Citeline, a Norstella company

In this week's Digital Health Roundup, MedTech Insight's Shubham Singh explores how Ketryx's launch of validated AI agents could reshape compliance automation in medtech. Marion Webb highlights news from BCI makers Synchron, Axoft and Subsense. Elizabeth Orr discusses AI advances at the FDA.

Plus deals involving Roche/Vividion, Alto/Chase, Biogen/City Therapeutics, Sanofi/Nurix and Naya/Invo.

Acadia’s Nuplazid for hallucinations and delusions associated with Parkinson’s disease psychosis appears safe from generic competition until well into the next decade, following a favorable infringement and validity decision by a US district court.

J&J presented data at the American Society of Clinical Oncology meeting showing more than five-year disease- and therapy-free survival, but a myeloma working group will need to define what makes a cure.

Sun readies US debut of Leqselvi for alopecia areata, while PD-L1 inhibitor Unloxcyt is in the line up once the Checkpoint Therapeutics deal is completed. Management also discusses limited clarity on President Trump’s most favored nation pricing push, pipeline tweaks and M&A outlook.

The imaging, Varian, and advanced therapies segments – which are more reliant on equipment sales – are more heavily affected, with tariffs applying to roughly 55% of their revenue base. In diagnostics, the company expects minimal exposure due to sufficient US value-added manufacturing.

As firms in OTC drug, dietary supplement and personal care/beauty sectors reported results for January-March period after Trump announced reciprocal tariffs, they buckled up for more changes in the president’s thinking likely to affect consumer spending as well as their costs.

If US tariffs on pharmaceutical supply chain products come into force they could be disruptive for companies. Ewan Townsend, of the international law firm Arnold & Porter, explains how companies can mitigate issues through negotiating with suppliers and reallocating tariff responsibilities.

The remarks from the new CBER director suggest Prasad will not be involved in most product-specific decisions.

CBER's Nicole Verdun wants rare disease sponsors with stalled treatments to circle back because the FDA's evolved thinking on clinical trial designs may offer another opportunity for cast away products.

The White House requested $6.8bn for the FDA, down 3.9% from the current funding level, but does not propose any legislative changes. In previous years, the agency used the budget process to seek statutory fixes specific to generic drugs and shortages.

The reductions across medical product programs in the agency’s budget request include hundreds of positions funded by user fees, which may foreshadow its upcoming user fee restructuring strategy.