After nearly three months of the U.S. federal government operating on stopgap spending measures, Congress has agreed to a $1.4 trillion spending bill for fiscal 2021. The omnibus package, which includes $97 billion for the Department of Health and Human Services, gives both the FDA and NIH small increases in funding.

The digital medicine company Physiq Inc. has received a contract from the NIH to develop an artificial intelligence (AI)-based index that can provide an early warning that a patient with COVID-19 is in decline and needs medical treatment. The index, called the COVID-19 Decompensation Index (CDI) Digital Biomarker, will run on Physiq’s existing Accelerateiq computing platform, analyzing physiological data from FDA-cleared wearable devices to create a personalized baseline for patients who have tested positive for COVID-19.

While the emergency use authorization (EUA) the FDA granted Aug. 23 for convalescent plasma remains a political talking point, the agency moved ahead Sept. 2, issuing an updated, immediately effective guidance on the use of convalescent plasma to treat COVID-19 patients in ongoing clinical trials, on an expanded access basis or under the EUA.

The issue of the U.S. federal government’s response to the COVID-19 pandemic was revisited yet again in a hearing in the House of Representatives. While partisanship was on full display, Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said he is “cautiously optimistic” about the prospects for a vaccine and that the development of candidates has not compromised scientific principles.

Researchers from the Encyclopedia of DNA Elements (ENCODE) consortium reported data from the third phase of the project. Phase III data, which were published in more than a dozen papers in Nature and its sister journals on July 29, 2020, consisted of 6,000 experiments performed on around 1,300 samples.

Two subcommittees of the U.S. House Appropriations Committee have moved their respective appropriations proposals for the FDA and the NIH, restarting a process that has worked smoothly over the past couple of years. Still, Republicans in both committees objected to the use of emergency funding mechanisms in lieu of more routine appropriations.

The question of prices for a COVID-19 vaccine have raged in recent days. Gary Disbrow, acting director of the Biomedical Advanced Research and Development Authority (BARDA), told members of a Senate committee that vaccines developed with the help of taxpayer funding will come with an appropriate reduction in price. However, CDC Director Robert Redfield emphasized that the cold-chain distribution system for those products requires the same kind of at-risk investment that is used for vaccine development.