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
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
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
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
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
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
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 - This is an article in our 2023 series, “Life Sciences Transactional Insights”, which aims to provide key practical takeaways for our transactional...more
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
'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 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
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