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BioWorld - Friday, December 26, 2025
Home » Topics » North America » U.S.

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U.S. flag on columned building

Stopgaps help some survive, but over time, NIH funding is unique

Aug. 22, 2025
By Anette Breindl
No Comments
On Thursday, the Supreme Court handed the Trump administration another significant victory in its attempts to defund NIH-sponsored research. In a 5-4 decision, the justices paused the June 16 order of U.S. District Judge William Young to restore funding for hundreds of canceled NIH research grants focusing on gender and diversity, equity and inclusion (DEI). The funding had first been cut through a series of executive orders shortly after President Donald Trump resumed power in January.
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CMS logo and website

Stakeholders press CMS to act on breakthrough device coverage

Aug. 21, 2025
By Mark McCarty
A group of stakeholders including medical device makers have penned a letter to Centers for Medicare & Medicaid Services administrator Mehmet Oz to urge the agency to cover breakthrough medical devices, an attempt to resurrect administrative action on a question that legislators failed to address in 2024.
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Money sack with British pound symbol

Neurovalens raises £6M for neurostimulation devices

Aug. 21, 2025
By Shani Alexander
Neurovalens Ltd raised £6 million (US$8 million) in an investment round for its non-invasive neurostimulation devices, which treat insomnia and manage anxiety. The company will use the funds to expand its presence in the U.S. and accelerate sales of its U.S. FDA-cleared devices, Modius Sleep and Modius Calm. The round was led by the Investment Fund for Northern Ireland (IFNI) with support from new and existing investors.
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Signots Stelo

Signos adds AI to CGM to drive weight loss

Aug. 21, 2025
By Annette Boyle
Signos Inc. landed U.S. FDA clearance for its over-the-counter glucose monitoring system, which combines Dexcom Inc.'s non-prescription Stelo continuous glucose monitor with an AI-powered platform focused on weight management and metabolism. The sensor transmits glucose readings to a smartphone app that interprets the data, provides guidance for healthy habits and educates the user.
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Novocure's Optune Lua

Novocure files PMA for use of Optune in pancreatic cancer treatment

Aug. 21, 2025
By Holland Johnson
Novocure GmbH said it submitted a premarket approval application to the U.S. FDA for its Optune Lua wearable device tumor treating fields therapy for the treatment of locally advanced pancreatic cancer.
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K-Organoid Consortium
Drug design, drug delivery & technologies

South Korea forms new organoid consortium for nonanimal testing

Aug. 21, 2025
By Marian (YoonJee) Chu
No Comments
South Korea’s Ministry of Food and Drug Safety (MFDS) launched a new industry-academia-research consortium to support the nation’s organoid industry, expected to grow in light of the U.S. FDA’s shift away from animal testing in the development of novel drugs.
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US-health-flag-medicare.png

MedPAC anticipates doubling of Medicare spending by 2032

Aug. 21, 2025
By Mark McCarty
The Medicare Payment Advisory Commission said in a recent report that Medicare spending in the U.S. is poised to nearly double to $1.9 trillion over the coming eight years, a figure that is likely to apply ever-increasing price pressures on makers of devices, diagnostics and pharmaceuticals.
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K-Organoid Consortium

South Korea forms new organoid consortium for nonanimal testing

Aug. 21, 2025
By Marian (YoonJee) Chu
No Comments
South Korea’s Ministry of Food and Drug Safety (MFDS) launched a new industry-academia-research consortium to support the nation’s organoid industry, expected to grow in light of the U.S. FDA’s shift away from animal testing in the development of novel drugs.
Read More
Wooden blocks spelling TARIFFS with a U.S. flag on top, placed on a map of Europe

EU, US lock in 15% max Rx tariff, no relief for medtech

Aug. 21, 2025
By Mari Serebrov
No Comments
No matter what level of tariff the Trump administration ends up imposing on biopharmaceuticals across the world, drugs and their precursors originating in the EU will face no more than a 15% tariff when imported to the U.S., according to an Aug. 21 EU-U.S. joint statement regarding the trade framework agreement between the two trade partners.
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Nicox’s NCX-470 noninferior to latanoprost in second phase III

Aug. 21, 2025
By Karen Carey
No Comments
Showing similar results as the first phase III trial completed in 2022, Nicox SA’s nitric oxide-donating bimatoprost eye drop, NCX-470, met the primary endpoint in the phase III Denali trial for open-angle glaucoma or ocular hypertension, clearing the way for regulatory filings in both the U.S. and China.
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