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A repository for the most well-read content on JD Supra at any given time, along with occasional roundups of popular content by specific topic. Also stop by for monthly recaps of hot articles for the previous... more +
A repository for the most well-read content on JD Supra at any given time, along with occasional roundups of popular content by specific topic. Also stop by for monthly recaps of hot articles for the previous thirty days. less -
McDermott+

Trump Administration Executive Order Tracker - updated 8.18.25

McDermott+ on

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

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

Breaking the Patent Thicket: Why the Proposed ETHIC Act Could Have Big Implications on Pharma Patent Law

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

On July 15, 2025, U.S. Senators Peter Welch (D‑VT), Josh Hawley (R‑MO), and Amy Klobuchar (D‑MN) introduced the ETHIC Act—the Eliminating Thickets to Increase Competition Act (S. 2276)—in the U.S. Senate. The bill is designed...more

ArentFox Schiff

Investigations Newsletter: Texas Alleges That Eli Lilly Patient Assistance Programs Violates AKS

ArentFox Schiff on

Texas Alleges That Eli Lilly Patient Assistance Programs Violates AKS - The state of Texas and Health Choice Alliance, LLC filed a complaint alleging that pharmaceutical manufacturer Eli Lilly & Company, Inc. violated the...more

Bass, Berry & Sims PLC

False Claims Act Settlements to Know from the First Half of 2025

Bass, Berry & Sims PLC on

With the first half of 2025 in the rearview mirror, the government’s continued focus on False Claims Act (FCA) enforcement shows no signs of slowing. In fact, the Department of Justice recently announced the results of a...more

Blank Rome LLP

Federal and State Agencies Ramp Up Scrutiny of the GLP-1 Drug Market

Blank Rome LLP on

Overview - As demand for GLP-1 drugs continues to skyrocket, federal and state agencies are turning their attention to the GLP-1 market and ramping up efforts to address the perceived risks associated with counterfeit and...more

Alston & Bird

Government Pivots to False-Certification Theory in Regeneron Case

Alston & Bird on

Our Health Care Litigation Team discusses a District of Massachusetts case holding that allows the government to switch liability theories in its False Claims Act lawsuit against Regeneron Pharmaceuticals....more

Dacheng

China’s Landmark Merger Unwind: Unpacking the Wuhan Yongtong/Shandong Huatai Case from a Practitioner’s Perspective

Dacheng on

Since China’s Anti-Monopoly Law (AML) was implemented in 2008, the nation has reviewed over 6,000 concentrations. While most were cleared unconditionally and conditional decisions primarily involved behavioral remedies, an...more

Bass, Berry & Sims PLC

Healthcare Trends & Transactions Q2 2025

Bass, Berry & Sims PLC on

The healthcare mergers and acquisitions (M&A) market remained active in Q2 2025, with several sectors including physician practice management (PPM), clinical research, and digital health experiencing continued investment and...more

Greenbaum, Rowe, Smith & Davis LLP

First Circuit Decision Regarding Anti-Kickback Statute Standard Widens Circuit Split and Creates Potential for Supreme Court...

Greenbaum, Rowe, Smith & Davis LLP on

The U.S. Court of Appeals for the First Circuit, in United States v. Regeneron, has joined the Sixth and Eighth Circuits in adopting the “but-for” standard to find that a violation of the Anti-Kickback Statute (AKS) triggers...more

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

Beyond Guinea Pigs: Patent Risks and Opportunities in AI-Enabled Drug Development

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

On April 10, 2025, the U.S. Food and Drug Administration (FDA) announced a landmark initiative to phase out animal testing in drug development, signaling a major shift toward human-relevant, science-driven alternatives. This...more

McDermott Will & Schulte

Trending in Telehealth: June 2025

McDermott Will & Schulte on

Trending in Telehealth highlights monthly state legislative and regulatory developments that impact the healthcare providers, telehealth and digital health companies, pharmacists and technology companies that deliver and...more

White & Case LLP

Healthy returns: European life sciences M&A heats up as sector faces demographic reckoning

White & Case LLP on

Dealmaking in Europe’s life sciences sector has been relatively muted in recent years, but the first half of 2025 has shown signs of strength as companies respond to the stark realities of an aging population - Earlier this...more

Barnea Jaffa Lande & Co.

