News & Analysis as of

Biotechnology Life Sciences

Knobbe Martens

Life Science Update | August 2025

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The Trump administration is considering changing the U.S. patent maintenance fee structure from the existing three fixed flat fees to an annual, value‑based “tax” model where patent holders would pay 1%–5% of the estimated...more

Hogan Lovells

New FDA approval process promotes development of rare disease gene therapies

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The U.S. Food and Drug Administration (FDA) announced a new process called “Rare Disease Evidence Principles” (RDEP), under which eligible drugs and biologics for ultra-rare diseases caused by known genetic defects will...more

Ropes & Gray LLP

Reintroduction of the BIOSECURE Act: Potential Impact on the Biotechnology Industry

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The BIOSECURE Act (“the Act”), which received bipartisan support in both the U.S. House of Representatives and U.S. Senate in 2024 but was not ultimately passed into law, has re-emerged in this session of Congress, but with...more

Gardner Law

[Hybrid Event] Navigating What’s Next: AI, Compliance, and Regulation in Life Sciences - November 6th, Mountain View, CA

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Gardner Law is excited to announce Navigating What's Next: AI, Compliance, and Regulation in Life Sciences, being held live at the Shashi Hotel in the heart of Silicon Valley on November 6, starting at 9:00 a.m. Pacific Time....more

Bergeson & Campbell, P.C.

NSF Announces Nearly $32 Million Investment to Accelerate AI-Driven Approaches in Protein Design, Strengthening the U.S....

The National Science Foundation Directorate for Technology, Innovation and Partnerships (NSF TIP) announced on August 7, 2025, an investment of nearly $32 million to five teams across the United States through the NSF...more

American Conference Institute (ACI)

[Event] West Coast Summit for Women Leaders in Life Sciences Law - October 28th - 29th, San Jose, CA

Secure your place today for ACI's Inaugural West Coast Summit for Women Leaders in Life Sciences Law. Join industry leaders from pharmaceuticals, biotech and MedTech for an immersive two-day event that explores practical...more

Ballard Spahr LLP

The Future of Life Sciences Facilities

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The life science real estate market is undergoing a period of adjustment in 2025, marked by ups and downs in different segments of the life science sector. Following the frenetic pace of recent years, the market has cooled...more

Ballard Spahr LLP

Life Sciences Perspective On Emerging U.S. Patent Reform Efforts

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Though largely absent from mainstream news, proposed reforms to patent law are poised to affect everything from biotech startups to major pharmaceutical R&D programs. Specifically, there are four ongoing bipartisan efforts to...more

Ballard Spahr LLP

Trends In Dealmaking

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As the page turned on 2025, optimism was high among life sciences dealmakers. Elections in the U.S. and other major economies had concluded, interest rates were poised to come in to focus, and the regulatory environment...more

ArentFox Schiff

RFK Jr., HHS Pull the Plug on Federal Funding for mRNA Vaccine Research and Development

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On August 5, the US Department of Health and Human Services (HHS) announced a significant change in its vaccine development strategy, ending its support for mRNA vaccine projects under the Biomedical Advanced Research and...more

American Conference Institute (ACI)

[Event] Pharma & Biotech Patent Litigation USA - October 14th - 15th, New York, NY

Attend ACI's inaugural Forum on Pharma & Biotech Patent Litigation USA and garner a winning edge in the high- stakes life sciences patent ligation arena. Get the in-depth and practical information that you need to develop...more

Proskauer - The Patent Playbook

Federal Circuit Reverses $4.7M Verdict in Labcorp v. QIAGEN: Claim Scope and Doctrine of Equivalents in the Crosshairs

The Federal Circuit recently reversed a $4.7M verdict in a patent lawsuit involving two patents concerning next-generation sequencing methods—U.S. Patent Nos. 10,017,810 and 10,450,597. Both patents concern DNA preparation...more

Maynard Nexsen

Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 247: Reimagining Cell Therapy for Solid Tumors with...

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Ming-Wei Chen and Fanheng Zhou, the scientists behind RephImmune, join hosts Lynnsey and Matthew to discuss how their biotech startup is developing a next-generation cell therapy platform designed to overcome the limitations...more

Goodwin

European Commission Approves Moderna’s Updated COVID-19 Vaccine

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On July 30, 2025, Moderna announced that the European Commission (EC) granted marketing authorization for the updated formulation of Moderna’s COVID-19 vaccine Spikevax®.  The updated vaccine targets the LP.8.1 variant of...more

McDonnell Boehnen Hulbert & Berghoff LLP

AI News Roundup – U.S. government and chipmakers make deal on AI chip exports to China, generative AI used to develop antibiotics,...

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

Fenwick & West LLP

10 Critical Missteps to Avoid When Building AI Governance Policies for Life Sciences Companies

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Life sciences companies racing to harness artificial intelligence often stumble into preventable traps that can derail innovation and create lasting legal exposure. ...more

Bergeson & Campbell, P.C.

EC Begins Public Consultation on Biotech Act

The European Commission (EC) began a public consultation on August 4, 2025, on the European Biotech Act in the form of an online questionnaire. According to the EC, the aim is to gather evidence and views from stakeholders...more

Arnall Golden Gregory LLP

DOJ Sharpens Focus on Cybersecurity Compliance in Healthcare: Illumina FCA Settlement Signals Broader Trend

On July 31, 2025, the U.S. Department of Justice announced that Illumina Inc. agreed to pay $9.8 million to resolve False Claims Act (“FCA”) allegations concerning cybersecurity deficiencies in its genomic sequencing systems...more

Maynard Nexsen

Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 246: The Next Generation of Treatment for Alzheimer's...

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Lynnsey and Matthew are joined by Neal Goodwin and Pawel Krysiak of Jaya Bio, a preclinical life sciences company developing gene therapies for genetically defined neurodegenerative diseases. They share how their team is...more

Cooley LLP

Key Trends and Considerations in Cross-Border Life Sciences Partnering-Licensing and NewCo Transactions Between Chinese and...

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Over the past decade, the landscape of cross-border partnering in the life sciences sector has undergone a dramatic transformation, particularly in transactions between Chinese biotech companies and their US and European...more

Morgan Lewis

UK Life Sciences Sector Plan: What In-House Legal and Compliance Teams Need to Know

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The UK government recently unveiled its 10-year Life Sciences Sector Plan, putting forward a comprehensive strategy for transforming the UK into a global leader in life sciences by 2035. This LawFlash outlines key areas of...more

Orrick, Herrington & Sutcliffe LLP

From Federal to State: Building the New Life Sciences Capital Stack | Life Sciences Snapshot – Q3 2025

This year, U.S. VC funding into the life sciences sector has cooled: Q1 softness was followed by a decade low in VC transactions in Q2. Despite the moderation in dealmaking volume, investors continued to deploy sizable...more

Fenwick & West LLP

Seattle Tech Week 2025: What Makes Seattle the Next Great Tech Hub?

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Seattle Tech Week is on the horizon, and the anticipation is building as the city prepares to showcase its thriving tech ecosystem. Seattle has long been a home to tech giants, but in recent years, it has transcended its...more

A&O Shearman

A new European strategy to foster life sciences innovation and market access

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On July 2, 2025, the European Commission released its communication “Choose Europe for life sciences. A strategy to position the EU as the world’s most attractive place for life sciences by 2030” (the Strategy). ...more

Foley & Lardner LLP

The Patent Eligibility Restoration Act and Life Sciences Innovation

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The biotechnology and life science sectors underpin breakthroughs in health care, agriculture, and environmental sustainability by leveraging living systems to create next-generation medicines, diagnostics, and bio-based...more

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