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Home » Topics » Regulatory » NIH

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BIO CEO 2025: Navigating from policy to innovation to patients

Feb. 11, 2025
By Karen Carey
The fast pace in which the Trump administration has rolled out changes to how government and businesses operate – a disruptive effort that appears to be creating a new world order – has caught the attention of biopharma industry leaders who spoke Tuesday at the Biotechnology Innovation Organization’s CEO and Investor Conference in New York.
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Dollar sign dropper and test tube

Court orders full stop to US NIH slashing of indirect rates

Feb. 11, 2025
By Mari Serebrov
The immediate implementation of the U.S. NIH’s guidance to cut indirect costs included in its grants to 15% was quickly halted late Feb. 10 when a federal district judge granted a nationwide temporary restraining order in two separate challenges to the cuts that were to go into effect that day on all existing and new NIH grants.
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Lisa Ricciardi, CEO, Cognition

BIO CEO 2025: Cognition CEO debates policy while advancing CT-1812

Feb. 11, 2025
By Karen Carey
Cognition Therapeutics Inc. evolved from the work of a neuroscientist and a chemist working in the San Francisco Bay area, seeking out targets to block the effects of Alzheimer’s disease. Since the company’s 2007 inception, it has received close to $200 million in U.S. NIH grant funding. Investors often tell CEO Lisa Ricciardi, who joined the company in 2020: “’That’s because you have a relationship with the FDA.’ Well, no. It’s because it’s competitive” and the company’s research has met the muster. “You have to apply two or three times. … It’s with rigor that these results are generated and that we’re able to get more funding.”
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Female scientist looking through microscope

Scientists warn NIH cost-cutting will impair research

Feb. 10, 2025
By Nuala Moran
From Feb. 10, the U.S. NIH is to cut the amount of its grants that go to indirect costs, in a move it says will save $4 billion per annum, but which scientists say will hit breakthrough biomedical research. The NIH announced the cut on Friday, Feb. 7, saying there would be a flat rate of 15% for indirect costs, such as running laboratories, buying and maintaining equipment, data processing and storage, across all of its grants. That compares to an average rate historically of between 27% and 28%, the NIH said.
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Analysis

Admin's actions toward science agencies 'not a measured reappraisal'

Feb. 7, 2025
By Anette Breindl

In the early days of the second Trump administration, what will happen to various government science agencies is not yet clear. Given the communications blackout imposed on agencies including the NIH and the CDC, most of what is known comes from anonymous sources and secondhand reports. Executive orders affecting the agencies are also still in the process of being interpreted, as well as subject to multiple legal challenges.


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US flag and HHS logo

Mum’s the word at US health agencies awaiting new leadership

Jan. 23, 2025
By Mari Serebrov
With key officials yet to be confirmed at the U.S. Department of Health and Human Services, the acting secretary imposed an immediate pause throughout the department on publicly issuing any document or communication without first getting it approved by a presidential appointee.
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Hand holding radioactive symbol
Gastrointestinal

NIH grant supports evaluation of ghrelin for radiation-induced gastrointestinal syndrome

Jan. 20, 2025
The Feinstein Institutes for Medical Research has been awarded a 5-year, $2.9 million grant from the National Institutes of Health (NIH) to investigate the potential of human ghrelin as a medical countermeasure against radiation-induced gastrointestinal syndrome.
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U.S. Capitol building

New Year rings in a new US Congress

Jan. 3, 2025
By Mari Serebrov
It was in with the new and out with the old Jan. 3 as the gavel came down on the first session of the 119th U.S. Congress. Although Republicans will control both the House and Senate for the next two years, their narrow majority could prove a challenge to passing some of President-elect Donald Trump’s agenda, including his proposal to cut the corporate tax rate to 15% for companies that manufacture their products in the U.S.
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U.S. White House

President-elect: Trump 2.0 health reforms not that ‘radical’

Jan. 2, 2025
By Mari Serebrov
As investors and industry alike try to read the tea leaves of what the upcoming change in administrations holds for the U.S., speculation abounds about what Trump 2.0 will mean for the biopharma and med-tech spaces.
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Biontech’s $1.26B vaccine royalty settlement clears path forward

Dec. 30, 2024
By Mari Serebrov
Biontech SE agreed to pay up to nearly $1.26 billion in two separate settlements to resolve royalty disputes with the U.S. NIH and the University of Pennsylvania related to the COVID-19 vaccine the company partnered with Pfizer Inc.
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