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BioWorld - Saturday, June 13, 2026
Home » Topics » Regulatory » NIH

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ENCODE project illustration
Phase IV now underway

Data reported from ENCODE phase III

July 29, 2020
By Anette Breindl
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.
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U.S. flag and money

Partisan votes on U.S. federal agency appropriations foreshadow showdown between House, Senate

July 8, 2020
By Mark McCarty
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.
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Coronavirus vaccine/therapeutics illustration

Taxpayer-enabled COVID-19 vaccines will cost less, but distribution system requires another at-risk investment

July 2, 2020
By Mark McCarty
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.
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Coronavirus vs U.S. wrecking balls

Pandemic-weary nation prepares for next COVID-19 wave

June 23, 2020
By Mari Serebrov
The bad news is, yes, the U.S. is in for a second wave of COVID-19, which is expected to hit during the upcoming flu season. The good news is the nation is much better prepared for the next wave, the NIH’s Anthony Fauci told a House Energy and Commerce Committee Tuesday.
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NIAID Director Anthony Fauci speaking at a White House briefing

Fauci ‘cautiously optimistic’ regarding COVID-19 vaccine; Giroir projects 50M tests per month by September

May 12, 2020
By Mark McCarty
The May 12 Senate hearing regarding the COVID-19 pandemic included the usual conversations about contact tracing, but Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said he is “cautiously optimistic” that one of the vaccines currently in trial in the U.S. will work, but that it is unlikely a vaccine will be ready by September 2020. In contrast, Assistant Secretary for Health Brett Giroir said testing capacity may reach 50 million tests per month by that time, thanks in part to the fact that antigen testing is now part of the FDA’s emergency use authorization mechanism.
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NIH’s Collins says need for supplies will be factored into Shark Tank grants for COVID-19 tests

May 7, 2020
By Mark McCarty
The U.S. National Institutes of Health recently announced a competitive grant opportunity for testing for the SARS-CoV-2 virus, which has been characterized as a “Shark Tank-like” program, and NIH director Francis Collins said in a May 7 Senate hearing that one of the criteria for awards is whether supplies can be made readily available for that test, the lack of which has been a significant impediment to testing in the U.S.
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Remdesivir capsule

Fauci calls remdesivir 'new standard of care' for COVID-19 as FDA works with Gilead to aid drug’s availability

April 29, 2020
By Michael Fitzhugh
Following revelations that a randomized, placebo-controlled study of the Gilead Sciences Inc.’s antiviral, remdesivir, reduced time to recovery for hospitalized patients with "advanced" COVID-19, along with additional data from an open-label phase III trial from its maker, the FDA is "working with Gilead to figure out a mechanism to make this easily available to people who need it," Anthony Fauci, director of the NIH’s National Institute for Allergy and Infectious Diseases (NIAID), said April 29.
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U.S. Capitol building
Support for NIH boost still strong

DeLauro says House, Senate leaders agree on coronavirus supplemental

March 4, 2020
By Mark McCarty
The March 4 congressional hearing on the budget for the NIH was peppered with questions about the COVID-19 outbreak, although the general sentiment is that the agency will receive yet another boost in appropriations in fiscal 2021.
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U.S. Capitol building

Budget draft for 2021 eyes NIH cuts along with 10% hit to HHS funding

Feb. 10, 2020
By Mark McCarty
In a budget proposal sure to spark opposition, the Trump administration has proposed to provide the National Institutes of Health with only $38 billion in fiscal 2021, several billion dollars short of the agency’s funding for the current fiscal year. The proposal also calls for funding of less than $95 billion for the Department of Health and Human Services, a 10% reduction in funding that includes an adjustment for drug pricing proposals and a $5 million cut to FDA monies for the 21st Century Cures Act.
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U.S. flag, stethoscope

Spending bills would end drug sample blocking, repeal device tax

Dec. 17, 2019
By Mark McCarty
The U.S. House of Representatives passed two spending packages that boosted funds for both the FDA and the NIH, but device and generic drug makers saw other benefits. The House legislation would allow makers of biosimilars and generic drugs to sue brand names for blocking access to the index article, but also repealed the medical device tax, a change that would bolster development of the novel therapies that are the industry’s lifeline. Both spending bills carry numerous provisions related to the health care economy and will go to the Senate for passage, hopefully before the government runs out of money Dec. 20.
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