News & Analysis as of

Research and Development European Union

Goodwin

Global Biosimilar Updates - Spring 2025

Goodwin on

Celltrion’s ustekinumab biosimilar, STEQEYMA®, has won its first bid within 2 months of its launch in January of 2025. Since launch, STEQEYMA® has secured contracts in four regions of Italy, including, Piemonte, Valle...more

Akin Gump Strauss Hauer & Feld LLP

Calling-in from COP29: What You Missed and What Comes Next

World leaders, scientists, government decision-makers, private sector actors, climate actionists and other stakeholders have convened at 29th Conference of the Parties (COP29) to the United Nations Framework Convention on...more

WilmerHale

Measures in Support of Innovation in the European Union’s AI Act - AI Regulatory Sandboxes

WilmerHale on

This blog post discusses the EU Artificial Intelligence Act’s (“AI Act”) measures in support of innovation. These measures will be particularly relevant for companies engaged in research and development activities....more

Mintz - Health Care Viewpoints

OHRP Workshop Highlights Artificial Intelligence Uses, Concerns in Human Research

The Department of Health and Human Services (HHS) Office for Human Research Protections (OHRP) recently held its 2024 Exploratory Workshop titled “The Evolving Landscape of Human Research with AI – Putting Ethics to Practice”...more

Walkers

Global Legal Insights FinTech 2024: Ireland chapter

Walkers on

The Irish government has been supportive of the development of the financial services sector in Ireland and this extends to fintech. The government’s strategy for the development of Ireland’s international financial services...more

White & Case LLP

AI Watch: Global regulatory tracker - OECD

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The OECD's AI recommendations encourage Member States to uphold principles of trustworthy AI. Laws/Regulations directly regulating AI (the “AI Regulations”) The OECD's Recommendation of the Council on Artificial...more

Eversheds Sutherland (US) LLP

UK's FCA consults on payment optionality for investment research

The FCA consultation paper CP24/7 “Payment Optionality for Investment Research” considers the reintroduction of the bundling of research payments with broker’s execution fees....more

TransPerfect Legal

GDPR Compliance: At the Intersection of AI and Life Sciences

TransPerfect Legal on

Late last month, the Association of Corporate Counsel (ACC) hosted a panel on artificial intelligence and how it is rapidly transforming the life sciences sector, allowing companies to leverage large datasets to accelerate...more

Skadden, Arps, Slate, Meagher & Flom LLP

EU and Germany Lay Groundwork for the Use of Medical Data for Research and AI Training

Both the EU and Germany are taking significant steps to accelerate digitalization in the health sector and facilitate the exchange and use of health data for research and innovation purposes. They aim to improve...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

Hogan Lovells

New Commission Action Plan to boost biotechnology and biomanufacturing in the EU

Hogan Lovells on

Today, 20 March 2024, the European Commission issued an important Communication aimed at boosting biotechnology and biomanufacturing in the EU. These sectors are identified as key strategic areas with ever-increasing growth...more

Sheppard Mullin Richter & Hampton LLP

Protective Packaging: The EU’s Economic Security Package Changes the Landscape in Global Technology Controls

The EU plans to step up controls on its home grown technology. That is the short version. The longer version is a (pretty dry) recitation of the proposed legislation and whitepapers that were published last week as the...more

A&O Shearman

Draft EU Foreign Investment Screening Regulation sets out more comprehensive screening regime

A&O Shearman on

On 24 January 2024, the European Commission (EC) published its proposed reform of foreign investment screening in the EU. The proposal introduces more comprehensive rules for the review of foreign investments and strengthens...more

McDermott Will & Emery

Transaction Trends in Life Sciences

In November, we were delighted to once again host our annual European Health & Life Sciences Symposium in Paris. The event attracted a large number of healthcare professionals, investors and dealmakers to the Shangri-La Hotel...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

WilmerHale

EC Issues Revised Guidelines on Agreements Between Competitors: 10 Key Takeaways

WilmerHale on

On June 1, 2023, the European Commission (EC) adopted revised Horizontal Guidelines (HGs) and two updated block exemption regulations (BERs) on research and development (R&D) and “specialisation” agreements. These materials...more

Bergeson & Campbell, P.C.

EuropaBio Offers Recommendations on Biomanufacturing

On June 30, 2023, EuropaBio announced that it “set[] in stone the first European recommendations on biomanufacturing with the publication of its Biomanufacturing Policy Summit 2023 report.” On March 15, 2023, EuropaBio hosted...more

Orrick, Herrington & Sutcliffe LLP

Horizontal Cooperation Agreements – New EU Regulations and Guidelines

On 1 June 2023, the European Commission has announced the adoption of updated Horizontal Block Exemption Regulations on Research and Development (R&D) and Specialization agreements (HBERs) and revised Horizontal Guidelines....more

Skadden, Arps, Slate, Meagher & Flom LLP

New EU Competitors Cooperation Framework: Stricter on Information Exchange, Broader on Joint Sustainability Agreements

On June 1, 2023, the European Commission (EC) adopted a revised legal framework that block-exempts research and development (R&D) and specialisation agreements between competitors from the prohibition of anticompetitive...more

Morrison & Foerster LLP

European Digital Compliance: Key Digital Regulation & Compliance Developments - March 2023

To help organizations stay on top of the main developments in European digital compliance, Morrison Foerster’s European Digital Regulatory Compliance team reports on some of the main topical digital regulatory and compliance...more

White & Case LLP

Decarbonizing in a downturn: Can the mining & metals sector afford (not) to change?

White & Case LLP on

Softening commodity prices and economic headwinds may deter miners and metal companies from deploying the significant capital expenditure required to decarbonize....more

Bergeson & Campbell, P.C.

EUON Publishes Nanopinion on Urinary MicroRNA-based Early Cancer Detection Using Nanowire-based Devices

On May 31, 2022, the European Union (EU) Observatory for Nanomaterials (EUON) published a Nanopinion entitled “Urinary MicroRNA-based Early Cancer Detection Using Nanowire-based Devices” by Dr. Yasui Takao on using nanowire...more

McDermott Will & Emery

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

McDermott Will & Emery on

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

Skadden, Arps, Slate, Meagher & Flom LLP

Proposed EU Competitor Cooperation Guidelines Tougher on Information Sharing, but Scope Provided for Sustainability Agreements

The European Commission (Commission) is accepting public comment on its proposed revisions to European Union regulations and guidance on common competitor cooperation arrangements, which are due to expire on 31 December 2022....more

White & Case LLP

The new draft EU horizontal antitrust rules – A snapshot overview

White & Case LLP on

On 1 March 2022, the European Commission ("EC") published for consultation two draft revised horizontal block exemption regulations ("HBERs") on research & development ("R&D") and specialisation agreements, as well as draft...more

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