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Hogan Lovells

California’s new climate disclosure laws: Implications for the life sciences and health care sector

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California is rolling out two climate disclosure laws—SB 253 and SB 261—that will soon require major companies that operate in California to publicly report their greenhouse gas (GHG) emissions and climate-related financial...more

Venable LLP

The Return of CBER Director Prasad, FDA Announces New Chief Counsel, and FDA Budget Watch

Venable LLP on

In our Venable FDA Pulse series, we report on critical developments within the Food and Drug Administration (FDA or the Agency) that may affect the Agency′s structure and stakeholder interactions. ...more

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

Morgan Lewis - As Prescribed

Orphan Drugs, Big Breaks: The Quiet Carve-Out in the 'One Big Beautiful Bill Act'

The One Big Beautiful Bill Act takes a big step in the rare disease space by expanding the contours of the orphan drug exclusion, a once narrow exception that permitted manufacturers of rare disease drugs and biologics to be...more

Ropes & Gray LLP

HALT Fentanyl Act: Unpacking its Significant Reforms for Controlled Substance Research

Ropes & Gray LLP on

On July 16, 2025, President Trump signed the Halt All Lethal Trafficking of Fentanyl (“HALT Fentanyl”) Act into law. The law permanently reclassifies “fentanyl-related substances” into Schedule I of the Controlled Substances...more

Jones Day

Congress Expands Orphan Drug Exemptions From Medicare Price Negotiations

Jones Day on

The One Big Beautiful Bill Act ("OBBB") expands exemptions for orphan drugs from mandatory Medicare price negotiations and modifies their eligibility timeline....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

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

Hogan Lovells on

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

Dacheng

SAMR Publishes Official Review on China’s Antitrust Enforcement in 2024: Key Developments and Takeaways

Dacheng on

On June 7, 2025, China’s State Administration for Market Regulation (SAMR) released the 2024 Annual Report on Antitrust Enforcement (“Report”), providing a comprehensive overview of key legislative developments, enforcement...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

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

Cozen O'Connor

The State AG Report – 06.26.2025

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: • All AGs Settle with Purdue Pharma over Opioid-Related...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

Holland & Knight LLP

U.S. Pharmaceutical Manufacturing and Supply Chain: 2025 Risks, Opportunities for Stakeholders

Holland & Knight LLP on

The U.S. House of Representatives Committee on Energy and Commerce's Subcommittee on Health held a recent hearing titled "Made in America: Strengthening Domestic Manufacturing and the Health Care Supply Chain." The hearing...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

Cozen O'Connor

The State AG Report – 06.12.2025

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: • Connecticut Law Aims to Weed Out Illegal Sales of...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

Mintz - Health Care Viewpoints

PBMs Sue Arkansas Over Restrictive PBM Ownership Law

On April 16, 2025, Arkansas enacted Act 624 (the Act), an unprecedented law prohibiting pharmacy benefit managers (PBMs) from owning or operating pharmacies in the state. As we discussed in our May 2025 blog post, the law’s...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

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

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

White & Case LLP

Arkansas Bans PBMs from Owning Pharmacies, Escalating Scrutiny of Vertical Integration in Pharmacy Distribution

White & Case LLP on

In a first-of-its-kind move, Arkansas Governor Sarah Huckabee Sanders has enacted legislation prohibiting pharmacy benefit managers ("PBMs") from owning or operating pharmacies within the state. The law—Act 624—takes effect...more

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