Tariffs threaten Ireland's pharma powerhouse status

It seems it is only a matter of time before President Trump outlines new tariffs on the pharmaceuticals industry. That means that Ireland, long a pharma manufacturing haven thanks to generous tax policies and a skilled workforce, now finds itself in the crosshairs of his administration, as do the many global drugmakers who have set up shop there.

The Cork region alone houses sprawling campuses operated by the likes of Pfizer, Lilly, and J&J — evidence of a decades-long buildup that helped fuel local economies and U.S. drug supply chains alike. Now, as STAT's Andrew Joseph writes reports from Ireland, any further investment may be at risk.

"It may take time for the damage of this to be worked out," a leader of one trade union told STAT. But because of Ireland's reliance on exports to the U.S., if tariffs go into effect, "Ireland will get caught."

Policy

How to think about the tariffs' impact — before they hit

Speaking of tariffs, while their exact scope and timing remains unknown, what is certain is that the they are coming.

The Trump administration has already launched a formal investigation to assess whether drug imports pose a national security risk — a step seen as a prelude to new levies — and companies, investors, and consumers are already on edge.

Tariffs could trigger price hikes, shortages, and stalled production, with drugmakers now weighing moves like reshoring manufacturing, reworking tax structures, and shifting intellectual property. STAT's Ed Silverman walks through all the implications in a new piece this morning, including what tariffs might mean for the active pharmaceutical ingredients, generics, and more.

medicare

Novo Nordisk mounts unusual challenge to price negotiation program

A number of drugmakers have challenged the Medicare drug price negotiation program, to no avail. Now, Novo Nordisk is taking an unusual approach to blunt its impact, and the success of its effort could have consequences for other drugmakers.

Specifically, the Danish drugmaker is arguing that that six of its insulin products should be treated as separate drugs and not a single entity, even though they all contain the same active ingredient, insulin aspart. The outcome could shape future negotiations for other blockbusters like Ozempic and Wegovy, which share the active ingredient semaglutide, STAT's John Wilkerson writes.

At a recent appeals court hearing, two judges expressed skepticism about whether they could even review Medicare's drug selections, while one seemed more open to Novo's argument.

autoimmune Conditions

FDA approves blockbuster Dupixent for chronic hives

From my colleague Jonathon Wosen: Sanofi and Regeneron's blockbuster Dupixent notched another win on Friday when the Food and Drug Administration approved the therapy for chronic spontaneous urticaria, or CSU, a condition marked by itchy, irritating hives. The decision comes after two late-stage trials found that Dupixent, an antibody that blocks a pair of immune signals, IL-4 and IL-13, significantly reduced symptom severity and was generally safe.

The FDA had rejected the companies' initial application in 2023, requesting additional data after the pharma firms reported that one of their Phase 3 studies had failed.

Dupixent, which was already approved for several conditions, including eczema and asthma, brought in more than $14 billion in global sales last year. The FDA decision expands the drug's use to 300,000 patients in the U.S. who are 12 or older and whose symptoms have persisted despite prior antihistamine treatment. But Dupixent will face competition from Xolair, a drug owned by Novartis and Roche that is approved for CSU and already on the market.

autoimmune CONDITIONS

Roivant tightens its grip on Immunovant

Roivant Sciences is taking tighter control of Immunovant, replacing the biotech's CEO and CFO with executives from within its own ranks — a move signaling deeper operational integration as the company advances its next-gen autoimmune drug, STAT's Adam Feuerstein writes.

The management shakeup comes on the heels of positive clinical trial data for IMVT-1402, Immunovant's FcRN-blocking antibody, now heading into Phase 3 trials with a narrowed focus on six autoimmune indications — with Graves disease being the most advanced indication. While Roivant is downplaying any change in strategy, investors remain cautious given the company's capital-intensive road ahead. Itsshares have slid 20% since March.

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