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Arnall Golden Gregory LLP

Trimming the Fat: Supreme Court Slims Down Skinny Label Liability

On June 4, 2026, the United States Supreme Court issued its decision in Hikma Pharmaceuticals USA Inc. v. Amarin Pharma, Inc. In its decision, the Supreme Court reversed the Federal Circuit, and held that Amarin’s complaint...more

Akerman LLP - Health Law Rx

What the FTC’s Ascension/AmSurg Order Means for Nonprofit Healthcare Deals

The Deal - On June 2, 2026, the Federal Trade Commission (FTC) required nonprofit health system Ascension Health Alliance to divest several ambulatory surgery centers (ASCs) as a condition of closing its proposed $3.9...more

Alston & Bird

Health Care Week in Review | CMS Releases Interim Final Rule on Medicaid Work Requirements; House Appropriations Subcommittee...

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Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more

Holland & Knight LLP

Federal IDR Process Overhaul Finalized: What Stakeholders Need to Know

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The U.S. Departments of the Treasury, Labor, and Health and Human Services (the Departments), along with the U.S. Office of Personnel Management, issued a final rule on May 28, 2026, implementing several modifications to the...more

Vedder

U.S. DOL’s Wage and Hour Division Issues New FLSA Compliance Guidance

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On May 28, 2026, the U.S. Department of Labor’s (DOL) Wage and Hour Division (WHD) issued a collection of opinion letters that provide guidance on several important issues under the Fair Labor Standards Act (FLSA)....more

Wolf, Greenfield & Sacks, P.C.

Hikma v. Amarin: What the Supreme Court’s Decision Means for Skinny Labels and Induced Infringement

The Supreme Court has issued a unanimous decision in Hikma v. Amarin, holding that Amarin did not meet its pleading burden of plausibly alleging that Hikma induced infringement of Amarin’s patents relating to reducing the...more

The Volkov Law Group

DOJ Announces New West Coast Health Care Fraud Strike Force

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The Department of Justice (“DOJ”) continues to expand its aggressive health care fraud enforcement efforts with the announcement of a new West Coast Health Care Fraud Strike Force....more

Robins Kaplan LLP

Supreme Court Rejects “Possibility” Standard for Induced-Infringement Claims Against Skinny-Label Generics

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The Supreme Court issued a unanimous decision for Hikma in Hikma Pharmaceuticals USA Inc. v. Amarin Pharma, Inc. It reversed the Federal Circuit and held that Amarin failed to state a claim that Hikma induced infringement...more

McDermott+

McDermott+ Check-Up – June 5, 2026

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The Senate passed the reconciliation 2.0 package, which funds ICE and CBP and includes no healthcare provisions. The bill now moves to the House, though Republican leadership cancelled Friday votes, postponing further action...more

McDermott+

Trump administration executive order tracker 6.5.26

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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

Jones Day

New Rule Amends No Surprises Act Dispute Process for Out-of-Network Health Care Payments

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On May 28, 2026, the Departments of Health and Human Services, Labor, and the Treasury finalized a rule implementing changes to the No Surprises Act's independent dispute resolution process, including new standardized...more

Akin Gump Strauss Hauer & Feld LLP

SCOTUS Unanimously Holds that Affirmative, Purposeful Conduct is Required to Allege Induced Infringement in Skinny Label Case

The Supreme Court unanimously held that for a complaint of induced infringement, a patent owner must allege that the accused infringer took affirmative, not passive, steps to encourage direct infringement. Thus, where a...more

DLA Piper

Food and Beverage News and Trends - June 2026

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Prater named new head of FDA Human Foods Program. Donald Prater, DVM, has been appointed Acting Deputy Commissioner for Food at the United States Food and Drug Administration (FDA). He replaces Kyle Diamantas, who was named...more

Hogan Lovells

Conformity assessment of continuously learning AI-based medical devices in the EU

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The conformity assessment of AI-based medical devices (“AIMD”) raises questions for companies developing and marketing such devices. This is true in particular for AIMDs that continue to learn after being placed on the...more

Latham & Watkins LLP

UK Reforms Clinical Trials Regulations

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The new framework includes a combined regulatory-ethics review process, expedited approval timelines, and an automatic authorisation pathway for low-risk trials, among other changes....more

Ogletree, Deakins, Nash, Smoak & Stewart,...

HHS Restructuring and New Enforcement Signal Increased Focus on Privacy, Security, and Health Plans

On May 18, 2026, the U.S. Department of Health and Human Services (HHS) announced the restructuring of its Office for Civil Rights (OCR) enforcement efforts, establishing a dedicated unit for privacy and security enforcement...more

Pullman & Comley, LLC

Legal Protections for Gender-Affirming Care in Connecticut

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Over the past several years the U.S. government and many state governments have undertaken a sustained series of actions aimed at restricting the legal rights and protections of transgender and non-binary populations....more

Hogan Lovells

Economic simplification act: long-awaited reform and positive developments for clinical research in France

Hogan Lovells on

Law No. 2026-403 of 26 May 2026 on the simplification of economic activity introduces several measures that have long been awaited by stakeholders in the healthcare sector. Against a backdrop of increasing competition among...more

Morgan Lewis

Amarin v. Hikma: Supreme Court Applies Twombly, Iqbal and Leaves Induced-Infringement Standards Untouched

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The US Supreme Court’s recent decision in Hikma Pharmaceuticals USA Inc. v. Amarin Pharma Inc. clarifies what federal pleading standards demand in induced-infringement cases involving pharmaceutical “skinny” labels and...more

Mintz - Health Care Viewpoints

OIG Focuses on Prevention in New Medicare Advantage Risk Adjustment Report

The Office of the Inspector General (OIG) continues to focus on Medicare Advantage (MA) risk adjustment payments, issuing a report this week detailing its audit of MA risk adjustment payments based on acute stroke diagnosis...more

Morgan Lewis

DOJ Announces Fast-Track Review Process for Benefits Fraud False Claims Act Matters

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The US Department of Justice’s Civil Division recently announced reforms designed to accelerate the review and enforcement of False Claims Act whistleblower matters alleging fraud against federally funded, state-administered...more

Katten Muchin Rosenman LLP

Navigating FDA Risks in Life Sciences M&A: A Practical Diligence Guide

Counsel advising acquirers in pharmaceutical, biotechnology, and medical device transactions must assess a target's compliance with Food and Drug Administration (FDA) requirements in granular detail as a fundamental...more

Mayer Brown

Supreme Court Holds That to State a Claim for Inducing Patent Infringement, the Complaint Must Plausibly Allege That the Defendant...

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Hikma Pharmaceuticals USA Inc. v. Amarin Pharma, Inc., No. 24-889 - Introduction - Yesterday, the Supreme Court held in a unanimous 9-0 decision that induced patent infringement requires active steps to encourage...more

Polsinelli

The Work Behind the Work Requirement: CMS Imposes Sweeping Medicaid Community Engagement Rule

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Key Takeaways - On June 1, CMS released an interim final rule implementing the new Medicaid community engagement requirement (i.e., work requirement) as a condition of Medicaid eligibility for adults aged 19-64 with access to...more

Sheppard

OHCA Releases Proposed Emergency Regulations Implementing AB 1415 Reporting Requirements for Private Equity (PE) and Management...

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Since Governor Newsom signed AB 1415 into law last October, stakeholders have been awaiting the release of draft regulations from California’s Office of Health Care Affordability (“OHCA”) to clarify the statute’s notice and...more

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