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Proposed Legislation Pharmaceutical Industry

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

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

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

Knobbe Martens

Eyeing the Prize of the U.S. Patent System, the Trump Administration Proposes Patent Maintenance Fee Overhaul

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The Trump administration is considering changing the U.S. patent maintenance fee structure from the existing three fixed flat fees to an annual, value‑based “tax” model where patent holders would pay 1%–5% of the estimated...more

McDermott Will & Schulte

Trending in Telehealth: June 2025

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

Hogan Lovells

Medicines shortages under the EU pharma law package

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The proposed recast of European pharmaceutical law includes novel requirements to combat medicines shortages. Medicines shortages are a hot topic in the EU. Several stricter obligations for marketing authorization holders as...more

Perkins Coie

SAFE Sunscreen Standards Act: Bipartisan Push to Modernize U.S. Sunscreen Regulation

Perkins Coie on

On June 3, 2025, lawmakers introduced the Supporting Accessible, Flexible, and Effective (SAFE) Sunscreen Standards Act in the U.S. House of Representatives, aiming to bring U.S. sunscreen regulations in line with scientific...more

Latham & Watkins LLP

Senators Introduce Legislation to Restrict Direct-to-Consumer Drug Advertising

Latham & Watkins LLP on

On June 12, 2025, Senators Bernie Sanders (I-Vt.) and Angus King (I-Maine) introduced the End Prescription Drug Ads Now Act, with Senators Chris Murphy (D-Conn.), Peter Welch (D-Vt.), Jeff Merkley (D-Ore.), and Dick Durbin...more

Goodwin

A Look Ahead in Life Sciences: What We Are Tracking in the Third Quarter of 2025 and Beyond

Goodwin on

As the life sciences, medtech, and diagnostic industries continue to grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving and emerging...more

Brownstein Hyatt Farber Schreck

The First Amendment and Direct-to-Consumer (DTC) Prescription Drug Ads

Department of Health and Human Services Secretary Robert F. Kennedy, Jr. has made no secret of his disdain for television advertisements for prescription drugs. As a presidential candidate, he promised to ban those ads by...more

Latham & Watkins LLP

Drug Pricing: FDA Considerations Under Recent Executive Orders and Congressional Bills

Latham & Watkins LLP on

President Trump’s executive orders and legislative proposals from Congress leverage FDA to help lower drug prices, address anti-competitive practices, and accelerate generic drug approvals....more

Foley & Lardner LLP

Direct-to-Consumer Drug Ads Are Under Attack – Pharmaceutical Companies Beware

Foley & Lardner LLP on

On June 12, 2025, Senators Bernie Sanders (I-VT) and Angus King (I-ME) introduced the End Prescription Drug Ads Now Act (the Act) that would prohibit pharmaceutical companies and arguably any other entity engaged in...more

Dacheng

China Monthly Antitrust Update: June 2025

Dacheng on

This monthly report outlines key developments in China’s antitrust sector for June. The following events merit special attention: SAMR Seeks Comments on Provisions for Curbing Acts of Abusing Administrative Power to Eliminate...more

Latham & Watkins LLP

Healthcare Life Sciences Drug Pricing Digest - June 2025 #2

Latham & Watkins LLP on

Some commentators are expecting that further details regarding the so-called most favored nation (MFN) pricing policy will be released in the coming days, while other sources indicate that no further information beyond a...more

Maynard Nexsen

Taking the Pulse: A Health Care & Life Sciences Video Podcast | Episode 239: Understanding the 340B Pricing Program with Chuck...

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Heather Hoopes-Matthews and Matthew Roberts welcome Chuck Melendi, a seasoned healthcare consultant and former executive with decades of experience in pharmaceuticals, biotech, and medical devices. Chuck joins us to examine...more

Fish & Richardson

The PREVAIL Act Is Back. Will It Prevail This Time?

Fish & Richardson on

On May 1, 2025, Senators Chris Coons (D-DE), Thom Tillis (R-NC), Dick Durbin (D-IL), and Mazie Hirono (D-HI) reintroduced the Promoting and Respecting Economically Vital American Innovation Leadership (PREVAIL) Act. The...more

Seyfarth Shaw LLP

States Seeking Remedies for the Rising Costs of Prescription Drugs

Seyfarth Shaw LLP on

As expected, the lawsuits have commenced following the enactment of the Arkansas legislation prohibiting pharmacy benefit managers (PBM’s) from owning or operating actual pharmacies within the state. Michigan has filed its...more

Bradley Arant Boult Cummings LLP

Makary Says Psychedelics Are Maybe Okay, M’Kay?

Drugs are bad, m’kay. But what if they’re not? Psilocybin continues to be in the limelight for its potential medicinal uses, including most particularly its potential to combat the nation’s growing mental health crisis. Last...more

Dorsey & Whitney LLP

23andMe Sparks Lawmaker Race to Protect Genetic Data in Bankruptcy

Dorsey & Whitney LLP on

When direct-to-consumer genetic testing company 23andMe Holding Co. and its affiliates (together, “23andMe”) filed for chapter 11 bankruptcy on March 24, 2025, they possessed data from over 15 million customers. Specifically,...more

Cozen O'Connor

The State AG Report – 05.29.2025

Cozen O'Connor on

Here are curated AG and federal regulatory news stories highlighting key areas in which state and federal regulators’ decisions are having an impact across the US: • NY Fights FAIR to Expand State Consumer Protection Law - ...more

Morgan Lewis

Blockbuster Biologics Review | Issue 27

Morgan Lewis on

Welcome to the latest issue of Blockbuster Biologics Review, which covers the status and developments of post-grant challenges and patent litigations implicating blockbuster biologics and legislative proposals related to...more

Hogan Lovells

AI Summit panelists weigh emerging data & privacy risks for novel technology

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Hogan Lovells and the AI Health Care Coalition recently hosted their fourth annual AI Health Law & Policy Summit, where thought leaders and policymakers gathered to discuss a variety of topics including data and privacy...more

Hogan Lovells

AI Summit panelists mull complexities of EU’s AI Act, global compliance considerations

Hogan Lovells on

Hogan Lovells and the AI Health Care Coalition recently hosted their fourth annual AI Health Law & Policy Summit, where thought leaders and policymakers gathered to discuss a variety of topics including evolving regulatory...more

Morgan Lewis - As Prescribed

Bipartisan Drug Pricing Reform: The FPDP Act and Revival of Most-Favored-Nation Pricing

As part of a broader resurgence in pharmaceutical pricing reform and manufacturing policies in 2025, President Donald Trump and bipartisan congressional leaders have introduced contemporaneous proposals to lower prescription...more

Latham & Watkins LLP

Healthcare Life Sciences Drug Pricing Digest - May 2025 #2

Latham & Watkins LLP on

Our Drug Pricing and Market Access team tracks recent developments in healthcare reform, the Medicaid Drug Rebate Program, the 340B Program, Medicare, and state law....more

McCarter & English, LLP

Recent Trends in State Antitrust Enforcement

State attorneys general (state AGs) are expected to ramp up antitrust enforcement. Some would argue that enforcement is an effort to fill a perceived gap left by the Trump administration, but state AGs have been signaling...more

DLA Piper

President Trump Signs Executive Order Aimed at Reducing Prescription Drug Prices

DLA Piper on

President Donald Trump signed an Executive Order (EO) titled “Delivering Most-Favored-Nation Prescription Drug Pricing to American Patients” aimed at reducing prescription drug prices for Americans by ensuring they do not pay...more

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