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BioWorld - Thursday, January 15, 2026
Home » Topics » Regulatory » Policy

Policy
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And then there was one: Abbvie reaches MFN pricing deal

Jan. 13, 2026
No Comments
Abbvie Inc. announced its agreement to focus on improving access and lowering the cost of medicines, becoming the latest pharma to fall in line with the Trump administration’s most-favored nation (MFN) pricing deal. Regeneron Pharmaceuticals Inc. now remains the only firm originally included in President Donald Trump’s July 31 MFN ultimatum that has yet to finalize terms.
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ACIP expands again, but no new infectious disease experts added

Jan. 13, 2026
By Mari Serebrov
No Comments
U.S. Health and Human Services Secretary Robert Kennedy has once again expanded the CDC’s Advisory Committee on Immunization Practices (ACIP), this time adding two more ob-gyns to the membership list. As a result, the ACIP, which can have up to 19 members, now numbers 13, three of whom are ob-gyns.
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Pen and paper

Pace of EOs slows, but still wields big impact

Jan. 13, 2026
By Mari Serebrov
No Comments
Perhaps the biggest indicator of U.S. President Donald Trump’s activism in his second term is the 225 executive orders (EOs) he issued in 2025. The pace of those orders seems to have slowed, with “only” 16 released in the last quarter of the year. Four of the recent EOs could impact drug and device companies in a myriad of ways.
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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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