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Research and Development

Health Care Compliance Association (HCCA)

Their Terms Ended by Trump, SACHRP Members Form New Committee, Vow to Continue ‘Mission’

Reflecting thwarted desires to continue their terms, while answering calls from trial administrators and oversight leaders, seven former members of the highest-ranking federal advisory panel on human research...more

Cooley LLP

Senate Changes to Proposed Legislation Would Permit Immediate Deduction of Domestic R&E Expenditures Permanently, in Some Cases...

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On June 16, the Senate Finance Committee (SFC) released revisions to the “One Big Beautiful Bill Act” (OBBBA) passed by the US House of Representatives on May 22. As described in this June 4 Cooley client alert, the OBBBA...more

Frost Brown Todd

Substantiating the Right to Claim QSBS Tax Benefits | Part 1

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Section 1202 provides an exclusion from capital gains when a stockholder sells qualified small business stock (QSBS), assuming all eligibility requirements are satisfied. Section 1045 provides for the tax-free rollover of...more

Wilson Sonsini Goodrich & Rosati

Senate Finance Committee Proposes Permanently Restoring Expensing for Domestic R&D Expenditures

On June 16, 2025, the Senate Finance Committee released its draft of the tax provisions in H.R. 1 (commonly referred to as the “One Big Beautiful Bill” (the SFC Bill)). We previously covered the original legislation passed by...more

Goodwin

Teva and Fosun Partner to Develop a Novel Immunotherapy Targeting Melanoma and Other Cancers

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Teva Pharmaceutical Industries Ltd. (“Teva”) and Shanghai Fosun Pharmaceutical (Group) Co. (“Fosun Pharma”) recently announced a partnership to accelerate the development of Teva’s TEV-56278, a novel fusion protein that uses...more

Seyfarth Shaw LLP

The Week in Weed: June 2025 # 2

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Welcome back to The Week in Weed, your Friday look at what’s happening in the world of legalized marijuana. This week, a bill headed to the President’s desk may ease restrictions on cannabis research. Facebook and Instagram...more

Eversheds Sutherland (US) LLP

Senate’s version would permanently extend TCJA provisions and close interest loopholes

On June 16, 2025, the Senate Finance Committee released proposed text for tax provisions to be included in the Senate’s version of the One Big Beautiful Bill Act (OBBB). Our prior Alert addresses the House version of the...more

Ropes & Gray LLP

With Implementation Deadline Looming, ORI Releases Sample Research Misconduct Policies and Procedures

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On June 4, 2025, the U.S. Department of Health and Human Services Office of Research Integrity (“ORI”) published a Sample Policies and Procedures for Addressing Allegations of Research Misconduct (“Sample Policy”) to align...more

Gardner Law

The Importance of a Clinical Trial Strategy

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Developing a medical product, such as a medical device, comes with important milestones that can cause a project to sink or swim. One major milestone is amassing the clinical data needed to support pre-market submissions....more

Ropes & Gray LLP

What Are the Key Takeaways From Rachel Reeves’ Spending Review and Who Will be the Biggest Winners?

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Rachel Reeves, the UK’s Chancellor of the Exchequer, has revealed the Government’s Spending Review 2025 (SR25) setting out departmental budgets until 2029 and capital investment until 2030. The SR25 is in line with the...more

Fenwick & West LLP

What We’re Watching Ahead of BIO 2025: Trends Shaping the Future of Biotech

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As we head into BIO 2025 in Boston, our teams are closely watching trends in biotech and how those affect financings, business development, IP protection, risk, and litigation strategy. Here are eight key trends we’re...more

McGuireWoods Consulting

Trump’s Health Care Budget Cuts: Part Two

This is part two of a series on health care budget cuts. The President’s Budget Requests Dramatically Reduce Biomedical Research - The president’s budget request was a major disappointment to those interested in...more

Fenwick & West LLP

House Reconciliation Bill Would Restore Expensing for Domestic R&D Prospectively

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On May 22, 2025, the U.S. House of Representatives passed a reconciliation bill (commonly referred to as the “One Big Beautiful Bill”), which would restore expensing for domestic research and development expenses incurred in...more

King & Spalding

Administrative, Congressional, and State Interest Signal a Potential Breakthrough Moment for Psychedelics

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The development of innovative pharmaceuticals targeting refractory mental health conditions has stagnated for decades. In recent years, however, psychedelics have garnered scientific and public attention for their potential...more

Woodruff Sawyer

[Ongoing Program] Risk Management for Your Life Sciences Company: Webinar 3 - International Clinical Trials Country Requirements-...

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From lab to commercialization: Navigate the evolving risks of life science companies - Life science companies face rapidly evolving risks—from navigating insurance needs during early funding stages to understanding...more

Cooley LLP

Proposed Tax Legislation Would Permit Immediate Deduction of Domestic R&E Expenditures for Limited Period

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On May 22, 2025, the US House of Representatives passed the “One Big Beautiful Bill Act” (OBBBA), which includes a temporary suspension of the amortization requirement for domestic research and experimentation (R&E)...more

Woodruff Sawyer

[Ongoing Program] Risk Management for Your Life Sciences Company: Webinar 2 - AI In Real Life (Science): Exploring Real World...

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From lab to commercialization: Navigate the evolving risks of life science companies - Life science companies face rapidly evolving risks—from navigating insurance needs during early funding stages to understanding...more

Woodruff Sawyer

[Ongoing Program] Risk Management for Your Life Sciences Company: Webinar 1 - Navigating Risk from Lab to IPO: A Guide to...

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From lab to commercialization: Navigate the evolving risks of life science companies - Life science companies face rapidly evolving risks—from navigating insurance needs during early funding stages to understanding...more

Bergeson & Campbell, P.C.

House Subcommittees Will Hold Hearing on “Pursuing the Golden Age of Innovation: Strategic Priorities in Biotechnology” on June 5

On June 5, 2025, the House Science and Technology Subcommittees on Energy and on Research and Technology will hold a joint hearing on “Pursuing the Golden Age of Innovation: Strategic Priorities in Biotechnology.” The...more

Carlton Fields

“Restoring Gold Standard Science” Executive Order Steps Away From Biden Administration’s “Equitable” Approach

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Both President Trump’s and President Biden’s administrations have emphasized in executive orders and presidential memoranda the need for objective, science-based decision-making. However, Trump’s May 23, 2025, Executive Order...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

Bradley Arant Boult Cummings LLP

Alabama Legislature Wraps Up Productive Session on Business Tax Bills

The Alabama Legislature adjourned sine die near midnight on May 14, 2025, with the final legislative meeting day bogged down with filibusters by certain senators. Fortunately, a spate of tax bills had already passed both the...more

Bergeson & Campbell, P.C.

NASEM Releases Quadrennial Review of NNI, Recommends Renewed and Expanded Infrastructure

On May 20, 2025, the National Academies of Sciences, Engineering, and Medicine (NASEM) announced the release of a report entitled Quadrennial Review of the National Nanotechnology Initiative (2025): Securing U.S. Global...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

Morgan Lewis - As Prescribed

New Measures to Encourage Clinical Trials in the United Kingdom

While the US Food and Drug Administration has been experiencing recent reorganization and cuts in personnel, the United Kingdom has its own upcoming policy changes making it easier and faster to initiate and maintain UK...more

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