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International AI Regulatory Contrast: Evolving frameworks in the EU, UK, and US

In the EU, the AI Act has been approved, carrying significant implications for medical device, technology, and pharmaceutical firms. In the US, there is no comprehensive federal AI legislation, but at least 45 states have...more

JPM2025: Regulation of artificial intelligence: Navigating a new frontier in health care

Artificial intelligence (AI) is transforming the health care landscape, from diagnostics to drug development and clinical trials. As AI technologies rapidly evolve, global regulators face the complex task of regulating AI to...more

JPM2025: AI integration into UK’s MHRA’s processes presents opportunities, and challenges for regulating medicinal product...

Access to first-in-class medicinal products that can save and transform lives is crucial for patients in the UK – and the earlier the access, the more significant the impact. Equally vital, however, is that such products are...more

JPM2024: Manufacturing outlook for transformative technologies

Cell, tissue, and gene therapies (CTGT) have for years offered the potential for truly personalized medicine for many near-incurable disease indications. In addition, radiopharmaceuticals and custom medical device...more

JPM2024: transactional considerations in view of a (proposed) broader Bolar exemption in EU

Recent European Commission (Commission) proposals, including a broadening of the so-called ‘Bolar exemption’, would substantially change various incentive schemes related to medicinal product approvals, with the stated goal...more

日本企業を取り巻くAPACライフサイエンス産業において、ゼネラルカウンセルが注目する重要課題についてパネリストが議論

2023年10月4日に東京事務所にて開催された「ライフサイエンス・サミット」では、ホーガン・ロヴェルズのライフサイエンス・ヘルスケア分野のアジア太平洋(APAC)リードであるフレデリック・チェン博士(東京事務所代表パートナー)、メリッサ・ビアンキ(ワシントンDC事務所パートナー)、ペニー・パウウェル(ロンドン事務所パートナー)、カレン・テイラー(ノーザンバージニア事務所パートナー)、へイン・ファン・デン・ボス(アムステルダム事務所パートナー)が、...more

Horizons 2023: Panelists discuss key issues keeping APAC life sciences GCs up at night

We were pleased to welcome industry leaders to our Life Sciences and Health Care Horizons event in Tokyo, where Hogan Lovells Tokyo office managing partner and Asia-Pacific (APAC) lead for the Life Sciences and Health Care...more

Spring cleaning: a transactional check-up for life sciences companies

Spring cleaning: a transactional check-up for life sciences companies - This is an article in our 2023 series, “Life Sciences Transactional Insights”, which aims to provide key practical takeaways for our transactional...more

Harnessing transformative technologies to enhance vein-to-vein supply chain

Advanced therapy medicinal products (ATMPs) and blockchain technology represent two of the most promising current developments in the pharmaceutical and technology sectors respectively. This article considers the potential...more

To opt out or not to opt out, that is the question………

'Go live’ of Unitary Patents and the corresponding Unified Patent Court (UPC) system in the EU is imminent. The UPC system has particular relevance to life sciences and technology transactional and commercial contracts where...more

Cell and gene therapy transactions carry unique risks for both licensor and licensee

Cell and gene therapy transactions have increased dramatically over the last few years, in both number and complexity, and have given rise to a number of issues that merit further attention. In the article below, we outline a...more

How Life Sciences and Pharmaceutical Companies Can Harness Opportunity in Their Supply Chains

In this hoganlovells.com interview, Hogan Lovells counsel Penny Powell talks about disruptive technologies, the increasing trend towards collaboration and joint venture agreements, the opportunities and regulatory burdens...more

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