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Research and Development

Epstein Becker & Green

Executive Actions Impact Federally Funded Research: What Institutions Should Do Now – Diagnosing Health Care Video Podcast

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From removing diversity, equity, and inclusion initiatives to suspending foreign aid and canceling federal funding, it is clear that the current administration is drastically changing the landscape of government-funded...more

Jones Day

Blurring the Line Between the Dry and Wet Lab: Joint Inventorship in AI-Assisted Life Science Inventions

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In 2024, not one but two Nobel Prizes (in Chemistry and Physics) were awarded to researchers for their work in artificial intelligence ("AI"). Particularly noteworthy for the life science community is the Nobel Prize in...more

Goodwin

Global Biosimilar Updates - Spring 2025

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Celltrion’s ustekinumab biosimilar, STEQEYMA®, has won its first bid within 2 months of its launch in January of 2025. Since launch, STEQEYMA® has secured contracts in four regions of Italy, including, Piemonte, Valle...more

Blake, Cassels & Graydon LLP

Budget 2025-2026 du Québec : Points saillants en matière de fiscalité

Le 25 mars 2025, le ministre des Finances du Québec, Eric Girard, a déposé le budget 2025-2026 du Québec (le « budget 2025-2026 »). Intitulé Pour un Québec fort, ce budget est axé sur des investissements ayant pour but...more

Blake, Cassels & Graydon LLP

Select Tax Highlights of the 2025-2026 Quebec Budget

On March 25, 2025, Quebec’s Minister of Finance, Eric Girard, tabled Quebec’s 2025-2026 Budget. This year’s budget, titled For a Strong Québec, is focused on investments to help Quebecers build a strong economy and contains...more

Health Care Compliance Association (HCCA)

New NIH Head: Indirect Payments ‘Tips’; Republican Senator Calls Them ‘Grift’

Research universities have had one less worry (at least temporarily) since Judge Angel Kelley of the U.S. District Court for the District of Massachusetts granted a preliminary restraining order prohibiting NIH from imposing...more

Blank Rome LLP

Other Transactions: A Flexible and Efficient Acquisition Tool for the Department of Defense

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On March 6, 2025, the Defense Secretary released a memorandum directing the Department of Defense (“DoD”) to adopt the Software Acquisition Pathway (“SWP”) to speed up the development, procurement, and delivery of software...more

Fenwick & West LLP

Navigating and Litigating 'Commercially Reasonable Efforts' Provisions: Considerations and Strategies for Tech & Life Sciences...

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Commercially reasonable efforts (CRE) provisions are a common feature in technology and life sciences agreements, particularly in development collaborations, licensing deals, and milestone-based contracts. ...more

Knobbe Martens

FDA Publishes Case Studies and User Guide for Rare Disease Drug Developers

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Drug development programs face unique challenges in demonstrating the safety and effectiveness of drugs for treating rare diseases. The FDA’s Accelerating Rare disease Cures (ARC) Program started the Learning and Education to...more

Knobbe Martens

National Institutes of Health (NIH) Announces Plan to Centralize Peer Review Process

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On March 6, 2025, the National Institutes of Health (NIH) announced plans to centralize peer review of all applications for grants, cooperative agreements and research and development contracts within its Center for...more

Gardner Law

Why Compliance Audits Are Non-Negotiable

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In today’s heightened enforcement environment, compliance auditing isn’t just a best practice—it’s a necessity. Federal and state laws and industry guidance, including the Office of Inspector General (OIG) Compliance Program...more

Hinckley Allen

Impact of the Trump Administration’s Executive Orders and Actions for Academic Institutions & Federal Funded Research Community

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The Trump Administration’s first two months have been marked by a flurry of actions impacting federal grant recipients, federal contractors, and academic and scientific researchers. These unprecedented measures, including...more

Mintz

Trump Administration Receives 8,755 Comments for AI Action Plan — AI: The Washington Report

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The Trump administration’s Office of Science and Technology Policy received 8,755 comments in response to its Request for Information for the development of its AI Action Plan implementing the Trump AI Executive Order issued...more

Health Care Compliance Association (HCCA)

[Event] Healthcare Research Compliance Academy - March 24th - 27th, Chicago, IL

HCCA's Healthcare Research Compliance Academy is a three-and-a-half-day interactive educational program with a focus on the highly specialized and complex regulations and issues that affect research compliance professionals....more

Miller Canfield

Are Wages for Research Credit Purposes Limited to “Reasonableness?”

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Smith v. Commissioner, a pending research credit case in the United States Tax Court, presents an issue of first impression: Is a partner’s self-employment income in a partnership allowable as a qualified research expense...more

Husch Blackwell LLP

Navigating Clinical Research Agreements and Regulatory Strategy for Successful Commercialization

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Clinical research agreements (CRAs) and developing a regulatory strategy—particularly in connection with the Food and Drug Administration (FDA)—are crucial for a company’s ability to bring innovative life sciences products to...more

Dentons

Iowa Tax Credit Overhaul: What A New Bill Could Mean for Venture Investment, Job Growth, and R&D

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The Iowa Economic Development Authority (“IEDA”) recently unveiled its bill (HSB 305 and SSB 1205) to overhaul Iowa’s tax credit system. The bill is expected to go through the legislative process in both chambers soon for the...more

Cozen O'Connor

Democratic AGs Block NIH Grant Cuts

Cozen O'Connor on

A coalition of 22 Democratic AGs obtained a preliminary injunction blocking the implementation of the Supplemental Guidance to the 2024 NIH Grants Policy Statement: Indirect Cost Rates (Rate Change Notice), which would have...more

Miller Canfield

Comments Solicited on Michigan Research Credit Draft Notice

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The Michigan Department of Treasury released a draft of a notice regarding the new research and development credit. ...more

Wiley Rein LLP

Update: Federal Judge Blocks NIH Cap on Indirect Rates for Grants

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On March 5, 2025, Judge Angel Kelley, a federal district court judge sitting in Massachusetts, granted a nationwide preliminary injunction which serves to temporarily block the Trump Administration’s attempt to cap the...more

Health Care Compliance Association (HCCA)

‘Waking Up With Panic Attacks’: NIH 15% Plan Caps Tumultuous Weeks Under New Administration

If NIH succeeds in imposing an across-the-board indirect cost rate of 15%, rough estimates indicate the University of Michigan could lose $119 million a year. Emory University could be down $75 million. For the University of...more

Morgan Lewis - As Prescribed

Venture Philanthropy More Important Than Ever for Rare Disease Care

Private foundations providing support, resources, and advocacy for individuals and families affected by rare diseases have played an important role for more than 30 years in the advancement of treatments for rare diseases....more

Bilzin Sumberg

Miami’s Aerospace Scene is Ready for Takeoff

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South Florida has long been a hub for aviation, with its massive airport infrastructure and deep ties to the global cargo industry.  But over the last few years, something bigger has been happening – literally. Aerospace...more

Epstein Becker & Green

President Trump’s Artificial Intelligence (AI) Action Plan Takes Shape as NSF, OSTP Seek Comments

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On January 23, 2025, as one of the first actions of his second term, President Trump signed Executive Order (EO) 14179, “Removing Barriers to American Leadership in Artificial Intelligence,”  making good on a campaign promise...more

McDonnell Boehnen Hulbert & Berghoff LLP

AI News Roundup – Mass layoffs of federal workers impact NIST and AI Safety Institute, Google unveils AI “co-scientist” system,...

To help you stay on top of the latest news, our AI practice group has compiled a roundup of the developments we are following....more

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