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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

Foley & Lardner LLP

Health Care Marketing Enforcement: FTC Targets Telehealth Company for Deceptive Weight Loss Marketing Claims

Foley & Lardner LLP on

On July 14, 2025, the operators of telemedicine company Southern Health Solutions, Inc., doing business as Next Medical and NextMed, agreed to settle the Federal Trade Commission’s (FTC) charges that the company’s weight‑loss...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

Husch Blackwell LLP

DOJ Announces Largest-Ever National Healthcare Fraud Takedown and Launches New Data Fusion Center

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In June 2025, the Department of Justice (DOJ) announced its 2025 National Health Care Fraud Takedown, marking the largest coordinated healthcare fraud enforcement action in DOJ history. The sweep included charges against a...more

McDermott Will & Schulte

Trending in Telehealth: June 2025

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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

Vedder Price

DOJ Charges 324 Defendants in Unprecedented Health Care Fraud Takedown

Vedder Price on

On June 30, 2025, the Department of Justice (DOJ) filed criminal charges against 324 defendants across the country alleging participation in various health care fraud schemes. The DOJ identified the operation as the 2025...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

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

Cooley LLP

Janssen v. Teva: Federal Circuit Upholds Claims to Pharmaceutical Dosing Regimen, Clarifies Presumption of Obviousness for...

Cooley LLP on

On July 8, the US Court of Appeals for the Federal Circuit issued a precedential opinion in Janssen Pharmaceuticals, Inc. et al. v. Teva Pharmaceuticals USA, Inc. affirming the district court’s finding that patent claims to a...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

Mintz - Health Care Viewpoints

FDA in Flux — July 2025 Newsletter

Mintz - Health Care Viewpoints on

Welcome to FDA in Flux — A Mintz newsletter tracking rapid changes in policy and agency actions that impact medical, life sciences, and consumer product investment decisions and development strategies....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

Akin Gump Strauss Hauer & Feld LLP

Republicans Pass the One Big Beautiful Bill Act Ahead of the July 4 Deadline

Akin Gump Strauss Hauer & Feld LLP on

On June 16, 2025, Senate Finance Committee Chairman Mike Crapo released text and a section-by-section summary of the Senate’s proposed One Big Beautiful Bill Act. The Senate passed a revised version of this measure on July 1,...more

Wilson Sonsini Goodrich & Rosati

FDA Announces “Priorities for a New FDA” and a New Vouchers Program to Address National Priorities

Wilson Sonsini Goodrich & Rosati on

On June 10, 2025, FDA Commissioner Martin A. Makary and Chief Medical and Science Officer Vinay Prasad published an article in the Journal of the American Medical Association titled, “Priorities for a New FDA.”1 The article...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

Alston & Bird

Health Care Week in Review | House Passes Budget Reconciliation Package; MAHA Commission Releases Childhood Chronic Disease Report

Alston & Bird on

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

Patrick Malone & Associates P.C. | DC Injury...

Better Health Care Newsletter - May 2025

Patrick Malone & Associates P.C. | DC Injury... on

Great thinkers have sought for centuries to convey a crucial truth about humanity’s interconnection. As the poet John Donne wrote: “No man is an island, entire of itself; every man is a piece of the continent, a part of the...more

Morgan Lewis - As Prescribed

Drug Pricing & Access in 2025: Issues to Watch and Developing Strategies

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The pharmaceutical industry is a critical component of the global economy, impacting public health, national security, and economic stability. Recent developments—including investigations into the national security...more

Ropes & Gray LLP

China Formalizes Regulatory Data Protection Mechanism

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Recently, the National Medical Products Administration (NMPA) issued the draft version of 'Implementation Measures for Drug Trial Data Protection (hereinafter referred to as the 'Draft for Comments'), aiming to clarify the...more

Harris Beach Murtha PLLC

GLP-1 Weight-Loss Drugs Off Shortage List; Deadlines to Stop Compounding

Harris Beach Murtha PLLC on

Glucagon-like peptide-1 agonists, a class of medications known as GLP-1s, have grown in popularity, initially for the treatment of type 2 diabetes and more recently for obesity and other labeled and off-label indications for...more

Hendershot Cowart P.C.

FDA Update: Current Guidelines for Semaglutide and Tirzepatide Compounding

Hendershot Cowart P.C. on

Weight loss clinics, telehealth companies, physicians, and pharmacies that have been prescribing or dispensing compounded GLP-1 medications must prepare for significant changes following the Food and Drug Administration’s...more

Sheppard Mullin Richter & Hampton LLP

FDA’s Semaglutide Shortage Resolution: Legal Implications and Risks for Compounding Pharmacies

Sheppard Mullin Richter & Hampton LLP on

Last month, the U.S. Food and Drug Administration (the “FDA”) announced in a Declaratory Order the resolution of the shortage of semaglutide injection products Wegovy and Ozempic (the “February Declaratory Order”). On March...more

Wilson Sonsini Goodrich & Rosati

FDA Can Keep Tirzepatide off the Drug Shortage List, Judge Says

Wilson Sonsini Goodrich & Rosati on

On March 5, 2025, the U.S. District Court for the Northern District of Texas denied the Outsourcing Facilities Association’s motion for a preliminary injunction to prevent the U.S. Food and Drug Administration (FDA) from...more

Stikeman Elliott LLP

Health Canada Consults on Pathway for Health Products Containing CBD

Stikeman Elliott LLP on

Health Canada recently announced that it is exploring a regulatory pathway that would allow products containing cannabidiol (“CBD”) to be purchased without a prescription. Under the current regulatory scheme, all health...more

ArentFox Schiff

FDA Announces End to Semaglutide Shortage, Impacting Compounders and Telehealth Providers Offering Injectable GLP-1 Drugs

ArentFox Schiff on

Last week, the US Food and Drug Administration (FDA) announced the end of a years-long shortage of semaglutide injection products — a popular glucagon-like peptide 1 (GLP-1) weight loss and diabetes medication. As a result,...more

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