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BioWorld - Saturday, May 30, 2026
Home » Topics » Regulatory » Policy

Policy
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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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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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AAP unveils its own updated childhood vaccine schedule

Aug. 19, 2025
By Mari Serebrov
No Comments
For more than 30 years, the U.S. CDC’s Advisory Committee for Immunization Practices (ACIP) and the American Academy of Pediatrics (AAP) worked together to harmonize their evidence-based vaccine schedules. Not anymore.
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3-30-Medtronic-Symplicity-Spyral.png

New hypertension guidelines shot in the arm for RDN

Aug. 18, 2025
By Mark McCarty
Several cardiology societies in the U.S. have updated their guidelines for management of hypertension, which for the first time includes and endorsement of renal denervation (RDN). Two companies are poised to benefit from the news, including Medtronic plc with its Symplicity Spyral device and Recor Medical Inc., and its Paradise RDN system.
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U.S. Capitol building

Congress eyes bills for TPLF as funding predicted to triple

Aug. 15, 2025
By Mark McCarty
The amounts invested in third-party litigation funding (TPLF) are expected to increase more than three-fold in the coming years, and the U.S. Congress has finally taken note of the predicament. Both the House and the Senate have introduced bills to tackle the problems of TPLF.
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Lilly to put up drug prices in Europe

Aug. 15, 2025
By Nuala Moran
No Comments
Eli Lilly and Co. has fallen into line with U.S. President Donald Trump’s May 12 executive order on most-favored nation pricing, announcing it will put up drug prices in Europe in order to make them lower in the U.S. In a statement on Aug. 14, the company said it supports the Trump administration’s objective of more fairly sharing costs of “breakthrough medical research” across developed countries.
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Tablets on conveyor belt

US API stockpile added to onshoring toolbox

Aug. 14, 2025
By Mari Serebrov
No Comments
In his latest effort to incentivize domestic manufacturing of drugs and their key ingredients, U.S. President Donald Trump issued an executive order Aug. 13 to replenish the country’s nearly empty Strategic Active Pharmaceutical Ingredients Reserve (SAPIR), giving a preference to U.S.-produced APIs.
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Dollar sign dropper and test tube

Trump EO to change the landscape of US grants, awards

Aug. 11, 2025
By Mari Serebrov
No Comments
Billing it as a necessary reform to protect tax dollars from frivolous government spending, redundancy and waste, U.S. President Donald Trump issued a new executive order (EO) requiring his political appointees to sign off on grants and awards from agencies such as the NIH and to monitor those awards over time to ensure they’re being used properly.
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US map with arrows pointing inward

US FDA looking to help with Rx moving woes ahead of tariff

Aug. 7, 2025
By Mari Serebrov
No Comments
Location, location, location. While location is as important in manufacturing as it is in buying a home, it could become even more so for drug companies when, and if, the global biopharma sector tariff U.S. President Donald Trump continues to tease becomes a reality. In the shadow of the impending tariff, the FDA is working on a draft framework, the two-phase FDA PreCheck, to make it faster and easier for biopharma companies to relocate their manufacturing to the U.S.
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