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Epstein Becker & Green

Federal Regulators Announce Non-Enforcement of the 2024 Rule for Mental Health Parity

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On May 9, 2025, the Departments of Labor, Health and Human Services, and Treasury (collectively, “the Departments”) asked the D.C. federal court to suspend litigation while they consider whether to rescind or modify the 2024...more

Arnall Golden Gregory LLP

Limitations to the Anti-Kickback Statute? Seventh Circuit Reverses Conviction Finding “Aggressive” Marketing Tactics Insufficient...

On April 14, 2025, the United States Court of Appeals for the Seventh Circuit reversed the conviction of the owner of a durable medical equipment (“DME”) distributor, ruling that there was insufficient evidence to support a...more

Epstein Becker & Green

Will Colorado’s Historic AI Law Go Live in 2026? Its Fate Hangs in the Balance in 2025

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On May 17, 2024, Colorado Governor Jared Polis signed Colorado’s historic artificial intelligence (AI) consumer protection bill, SB 24-205, colloquially known as “Colorado’s AI Act” (“CAIA”), into law....more

Arnall Golden Gregory LLP

What the Dissolution of DOJ’s Consumer Protection Branch Means for Future Life Sciences and Consumer Protection Enforcement

The Department of Justice’s decision to shutter the Consumer Protection Branch (“CPB”) by September 30, 2025, is sending shockwaves across multiple industries. Known for its unique dual mandate to pursue both civil and...more

Epstein Becker & Green

Eleventh Circuit Addresses Rule 9(b) Heightened Pleading Standard in False Claims Act Case

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The U.S. Court of Appeals for the Eleventh Circuit has concluded that a successful False Claims Act (FCA) claim should “allege not just a scheme, but a scheme that actually led to false claims being submitted to the...more

Epstein Becker & Green

Medicare Drug Price Negotiation Program: The Inflation Reduction Act “Pill Penalty” and Other IRA Reforms on the Horizon for 2026

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When Congress adopted the Inflation Reduction Act (IRA) in 2022, creating the Medicare Drug Price Negotiation Program (MDPNP), the bill did not receive support from any Republican senators....more

Holland & Knight LLP

New York Budget Omits Changes to State's "Disclosure of Material Transactions" Law

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In a prior blog post, we summarized proposed legislation included in New York Gov. Kathy Hochul's state fiscal year (FY) 2025-2026 budget that would have subjected "material transactions" to additional disclosure and...more

Rivkin Radler LLP

Estate Planning for Loved Ones Struggling with Mental Health and Substance Abuse Disorders

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May is mental health month, the perfect time to address this important topic. Mental health and substance abuse disorders affect many families. These issues need to be considered in estate planning. Mental health and...more

Orrick, Herrington & Sutcliffe LLP

How Shifting Trade Dynamics Are Reshaping U.S. Healthcare | Life Sciences Snapshot – Q2 2025

Q1 2025 marked another strong quarter for life sciences VC financing, but the industry faces unique headwinds amid ongoing shake-ups in regulatory leadership and US trade relationships. Key takeaways for Q1 2025 include: •...more

McDermott+

Healthcare Preview for the Week of: May 12, 2025

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Reconciliation Text Is Here - Late Sunday night, May 11, 2025, the House Committee on Energy and Commerce released the much-anticipated budget reconciliation bill text ahead of its scheduled markup on May 13, 2025. ...more

McDermott Will & Emery

European Health & Life Sciences Symposium 2025 / May 2025 - Transaction and Financing Trends in Life Sciences

McDermott Will & Emery on

In April, McDermott was pleased to once again host our annual European Health & Life Sciences Symposium in Paris. Welcoming a crowd of more than 300 innovators, investors, business leaders and advisers from across the...more

Schwabe, Williamson & Wyatt PC

Latest Federal Court Cases: Pharmaceutical Patent Protections

This week, we take a closer look at two precedential cases concerning pharmaceutical patent protections as applied to drugs in development. In Incyte Corp. v. Sun Pharm., Judge Hughes entered a dissent pushing back on the...more

A&O Shearman

Northern District Of California Dismisses Securities Class Action Against Biopharmaceutical Company For Failure To Adequately...

