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Gordon Rees Scully Mansukhani

HHS and DEA Extend Telemedicine Flexibilities for Prescribing Controlled Medications Through 2026

The U.S. Department of Health and Human Services (HHS), working with the Drug Enforcement Administration (DEA), has issued a fourth temporary extension of telemedicine flexibilities, first introduced in response to the...more

Morgan Lewis

DOJ Announces Highest-Ever Annual False Claims Act Recoveries: Over $6.8 Billion in Fiscal Year 2025

Morgan Lewis on

The US Department of Justice (DOJ) has announced that recoveries from False Claims Act (FCA) settlements and judgments in fiscal year 2025 exceeded $6.8 billion, the highest annual amount in FCA history and more than double...more

K&L Gates LLP

BIOSECURE Act: What You Need to Know

K&L Gates LLP on

The National Defense Authorization Act for Fiscal Year 2026, signed into law on 18 December 2025, includes the BIOSECURE Act (the Act), which establishes a new framework governing the use of certain biotechnology equipment...more

Axinn, Veltrop & Harkrider LLP

AI, Private Equity, and Fixes That Work: Key Takeaways from the FTC Alongside the JP Morgan Healthcare Conference

Against the backdrop of the San Francisco JPMorgan Healthcare Conference, Axinn, Cornerstone, and Concurrences hosted a reception and dinner on January 14, 2026, to discuss the Trump administration’s antitrust enforcement...more

Hogan Lovells

OIG says Discount Safe Harbor protects some market share discounts, confirms scope of protection for bundled discounts in...

Hogan Lovells on

In an advisory opinion published at the end of 2025, the U.S. Department of Health and Human Services Office of Inspector General (OIG) addressed—to a degree—several longstanding questions under the Discount Safe Harbor to...more

A&O Shearman

EU Bioeconomy Strategy 2025: Regulatory Signals for Supply Chains, Investment and Sustainability

A&O Shearman on

The European Commission’s (Commission) 2025 communication “A Strategic Framework for a Competitive and Sustainable EU Bioeconomy” (the Framework) positions bioeconomy as a core pillar of EU competitiveness and industrial...more

Proskauer - Employee Benefits & Executive...

Planning for Your Next DOL Investigation Just Got Easier

Spoiler alert. We are about to reveal the secret to learning what the U.S. Department of Labor’s Employee Benefits Security Administration (“EBSA”) will be focused on the next time it investigates your employee benefit...more

ArentFox Schiff

Investigations Newsletter: DOJ Reports Record FY 2025 False Claims Act Recoveries Exceeding $6.8 Billion

ArentFox Schiff on

DOJ Reports Record FY 2025 False Claims Act Recoveries Exceeding $6.8 Billion - The US Department of Justice (DOJ) announced a record $6.8 billion in False Claims Act (FCA) settlements and judgments for fiscal year 2025,...more

Proskauer - The Patent Playbook

Supreme Court Takes Up Hikma v. Amarin: Induced Infringement and Skinny Labels in the Crosshairs

The Supreme Court’s decision to review Hikma Pharmaceuticals USA Inc. v. Amarin Pharma Inc. places renewed attention on a familiar but unsettled issue in pharmaceutical patent law: how the induced infringement doctrine...more

Foley & Lardner LLP

Personalizing Cancer Therapy For Complex Molecular Blueprints: Insights from the I-PREDICT Trial

Foley & Lardner LLP on

One of the persistent challenges in precision oncology is the fact that most advanced cancers are complex and highly individualized. A recent study published by Jason K. Sicklick, MD and colleagues (J. Clinical Oncology)...more

Mintz

Perspectives on JPM 2026 from Life Sciences Co-chair Cheryl Reicin

Mintz on

The annual JPM Healthcare Conference held in early January sets the stage for the year of life science deals. Unlike the pre-COVID days when San Francisco’s streets were jam-packed and “entrepreneurial” locals tried to rent...more

Mitchell, Williams, Selig, Gates & Woodyard,...

Multidecadal Change in Pesticide Concentrations Relative to Human Health Benchmarks in the Nation's Groundwater: U.S. Geological...

