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Latest News & Analysis
Spanish biosimilars developer mAbxience has struck a deal with Italy’s Abiogen covering an undisclosed biosimilar for the Italian market.
Krka has provided updates for its pair of joint ventures in two key Asian markets, India and China, as the Slovenian firm reported its first-quarter financial results.
In this week's episode: Novo Nordisk’s CEO forced out; quantifying biopharma’s contribution to the US economy; a history of MASH deals; lift for AstraZeneca’s asthma ambitions; and major Japanese firms see US revenue growth.
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.
Spotlight On Tariffs
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.
Medtronic expects operating profit to grow approximately 7% in fiscal 2026, excluding tariff impacts. If tariffs materialize at the upper end of the projected range, operating profit growth could drop by 2.2 to 3.2 percentage points.
Pharma firms tended to downplay first-quarter trends in full-year guidance. However, raised guidance seems fragile amid ongoing foreign exchange effects and Medicare Part D redesign pressures.
The US’ 90-day suspension of higher “reciprocal tariffs” will expire on 9 July, raising fears that the 31% tariff rate on Swiss medtech and other goods exported to the US might make a comeback. While the tariff situation changes on an almost daily basis, medtechs should forearm for any eventually, say local business organizations.
Changes At The FDA
FDA Commissioner Martin Makary will give industry a new avenue for access and influence despite his and HHS Secretary Robert F. Kennedy Jr.’s claims that the pharma-FDA relationship is too cozy.
Pink Sheet reporter and editors discuss the new clinical trial requirements that the FDA announced for COVID-19 vaccines, the updated label for Novavax’s newly approved COVID-19 vaccine, and other vaccine-related events that were part of a busy week for policy in the sector.
The FDA’s advisors split on whether to update COVID-19 vaccines for the fall. The agency refused to discuss the impact of the new vaccine framework on availability.
The budget authority total, which is significantly higher than the amount floated in an April OMB draft document, suggests there may have been successful lobbying to increase FDA funding.
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