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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

Knobbe Martens on

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

McDermott+ on

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

Weintraub Tobin on

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

Husch Blackwell LLP on

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

Quarles & Brady LLP on

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

Epstein Becker & Green on

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

Roetzel & Andress on

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

King & Spalding

Executive Order Continues Focuses on Anticompetitive Regulations

King & Spalding on

On April 9, 2025, President Trump issued an executive order, titled “Reducing Anti-Competitive Regulatory Barriers” (the EO), directing federal agencies to identify and rescind or modify anticompetitive regulations. The EO...more

Kohrman Jackson & Krantz LLP

Senate Bill 268 Introduced to Regulate Veterinarian Telehealth Services

A bill sponsored by Ohio Senators Shane Wilkin and Steve Huffman was recently introduced which would establish requirements and procedures for a veterinarian licensed to practice in Ohio to conduct telehealth services....more

Mintz - Health Care Viewpoints

OIG Issues Another Favorable Advisory Opinion on Patient Recruitment Efforts by Community Health Centers

The Office of Inspector General for the Department of Health and Human Services (OIG) recently issued a favorable Advisory Opinion on a proposed arrangement by a community health center (Health Center) designated under...more

Jaburg Wilk

Work Hard, Play Hard: A Perspective on Life Balance

Jaburg Wilk on

In the competitive landscape of business, we often become consumed by working harder and longer than others as some type of badge of success. In the legal profession this comes in the form of billable hours, client demands,...more

Nelson Mullins Riley & Scarborough LLP

Attention SNFs: Enhanced 855A Disclosure Requirement Deadline Extended to August 1, 2025

This article is an update to a December 2024 client alert. On April 17, 2025, the Centers for Medicare and Medicaid Services ("CMS") extended the revalidation deadline for its 855A skilled nursing facility...more

DLA Piper

Food and Beverage News and Trends - April 2025 #2

DLA Piper on

President Trump directs agencies to repeal regulations without notice and comment rulemaking. President Donald Trump issued a Presidential Memorandum on April 9, directing the repeal of "unlawful regulations" deemed to impede...more

Adler Pollock & Sheehan P.C.

Newly Married? Young Parents? Start Your Estate Plan Now

Estate planning is not a task that often comes to mind for those who are newlyweds or those parents who are in the midst of raising young children. Either you’re still enjoying the post-wedding excitement and promise of a new...more

Robins Kaplan LLP

Liquidia Techs., Inc. v. FDA

Robins Kaplan LLP on

Yutrepia® (treprostinil inhalation powder) - Case Name: Liquidia Techs., Inc. v. FDA, No. 24-2428 (D.D.C. Feb. 27, 2025) (Kelly, J.) Drug Product and Patent(s)-in-Suit: Yutrepia® (treprostinil inhalation powder) Nature of...more

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