The United States Geological Survey (“USGS”) issued a report titled: … Multidecadal Change in Pesticide Concentrations Relative to Human Health Benchmarks in the Nation’s Groundwater (“Report”)....more

Lippes Mathias LLP

Needles and Notices: New York Warns Consumers of Unlicensed Med Spa Practices

Lippes Mathias LLP on

Following a statewide inspection of more than 200 medical spas (commonly referred to as “med spas”), the New York Department of State (the “DOS”) issued a Consumer Alert on January 8, 2026, warning about risks associated with...more

Akerman LLP - Health Law Rx

The Zafirov Appellate Argument — Panel Steers Parties to Address Whistleblower Control

The much-anticipated appellate showdown regarding the constitutionality of the whistleblower (or qui tam) provision of the federal False Claims Act (FCA) took place before a three-judge panel of the Eleventh Circuit Court of...more

Oberheiden P.C.

Healthcare & the Whistleblower Protection Act: Answers to FAQs

Oberheiden P.C. on

Healthcare fraud is a major issue. According to federal government estimates, it costs taxpayers in the realm of $100 billion every year. While the U.S. Department of Justice (DOJ) and U.S. Department of Health and Human...more

Maynard Nexsen

Episode 265: Redesigning Clinical Trials Through Technology with Patrick McCarthy of Validcare

Maynard Nexsen on

Hosts Heather and Lauren sit down with Patrick McCarthy, CEO of Validcare, to discuss how technology is reshaping the future of clinical research. Patrick shares how Validcare is re-engineering the traditional CRO model,...more

Thompson Coburn LLP

The Importance of Coordinated Oversight in Internal Health Care Investigations

Thompson Coburn LLP on

Internal investigations are an important component of an effective legal and compliance program within health care organizations. These investigations may arise from many varied situations ranging from patient complaints,...more

Krieg DeVault

DEA Extends COVID-Era Telemedicine Flexibilities to December 31, 2026

Krieg DeVault on

On December 31, 2025, the Department of Health and Human Services (HHS) and the Drug Enforcement Administration (DEA) announced that that they were issuing a Fourth Temporary Extension of the COVID-19 Telemedicine...more

Troutman Pepper Locke

2025 State AG Year in Review

Troutman Pepper Locke on

State attorneys general (AGs) are among the most active and influential regulators in the U.S., using broad statutory authority, political visibility, and growing technical knowledge to shape policy and enforcement across...more

McDonnell Boehnen Hulbert & Berghoff LLP

AI News Roundup – Apple chooses Google Gemini AI to power updated Siri, AI tool discovers treatment for rare disease, US imposes...

To help you stay on top of the latest news, our AI practice group has compiled a roundup of the developments we are following....more

McDonnell Boehnen Hulbert & Berghoff LLP

Supreme Court to Resolve Dispute Over Marketing of “Skinny Labeled” Generics

The Hatch-Waxman Act has always represented a delicate balance between the interests of innovator and generic drugmakers: innovators seek to maintain exclusivity as broadly and long as possible, generics seek to come to...more

Morrison & Foerster LLP

Supreme Court Takes Up Hikma v. Amarin

On Friday, the Supreme Court granted certiorari in Hikma Pharmaceuticals v. Amarin Pharma, ending an almost three-year lull in patent cases at the Court. The case presents two related questions, one framed specifically in the...more

Hissey, Mulderig & Friend, PLLC

Ozempic Blindness Lawsuits: Legal Claims Allege GLP-1 Drugs Linked to NAION Vision Loss

Glucagon-like peptide-1 receptor agonist drugs (commonly referred to as GLP-1 agonists) have become widely prescribed for type 2 diabetes and weight loss. Medications such as Ozempic, Wegovy, Mounjaro, and other GLP-1 drugs...more

Morgan Lewis - As Prescribed

Awash in Data? FDA Removes a Barrier in Real-World Evidence Generation

On December 15, 2025, the US Food and Drug Administration (FDA) issued a press release announcing that FDA eliminated a major barrier to the use of real-world evidence (RWE) in medical device regulatory submissions. ...more

Groom Law Group, Chartered

This Week From the Hill (January 11 – 17, 2026)

Each week while Congress is in session, our Policy team delivers a key update to highlight a topical benefits, health, or retirement news item from the Hill, such as a newly introduced bill, a summary of a committee hearing,...more

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