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.

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.

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.

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.