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BioWorld - Tuesday, January 13, 2026
Home » Topics » Regulatory » Policy

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Globe and China flag

China slashes tariffs on some medical devices

Jan. 9, 2026
By Tamra Sami
Beginning Jan. 1, 2026, China will apply provisional import tariff rates lower than the most-favored-nation rates on 935 items, the State Council announced. The move aims to boost collaboration between domestic and international sectors, and to leverage resources of both to expand the supply of high-quality goods.
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Yellow umbrella in a storm

High pressure areas predicted for 2026 medical device landscape

Jan. 8, 2026
By Mari Serebrov
It doesn’t take a meteorologist to see the storm clouds of uncertainty that will continue to roll in on health care across the globe this year. While the prospects for the medical device industry may be sunnier than for other aspects of health care, some high pressure areas likely will present challenges.
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Policy

Appeals court says no to cap on indirect costs in NIH grants

Jan. 8, 2026
By Mari Serebrov
No Comments
Unless the U.S. Supreme Court steps in to reverse the decision, the NIH’s attempt to cap indirect costs at 15% in all its grants is dead. The U.S. Court of Appeals for the First Circuit upheld a permanent injunction Jan. 5 that was issued by a lower court, vacating an NIH supplemental guidance imposing the across-the-board cap both retroactively and prospectively.
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U.S. vaccine illustration

Industry considering options amid US vaccine upheaval

Jan. 7, 2026
By Mari Serebrov
No Comments
The chaos Health and Human Services Secretary Robert Kennedy has injected into the U.S. vaccine market could have long-term consequences as vaccine makers reevaluate business decisions and pipelines.
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Appeals court says no to cap on indirect costs in NIH grants

Jan. 6, 2026
By Mari Serebrov
No Comments
Unless the U.S. Supreme Court steps in to reverse the decision, the NIH’s attempt to cap indirect costs at 15% in all its grants is dead. The U.S. Court of Appeals for the First Circuit upheld a permanent injunction Jan. 5 that was issued by a lower court, vacating an NIH supplemental guidance imposing the across-the-board cap both retroactively and prospectively.
Read More
Yellow umbrella in a storm

Stormy year in biopharma forecast

Jan. 6, 2026
By Mari Serebrov
No Comments
It doesn’t take a meteorologist to predict another stormy year for the biopharma sector, not just in the U.S., but also in Europe. Lurking within those storms, though, could be a few silver linings.
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U.S. Capitol building, Washington D.C.

New legislation would apply product liability principles to AI

Jan. 6, 2026
By Mark McCarty
Software as a service has typically been less susceptible to liability than products, but that may soon come to an end if the AI LEAD Act, sponsored by a bipartisan pair of members of the Senate, gains sufficient traction.
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US vaccine schedule slashed to international standards

Jan. 5, 2026
By Mari Serebrov
No Comments
With the stroke of a pen and no input from the CDC’s Advisory Committee for Immunization Practices, acting CDC Director Jim O’Neill cut the number of vaccines the agency routinely recommends for children to 11 on Jan. 5, down from 17 in 2024.
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2025 US regulatory word cloud
The year in review

Year marked by chaotic regulatory uncertainty in US

Dec. 31, 2025
By Mari Serebrov
No Comments
If the 2025 U.S. life sciences regulatory scene were to be summed up in one word, it would have to be uncertainty. Two words might be more definitive – chaotic uncertainty.
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EU flags at European Commission building
The year in review

Trump trade and pricing policies piled pressure on Europe in 2025

Dec. 24, 2025
By Nuala Moran
No Comments
After an all-night negotiating session that concluded after 5 am on Dec. 12, political agreement was finally reached on the long-awaited EU pharmaceutical legislation. The aim of the new rules is to improve patient access and increase the competitiveness of the sector, but for the industry, it was too little too late in terms of the incentives, and potentially damaging in the measures to improve access.
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