Israel Competition Authority Intensifies Enforcement Measures and Indicts Schestowitz VP for a Suspected Cartel in the Food Sector

Barnea Jaffa Lande & Co. on

The Israel Competition Authority (ICA) conducted a thorough investigation of the S. Schestowitz Group, an Israeli company in the food and consumer goods sector, due to suspicions the company operated a cartel in the food...more

Goodwin

Lupin and Zentiva Reach Agreement to Commercialize Certolizumab Pegol Biosimilar

Goodwin on

On July 9, 2025, Lupin Limited and Zentiva Group announced a license and supply agreement to commercialize Lupin’s biosimilar of Certolizumab Pegol across multiple global markets. ...more

Morrison & Foerster LLP

Top 10 International Anti-Corruption Developments for June 2025

Morrison & Foerster LLP on

Designed for busy in-house counsel, compliance professionals, and anti-corruption lawyers, this newsletter summarizes some of the most important international anti-corruption law and enforcement developments from the past...more

Foley & Lardner LLP

Navigating FDA’s Proposed Guidance on AI and Non-Animal Models: Safeguarding Innovation in Drug Development

Foley & Lardner LLP on

In April 2025, the U.S. Food and Drug Administration (FDA) released a landmark guidance titled “Roadmap to Reducing Animal Testing in Preclinical Safety Studies,” outlining its commitment to advancing New Approach...more

ArentFox Schiff

Investigations Newsletter: Federal Court Imposes Nearly $1 Billion in FCA Damages and Penalties Against Omnicare and CVS

ArentFox Schiff on

Federal Court Imposes Nearly $1 Billion in FCA Damages and Penalties Against Omnicare and CVS - On July 7, Southern District of New York District Judge Colleen McMahon increased a False Claims Act (FCA) judgment from $136...more

Tucker Arensberg, P.C.

DOJ and HHS Launch New False Claims Act Working Group to Target Healthcare Fraud

Tucker Arensberg, P.C. on

The U.S. Department of Health and Human Services (HHS) and the Department of Justice (DOJ) have jointly announced the launch of a reinvigorated DOJ-HHS False Claims Act Working Group aimed at enhancing interagency...more

Dorsey & Whitney LLP

DOJ & HHS Announce Reinvigoration of False Claims Act Working Group and Healthcare Fraud Enforcement Priorities

Dorsey & Whitney LLP on

The Department of Justice and the Department of Health and Human Services announced the reinvigoration of a False Claims Act (“FCA”) Working Group, a joint effort between the two agencies. ...more

Hogan Lovells

UK and U.S. economic prosperity deal takes effect – Key takeaways

Hogan Lovells on

The Economic Prosperity Deal agreed between the UK and the U.S. sets out high level trade commitments and areas for further negotiation between the two countries. A series of implementing measures are described in Executive...more

Smart & Biggar

Update on biosimilars in Canada – June 2025

Smart & Biggar on

This article provides an update on developments in the biosimilar space in Canada—regulatory, approvals, pending submissions, litigation, and market access—since our March 2024 update. Consultation on revised biosimilar...more

Brownstein Hyatt Farber Schreck

AmCham Forum Showcases Business Opportunities in Egypt

Brownstein Hyatt Farber Schreck on

From May 25 to 26, the American Chamber of Commerce in Egypt (AmCham Egypt), in collaboration with the U.S. Chamber of Commerce, the U.S.-Egypt Business Council and the Egypt-U.S. Business Council, hosted the U.S.-Egypt...more

Hogan Lovells

EU Pharma Law Package: Council Position on Reduction of Regulatory Exclusivity Rights

Hogan Lovells on

On 4 June 2025, the Council of the EU adopted its position on the EU Pharma Law Package legislative proposal to revise the EU’s general pharmaceutical legislation. The Council, consisting of all the 27 EU Member States and...more

Brownstein Hyatt Farber Schreck

Most-Favored-Nation Drug Pricing in the U.S.

Brownstein Hyatt Farber Schreck on

On May 12, President Trump issued an Executive Order (EO) on drug pricing: “Delivering Most-Favored-Nation Prescription Drug Pricing to American Patients.” The EO requires a 30-day government negotiation with drug companies...more

DLA Piper

The Federal Circuit Widens The ITC as a Venue for Life Sciences

DLA Piper on

Federal Circuit reshapes foundational requirements for viability of a case in the ITC - Pharmaceutical and life sciences companies have historically been rare participants before the International Trade Commission (ITC) – in...more

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