News & Analysis as of

Federal Funding Life Sciences

Ropes & Gray LLP

Closeout Requirements During Appeals of Terminations of NIH Research Grants

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On July 7, 2025, the National Institutes of Health (NIH) Office of Policy for Extramural Research issued NOT-OD-25-128, titled “Guidance on Enforcement of Closeout Requirements During the Appeals Process” (the Notice). The...more

Cooley LLP

NIH Announces New Antidiscrimination Certification Heightening FCA Risk for Some Life Sciences Companies

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On April 21, 2025, the National Institutes of Health (NIH) announced a new civil rights term and condition of award for NIH grants, cooperative agreements and other transaction awards. The new term states that recipients of...more

Foley & Lardner LLP

Rethinking University Research: Innovating the Innovation Ecosystem to Support Life Sciences and Personalized Medicine

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Personalized medicine—tailoring treatments to individual patients based on their genetic makeup, lifestyle, and environment—is transforming healthcare. But this revolution didn’t begin in the private sector. It was sparked...more

Lathrop GPM

Trump Executive Order Restricts Funding for “Dangerous Gain-of-Function Research”

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On May 5, the Trump administration issued Executive Order 14292, “Improving the Safety and Security of Biological Research,” which effectively ends federal funding for “dangerous gain-of-function research” and other life...more

Epstein Becker & Green

National Science Foundation (NSF) Imposes 15% Indirect Cost Rate Cap: What to Know

Epstein Becker & Green on

On May 2, 2025, the National Science Foundation (“NSF”) issued a “Policy Notice: Implementation of Standard 15% Indirect Cost Rate” (NSF 25-034) (hereinafter “Policy Notice”) adopting a uniform 15% Indirect Cost Rate (“IDC”)...more

Akin Gump Strauss Hauer & Feld LLP

Improving the Safety and Security of Biological Research (Trump EO Tracker)

This Executive Order establishes a policy of the United States to ensure that federally funded research benefits American citizens without jeopardizing national security, strength or prosperity. The order seeks to strengthen...more

Troutman Pepper Locke

Is Bayh-Dole the Next Lever in the Push to Onshore Pharma Manufacturing?

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The U.S. government is pushing to redomesticate the manufacturing of pharmaceutical, biotech, gene therapy, and medical device products, both to bolster U.S. manufacturing generally and to address continuing shortages of...more

Bergeson & Campbell, P.C.

National Security Commission on Emerging Biotechnology’s Final Report Includes Recommendations to Boost Economy and Protect...

The National Security Commission on Emerging Biotechnology (NSCEB) announced on April 8, 2025, the availability of its final report and action plan, “urging Congressional action to bring the full weight of American innovation...more

Jones Day

Innovative Insights: Legal Updates in Life Sciences | First Quarter 2025

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Artificial intelligence is revolutionizing life science R&D (particularly in the realm of drug discovery) and challenging the traditional "human inventorship" requirement for U.S. patents. Recent guidance from the USPTO...more

Jones Day

Executive Orders and Policy Updates

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Since President Trump's inauguration, the Trump administration has issued a number of executive orders and policy actions with potential impacts for the life sciences industry. Notable actions include rescinding Biden-era...more

Latham & Watkins LLP

Update: The NIH Funding Cuts: Implications and Status of Lawsuits

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The proposed cuts would place a 15% indirect cost rate on all new and existing grant awards received by research institutions and universities....more

Stikeman Elliott LLP

Canada and Manitoba Sign Pharmacare Agreement Under New Pharmacare Act

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Canada’s Bill C-64, An Act respecting pharmacare (the “Pharmacare Act”) received royal assent on October 10, 2024 and established a framework for national pharmacare. On February 27, 2025, the Hon. Mark Holland, Canada’s...more

Smart & Biggar

Minister of Health announces new bilateral agreements with provinces for rare disease drugs

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We previously reported on Canada’s first-ever National Strategy for Drugs for Rare Diseases, which included up to $1.4 billion in funding for provinces and territories, to be negotiated through bilateral agreements. This...more

Holland & Knight LLP

Massachusetts District Court Temporarily Blocks NIH Research Funding Cut

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A Massachusetts federal judge has issued a temporary restraining order preventing the implementation and enforcement of the National Institutes of Health's (NIH) research funding cut (NOT-OD-25-086) (the Rate Change Notice)....more

Holland & Knight LLP

NIH Cuts Research Funding for Indirect Costs

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The National Institutes of Health (NIH) published guidance late on Feb. 7, 2025, setting the indirect cost rate for NIH grants at 15 percent, replacing the negotiated indirect cost rates at many universities, which typically...more

Bergeson & Campbell, P.C.

NNCO Releases NNI Supplement to President Biden’s 2025 Budget

On December 19, 2024, the National Nanotechnology Coordination Office (NNCO) released The National Nanotechnology Initiative Supplement to the President’s 2025 Budget, which also serves as the annual report for the National...more

Epstein Becker & Green

Investors, Researchers, and Business Leaders Take Note: $110M Awarded to Advance Women’s Health

Epstein Becker & Green on

On October 23, 2024, Dr. Jill Biden, first lady of the United States,  announced the winners of $110 million in awards on behalf of the Advanced Research Projects Agency for Health (ARPA-H) to accelerate transformative...more

Goodwin

Recent Bayh-Dole Act News: Comments on the Draft Framework; HHS Refuses to March-In on Xtandi; and Delayed Contracting Doesn’t...

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U.S. universities and academic institutions rely heavily on federal grants to fund their research and generate innovations in life sciences. Universities often out-license patents protecting inventions created using federal...more

K&L Gates LLP

Governor Josh Shapiro Launches First Statewide Economic Development Strategy in Nearly Two Decades

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From 2018 to 2022, Pennsylvania was outspent on economic development incentives by neighboring states in both total incentive spending and average deal size. Over the same period, neighboring states also outspent Pennsylvania...more

Polsinelli

Fall Congressional Forecast: Eye on Federal Funding and Health Care

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Congress faces a crowded agenda this fall comprised of must-pass policy initiatives and potential political messaging opportunities in the lead up to the November midterm elections. With control of both chambers at stake, the...more

Fox Rothschild LLP

COVID-19 Fraud Enforcement Task Force Cracks Down on Pandemic-Related Fraud

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In May 2021, Attorney General Merrick Garland announced the creation of the COVID-19 Fraud Enforcement Task Force. The Task Force is comprised of more than a dozen federal agencies that are investigating and prosecuting...more

Hogan Lovells

Coronavirus: The Hill and the Headlines, May 2021 # 4

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In Washington: The Food and Drug Administration (FDA) has authorized the use of the Pfizer vaccine for 12 - 15 years old. An advisory committee of the Centers for Disease Control and Prevention is expected to meet shortly to...more

Hogan Lovells

Coronavirus: The Hill and the Headlines, April 2021 # 5

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In Washington: President Biden said Wednesday that he expects the U.S. will share surplus coronavirus vaccine doses with Canada and Central American countries. “We don’t have enough to be confident to send it abroad now, but...more

Hogan Lovells

Coronavirus: The Hill and the Headlines, March 2021 # 13

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In Washington: The Internal Revenue Service (IRS) is planning to extend the tax-filing deadline to mid-May, according to two top House Democrats. A news release Wednesday from House Ways and Means Committee Chairman Richard...more

Hogan Lovells

Coronavirus: The Hill and the Headlines, March 2021 # 5

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In Washington: Sen. Joe Manchin (D-WV) continued his 11th-hour standoff on unemployment benefits that ended up holding up the Senate from moving forward with its coronavirus relief package Friday. ...more

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