Citeline, a Norstella company

J&J's EMEA head of digital solutions, Julia Fishman, talks about the major hurdles in scaling digital innovation, tips for clinical adoption and what’s up next on J&J’s innovation road map. Robot-assisted surgery pioneer Ivo Broeders gives his perspective on the difficulties in clinical adoption.

The KINCISE 2 Surgical Automated System aims to “reduce the physical burden on surgeons compared to manual impaction in primary and revision hip and revision knee replacement procedures,” said J&J MedTech.

After previously partnering on denosumab, Alvotech and Dr Reddy’s have announced a further alliance to co-develop a biosimilar version of Keytruda (pembrolizumab).

Several years after the initial signing of their agreement, Formycon and Fresenius Kabi announced the launch of their Stelara biosimilar Otulfi in Canada, adding another key market to their list.

Quest reaffirmed its full-year guidance despite macroeconomic concerns and tariff uncertainty. Revenues are expected between $10.7bn and $10.85bn. Adjusted earnings per share (EPS) is estimated in the $9.55 to $9.80 range for the full year, with EPS between $8.62 and $8.87.

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.

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.