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Health Updates

Read need-to-know updates, commentary, and analysis on Health issues written by leading professionals.
Polsinelli

Drug Pricing and Payment Executive Order Shows Trump Administration’s Cards

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On April 15, 2025, President Trump signed the Lowering Drug Prices by Once Again Putting Americans First Executive Order (Executive Order). The Executive Order revives and expands several pharmaceutical pricing and payment...more

Robins Kaplan LLP

Janssen Prods., L.P. v. EVER Valinject GmbH

Robins Kaplan LLP on

Yondelis® (trabectedin) - Case Name: Janssen Prods., L.P. v. EVER Valinject GmbH, Civ. No. 24-7319, 2025 WL 639380 (N.D. Ill. Feb. 27, 2025) (Harjani, J.)  Drug Product and Patent(s)-in-Suit:  Yondelis® (trabectedin); U.S....more

Dentons

Ep. 58 – Addressing Potential Discrimination in Patient Care Decision Support Tools

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Effective May 1, 2025, the Section 1557 regulations require covered healthcare providers to take reasonable steps by May 1, 2025, to identify and mitigate the risk of discrimination when they use AI and other emergency...more

Hinshaw & Culbertson - Health Care

Beyond the Glow: Key Medical Spa Compliance Challenges and Legal Pitfalls

The medical spa industry is rapidly growing, driven by technological advances and shifting consumer preferences for cosmetic and wellness services. While this growth offers many business opportunities for healthcare...more

Venable LLP

FDA to Phase Out Eight Artificial Dyes by 2026

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On April 22, 2025, the U.S. Department of Health and Human Services and the U.S. Food and Drug Administration announced a series of new measures to quickly phase out all petroleum-based synthetic dyes from the nation’s food...more

Mintz

[Podcast] Health Law Diagnosed – Health Care Transaction Review Laws and the New Normal

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In the latest episode of Health Law Diagnosed, host Bridgette Keller discusses the evolving legislative and regulatory landscape impacting health care transactions, particularly for private equities and hedge funds. She is...more

American Conference Institute (ACI)

[Event] 23rd Advanced Summit on Life Sciences Patents - May 19th - 20th, New York, NY

At ACI’s 23rd Advanced Summit on Life Sciences Patents, you can expect informational overviews and thorough discussion of every facet of the industry. In a time of major legislative, regulatory, and judicial change, you can't...more

Fenwick & West LLP

Familiar Tactics, New Targets: Non-Practicing Entities Move Into Life Sciences and Consumer Tech

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High-volume patent monetization entities have long focused on targets in the information technology and software sectors. But that trend is shifting....more

McDonnell Boehnen Hulbert & Berghoff LLP

Metacel Pharmaceuticals LLC v. Rubicon Research Private Ltd. (Fed. Cir. 2025)

The Federal Circuit affirmed a District Court decision that the label for a generic drug obtained from an ANDA would not induce infringement by reciting optional drug storage conditions the read on the NDA holder's Orange...more

Knobbe Martens

Hard to Stomach: Things You Say to Prosecute a Patent Can and Will Be Used Against You

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AZURITY PHARMACEUTICALS, INC. v. ALKEM LABORATORIES LTD. Before Murphy, Moore, and Chen. Appeal from the United States District Court for the District of Delaware. Arguments and amendments made during prosecution of a parent...more

Sheppard Mullin Richter & Hampton LLP

State Antitrust Enforcement Roundup: New Laws; New Potential Legislation; and New (and Broader) Areas of Focus

The number of U.S. states implementing or considering new antitrust laws (or supplementing existing laws) targeting proposed transactions continues to grow. As detailed in our healthcare merger matrix, many states have...more

McDermott+

The Leaked OMB Passback Document: What It Is and Isn’t

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Last week, a sensitive internal government document was leaked to the public: the White House Office of Management and Budget’s (OMB’s) passback to the US Department of Health and Human Services (HHS) laying out proposed...more

Sheppard Mullin Richter & Hampton LLP

Navigating the Evolving Pharmacy Landscape in 2025: Challenges, Opportunities and Innovations

