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BioWorld - Wednesday, December 10, 2025
Home » Topics » Regulatory » NIH

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Colorized transmission electron micrograph of an mpox virus particle

Siga stumbles in mpox study as Bavarian Nordic ramps up

Aug. 15, 2024
By Lee Landenberger
As mpox has now been found in the EU, the race for an effective vaccine has accelerated, with a study failure but increased vaccine production from Europe. The U.S. NIH just released top-line results from a preliminary analysis of a placebo-controlled study of Siga Technologies Inc.’s antiviral, tecovirimat, showing it missed the primary endpoint of statistically significant improvement within 28 days post-randomization in time to lesion resolution for patients in the Democratic Republic of the Congo.
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Scanning electron microscope image of SARS-CoV-2.

US NIH-funded study discloses no clear biomarkers for long COVID

Aug. 13, 2024
By Mark McCarty
The U.S. National Institutes of Health sponsored a study that was designed to establish whether there are any biomarkers that are strongly associated with the constellation of symptoms known as long COVID, but the study shed little light on the question.
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More reforms proposed for US NIH

June 17, 2024
By Mari Serebrov
With all the criticism the U.S. NIH has been getting of late, it’s not surprising that yet another reform proposal for the research agency is brewing in Congress. In unveiling a proposed framework to reform the NIH, House Energy and Commerce Committee Chair Cathy McMorris Rodgers (R-Wash.) recognized the critical role the agency plays in life-saving medical research and innovation.
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Artificial intelligence and digital health icons

US NIH releases AI prognostic for response to cancer immunotherapy

June 12, 2024
By Mark McCarty
The U.S. National Institutes of Health has jumped into the artificial intelligence pool with a prognostic that predicts a patient’s response to immune checkpoint inhibitors as cancer therapies.
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Many NIH-funded trials missing the mark on inclusion

May 30, 2024
By Mari Serebrov
Despite U.S. NIH policy and its peer-review grant process, providing for inclusive enrollment in phase III NIH-funded clinical trials seems to be a check-the-box exercise for many researchers. In a review of a sample of phase III NIH-funded trials conducted between 2016 and 2020, the Health and Human Services Office of Inspector General found that two-thirds had the required inclusive enrollment plans, but 57% of the trial plans provided no explanation or rationale for the enrollment targets.
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US NIH step closer to including price, as access, in licenses

May 29, 2024
By Mari Serebrov
Price is working its way indirectly into licensing agreements for U.S. NIH-funded inventions, be they drugs, biologics, vaccines or medical devices.
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Illustration of Borrelia burgdorferi bacteria
Infection

Decoding B. burgdorferi’s reliance on the Opp system to identify new targets against Lyme disease

May 23, 2024
Researchers from Purdue University and the National Institutes of Health (NIH) have identified a potential target for treating Lyme disease, a prevalent tick-borne illness of increasing concern worldwide. Current treatment for Lyme disease is based on long-term administration of broad-spectrum antibiotics, with significant costs and impact on patients’ quality of life.
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Report leads to suspension of Ecohealth, NIH rebuke

May 21, 2024
By Mari Serebrov
Citing the need to protect the public interest, the U.S. Department of Health and Human Services ordered an immediate government-wide funding suspension May 15 of Ecohealth Alliance Inc. while formal debarment proceedings are pending against the New York-based nongovernmental organization.
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Report leads to suspension of Ecohealth, NIH rebuke

May 16, 2024
By Mari Serebrov
Citing the need to protect the public interest, the U.S. Department of Health and Human Services ordered an immediate government-wide funding suspension May 15 of Ecohealth Alliance Inc. while formal debarment proceedings are pending against the New York-based nongovernmental organization.
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NIH researcher looking through a microscope

Sen. Cassidy calls for NIH reforms, questions US ROI

May 13, 2024
By Mari Serebrov
Is the U.S. getting the best return on investment (ROI) for its NIH buck? That’s the basic question at the heart of a white paper Sen. Bill Cassidy (R-La.) issued May 9 to continue a conversation he started in September on the reforms needed at the country’s premier biomedical research institution.
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