News & Analysis as of

Biotechnology Healthcare

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

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

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

Orrick, Herrington & Sutcliffe LLP

Medical Devices, Cybersecurity & The False Claims Act: What are the Key Takeaways from the Illumina - DOJ Settlement?

Illumina, Inc., a publicly-traded biotechnology company, agreed to a $9.8 million settlement with the U.S. Department of Justice (DOJ) in response to alleged violations of the False Claims Act (FCA). DOJ alleged that Illumina...more

ArentFox Schiff

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

ArentFox Schiff on

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

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

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

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

Troutman Pepper Locke

Exclusive Licensing May Offer Biotechs a Financial Lifeline

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With volatile market conditions and recent FDA shakeups, biotech companies are increasingly focused on bolstering cash runways and accelerating R&D efforts. But fierce competition for financing has some biotechs turning to...more

Arnall Golden Gregory LLP

FDA in the “Computer Age” — AI Adoption Accelerates as Staffing Shrinks

Neil Young once sang of adapting to a world ruled by data and digital minds in “Computer Age.” Today, that vision feels increasingly real as the Food and Drug Administration turns to artificial intelligence (“AI”) in the face...more

Knobbe Martens

Bipartisan Law Introduced to Clarify Patent Eligibility

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For the past decade, controversy regarding the laws of patent eligibility has created uncertainty in the minds of inventors and investors, especially in the biotechnology, medical diagnostics, and software industries adjacent...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

Sheppard Mullin Richter & Hampton LLP

Guarding Against the Unknown: M&A Due Diligence of AI Companies in Data-Sensitive Sectors

M&A in the AI sector is redefining deal risk, especially when sensitive data is involved. As AI companies power breakthroughs in biotech, healthcare, defense, and critical infrastructure, the stakes for companies acquiring...more

Troutman Pepper Locke

Embattled Biotechs Facing Uncertainty at the FDA Look to Collaborative Deal Structures

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Biotechs have faced several challenging years with slumping valuations and a competitive funding environment. However, the latest slew of retirements and layoffs at the FDA could present their greatest challenge yet....more

Bennett Jones LLP

BBHIC 2025: Key Insights From Canada’s Leading Healthcare Investment Conference

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The Bloom Burton & Co. Healthcare Investor Conference (BBHIC), held in Toronto this week, drew over 1,500 global participants to one of Canada's leading events for healthcare investment and innovation. The conference brought...more

Maynard Nexsen

Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 234: Life-Saving Collaboration in the Life Sciences...

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Recorded at SCBio’s 2025 annual conference, hosts Heather and Matthew welcome keynote speaker John Crowley, President and CEO of the Biotechnology Innovation Organization (BIO), the world’s leading advocacy group for the life...more

McDermott Will & Schulte

European Health & Life Sciences Symposium 2025: Key Takeaways

In April 2025, we were proud to host the annual European Health & Life Sciences Symposium at the Shangri-La hotel in Paris. Attended by some 300 delegates from across the industry, participants including investors,...more

Downs Rachlin Martin PLLC

Mass General Brigham study offers promise that nasal spray targeting neuroinflammation could become an effective treatment for TBI

The secondary cascade, although a normal physiological response, can contribute to ongoing neuroinflammation, oxidative stress and axonal injury, continuing in some cases years after the initial insult.  There is no clearly...more

McGuireWoods Consulting

Health Care Executive Orders And Legal Actions: Part Six

On March 14, 2025, President Trump rescinded a number of Biden-era executive orders (EOs), two of which are health related. Executive Order 13994 (2021): The Ensuring a Data Driven Response to COVID-19 and Future...more

Goodwin

Goodwin’s 2025 Rare Disease Symposium: Momentum Builds for Addressing Critical Diagnosis and Treatment Gaps

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Goodwin’s 2025 Rare Disease Symposium, held on February 5 in Boston and virtually, gathered patient advocates and caregivers, providers, researchers, biotech and medtech leaders, investors, and policy experts to discuss the...more

Mintz Edge

The State of the Funding Market for AI Companies: A 2024 - 2025 Outlook

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Artificial intelligence (AI) has emerged as an influential technology, driving notable investments across various industries in recent years. In 2024, venture capital (VC) funding for AI companies reached record levels,...more

Jones Day

No Need to Show Reasonable Expectation of Success Regarding Inherent Property

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The Federal Circuit affirmed six PTAB decisions that held unpatentable as obvious 79 claims of three Cytiva Bioprocess (“Cytiva”) challenged patents and reversed the PTAB decision upholding four claims....more

Ballard Spahr LLP

Key Takeaways From the 2025 J.P. Morgan Health Care Conference

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Cautious Optimism for Deal Making. The general consensus is that we will likely see an increase in M&A and capital market transactions in the life sciences sector in 2025....more

Goodwin

The 43rd Annual J.P. Morgan Healthcare Conference Starts Today - A Who’s Who in Biologics at this Year’s Conference

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The JP Morgan Healthcare Conference (“JPM”) “is the largest and most informative health care investment symposium in the industry which connects global industry leaders, emerging fast-growth companies, innovative technology...more

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