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On May 5, 2025, Judge Yvonne Gonzalez Rogers of the United States District Court for the Northern District of California granted a motion to dismiss a proposed class action asserting claims against a biopharmaceutical company...more

Goodwin

Most Favored Nation Drug Pricing Executive Order Resurrects Prior President Trump Policy

Goodwin on

On May 12, 2025, President Trump signed the most recent Executive Order on drug pricing, Delivering Most-Favored-Nation Prescription Drug Pricing to American Patients. ...more

Morrison & Foerster LLP

Key Takeaways from the National Association of Attorneys General 2025 General Symposium

Beginning on April 7, 2025, the National Association of Attorneys General (NAAG) held its three-day Symposium in Nashville, Tennessee. Throughout the forum, attorneys general, their senior staff, federal officials, and other...more

Akin Gump Strauss Hauer & Feld LLP

FDA Grants Three Natural Food Additive Petitions

On May 9, 2025, the U.S. Food and Drug Administration (FDA) granted three color additive petitions, approving two new colorings and expanding one existing approval. These approvals come after the agency’s announcement last...more

Akin Gump Strauss Hauer & Feld LLP

Delivering Most-Favored-Nation Prescription Drug Pricing to American Patients (Trump EO Tracker)

This order makes it the policy of the United States to have the most-favored-nation price for prescription drugs and biologics. The order directs the Secretary of Commerce and the United States Trade Representative to take...more

Rothwell, Figg, Ernst & Manbeck, P.C.

Jazz Pharma. v. Avadel CNS Pharma: Federal Circuit Applies a Fact-Specific Approach to the Patent Infringement Safe Harbor

In a precedential ruling, the U.S. Court of Appeals for the Federal Circuit in Jazz Pharma. v. Avadel CNS Pharma., 2025 WL 1298920, — F.4th — (Fed. Cir. May 6, 2025), addressed the scope of the 35 U.S.C. § 271(e)(1) “safe...more

Mintz - Health Care Viewpoints

Appeals Court Rejects AstraZeneca’s Challenge to Medicare Drug Price Negotiation Program

A federal appellate court has handed down the first appellate-level decision addressing the merits of drug manufacturers’ challenges to the Inflation Reduction Act of 2022's (IRA) Medicare Drug Negotiation Program...more

Jackson Lewis P.C.

Cal/OSHA Standards Board Considers Subcommittee in Response to NIOSH Cuts

Jackson Lewis P.C. on

The California Occupational Safety and Health Standards Board (OSHSB) is considering the formation of a subcommittee to tackle challenges arising from the dismantling of the National Institute for Occupational Safety and...more

J.S. Held

Beyond Safety & Effectiveness: Business Reasons to Prioritize Human Factors in Medical Device Design

J.S. Held on

To err is human. We have short attention spans and get distracted easily. We have unreliable memories and forget. We have a limited ability to process information, and we overgeneralize rules-of-thumb to the wrong situations....more

Wyrick Robbins Yates & Ponton LLP

ConnectiCut to the Chase: Lessons from the Connecticut AG's Latest CTDPA Enforcement Report

On April 17, 2025, the Connecticut Office of the Attorney General (“OAG”) released an Updated Enforcement Report Pursuant to the Connecticut Data Privacy Act (“Report”). The Report, the second issued by OAG (read our...more

Holland & Knight LLP

Ministerio del Trabajo de Colombia emitió lineamientos ante emergencia sanitaria

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El Ministerio de Salud y Protección Social de Colombia expidió la Resolución 691 de 2025, mediante la cual declaró la emergencia sanitaria en todo el territorio nacional debido al brote activo del virus de la fiebre amarilla....more

Venable LLP

BiologicsHQ Monthly Injection - March 2025

Venable LLP on

On March 17, 2025, Senators Chuck Grassley (R-IA), John Cornyn (R-TX), Richard Blumenthal (D-CT), and Richard Durbin (D-IL) re-introduced the “Affordable Prescriptions for Patients Act” (“APPA”), which previously passed the...more

Marshall Dennehey

Commonwealth Court Clarifies Scope of IREs, Orders Remand in Light of Duffey Decision

Marshall Dennehey on

Del Val Home Improvements v. Gaw; No. 1117 C.D. 2022; filed March 19, 2025; Judge Wojcik - In a case hinging on the interpretation of impairment rating evaluations (IREs) under the Act, the Commonwealth Court has ordered a...more

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