As we stride further into 2025, the pharmacy industry faces a landscape teeming with challenges and opportunities. From tackling drug price transparency to juggling implementation of artificial intelligence, the industry is...more

Skadden, Arps, Slate, Meagher & Flom LLP

FDA Seeks To Remove Petroleum-Based Dyes From US Food Supply

On April 22, 2025, Secretary of Health and Human Services Robert F. Kennedy Jr. and Commissioner of the Food and Drug Administration (FDA) Dr. Martin Makary announced that FDA is taking actions to remove petroleum-based dyes...more

Weintraub Tobin

CMS Ramps Up Enforcement of Hospital Price Transparency Rule

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The Hospital Price Transparency Law, codified at 45 CFR Part 180 and effective as of January 1, 2021, was implemented to provide the public with accessible hospital pricing information, aiming to eliminate hidden fees and...more

McCarter & English, LLP

Texas District Court Vacates FDA’s Final Rule Expanding Oversight to Laboratory Tests in Hospitals

In our May 2024 Healthcare Alert, we discussed a final rule published by the US Food and Drug Administration (FDA) amending its regulations to include in vitro diagnostic products (IVDs), even those manufactured in a...more

Husch Blackwell LLP

Analyzing Virginia’s New PRA for Protecting Consumer Reproductive and Sexual Health Information

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Keypoint: A new Virginia law prohibits the collection, use, or sharing of reproductive or sexual health information without consent and provides Virginians with a private right of action for at least $500 per violation. As...more

Proskauer - The Patent Playbook

Federal Circuit Affirms Stem Cell Product-by-Process Claims: Lessons in Claim Construction and Inherency from Restem LLV v. Jadi...

The Federal Circuit issued a precedential opinion on March 4, 2025, that serves as valuable guidance for product-by-process claims, particularly in the context of inherency in claim construction. In Restem, LLC v. Jadi Cell,...more

Woodruff Sawyer

The Aging Workforce: Ergonomics, Comorbidities, Lighting, and Strategies for Reducing Claims

Woodruff Sawyer on

The aging of the American workforce is the most important demographic shift impacting businesses today. Data from the Bureau of Labor Statistics (BLS), Census Bureau, and the CDC/National Institute for Occupational Safety and...more

Morgan Lewis

(AI)n’t Done Yet: States Continue to Craft Rules to Manage AI Tools in Healthcare

Morgan Lewis on

As the regulation of artificial intelligence (AI) tools in healthcare settings rapidly evolves, state medical boards and related agencies are at the forefront of development and enforcement. While some states have taken...more

Quarles & Brady LLP

Part D Pharmacies Required to Enroll in Data Exchange Module to Help Drug Price Negotiation Cash Flow Issue

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On April 15, 2025, the Centers for Medicare & Medicaid Services (“CMS”) published the Contract Year 2026 Policy and Technical Changes Final Rule which amends the regulations governing various Medicare programs, including the...more

Morgan Lewis - As Prescribed

Drug Pricing & Access in 2025: Issues to Watch and Developing Strategies

The pharmaceutical industry is a critical component of the global economy, impacting public health, national security, and economic stability. Recent developments—including investigations into the national security...more

Groom Law Group, Chartered

One Court Permits Tobacco Premium Surcharge Claims to Proceed Beyond the Pleading Stage, While Dispositive Motions Remain Pending...

In fall 2024, plaintiffs filed a wave of putative class action lawsuits against employers challenging wellness programs that impose a health coverage premium surcharge on participants if they do use tobacco or do not complete...more

Epstein Becker & Green

Breaking Down the Shifting Vaccine Policy Landscape – Diagnosing Health Care Video Podcast

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Important changes are unfolding in the vaccine space. How have vaccine exemptions posed a significant risk to populations across the country? What are the long-lasting effects of the new administration's federal health...more

Roetzel & Andress

Exit Strategies for Healthcare Employment Agreements

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Join host Ericka Adler on the latest episode of the #HealthLawHotspot as she provides essential insights on how physicians and dentists can navigate the termination of their employment agreements. In this episode, Ericka...more

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