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BioWorld - Wednesday, December 17, 2025
Home » Topics » Regulatory » NIH

NIH
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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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U.S. FDA headquarters

Former FDA chief Hamburg notes ‘challenging’ times post-Trump win

Nov. 25, 2024
By Nuala Moran
Former U.S. FDA Commissioner Margaret Hamburg has added her voice to concerns that the incoming Trump administration’s pledge to slim down federal agencies will damage public health. “These are certainly challenging times,” Hamburg told delegates at the World Science Forum, Budapest, Hungary, meeting to discuss issues dominating the interface between science and policy.
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U.S. FDA headquarters

Former FDA chief Hamburg notes ‘challenging’ times post-Trump win

Nov. 22, 2024
By Nuala Moran
Former U.S. FDA Commissioner Margaret Hamburg has added her voice to concerns that the incoming Trump administration’s pledge to slim down federal agencies will damage public health. “These are certainly challenging times,” Hamburg told delegates at the World Science Forum, Budapest, Hungary, meeting to discuss issues dominating the interface between science and policy.
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Art concept for drug addiction
Substance use & poisoning

NIDA grant supports Sparian’s SBS-226 for opiate use disorder and withdrawal

Nov. 15, 2024
Sparian Biosciences Inc. has been awarded a $19.5 million, 5-year grant to fund development of SBS-226 from IND submission through phase I development. SBS-226 is a first-in-class dual μ-opioid receptor partial agonist and δ-opioid receptor full antagonist in development for opiate use disorder and opiate withdrawal syndrome.
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X/Y chromosomes
Healing the health divide

The science of gender-based medicine: many reasons, many manifestations

Nov. 14, 2024
By Anette Breindl
At the BioFuture 2024 conference held in New York in November, Seema Kumar, the CEO of Cure, described women’s health as something that has been directed at the “bikini area.” That “bikini” bias extended to both diseases and their causes – women’s health covered the breasts and reproductive system, and its causes were hormonal. Both concepts are far too narrow.
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People running from cliff of pills
Substance use & poisoning

NIDA grant supports Epivario’s work on epigenetic regulator for opioid use disorder

Oct. 2, 2024
Epivario Inc. has been awarded a small business innovation research (SBIR) grant of $275,000 from the National Institute on Drug Abuse (NIDA) to advance research toward the development of a novel epigenetic regulator as a treatment for opioid use disorder.
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Cancer

NIH fast track grant supports UP Oncolytics’ glioblastoma treatment

Oct. 1, 2024
UP Oncolytics Inc. has been awarded an NIH fast track grant to support the development of a treatment for glioblastoma using oncolytic Zika virus.
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3D illustration of skin layers
Dermatologic

Resvita Bio’s RVB-003 receives NIAMS funding for Netherton syndrome

Sep. 25, 2024
The National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) at the NIH has awarded Resvita Bio a $2.03 million phase II Small Business Innovation Research (SBIR) grant to advance RVB-003, a novel treatment for Netherton syndrome.
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Earth infected with pandemic
Infection

NIH establishes ReVAMPP pandemic preparedness research network

Sep. 16, 2024
The National Institutes of Health (NIH) has established a pandemic preparedness research network to conduct research on high-priority pathogens most likely to threaten human health with the goal of developing effective vaccines and monoclonal antibodies.
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Dollar sign droplet above test tube
Immune

Eydisbio’s development of TAK1 inhibitors for systemic sclerosis receives NIH funding

Aug. 29, 2024
Eydisbio Inc. has been awarded a $2.6 million phase II Small Business Innovation Research (SBIR) grant from the National Institute of Health’s (NIH) National Heart, Lung, and Blood Institute (NHLBI) to support its ongoing research into the efficacy of TAK1 inhibition in animal models of systemic sclerosis.
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