After a wave of high-profile pledges to bring pharmaceutical manufacturing back to the United States, a clearer picture of what reshoring actually looks like is starting to emerge. Tens of billions of dollars have been committed to new U.S. plants, but those investments are unlikely to translate into immediate gains in domestic production.

In this week’s episode of "The Top Line," Fierce’s Eric Sagonowsky sits down with Rosemary Coates, executive director of the Reshoring Institute, to unpack where the trend stands today and what comes next. Coates explains why the pharma industry is uniquely positioned to bring supply chains back to the U.S., and the challenges companies face as they try to do it.

To learn more about the topics in this episode:

• UCB unveils plan to build $2B biologics plant near its US headquarters in Atlanta

• Pharmas have promised $370B in US investments amid 2025's onshoring boom: DPR

• Global pharma manufacturing output surged in '25 in 'front-loading' response to US tariff threats: report

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While Lilly’s position in the obesity market and wider GLP-1 space has remained largely unshakeable in recent months, a crack in the company’s armor may be forming, according to at least one analyst. As that assessment dealt a blow to the company’s stock price in recent weeks, Lilly is plowing forward all the same with more details on its next wave of potential incretin drugs.

In this week’s episode of "The Top Line," the Fierce Pharma team breaks down Lilly’s recent HSBC downgrade, what it signals for the GLP-1 and obesity markets, and the data shaping the company’s next wave of diabetes and weight loss products. Fierce’s Eric Sagonowsky is joined by Kevin Dunleavy and Fraiser Kansteiner to unpack the latest and assess the commercial narrative around GLP-1s so far.

To learn more about the topics in this episode:

• With downgrade, HSBC casts doubt about Lilly's 'stairway to heaven' trajectory
• Lilly's triple-G bet lowers blood sugar, prompts 16.8% weight loss in phase 3 diabetes trial
• Lilly's obesity triple threat smashes efficacy expectations in phase 3 but proves intolerable for some
• Novo’s CagriSema tops semaglutide in ph. 3 diabetes study

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In this episode of The Top Line, host Chris Hayden speaks with Olive McCormick, Head of Quality and Qualified Person at Almac Clinical Services about why late‑breaking issues in clinical trials pose such significant risk — and what teams can do to prevent them. McCormick explains that operational misalignment, delayed communication, overlooked regulatory steps or misinterpretation of requirements under the new UK Clinical Trial Regulation can snowball quickly, putting both patient safety and organizational credibility at stake.

She and Hayden discuss how sponsors, CROs and site teams can keep trials on track by establishing strong communication channels and maintaining a unified understanding of responsibilities as studies reach key milestones. McCormick stresses the value of proactive engagement and early insight into potential challenges, noting that waiting too long to identify or resolve issues increases the likelihood of disruptions.

The episode calls on clinical research professionals to prioritize transparency, coordination and shared accountability. Whether you’re leading a trial or supporting one, the discussion offers practical guidance to help teams avoid the preventable setbacks that so often arise near the finish line.

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