News & Analysis as of

Manufacturers European Union

Goodwin

Lupin Announces Licensing Deal with Sandoz for Ranibizumab Biosimilar

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On August 12, 2025, Lupin Limited (“Lupin”) announced that it has partnered with Sandoz Group AG (“Sandoz”) to market and commercialize Lupin’s biosimilar ranibizumab across multiple regions. Ranibizumab is a recombinant...more

Hogan Lovells

The new European Accessibility Act (EAA)

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The EAA (i.e., Directive (EU) 2019/882) aims at improving the accessibility of certain products and/or services across the EU. It seeks to harmonize accessibility requirements, ensuring that people with disabilities can fully...more

BCLP

What is the European Accessibility Act and What Impact Will It Have on Your Business?

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The European Accessibility Act (EAA) came into force on 28 June 2025. It requires that all in-scope products and services placed on the market or provided after that date in the EU must meet specified accessibility...more

McDermott Will & Schulte

Cooperate, protect, and challenge: Responding to dawn raids conducted by EU competition authorities

Dawn raids conducted by antitrust authorities are stressful events. Among other issues, the ensuing investigations consume significant time and effort and often result in high fines for the companies involved. It is therefore...more

Hogan Lovells

The digital makeover of EU product legislation

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The European Commission unveiled in May the fourth Omnibus package (“Omnibus IV”), part of its broader Single Market Strategy to modernise and simplify EU product legislation in line with the digital age. Omnibus IV aims to...more

Barnea Jaffa Lande & Co.

European Commission Tightens Law Enforcement on Pharmaceutical Cartels

In July 2025, the European Competition Commission imposed a EUR 489,000 fine on Alchem International Pvt. Ltd. and its Hong Kong subsidiary for their involvement in a pharmaceutical cartel involving the active ingredient used...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

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

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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

Jones Day

Product Regulation and Metrology Bill Receives Royal Assent

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The Product Regulation and Metrology Act 2025 reforms the UK's post-Brexit product safety, metrology, and consumer protection frameworks....more

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

Eversheds Sutherland (US) LLP

Global Supply Chain Horizons - July 2025

Welcome to the latest edition of our quarterly global supply chain horizons providing you with a update on the key developments from around the world. Cross-Border - China and the US trade deal - On June 27, the PRC...more

Dorsey & Whitney LLP

New EU Packaging Rules Impact Manufacturers

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The Packaging and Packaging Waste Regulation (Regulation (EU) 2025/40), the European Union’s new regulation concerning the packaging of products placed on the European market (PPWR), came into force on 11 February 2025....more

Davis Wright Tremaine LLP

European Accessibility Act Goes Live

As of June 28, 2025, enforcement of the European Accessibility Act (EAA or the Act) can officially begin, marking a significant milestone for digital accessibility in the European Union (EU). The EAA establishes comprehensive...more

Barnea Jaffa Lande & Co.

Israel’s Import Reform: “What’s Good for Europe Is Good for Israel”

The “What’s Good for Europe Is Good for Israel” reform came into effect at the beginning of 2025, with considerable. This reform allows importers to import diverse products to Israel in a new standardization track, based on...more

Jones Day

The EU's Deforestation Regulation: Will There Be Further Changes?

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The EU's Deforestation Regulation (EUDR), designed to ensure that no products that contribute to deforestation are sold in, or exported from, the EU, continues to be criticized by EU Member States and major market players....more

Hogan Lovells

The path to circularity - Navigating through the EU’s sustainable product regulations on batteries, deforestation, ecodesign,...

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The European Commission's new efforts to boost the EU's competitiveness through the Clean Industrial Deal and sweeping regulatory simplification have garnered significant attention. At the same time, circularity remains a...more

Knobbe Martens

TELA Bio Launches OviTex Inguinal Reinforced Tissue Matrix in Europe

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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

Foster Garvey PC

U.S. Businesses Must Prepare for EU Accessibility Act Compliance by June 28

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The European Accessibility Act (“EAA”) takes effect across the European Union on June 28, 2025, for new products and services in the EU market. Products and services already on the market have a longer transitional period...more

King & Spalding

EUROPE - Navigating the Interplay Between EU AI Act and Medical Device Regulations: Strategic Update for the Healthcare Sectors

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Already highly regulated with a risk-based approach at their core, AI-powered medical devices and in vitro diagnostic medical devices face new regulatory constraints stemming from the EU AI Act, a horizontal legal instrument...more

Hogan Lovells

New MDCG guidance clarifies rules for medical device software available on online platforms

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The Medical Device Coordination Group (“MDCG”) has issued guidance on the safe making available of medical device software (“MDSW”) apps on online platforms (MDCG 2025-4). MDCG 2025-4 outlines the regulatory roles of online...more

Goodwin

Biosimilar Manufacturers to Expand Offerings in Europe and Japan

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

Herbert Smith Freehills Kramer

Accessibility Directive: Final countdown before application on 28 June 2025 - Businesses will be required to comply with new...

On 28 June 2025, businesses will be required to comply with accessibility requirements applicable across the European Union (EU) for a broad range of products and services. These obligations stem from Directive (EU) 2019/882...more

Morris James LLP

Analyzing the Impact of Recent Studies Linking Depo-Provera to Increased Meningioma Risk

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Recent scientific research has uncovered a significant association between the long-term use of Depo-Provera, a widely used injectable contraceptive, and the development of meningiomas, tumors affecting the membranes...more

Bracewell LLP

The Carbon Border Adjustment Mechanism: How to Navigate a Complex Mechanism

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This note is dedicated to importers and producers of specific goods from countries outside the European Union, who will be subject to carbon pricing equivalent to that applied to European manufacturers of the same goods,...more

DLA Piper

Industrials Regulatory News and Trends - June 2025

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On May 23, President Donald Trump announced that he was recommending a new “straight 50% tariff” on all goods from the European Union beginning June 1. Treasury Secretary Scott Bessent said he hoped this decision would “light...more

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