News & Analysis as of

United Kingdom European Union Life Sciences

Goodwin

Antitrust Life Sciences Quarterly Update 2025 Q2

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The first half of 2025 has seen an acceleration of M&A activity, including large-scale life sciences transactions, such as Merck’s $3.9 billion acquisition of SpringWorks, Sanofi’s $9.5 billion acquisition of Blueprint...more

Hogan Lovells

Key takeaways – UK MHRA’s response to consultation on ‘Medical Devices Regulations: Routes to market and in vitro diagnostic...

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The UK Medicines and Healthcare products Regulatory Agency (MHRA) has published its responses to the consultation on Medical Device Regulations: Routes to market and in vitro diagnostic devices carried out last year....more

Goodwin

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

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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

A&O Shearman

UK will permanently retain its UK+ exhaustion regime to allow continued supply of medicines into the UK

A&O Shearman on

The government has published its response to the consultation on the exhaustion regime for IP rights. The overall conclusion is that the UK will permanently maintain its UK+ IP exhaustion regime, the bespoke (and...more

Morgan Lewis - As Prescribed

New Measures to Encourage Clinical Trials in the United Kingdom

While the US Food and Drug Administration has been experiencing recent reorganization and cuts in personnel, the United Kingdom has its own upcoming policy changes making it easier and faster to initiate and maintain UK...more

Goodwin

Antitrust and Competition Life Sciences Year in Review 2024

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The last year (and particularly the last few months) of the Biden Administration brought a flurry of activity from the Federal Trade Commission (FTC) in the life sciences space, continuing a yearslong pattern of close...more

Faegre Drinker Biddle & Reath LLP

The UK Cyber Security and Resilience Bill

The UK government has recently announced that it plans to introduce a Cyber Security and Resilience Bill (Bill). The Bill seeks to update the 2018 Network and Information Security Regulations, which implemented the European...more

McDermott Will & Schulte

Private Markets Update | Summer 2024

McDermott Will & Schulte on

The Private Markets Update highlights key developments emerging from private markets across Europe, the UK and the United States, exploring the cross-border issues that matter to investors and sponsors in alternative assets. ...more

Goodwin

A Look Ahead in Life Sciences: What We Are Tracking in the Fourth Quarter of 2024 and Beyond

Goodwin on

As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape....more

BCLP

Navigating the FemTech regulatory landscape: which rules apply and what are the enforcement priorities?

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Security, scale or functionality – pick two. This computer science principle coined by the late Professor Anderson is particularly relevant to the FemTech industry. Anderson’s Rule states that for a system to provide high...more

Skadden, Arps, Slate, Meagher & Flom LLP

Antitrust in Life Sciences: A Dialogue With Anna Vernet

On March 26, 2024, Skadden hosted a discussion on key developments in antitrust enforcement in the pharmaceuticals and life sciences sectors. ...more

Akin Gump Strauss Hauer & Feld LLP

Akin Intelligence - March 2024

Welcome to the March edition of Akin Intelligence. This month, the EU AI Act was approved by the European Parliament, moving one step closer to becoming the first major AI law. In the U.S., the DOJ brought criminal charges...more

Goodwin

A Look Ahead in Life Sciences: What We Are Tracking in Q2 2024 and Beyond

Goodwin on

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

Skadden, Arps, Slate, Meagher & Flom LLP

The Informed Board - Winter 2024

The oversight obligations of boards continue to expand. Recent enforcement actions and new laws in areas such as cybersecurity, artificial intelligence and supply chains create new challenges for boards, as we explain in this...more

Goodwin

A Look Ahead in Life Sciences: What We Are Tracking in Q1 2024 and Beyond

Goodwin on

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

McDermott Will & Schulte

International News: Spotlight on Foreign Investment

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In this dynamic global landscape, investors have always been required to make savvy, smart choices. This requires navigating through the intricate web of bilateral treaty protection, exploring the vital role these agreements...more

A&O Shearman

UPC Insights: Security for legal costs

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The UPC decides that the defendant’s financial situation and location matter. On 30 October 2023, the Munich Central Division of the UPC (the Court) issued an order stating that NanoString must provide security to Harvard...more

McDermott Will & Schulte

European Health & Life Sciences Symposium 2023 | Key Takeaways

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200+ leading individuals in healthcare, life sciences and private equity gathered at the Shangri-La Hotel in Paris for the European Health & Life Sciences Symposium 2023 to enjoy a day packed with fireside chats, in-depth...more

McDermott Will & Schulte

Lowest-risk Clinical Trials Will Benefit From a New Notification Scheme and a Shorter Period for Application Processing

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On 12 October 2023, the Medicines and Healthcare products Regulatory Agency (the MHRA) announced that the healthcare and life sciences sector will benefit from a new streamlined notification scheme for lowest-risk clinical...more

A&O Shearman

Antitrust in focus - October 2023

A&O Shearman on

The Foreign Subsidies Regulation (FSR) establishes a new regime, enforced by the European Commission (EC), to regulate subsidies granted by non-EU countries to businesses active in the EU that could distort competition in EU...more

Goodwin

A Look Ahead in Life Sciences: What We Are Tracking in Q4 2023 and Beyond

Goodwin on

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

A&O Shearman

European Commission’s record gun-jumping fine on Illumina serves as warning to merging parties

A&O Shearman on

The European Commission (EC) has imposed a fine of around EUR432 million on genomics company Illumina for closing its acquisition of blood-based cancer test developer GRAIL before the conclusion of the EC’s merger control...more

McDermott Will & Schulte

Great Britain and European Union Timelines: What Are the Key Dates for Transition?

The Medicines and Healthcare products Regulatory Agency (MHRA) recently published long-awaited guidance confirming that there will be a delay in the implementation of new legislation for the Great Britain market and an...more

Hogan Lovells

Successful product launches across the EU, UK, and U.S.

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We were pleased to welcome industry leaders to our Life Sciences and Health Care Horizons event in Boston for the first time since the pandemic. At the event, Hogan Lovells attorneys Eliza Andonova, Ina Brock, Kristin...more

McDermott Will & Schulte

Health Data in the EU and UK – Regulatory Trends and Developments

In light of the increasing number of enforcement incidents under the General Data Protection Regulation (GDPR), organisations active in the Health and Life Sciences sectors in the United Kingdom, the European Union (EU) and...more

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