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Life Sciences Healthcare

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

Cautious Optimism For Capital Markets

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Life sciences capital markets in 2025 have been a mixed bag—some rays of light peeking through, but still, plenty of clouds for early-stage companies hoping to tap the public markets. After a long IPO drought, 2024 brought a...more

Gardner Law

Cybersecurity and the FCA: Illumina Signals "No Breach" Enforcement Risks

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A $9.8 million False Claims Act (FCA) settlement between Illumina Inc. and the U.S. Department of Justice (DOJ) is unique among cybersecurity enforcement actions because it didn’t result from a data breach, but, according to...more

Jones Day

Bill Seeks to Restrict 30-Month Stay in Hatch-Waxman Litigation to One Patent

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Senate Bill S. 4878 seeks to force innovator pharmaceutical companies to select a single Orange Book listed patent for the 30-month stay. ...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

Ballard Spahr LLP

Key Trends Shaping Life Sciences IP Licensing

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The life sciences industry continues to evolve rapidly, driven by technological advancements, shifting economic conditions, and global market dynamics. As companies navigate this complex landscape, several key trends are...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

Hogan Lovells

2025 Horizons Life Sciences and Health Care

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In 2025, Life Sciences and Health Care (LS&HC) companies face rapidly evolving regulatory paradigms that create transactional risks and require daily monitoring. After more than 70 national elections in 2024, the dust hasn’t...more

Ballard Spahr LLP

FDA Issues Guidance on AI for Medical Devices

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The Food and Drug Administration (FDA) issued final guidance Monday that explains how medical device manufacturers can use a Predetermined Change Control Plan (PCCP) to update AI-enabled device software functions (AI-DSFs)...more

McDermott+

Trump Administration Executive Order Tracker - updated 8.18.25

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Below is a tracker of healthcare-related executive orders (EOs) issued by the Trump administration, including overviews of each EO and the date each EO was signed. We will regularly update this tracker as additional EOs are...more

Ropes & Gray LLP

Artificial Intelligence H1 2025 Global Report: Deal trends, fundraising, segment highlights, and market outlook

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Despite uncertainty in global markets, AI remains a strategic priority among business executives, investors, and government, fueling sustained investment in AI infrastructure and dealmaking with AI developers and AI-enabled...more

Searcy Denney Scarola Barnhart & Shipley

Cancer and Medication: Advocating for Yourself and Your Health

Unfortunately, the risk of a cancer diagnosis is a very real concern with many common (and not-so-common) medications. While drug companies have a legal duty to ensure that their medications are safe, these companies don’t...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

Holland & Knight LLP

New Florida Law Attempts to Provide Leeway for Certain Stem Cell Treatments

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A new law in Florida, CS/CS/SB 1768, allows physicians to market and administer stem cell therapies that have not been approved by the U.S. Food and Drug Administration (FDA) for orthopedic conditions, wound care and pain...more

Patterson Belknap Webb & Tyler LLP

The FTC Challenges Edwards Lifesciences’ $945M Acquisition of JenaValve

On August 6, 2025, the Federal Trade Commission (“FTC”) filed a motion for preliminary injunction to block Edwards Lifesciences Corporation’s (“Edwards”) $945 million proposed acquisition of JenaValve Technology, Inc....more

WilmerHale

The Rise and Fall and Rise Again of VC “Mega-Rounds”

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Over time, there have been huge shifts in the amount of financing required to start and scale businesses. Advances such as cloud computing and open-source software have enabled technology startups to commence and grow their...more

Kelley Drye & Warren LLP

NAD Considers Material Connection Disclosures on LinkedIn

Agendia made two posts on LinkedIn that linked to articles in which Dr. Nathalie Johnson touts Agendia’s genomic test to evaluate early-stage breast cancer over Genomic Health’s competing test. Genomic Health filed an NAD...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

Akin Gump Strauss Hauer & Feld LLP

FDA Moves Forward on Fluoropolymers

On August 6, 2025, the U.S. Food and Drug Administration (FDA) became the latest governmental agency to confirm that fluoropolymers are both safe and necessary. After an independent safety review of fluoropolymers in medical...more

Troutman Pepper Locke

State AGs Join $202M Settlement Over HIV Drug Kickback

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On July 16, 49 attorneys general (AGs) announced that they joined a $202 million settlement with Gilead Sciences, Inc. (Gilead). Previously announced by the Department of Justice in April, the settlement resolved allegations...more

McDermott Will & Schulte

DOJ-HHS False Claims Act Working Group will pursue healthcare, life sciences enforcement priorities

The US Department of Justice (DOJ) and the US Department of Health and Human Services (HHS) recently announced the relaunch of the DOJ-HHS False Claims Act Working Group, intended to “strengthen[] [the agencies’] ongoing...more

Haynes Boone

False Claims Act - 2025 Mid-Year Review

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The False Claims Act continues to be one of the most commonly used weapons in the government’s enforcement arsenal to address various forms of fraud. In addition to our “Year in Review” publication providing an overview of...more

Sheppard Mullin Richter & Hampton LLP

DOJ False Claims “Working Group” Update

ICYMI over the holiday week (present company included), the U.S. Department of Justice (DOJ) announced a re-energized partnership with the U.S. Department of Health and Human Services (HHS) to enforce the False Claims Act...more

Hogan Lovells

China’s healthcare compliance guidelines: insights and actionable steps for life sciences companies

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In January 2025, China’s State Administration for Market Regulation (“SAMR”) introduced the Compliance Guidelines for Healthcare Companies to Prevent Commercial Bribery Risks (“Guidelines”), marking the first...more

Troutman Pepper Locke

Second FTC and DOJ Listening Session Focuses on Formulary and Benefit Practices and Regulatory Abuse in the Pharmaceutical...

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On July 24, the Department of Justice (DOJ) and Federal Trade Commission (FTC) held the second of three listening sessions focused on competition in the pharmaceutical marketplace as part of the agency's implementation of the...more

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