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BioWorld - Saturday, December 27, 2025
Home » Topics » Regulatory, BioWorld MedTech

Regulatory, BioWorld MedTech
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Microscope and coronavirus illustration

US-funded gain-of-function research paused for stiffer oversight

May 7, 2025
By Mari Serebrov
No Comments
In a throwback to the Obama administration, U.S. President Donald Trump signed an executive order pausing federally funded research using infectious pathogens and toxins that may pose a danger until a safer, more enforceable and transparent policy governing such research can be developed and implemented.
Read More
Illustration of stent angioplasty balloon in artery

UK’s NICE seeks to apply price pressures on drug-eluting stents

May 6, 2025
By Mark McCarty
The U.K. National Institute for Health and Care Excellence (NICE) opened a late-stage assessment for drug-eluting stents (DES) with an eye toward costs, advising clinicians that they should implant the least expensive DES unit that is clinically appropriate for that patient while the assessment is underway.
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US flag, gavel, book

Q’apel’s withdrawal of Hippo ends patent lawsuit with Route 92

May 6, 2025
By Mark McCarty
Q’apel Medical Inc., of Fremont, Calif., might have thought the company’s withdrawal of the Hippo catheter was nothing but a loss, but Route 92 Medical Inc. managed to shine a positive light on the withdrawal by dropping a patent lawsuit against Q’apel because of the Hippo device.
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Magnifying glass over globe, focused on Mexico

Annual US 301 trade report has louder bark

May 6, 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.
Read More
Pharmaceutical manufacturing

EO offers US onshoring relief, FDA steps up foreign inspections

May 6, 2025
By Mari Serebrov
No Comments
In an ongoing effort to onshore more of the biopharma supply chain, U.S. President Donald Trump signed an executive order (EO) late May 5 to shorten the time involved in bringing a new manufacturing plant or expansion online and to remove some of the incentives for foreign production of finished drugs and active pharmaceutical ingredients.
Read More
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.
Read More
Australia map, flag

Australia follows Canadian lead; Labor win a sharp rebuke to Trump

May 5, 2025
By Tamra Sami
No Comments
Australian biopharma stakeholders welcomed the reelection of Prime Minister Anthony Albanese, who promised to expand Medicare and to invest more in Australian research.
Read More
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.
Read More
U.S. flag on columned building
MDMA annual meeting

Compliance still important under new Department of Justice

May 2, 2025
By Mark McCarty
The U.S. Department of Justice may have dismantled its civil division, but that doesn’t mean companies in the life sciences can let their guard down.
Read More
CMS logo and website
MDMA annual meeting

CMS vows to put more emphasis on MA plans’ prior authorization

May 2, 2025
By Mark McCarty
Physicians aren’t the only ones who see prior authorization (PA) practices as a significant problem, but John Brooks, deputy administrator at CMS, told a med tech audience that a renewed focus on Medicare Advantage plans’ use of PA will not yield tangible results overnight.
Read More
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