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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

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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

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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 & Emery

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 & Emery

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 & Emery

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

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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

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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

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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 & Emery

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 & Emery

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

A&O Shearman

The Windsor Framework: MHRA to have power to licence all types of medicines to be supplied in the United Kingdom in single pack

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The European Commission and the United Kingdom government announced on Monday that they have come to agreement on measures to alleviate the remaining practical difficulties in the supply of medicines to Northern Ireland that...more

Goodwin

European Biosimilar Regulatory Updates

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STADA and Xbrane Announce Approval of Ranibizumab Biosimilar in UK - On January 16, 2023, STADA Arzneimittel AG (STADA) and Xbrane Biopharyma AB (Xbrane) announced that the UK’s Medicines and Healthcare product Regulatory...more

McDermott Will & Emery

HPE Europe 2022 | Key Takeaways

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Key Trends & Opportunities in Life Sciences and Healthcare Investing - The current macroeconomic environment is creating challenges for healthcare and life sciences businesses, which have been impacted hard by wage...more

Paul Hastings LLP

No Longer a ‘Nice to Have’: ESG and What it Means for Life Sciences Companies

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In April 2022, the U.K. Health Secretary, Sajid Javid, announced plans to prohibit the United Kingdom’s National Health Service (“NHS”) from buying goods and services connected with forced labour or human trafficking. This...more

Hogan Lovells

Safety first: MHRA response to UK medical device regulation consultation

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The UK Medicines and Healthcare products Regulatory Agency (MHRA) has published its response to its consultation on the future regulation of medical devices in the United Kingdom which ran between September and November...more

McDermott Will & Emery

Special Report: Developments in UK Life Sciences – Spring Update 2022

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MHRA LAUNCHES UK CLINICAL TRIAL REGULATION CONSULTATION - The UK Government, through the Medicines and Healthcare Products Regulatory Agency (MHRA) (the medicines and medical device regulator in the United Kingdom),...more

White & Case LLP

European IPO activity proved strong, led by e-commerce and tech listings

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While IPO activity was robust throughout Europe, the Nordic region stood out - It was a blockbuster year for IPOs of European firms, following the global trend. In total, 476 European firms listed last year, excluding...more

McDermott Will & Emery

MHRA Launches UK Clinical Trial Regulation Consultation

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The UK Government, through the Medicines and Healthcare Products Regulatory Agency (MHRA) (the medicines and medical device regulator in the United Kingdom), recently announced a consultation to change the UK clinical trial...more

Latham & Watkins LLP

European Healthcare & Life Sciences Market Update - H1 2022

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Welcome to the first edition of our European Healthcare & Life Sciences Market Update, a new report summarising key emerging trends, opportunities, and challenges facing the market in 2022. During the last 12 months, the...more

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