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BioWorld - Wednesday, December 24, 2025
Home » Topics » Regulatory » NIH

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Hemorrhagic stroke concept art
Cardiovascular

New mouse model of IVH shows local inflammation and no cognitive impairment

Feb. 15, 2023
Scientists from the National Institutes of Health and affiliated organizations established a novel mouse model of intraventricular extension of hemorrhage (IVH) for the purpose of measuring motor and cognitive function in acute and chronic stages of intracerebral hemorrhage, which is the most severe stroke subtype.
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Pancreas
Cancer

NIH grant supports partnership to study TGX-1214 with immune checkpoint inhibition for PDAC

Feb. 10, 2023
UC Davis Comprehensive Cancer Center is partnering with Targagenix Inc. and Northeastern University to study pancreatic ductal adenocarcinoma (PDAC). The partnership will receive nearly US$3 million over 5 years through funding from the National Institutes of Health (NIH).
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Pills spilling out of prescription bottle

BIO CEO 2023: Despite high prevalence of pain and addiction, clinical efforts drop, funding flat, BIO report finds

Feb. 9, 2023
By Karen Carey
The Biotechnology Innovation Organization (BIO) found in a new study that 77% of clinical programs focused on pain therapeutics five years ago are no longer active and that financings of companies working in the space are lackluster at best. Meanwhile, oncology companies, targeting an overall smaller market, have raised huge sums of venture capital money, $9.7 billion in 2021 vs. pain and addiction companies’ $228 million.
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3D illustration of a osteoclast
Musculoskeletal

Targeting La protein might be approach for osteoclast-driven fibrous dysplasia

Feb. 8, 2023
Bone-resorbing osteoclasts are key players in bone remodeling and their dysfunction has been implicated in several bone disorders such as fibrous dysplasia. Osteoclasts derive from monocytes stimulated by several cytokines, such as M-CSF and RANKL.
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US GAO: Improved oversight needed for high-risk research

Jan. 19, 2023
By Mari Serebrov
The U.S. Department of Health and Human Services received low marks on its latest Government Accountability Office (GAO) report card for its oversight of high-risk research involving potential pandemic pathogens, but legislative fixes might be necessary to ensure that all the gaps are closed.
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Lab mouse
Drug design, drug delivery & technologies

US spending bill spares animals in preclinical drug development

Dec. 30, 2022
By Mari Serebrov
Tucked into the 4,155-page, $1.7 trillion spending bill for fiscal 2023 that U.S. President Joe Biden signed into law Dec. 23 is a small provision that may have outsized impact on future biosimilar and other drug development. Championed by lawmakers on both sides of the political spectrum, the provision modernizes the data that can be used to support drug development, including alternatives to animal studies.
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Lab mouse

US spending bill spares animals in preclinical drug development

Dec. 29, 2022
By Mari Serebrov
Tucked into the 4,155-page, $1.7 trillion spending bill for fiscal 2023 that U.S. President Joe Biden signed into law Dec. 23 is a small provision that may have outsized impact on future biosimilar and other drug development. Championed by lawmakers on both sides of the political spectrum, the provision modernizes the data that can be used to support drug development, including alternatives to animal studies.
Read More
‘22 in review

VALID Act left out of omnibus legislation for US fiscal year 2023 budget

Dec. 27, 2022
By Mark McCarty
Congress has wrapped up the budget for fiscal year 2023 with yet another significant boost to funds for the National Institutes of Health, but the omnibus legislation also authorizes the U.S. FDA to designate academic research centers as centers of excellence for continuous drug manufacturing. A conspicuous omission from the omnibus was the Verifying Accurate, Leading-edge IVCT Development (VALID) Act for FDA regulation of lab-developed tests (LDTs), an omission that drew both praise and criticism from stakeholders.
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Microscope with slide

US senators call for halt on gain-of-function research until oversight improves

Dec. 6, 2022
By Mari Serebrov
Ironically, one of the casualties of the COVID-19 pandemic is an overdue review and revision of U.S. dual use research of concern (DURC) policies, as well as the Department of Health and Human Services’ Potential Pandemic Pathogen Care and Oversight guidance. Consequently, several senators are asking the White House to halt all ongoing and new viral gain-of-function and DURC studies in the life sciences that involve enhanced pathogens of pandemic potential.
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Microscope with slide

US senators call for halt on gain-of-function research until oversight improves

Dec. 5, 2022
By Mari Serebrov
Ironically, one of the casualties of the COVID-19 pandemic is an overdue review and revision of U.S. dual use research of concern (DURC) policies, as well as the Department of Health and Human Services’ Potential Pandemic Pathogen Care and Oversight guidance. Consequently, several senators are asking the White House to halt all ongoing and new viral gain-of-function and DURC studies in the life sciences that involve enhanced pathogens of pandemic potential.
Read More
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