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New Legislation Regulatory Requirements Pharmaceutical Industry

Hogan Lovells

Pharmacy compounding under the EU pharma law package

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Pharmacy compounding is one of the topics in the EU Pharma Law Package that has perhaps received less attention compared to topics such as regulatory exclusivity rights, shortages, and sustainability. The EU Pharma Law...more

Stikeman Elliott LLP

Canada’s Drug Agency Launches Public Consultation on Proposed List of Essential Prescription Drugs and Related Products

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On June 19, 2025, Canada’s Drug Agency (“CDA”) opened a public consultation to gather input on a proposed list of essential prescription drugs and related products. This initiative is part of the agency’s responsibilities...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

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

Kelley Drye & Warren LLP

2025 AGA Annual Meeting Wrap-Up: Day 3

In the last post of our three-part series, we discuss the final day of sessions at the 2025 Attorney General Alliance (AGA) Annual Meeting, which explored novel approaches for law enforcement collaboration, effective ways to...more

A&O Shearman

Council position on EU pharma package adopted

A&O Shearman on

On 4 June, the Council of the European Union (Council) adopted its negotiation position on the proposals for a new regulation and directive that make up the so-called ‘pharma package’. The pharma package now moves to the next...more

Hogan Lovells

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

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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

Goodwin

State Drug Transparency Laws - 2025 Update

Goodwin on

We previously reported on an uptick in the passage of state drug price transparency legislation. What follows is an update to that report. As of April 2025, approximately 23 states had passed drug price transparency laws....more

Quarles & Brady LLP

Arkansas Law Prohibits Pharmacy Benefit Managers from Obtaining or Holding Pharmacy Permits

Quarles & Brady LLP on

On April 16, 2025, Arkansas House Bill 1150 (the “Bill”) was signed by Governor Huckabee Sanders. The Bill will have substantial implications for pharmacy benefit managers (“PBMs”) and pharmacies across the country....more

Latham & Watkins LLP

Preparing for the European Health Data Space - Opportunities and Challenges for Europe’s Digital Future

Latham & Watkins LLP on

The EU regulation designed to facilitate secondary use of clinical data for research brings benefits for health research, but also poses challenges for companies....more

Hogan Lovells

The European Commission tackles shortages of critical medicines through the Critical Medicines Act

Hogan Lovells on

On Tuesday 11 March 2025, the European Commission published a legislative proposal for a Critical Medicines Act. The objective of this Act is to ensure stable supply and continuous availability of critical medicinal products,...more

Nelson Mullins Riley & Scarborough LLP

Gold Dome Report - Legislative Day 33 - March 2025

The Georgia House of Representatives achieved the trifecta on Thursday, combining three favorite legislative traditions in one moment on the floor: recognition of a local novelty with an invite resolution, the appearance of a...more

McDermott Will & Schulte

Trending in Telehealth: February 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

McDermott Will & Schulte

California Introduces Bill to Protect 340B Contract Pharmacy Arrangements

California legislators recently introduced AB 1460, which would prohibit prescription drug manufacturers from engaging in discriminatory practices aimed at providers participating in the 340B drug pricing program (covered...more

Nelson Mullins Riley & Scarborough LLP

Gold Dome Report - Legislative Day 25 - February 2025

Amidst the usual suits and blazers, white dresses and tuxedos have been appearing with increasing frequency around the Georgia State Capitol this spring. Apparently word is out amongst the city’s photographers that the...more

Maynard Nexsen

2025 Alabama Legislative Update: Regular Session

Maynard Nexsen on

Pharmacy Benefit Managers (PBMs) - This week, there were public hearings held on two pieces of legislation concerning PBMs, but they did not advance as there were no votes on the bills. SB93, sponsored by Senator Andrew...more

Holland & Knight LLP

Holland & Knight Health Dose: February 25, 2025

Holland & Knight LLP on

Holland & Knight Health Dose Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector....more

Blake, Cassels & Graydon LLP

Des développements législatifs touchent le secteur québécois des soins de santé

Une nouvelle politique fédérale et des modifications législatives au Québec amènent des changements au sein du secteur québécois des soins de santé. Un éventail varié d’entreprises dans ce secteur pourrait devoir s’adapter en...more

Mintz - Health Care Viewpoints

Massachusetts Aligns with National Trends and Enacts Sweeping Legislation to Regulate Pharmaceutical Benefit Managers

On the heels of a nationwide push to regulate pharmacy benefit managers (PBMs), Massachusetts enacted a landmark piece of legislation to increase transparency and oversight within the pharmaceutical supply chain, specifically...more

Bass, Berry & Sims PLC

Massachusetts HB5159 Expands Oversight of Private Equity Investment in the Health Care Industry

Bass, Berry & Sims PLC on

On January 8, the governor of Massachusetts signed House Bill 5159 into law (Law). At a high level, the new Law expands Massachusetts’ existing health care transaction notice process and implements new reporting and oversight...more

Epstein Becker & Green

Massachusetts Governor Maura Healey Signs into Law a Sweeping Health Care Market Oversight Bill

Epstein Becker & Green on

On January 8, 2025, Massachusetts Governor Maura Healey signed into law House Bill No. 5159, “An Act enhancing the health care market review process” (“H. 5159”), which was passed by the Massachusetts legislature in the last...more

Foley Hoag LLP - Medicaid and the Law

Gang of Six Introduces Historic 340B “Discussion Draft” Legislation

On February 2, 2024, the “gang of six”—a bipartisan group of six senators who have traditionally championed reforms to the 340B program1 —introduced a discussion draft of a bill that would modify the program that provides...more

McDermott+

Healthcare Preview for the Week of: November 27, 2023

McDermott+ on

Limited Time Before the End of the Year and January 19 First, welcome back from what was hopefully a wonderful and restful Thanksgiving break. Although this year will not entail a year-end government funding package, we are...more

McDermott Will & Schulte

Trending in Telehealth: November 8 – 14, 2023

McDermott Will & Schulte on

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

Goodwin

2023 State Drug Transparency Law Development Update

Goodwin on

In October 2021, we reported on an uptick in the passage of state drug price transparency legislation. As an update to that report, as of October 2023, approximately 22 states have now passed drug price transparency laws...more

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