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BioWorld - Monday, July 27, 2026
Home » Topics » Regulatory » Policy

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Gavel and scales

US states seek to undo HHS reorg, terminations

May 6, 2025
By Mari Serebrov
No Comments
Claiming that they’re suffering the consequences of a March 27 directive ordering a mass reduction in force and reorganization throughout the U.S. Department of Health and Human Services (HHS), 19 states and the District of Columbia took their grievances to court.
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Handshake with digital globe overlay

Med-tech financings and guidance strong despite tariffs

May 5, 2025
By Annette Boyle
April data and first quarter earnings reports show remarkable resilience in med tech, even as other sectors continue to suffer in response to tariffs and changing regulations. Not that tariffs proved insignificant: several companies reported annualized impacts north of half a billion dollars, but fundamentals and increased interest in med tech as a haven gave most players sufficient breathing room to absorb the impact with minimal adjustments.
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Magnifying glass over globe, focused on Mexico

Annual US 301 trade report has louder bark

May 5, 2025
By Mari Serebrov
No Comments
Echoing President Donald Trump’s justification for reciprocal tariffs, the U.S. Trade Representative’s annual Special 301 Report is a bit more aggressive in tone this year as it calls out trading partners that don't adequately enforce intellectual property rights or that otherwise discriminate against products from foreign companies.
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U.S. Capitol building, Washington D.C.
MDMA annual meeting

Klobuchar reiterates opposition to Trump tariffs

May 1, 2025
By Mark McCarty
Sen. Amy Klobuchar (D-Minn.) spoke to an industry meeting in Washington and expressed concerns about the situation at the U.S. FDA, but she also blasted the tariffs put in place by the Trump administration as lacking the proper statutory authority.
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US HHS touts NIH-developed universal vaccine platform

May 1, 2025
By Mari Serebrov
In a paradigm shift from private-sector partners, the U.S. Department of Health and Human Services (HHS) and the NIH announced May 1 the development of Generation Gold Standard, a next-generation, universal vaccine platform that uses a beta-propiolactone-inactivated, whole-virus to target pandemic-prone viruses.
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‘Everything is possible’: Pharmas navigate US market uncertainties

May 1, 2025
By Nuala Moran
“We are prepared for every scenario, even though we don’t know what some of those are.” That sums up the message from executives of Astrazeneca plc, GSK plc and Sanofi SA, when quizzed during presentations of their first-quarter 2025 results this week, about the fallout if pharmaceuticals they import to the U.S. are subject to tariffs.
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Stacks of coins separated by a crack

Filling the NIH funding gap to protect biopharma research

May 1, 2025
By Karen Carey
The Trump administration’s broad slash to university research budgets raises pertinent questions over impacts to the biopharma ecosystem, specifically how a changed trajectory of early research programs will affect tomorrow’s treatments and cures. Who is going to bridge research from idea to company if grants from the U.S. NIH are no longer an option?
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Exterior of NIH Vaccine Research Center

Senate hearing: US biomedical research at a crossroads

April 30, 2025
By Mari Serebrov
If the April 30 hearing on biomedical research before the U.S. Senate Appropriations Committee is any indication, the Trump administration could face a big challenge if it tries to cut more than 40% of the NIH’s budget in fiscal 2026 as proposed and slap a 15% cap on indirect costs.
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Handshake with digital globe overlay

Advamed, Medtech Europe sound off on tariffs

April 29, 2025
By Mark McCarty
No Comments
The Trump administration’s tariff activities provoked another set of responses from both Medtech Europe and the Advanced Medical Technology Association.
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China in red on globe
Chinabio 2025

US capital crunch pushes China biotechs to roundabout financings

April 29, 2025
By Marian (YoonJee) Chu
Tightening of U.S. regulation and capital is leading Chinese biotechs to alternative and new models of financing, ranging from cross-border licensing deals, M&As, the so-called newco model and overseas listings.
Read More
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