top Line,” we’re speaking with Jared Baeten, MD, Ph.D., Vice President, HIV Clinical Development, Gilead Sciences about how advancements in HIV treatment research have enabled individuals to lead longer and healthier lives by taking and staying on medication. Nevertheless, HIV persists as a significant public health challenge. To end the HIV epidemic, it is crucial to go beyond a biomedical approach and fully integrate social determinants of health into the collective response....

Mar 04, 202416 min

CAR-T boxed warnings: What comes next?

The FDA recently asked the six marketed CAR-T therapies to add a new boxed warning item on their labels to reflect the risk of secondary T-cell cancers. This decision follows an investigation into the new safety signal from postmarketing adverse event reports and clinical trials. In today’s episode, Fierce Pharma’s Angus Liu talks with regulatory experts Mwango Kashoki, M.D., SVP, Global Head of Regulatory Strategy at Parexel, and Steve Winitsky, M.D., VP, Technical, Regulatory Strategy at Parex...

Mar 01, 202434 min

Breaking down Eli Lilly’s ESG formula

This week on “The Top Line,” we explore the impact of environmental, social and governance measures, commonly known as ESG, on the pharmaceutical industry. Fraiser Kansteiner of Fierce Pharma engages in a conversation with Jim Greffet, Head of ESG Strategy at Eli Lilly, to gain insights. Greffet makes a compelling business case for integrating ESG into the core of drugmakers' DNA. He also discusses Eli Lilly’s specific ESG initiatives, illustrating how these strategies connect to the company’s e...

Feb 23, 202423 min

Gene editing's next act

Gene editing’s therapeutic application has transitioned from hypothetical to reality, marked by the recent approval of a CRISPR-based therapy for sickle cell and beta thalassemia. In the wake of these developments, new biotech companies are springing up spurred by advancements that redefine what conditions might soon become treatable. One contender in this rapidly changing landscape is Verve Therapeutics. This week on "The Top Line," Fierce Biotech’s Max Bayer sits down with the company’s CEO Se...

Feb 16, 202426 min
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