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.
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.
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.
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.
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.
Kinimmune Inc. has received US$400,000 in funding from the National Cancer Institute (NCI) at the National Institutes of Health (NIH) for its phase I STTR application to advance the preclinical development of KIN-102, an immunostimulant for intratumoral injection that is designed to turn cold tumors hot for synergy with immuno-oncology drugs, such as checkpoint inhibitors.
Small nuclear RNAs (snRNAs) play a crucial role in RNA splicing and cell functioning. The transcription of these RNAs is initiated by small nuclear RNA activation protein complex (SNAPc), and SNAPC4 is the subunit in charge of SNAPc-DNA binding. Previous studies have found that SNAPC4 deficiency led to decreased expression of these RNAs in animal models.
Navrogen Inc. has entered into a cooperative research and development agreement (CRADA) with researchers at the U.S. National Cancer Institute (NCI), part of the National Institutes of Health (NIH). Under this CRADA, Navrogen will sponsor the clinical investigation of the experimental antibody-drug conjugate (ADC) NAV-001, under supervision of the NCI.
Vivasc Therapeutics Inc. has initiated work under a second National Institutes of Health (NIH) phase I STTR research grant, in conjunction with Georgetown University.
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