News & Analysis as of

Life Sciences European Union

Goodwin

Antitrust Life Sciences Quarterly Update 2025 Q2

Goodwin on

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

Bergeson & Campbell, P.C.

EC Begins Public Consultation on Biotech Act

The European Commission (EC) began a public consultation on August 4, 2025, on the European Biotech Act in the form of an online questionnaire. According to the EC, the aim is to gather evidence and views from stakeholders...more

Hogan Lovells

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

Hogan Lovells on

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

European Biosimilar Updates - Formycon’s Ustekinumab and Alvotech’s Cetrolizumab Pegol

Goodwin on

On June 26, 2025, Formycon AG (“Formycon”) announced a distribution agreement with Teva Group subsidiary Ratiopharm GmbH (“Ratiopharm”) for the semi-exclusive commercialization of its Stelara biosimilar FYB202/Fymskina...more

Ropes & Gray LLP

[Podcast] Navigating Non-Competes and Other Exclusivity Provisions in Collaboration & License Agreements and Other Strategic...

Ropes & Gray LLP on

On this Ropes & Gray podcast, licensing and collaboration partner Hannah England and antitrust partner Lisa Kaltenbrunner discuss how EU antitrust rules impact non-competes and other exclusivity provisions in collaboration...more

A&O Shearman

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

A&O Shearman on

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

White & Case LLP on

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

A&O Shearman

A new European strategy to foster life sciences innovation and market access

A&O Shearman on

On July 2, 2025, the European Commission released its communication “Choose Europe for life sciences. A strategy to position the EU as the world’s most attractive place for life sciences by 2030” (the Strategy). ...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

Skadden, Arps, Slate, Meagher & Flom LLP

The European Health Data Space – What EU Health Care Providers and Data Holders Need To Know

- On 26 March 2025, the European Health Data Space (EHDS) Regulation entered into force. The regulation establishes a comprehensive framework for health-data sharing and access in the EU, with the dual aim of supporting the...more

Knobbe Martens

TELA Bio Launches OviTex Inguinal Reinforced Tissue Matrix in Europe

Knobbe Martens on

TELA Bio—which was founded in 2012 and is headquartered in Pennsylvania—is a medical device company that specializes in providing soft-tissue surgical products. According to TELA Bio, its soft-tissue reconstruction solutions...more

Goodwin

Biosimilar Manufacturers to Expand Offerings in Europe and Japan

Goodwin on

On June 9, 2025, biosimilar manufacturers Samsung Bioepis and Alvotech announced separate deals to expand their respective offerings in Japan and Europe. ...more

McGuireWoods LLP

Healthcare & Life Sciences Private Equity Deal Tracker: Great Point Acquires Eutecma

McGuireWoods LLP on

Great Point Partners (GPP) has announced the acquisition of a majority stake in Eutecma. Eutecma, founded in 2008 and based in Germany, is a developer of temperature-controlled packaging solutions for pharmaceutical cold...more

Bergeson & Campbell, P.C.

Call for Evidence for Impact Assessment of the European Biotech Act Will Close June 11, 2025

The European Commission (EC) began a call for evidence on May 14, 2025, for an impact assessment of the European Biotech Act. The EC states that the overall objective is to improve the size and competitiveness of the...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

Hogan Lovells

AI Summit panelists mull complexities of EU’s AI Act, global compliance considerations

Hogan Lovells on

Hogan Lovells and the AI Health Care Coalition recently hosted their fourth annual AI Health Law & Policy Summit, where thought leaders and policymakers gathered to discuss a variety of topics including evolving regulatory...more

WilmerHale

Healthcare & Antitrust: What to Expect in the New Trump Administration

WilmerHale on

Antitrust scrutiny of healthcare markets is nothing new. The Biden Administration and first Trump Administration focused antitrust enforcement efforts across the healthcare and life sciences industries. The newly installed...more

Jones Day

Revolutionizing EU Design Protection: Key Changes Under the New Designs and Models Regulation

Jones Day on

May 1, 2025, marked the entry into force of most provisions of Phase I of the new Regulation (EU) 2024/2822, which forms part of the "Designs and Models Package" adopted within the European Union. This text, in addition to...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

White & Case LLP

AI’s Expanded Role in the Life Sciences Regulatory Review Process: Key Developments in U.S. and EU

White & Case LLP on

Overview - - The U.S. Food and Drug Administration (FDA) announced that it aims to increase the agency’s use of artificial intelligence (AI) across its centers to accelerate scientific reviews by June 30, 2025. - The...more

Hogan Lovells

EMA’S NEW WORK PLAN: Leveraging data and AI to encourage innovation and research

Hogan Lovells on

The European Medicines Agency (EMA) published a workplan on its ambition to leverage high volumes of data and artificial intelligence (AI). On 7 May 2025, the European Medicines Agency (EMA) published a joint workplan with...more

A&O Shearman

The future of the robotics metaverse in the healthcare sector

A&O Shearman on

On 26 February 2025, the European Economic and Social Committee (EESC) adopted an opinion addressing the integration of robotics and the metaverse in healthcare. This forward-looking document outlines the opportunities and...more

McDermott Will & Schulte

Transaction and Financing Trends in Life Sciences - European Health & Life Sciences Symposium 2025

In April, McDermott was pleased to once again host our annual European Health & Life Sciences Symposium in Paris. Welcoming a crowd of more than 300 innovators, investors, business leaders and advisers from across the...more

Goodwin

CuraTeQ Biologics’ Trastuzumab biosimilar Receives Positive Opinion in Europe

Goodwin on

This week, CuraTeQ Biologics (a wholly owned step-down subsidiary of Aurobindo Pharma Limited) announced that its trastuzumab biosimilar, DAZUBLYS, has received a positive opinion from the European Medicines Agency Committee...more

Morrison & Foerster LLP

April 2025 Update on Regulation of New Genomic Techniques in the EU

On March 14, 2025, EU Member States agreed in the European Council on a common position to move forward with development of new rules for certain genetically modified plants generated using modern precision breeding methods...more

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