The Top Line

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 See omnystudio.com/listener for privacy information.

Annalee Armstrong, a key figure in Fierce Biotech's annual reports, and Gabrielle Masson, a presenter for the Fierce 15 at NYSE, delve into the fascinating selection process for this year's Fierce 15. They reveal the unique qualities that set these innovative biotech companies apart, from groundbreaking RNA therapies inspired by nature to the rise of women-led firms. The duo also shares insights into collaborations tackling obesity and mental health, showcasing the vibrant landscape of biotech's future.

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  See omnystudio.com/listener for privacy information.

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.

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.

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.See omnystudio.com/listener for privacy information.

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 See omnystudio.com/listener for privacy information.

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 for privacy information.

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 its flag in the US with $210M acquisition of generics manufacturer Upsher-Smith Emergent, pivoting away from CDMO business, sells Baltimore plant to acquisitive Bora for $30M See omnystudio.com/listener for privacy information.

Fierce Biotech and Fierce Pharma reporters Gabrielle Masson and Angus Liu discuss ASCO's biggest data drops and trends. They share insights on Keytruda's competition, Merck's strategic shift, and novel cancer vaccines. Experience the ASCO exhibit hall adventures with virtual reality and unique booth encounters. Learn about the intense competition, challenges, and amusing moments at the international conference.