This post is the second in our five-part series, Navigating Life Sciences Transactions, where our team of attorneys provides essential strategies and insights for successful life sciences transactions.
What Investors Look for in Early and Late-Stage Funding Rounds and How Regulatory Compliance Impacts Valuation
For early-stage life sciences and health tech companies, raising capital
As generative artificial intelligence (AI) continues to transform industries, its impact on patent law is raising critical legal questions. From the recognition of AI as an inventor and potential infringement risks posed by the AI-generated outputs to the use of AI in patent validity challenges, the legal landscape is rapidly evolving. This article explores how generative AI
This post is the first in our five-part series, Navigating Life Sciences Transactions, where our team of attorneys provides essential strategies and insights for successful life sciences transactions.
AI, Medical Devices, Digital Health, and the Future of Healthcare Transactions
Innovation in life sciences isn’t just about scientific breakthroughs—it’s about making the right business decisions.
Reed Smith has announced the dates and topics for it’s 11th annual health care conference from March 17-21, 2024. The conference will be conducted entirely virtually this year with CLE webinars offered throughout the week on important and timely topics for the health care industry.
The schedule of the sessions is below, all of the
On 3 February 2025, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) launched a consultation asking for stakeholders’ views on draft guideline in relation to the regulation of individualised mRNA cancer immunotherapies (Draft Guideline).
The aim of the proposed guideline is to establish a clear and streamlined regulatory pathway to authorisation so that
Traduction par Stephanie Faber de l’article The ReAIlity of What an AI System Is – Unpacking the Commission’s New Guidelines écrit par par Charles Helleputte, Andrea Otaola & Claire Murphy
La Commission européenne a récemment publié ses lignes directrices sur la définition d’un système d’intelligence artificielle (qui à la date de l’article ne sont
On February 13, 2025, a federal court issued a highly anticipated ruling in Estate of Gene B. Lokken v. UnitedHealth Group (CASE 0:23-cv-03514-JRT-SGE)—denying UnitedHealthcare’s attempt to dismiss certain state law claims and allowing breach of contract and good faith claims to move forward. It’s a major development in a case I first discussed
Welcome to the latest installment of Arnold & Porter’s Virtual and Digital Health Digest. This digest covers key virtual and digital health regulatory and public policy developments during January and early February 2025 from the United States, United Kingdom, and European Union.
In this issue, we discuss some useful international guidance documents from the International
Johnstone and National Disability Insurance Agency (NDIS) [2025] ARTA 106 (Link to AUSTLII).
Serious injury compensation claims have for some years included provision for technology supports. This NDIS decision is novel in that the participant sought a paid subscription to “Chat GPT” at a cost of $300 per month. In support of the claim,
The United States Court of Appeals for the First Circuit issued a pivotal ruling earlier this week, finding that in order to establish falsity in a False Claims Act (“FCA”) case premised on Anti-Kickback Statute (“AKS”) liability, the kickback must have been the “but-for” cause of the submission of the claim. The court’s decision hinged