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.
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.
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.
Imunon Inc. has entered into a cooperative research and development agreement with the National Institute of Allergy and Infectious Diseases (NIAID) for the evaluation of the immunogenicity and efficacy of two Imunon DNA-based Lassa virus vaccine candidates. Under the 3-year agreement, the NIAID will assess the efficacy of Placcine DNA constructs against Lassa virus in guinea pig and non-human primate disease models, including both prime and prime-boost vaccine strategies.
Exavir Therapeutics Inc. has received a US$3 million award from the National Institute of Allergy and Infectious Diseases (NIAID), a division of the National Institutes of Health, to support the development of XVIR-110.
Researchers from the U.S. National Institutes of Health and collaborators recently conducted a study investigating the mechanisms of HIV-1 resistance to integrase strand transfer inhibitors (INSTIs), such as the approved drug dolutegravir (DTG). They focused on understanding the mechanisms of resistance caused by mutations at positions 138, 140, and 148 and analyzed combinations of the mutations E138K, G140A/S, and Q148H/K/R, all conferring resistance to INSTIs.
While U.S. politics continues to delay Senate confirmation of the NIH director, other crucial positions at the agency that don’t require Senate action are being filled. Acting NIH Director Lawrence Tabak announced Aug. 2 that he has named Jeanne Marrazzo as director of the agency’s National Institute of Allergy and Infectious Diseases (NIAID).
While U.S. politics continues to delay Senate confirmation of the NIH director, other crucial positions at the agency that don’t require Senate action are being filled. Acting NIH Director Lawrence Tabak announced Aug. 2 that he has named Jeanne Marrazzo as director of the agency’s National Institute of Allergy and Infectious Diseases (NIAID).
Amygdala Neurosciences Inc. has been awarded a $2.0 million NIH grant to support IND-enabling and early-stage development of its selective, reversible, orally bioavailable aldehyde dehydrogenase 2 (ALDH2) inhibitor ANS-858 to treat alcohol use disorder (AUD).
Cardiologists have debated for some time whether obstructive sleep apnea (OSA) is a proven factor in a patient’s risk for heart disease, but the U.S. National Institutes of Health says newly published studies identify the specific mechanisms for this association. The studies offered data from more than 4,500 subjects and affirms the notion that OSA-driven hypoxia correlates well with the occurrence of a primary cardiovascular event, but the NIH says these findings need to be confirmed in another trial, hopefully one with enrollees whose OSA is deemed a high-risk version of the condition.
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