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White & Case LLP

New EU Responsibility and Liability Landscape for Smart Medical Devices in a Global Context

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Artificial intelligence (AI) is already indispensable in the healthcare and life sciences sector. Intelligent medical devices promise nothing less than a revolution in the art of healing. With its legislative projects on AI...more

A&O Shearman

European Commission fines Alchem in first cartel case involving a pharmaceutical API

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On 4 July 2025, the EC fined Alchem and its subsidiary EUR 489,000 for their role in a long-running cartel concerning the active pharmaceutical ingredient SNBB, used in the production of Buscopan and its generics. This marks...more

White & Case LLP

Healthy returns: European life sciences M&A heats up as sector faces demographic reckoning

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Dealmaking in Europe’s life sciences sector has been relatively muted in recent years, but the first half of 2025 has shown signs of strength as companies respond to the stark realities of an aging population - Earlier this...more

Jones Day

EU Geopolitical Risk Update - Key Policy & Regulatory Developments No. 121

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This regular alert covers key policy and regulatory developments related to EU geopolitical risks, including in particular, economic security, Russia’s war against Ukraine, health threats, and cyber threats. It does not...more

Jones Day

EU Markets Become More Accessible to Small and Medium-Sized Enterprises Thanks to Changes to the EU Prospectus Regulation: A...

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The European Union ("EU") Listing Act, approved by the EU Council on October 8, 2024, introduces key changes to the EU Prospectus Regulation, offering greater flexibility to access and issue securities on EU markets for small...more

Mayer Brown

Europe Daily News, 19 March 2025

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COMPETITION - Judgment of the Court of 19 March 2025 in Case T-142/23, Ivo Swenters Vs. European Commission Re: Competition - Agreements, decisions and concerted practices - Abuse of a dominant position - Market for the...more

A&O Shearman

Zooming in on AI - #14: Enforcement of the AI Act

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The European Union Artificial Intelligence Act (AI Act) entered into force on 1 August 2024. The AI Act establishes a risk-based approach to AI, prohibiting certain practices that are deemed unacceptable, such as social...more

White & Case LLP

First International Procurement Instrument case relating to EU medical devices in China’s public procurement market. The key...

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On 14 January 2025, the European Commission ("Commission") published the findings of its first investigation under the EU's International Procurement Instrument ("IPI"). Findings of the investigation concludes that China...more

A&O Shearman

Antitrust in focus - November 2024

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New U.S. merger control filing forms to take effect in February 2025 - Following publication in the Federal Register, the new Hart-Scott-Rodino (HSR) premerger notification forms will become effective on February 10, 2025....more

American Conference Institute (ACI)

U.S. Implications of the EU AI Act

The European Union (EU) is leading the global charge with AI regulations. U.S. companies are not beyond their regulatory reach, however, and should be preparing their AI risk mitigation efforts accordingly....more

A&O Shearman

European Commission approves EUR1 billion of state aid to revolutionize healthcare

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The European Commission (EC ) has approved the first Important Project of Common European Interest (IPCEI) in the health sector— IPCEI Med4Cure. Under the IPCEI, six EU member states will provide up to EUR1bn of state aid...more

A&O Shearman

Key antitrust findings - May 2024

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This newsletter is a summary of the antitrust developments we think are most interesting to your business. David Higbee (Global Head of Antitrust) and Dominic Long (Global Deputy Head of Antitrust) are our editors this month....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

McDermott Will & Schulte

Antitrust M&A Snapshot - Q2 2022

APRIL – JUNE 2022: KEY THEMES AND TAKEAWAYS - UNITED STATES - • An Overview of Agency Merger Challenges from January 2021 through June 2022 Parties continue to be cautious in litigating challenged transactions. Since...more

McDermott Will & Schulte

Update on European Data Protection Law

In mid-January 2021, the European Data Protection Board (EDPB) announced by press release that it has adopted jointly with the European Data Protection Supervisor (EDPS) written Opinions on the European Commission’s drafts...more

K&L Gates LLP

COVID-19: European Commission Details Plans to Postpone EU Medical Device Regulation and European Derogation Procedure to Get...

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The European Commission (EC) has published details of its proposal to postpone the application date of the Medical Devices Regulation (MDR) for one year. In addition, the EC proposes introducing a new procedure to address...more

Hogan Lovells

European Commission publishes factsheet on medical devices and in vitro medical devices for non-EU and non-EEA competent...

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Introduction The European Commission has published a factsheet addressed to competent authorities of third countries....more

Hogan Lovells

The European Commission publishes nine new guidance documents in relation to the MDR and IVDR

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On 20 November 2018, the European Commission published nine new documents intended to provide guidance to non-EU authorities and economic operators in relation to the Medical Devices Regulation (“MDR”) and In vitro Diagnostic...more

Hogan Lovells

European Commission invites targeted stakeholders for consultation on duplicate marketing authorisations for biological medicinal...

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The European Commission is seeking consultation on proposed clarifications for handling duplicate marketing authorisations from stakeholders....more

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