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BioWorld - Thursday, January 1, 2026
Home » Topics » Regulatory » Policy

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Gavel and scales
Policy

Harvard fighting back with lawsuit against Trump administration

April 23, 2025
By Nuala Moran
Harvard University has filed a lawsuit claiming the Trump administration’s freezing of its federal funding is unlawful and beyond the government’s authority. Announcing the move, Harvard’s president, Alan Garber, highlighted the impact of freezing $2.2 billion in grants – and the threat to freeze a further $1.1 billion – will have on the university’s biomedical research.
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World trade illustration

Ouch! Tariffs hit med tech harder than expected

April 22, 2025
By Annette Boyle
First quarter earnings reports from Johnson & Johnson and Abbott Laboratories provided some surprising insights into the likely hit med-tech companies will sustain with current tariffs. The main takeaway? The impact of the trade war with China is far greater than expected by most analysts.
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Diamond cut, ombre EU flag

TEAM NB says AI Act will challenge member states

April 22, 2025
By Mark McCarty
The European Association of Medical Device Notified Bodies inked a position paper on the EU Artificial Intelligence Act which recites some standing concerns. Perhaps the most interesting passage in the paper is that there is a need for a “well-coordinated approach between member states that are in charge of notified body oversight.”
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No more ‘fox guarding the henhouse’ under new state PBM law

April 22, 2025
By Mari Serebrov
Tired of waiting for the U.S. Congress to get around to making meaningful reforms to pharmacy benefit manager (PBM) practices, states are beginning to take the matter into their own hands. Arkansas recently became the first state to pass a law stopping PBMs, their affiliates or their parent companies from acting as a "fox guarding the henhouse" by being both a price setter and price taker, as the legislation puts it.
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Robert Williamson, Triumvira CEO and Hernan Bazan South Rampart CEO

The BioWorld Insider podcast: Bracing for the impact of tariffs and grant cuts

April 22, 2025
By Lee Landenberger
As pharma deals with the impact of U.S. NIH grant cuts and the imposition of tariffs, a lot of pressure is shifting to smaller and midcap companies, according to two executives who spoke on the newest BioWorld Insider podcast.
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World trade illustration

Ouch! Tariffs hit med tech harder than expected

April 21, 2025
By Annette Boyle
First quarter earnings reports from Johnson & Johnson and Abbott Laboratories provided some surprising insights into the likely hit med-tech companies will sustain with current tariffs. The main takeaway? The impact of the trade war with China is far greater than expected by most analysts.
Read More
Illustration of human body composed of molecules

Device makers wary of FDA guidance for AI-enabled software functions

April 21, 2025
By Mark McCarty
The U.S. FDA’s January 2025 draft guidance for AI-enabled device software functions has not fared well in terms of industry response. Two major trade associations argue that the draft is at least somewhat redundant with existing agency guidance.
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FDA sign

Makary’s vision for slimmed-down US FDA somewhat reassuring

April 21, 2025
By Mari Serebrov
Nearly three weeks into the job, U.S. FDA Commissioner Marty Makary provided a comprehensive overview of his vision for the much-reduced agency, even as he’s taking first steps to implement his agenda.
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World trade illustration

Ouch! Tariffs hit med tech harder than expected

April 17, 2025
By Annette Boyle
First quarter earnings reports from Johnson & Johnson and Abbott Laboratories provided some surprising insights into the likely hit med-tech companies will sustain with current tariffs. The main takeaway? The impact of the trade war with China is far greater than expected by most analysts.
Read More
Puzzle pieces missing from $100 bill

Budget woes ahead for US life sciences sector?

April 17, 2025
By Mari Serebrov
The next major shock wave to hit the U.S. biopharma and med-tech industries could be the fiscal 2026 federal budget. Nearly one-third of the discretionary budget for the Department of Health and Human Services (HHS) could be wiped out, according to the White House Office of Management and Budget’s “pre-decisional” budget proposal, or passback, for HHS.
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