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BioWorld - Monday, March 23, 2026
Home » Topics » Regulatory » NIH

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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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Red blood cells, DNA
Hematologic

NHLBI grant supports Geneventiv’s development of universal gene therapy for hemophilia

April 17, 2024
Geneventiv Therapeutics Inc. has been awarded a Direct to Phase II Small Business Innovation Research (SBIR) grant for approximately $2.5 million from the National Heart Lung Blood Institute (NHLBI) at the National Institutes of Health (NIH) to support development of a universal gene therapy for hemophilia A or B with or without inhibitors.
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Generic drugs and bottle

Still targeting Xtandi, groups ask CMS to do what NIH wouldn’t

April 10, 2024
By Mari Serebrov
Having failed in their efforts to get the U.S. NIH to march in on Xtandi’s patents under the Bayh-Dole Act because of price, Knowledge Ecology International and two other advocacy groups are now asking the Centers for Medicare & Medicaid Services (CMS) to do what the NIH refused to do. But rather than pressing for a march-in, which can be a lengthy process, the groups are pushing for CMS to use other statutory tools to clear the way for Xtandi (enzalutamide) generics to launch in the U.S. before Astellas Pharma Inc.’s three remaining patents for the prostate cancer drug expire in 2026 and 2027.
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Sanders proposes $10B more in NIH long COVID research

April 9, 2024
By Mari Serebrov
Before formally introducing legislation to spur R&D of treatments for long COVID, the U.S. Senate Health, Education, Labor and Pensions Committee is calling for stakeholder input on the proposal that would require $10 billion in dedicated, mandatory NIH funding to respond to the chronic condition over the next 10 years.
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Dollar sign dropper and test tube

US NIH under fresh scrutiny for questionable research funding

April 3, 2024
By Mari Serebrov
Does the NIH have the ability to screen for U.S. security issues in its award of research grants? That question is at the heart of an April 2 letter the Republican leadership of the House Energy and Commerce Committee sent to the Government Accountability Office in which it asked the government watchdog to examine the extent to which the NIH “adequately safeguards research funds from national security concerns related to the Chinese military or over the unethical use of human beings in research studies, especially from entities of concern in China.”
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Cancer

NIH grant supports Lamassu Bio’s SA-53 for p53 wild-type sarcomas

March 13, 2024
Lamassu Bio Inc. has been awarded a $2.05 million grant from the NIH and National Cancer Institute (NCI) for the development of SA-53 as a treatment for p53 wild-type sarcomas. SA-53 is designed to trigger the body’s natural defense mechanism p53 by blocking MDM2, a protein that deactivates p53 and contributes to treatment resistance.
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US flag with microscope

US NIH goes live with network for evaluating cancer screening tech

Feb. 28, 2024
By Mark McCarty
The U.S. National Institutes of Health reported the launch of a network for clinical trials that will examine the utility of cancer screening tools, which will start with a pilot study of multi-cancer detection (MCD) tests.
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