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BioWorld - Wednesday, April 29, 2026
Home » Topics » Regulatory » NIH

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Gloved hand holding COVID-19 vaccine vial, syringe
Immune

NIAID selects Tonix’s COVID-19 vaccine candidate TNX-1800 for inclusion in Project Nextgen trials

Nov. 3, 2023
The National Institute of Allergy and Infectious Diseases (NIAID) is set to conduct a phase I trial with Tonix Pharmaceuticals Holding Corp.’s TNX-1800 (recombinant horsepox virus, live vaccine), a vaccine candidate to protect against COVID-19.
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Telehealth credited with boosting effectiveness of care for opioid-use disorder

Oct. 30, 2023
By Mark McCarty
Advocates of expanded use of telehealth in the U.S. may believe they have an unfairly high evidentiary bar to meet to bring payers on board, but that evidentiary requirement just received support from the National Institutes of Health (NIH).
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3D concept image of nanoparticle layers
Immuno-oncology

NCI grant supports development of Duo Oncology's DUO-307

Oct. 30, 2023
Duo Oncology Inc. has been awarded a Small Business Technology Transfer grant by the National Cancer Institute (NCI) to support the development of DUO-307, a combination nanomedicine that delivers cytotoxic polymer conjugated gemcitabine (PGEM) and an immune modulating chemokine receptor type 2 antagonist (CCR2a) to tumor tissue.
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Monica Bertagnolli, NIH director

Despite chair’s opposition, US NIH nominee gets HELPing hand

Oct. 25, 2023
By Mari Serebrov
After nearly two years with an unconfirmed acting director at its helm, the U.S. NIH is one step closer to finally having Senate-confirmed leadership to steer the agency in a time pressed with political agendas, pandemic concerns and the potential for what could be life-altering innovations. The Senate Health, Education, Labor and Pensions (HELP) Committee voted 15-6 Oct. 25 to favorably report Monica Bertagnolli’s nomination to the full Senate for a confirmation vote as the next NIH director.
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Sanders decries NIH’s ‘become-a-billionaire program’

Oct. 24, 2023
By Mari Serebrov
U.S. Sen. Bernie Sanders (I-Vt.) is calling for an investigation into the NIH’s proposed grant of an exclusive patent license for a late-stage cervical cancer drug to a small company linked to a former NIH researcher.
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Monica Bertagnolli, NIH director

Drug prices, deals shadow hearing of US NIH nominee

Oct. 18, 2023
By Mari Serebrov
A week before the U.S. Senate Health, Education, Labor and Pensions Committee is scheduled to vote on the confirmation of Monica Bertagnolli as the next NIH director, she faced a grilling by the committee fueled by drug pricing agendas and deals the Biden administration made with certain lawmakers to advance her nomination.
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Scientist in lab with microscope
Drug Design, Drug Delivery & Technologies

NIH funding supports Integral Molecular’s discovery of antibodies

Oct. 6, 2023
Integral Molecular Inc. has been awarded funding totaling $896,000 from the National Institutes of Health (NIH), which will support its discovery of antibodies against difficult and conserved protein targets.
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Health professional, EHR/medical icons

US NIH preparing to dive into real-world data pool for basic research

Sep. 29, 2023
By Mark McCarty
The U.S. FDA may be the most prominent agency in the federal government when it comes to the use of real-world data (RWD), but the National Institutes of Health is keen to immerse itself in this trove of information. The agency has made a request for public comment on how NIH centers can best leverage RWD for biomedical and behavioral research, although some ethical and practical considerations may have to be overcome.
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Dollar sign droplet above test tube
Musculoskeletal

NIH award supports advancement of BITT’s CD40 antagonist antibody BITT-101 for Sjögren’s syndrome

Sep. 1, 2023
Boston Immune Technologies and Therapeutics Inc. (BITT) has been awarded funding by the National Institutes of Health (NIH) to support the preclinical development of BITT-101, its CD40 antagonist antibody for treating Sjögren’s syndrome. The award will help support steps toward an IND filing next year.
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Beaker and radioactive icons
Substance Use & Poisoning

NIAID grant supports Ceramedix's development of anti-ceramide antibody for GI ARS

Aug. 25, 2023
Ceramedix Holding LLC has been awarded a phase IIB Small Business Innovation Research (SBIR) grant valued at approximately US$3 million by the National Institute of Allergy and Infectious Diseases (NIAID) to support the evaluation of the non-clinical pharmacology of its lead drug candidate. The anti-ceramide antibody is in development through the National Institutes of Health (NIH) as a potential therapeutic to mitigate and/or treat illness due to radiation exposure.
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