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Polsinelli

2026 340B Program Update – 340B Rebate Model RFI Comments Due and Manufacturers Continue Restricting 340B Pricing

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Key Takeaways - HRSA has extended the deadline for comments on its proposed 340B rebate model pilot program to April 20, 2026. Covered entities have a limited window to submit detailed feedback on how the model would affect...more

Arnall Golden Gregory LLP

Section 232 Tariffs on Pharmaceuticals: 100% Duties on Patented Drugs and APIs Starting July 31, 2026

Key Takeaways - Under the Section 232 national security authority, an additional 100% duty will apply to certain patented pharmaceuticals and associated ingredients, including active pharmaceutical ingredients and key...more

A&O Shearman

Europe’s increased focus on the environment and corporate sustainability: an expensive game changer for the pharma industry...

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Over the past decade, the European Union has enacted a host of new legislation to protect the environment, promote sustainability, and tackle climate change, including the European Green Deal to new reporting and due...more

A&O Shearman

Two years on from its launch, how has the UPC impacted European patent litigation in the life sciences sector?

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The UPC has been reshaping European patent litigation since its launch in June 2023. More than 480 patents have now been litigated in the court, and the number of actions is steadily increasing. Initially, major...more

A&O Shearman

Medical devices: EU Commission proposes MDR and IVDR revision

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The EU Commission published its 170-page proposal on revisions of the Medical Device Regulation (EU) 2017/745 (MDR) and the In Vitro Diagnostic Regulation (EU) 2017/746 (IVDR) on December 16, 2025. After MDR and IVDR became...more

A&O Shearman

Q&A: Why data provenance is critical to AI-powered drug discovery

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Pharmaceutical research and development is becoming more expensive and taking longer. Innovative AI scale-ups and platforms are addressing this by quickly accumulating vast datasets, but the larger companies that buy them...more

A&O Shearman

Under the microscope: shareholder activism in life sciences and healthcare

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The life sciences and healthcare sector is a prominent target for shareholder activists. In 2025 a record 255 activist campaigns were launched worldwide, surpassing the previous high of 249 set in 2018, according to research...more

A&O Shearman

China’s pharma innovators pursue a range of deal structures to support global expansion

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Thanks to its scientific skills base, growing prowess in AI and a policy environment that supports rapid clinical trials, China has become one of the world’s leading markets for pharmaceutical innovation. Here we explore how...more

McGuireWoods LLP

FDA’s FY 2027 Legislative Proposals Include Game Changers for Life Science Private Equity

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The U.S. Food and Drug Administration’s fiscal year 2027 budget justification includes more than 20 legislative proposals spanning drug and biologic approval pathways, supply chain oversight, advertising standards and...more

McDermott+

Healthcare Preview for the Week of: April 13, 2026

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Congress’ two-week recess has officially ended, with the House returning tomorrow and the Senate back in session today. Both chambers are returning to full agendas, with attention focused on budget hearings, ongoing...more

Hanson Bridgett

EPA Releases Plan That May Require That Drinking Water Suppliers Begin Monitoring Microplastics

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On April 2, 2026, the U.S. Environmental Protection Agency and Department of Health & Human Services released a draft Sixth Contaminant Candidate List, or “CCL 6,” for public comment....more

McDermott Will & Schulte

Getting Form 483 responses right: FDA’s March 2026 draft guidance explained

In its March 2026 draft guidance, the US Food and Drug Administration (FDA) outlined its current thinking on how drug and certain product manufacturers should approach Form 483 responses to inspectional observations issued at...more

Bass, Berry & Sims PLC

CMS Finalizes Contract Year 2027 Medicare Advantage and Part D Final Rule and Rate Announcement

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Two recent announcements from the Centers for Medicare & Medicaid Services (CMS) continue to signal the Trump administration’s approach to the Medicare Advantage (MA) program, building on trends first seen in the Contract...more

Buchalter

Hidden Risks in Medical Technology Contracts — Evergreen Clauses and Undisclosed AI Use

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Many healthcare providers assume their technology contracts are static—negotiated once and largely administrative thereafter. That assumption is increasingly risky. Vendors are rapidly embedding artificial intelligence (AI)...more

Guidepost Solutions LLC

The Peptide Moment: How FDA’s Regulatory Reversal Creates Risk and Opportunity for Venture Capital and Private Equity

The New York Times reported on March 31, 2026 that the U.S. Food and Drug Administration is moving to lift its ban on more than a dozen injectable peptides that were restricted in 2023 over significant safety concerns. The...more

Warner Norcross + Judd

Tobacco Surcharge Programs: Recent Decisions Favor Employers, But Risk Remains

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Employers sponsoring wellness programs including tobacco surcharges have faced a growing wave of ERISA class action litigation over the past several years. These lawsuits primarily challenge whether such programs comply with...more

Epstein Becker & Green

FDA Meeting Invites Stakeholders to Weigh in on Dietary Supplement Ingredients

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On March 27, 2026, the Food and Drug Administration (“FDA”) held a public meeting entitled “Exploring the Scope of Dietary Supplement Ingredients.”...more

Sheppard, Mullin, Richter & Hampton LLP

FINCEN’s One-Two Punch: New Health Care Fraud Advisory Followed by Proposed Whistleblower Rule

In a notable back-to-back set of releases, the Financial Crimes Enforcement Network first issued a March 30, 2026 advisory urging financial institutions to identify and report suspicious activity tied to health care fraud...more

A&O Shearman

Launching the latest edition of our Life sciences and healthcare insights

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We have recently released the second edition of our Life sciences and healthcare insights report, where our global team explore the most important commercial, legal and regulatory issues facing life sciences and healthcare...more

Sheppard, Mullin, Richter & Hampton LLP

National AI Legislative Framework Announced: What Does This Mean for Healthcare Entities?

On March 20, 2026, the White House issued a National Policy Framework (the “Framework”) for artificial intelligence (AI) that addresses six key objectives. The Framework calls on Congress to establish a federal policy...more

Stevens & Lee

Indictment of Osteopathic Physician Signals Shift in Peptide Enforcement

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There has been a recent and sudden uptick in enforcement from federal agencies against medspa prescribers. Specifically, the Department of Justice (DOJ) recently indicted a licensed osteopathic physician for allegedly...more

Ice Miller

Employers Beware: You Could Be Liable Under GIPA for a Third-Party Provider Requesting Genetic Information During an Employee’s...

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The Illinois Genetic Information Privacy Act, (GIPA) has recently become one of the plaintiff class action bar’s favorite causes of action. GIPA regulates the collection, use, disclosure, and storage of genetic information....more

Husch Blackwell LLP

This Comes Back Later in Audits and Diligence

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This is the fifth in a six-part series on incentive design, deal structure, and how these issues surface in transactions and enforcement. Other relevant topics will be discussed in our upcoming presentation, Physician Owner...more

Morgan Lewis

EPA Targets Microplastics and Pharmaceuticals in Drinking Water

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The US Environmental Protection Agency (EPA) on April 2, 2026 published the draft Sixth Contaminant Candidate List (CCL 6), which for the first time identifies both microplastics and pharmaceuticals as contaminant groups for...more

Troutman Pepper Locke

Virginia Enacts New Restrictions on the Use of Noncompetes

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Employers will soon be obligated to provide employees with severance benefits if they want to have an enforceable noncompete in Virginia and they also will be prohibited from entering into noncompetes with health care...more

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