Sidley Global Life Sciences

Read here for Sidley’s “Securities Litigation Against Life Sciences Companies: 2024” report by Sara Brody, Sarah Hemmendinger, Francesca Brody, Robin Wechkin, and Zarine Alam.

In a highly anticipated decision, a federal court has struck down the final Food and Drug Administration (FDA) rule purporting to regulate laboratory-developed tests (LDTs) as medical devices.   The decision leaves open questions about whether the government will seek a stay pending appeal and whether Congress will fill the gap and expressly extend such authority to FDA, as well as providing an early major test case where the loss of Chevron deference may have made a significant difference to the legal analysis.   Read our insights here: https://bit.ly/3RCyrNi.

Join us on Monday, May 19 for our Boston Life Sciences Roundtable: Navigating New Frontiers, an afternoon of engaging discussions touching on the latest trends and hot topics including the new administration, new technologies, the investment landscape, and more. Our fifth annual event will feature timely insights from industry thought leaders, including Sidley lawyers Aaron Applebaum, Meenakshi Datta, Mathew Eapen, Deeona Gaskin, Jackson Garvey, and Rebecca Wood. Learn more and register here: https://bit.ly/43C83um.

Commercial and pre-commercial developers of potentially transformative medicines or drug-device combination products can now utilize a unique accelerated regulatory pathway in the UK. Article authored by Marie Manley and Victoria Kerr. Read more on "'Refreshed' UK-wide Innovative Licensing and Access Pathway (ILAP) Applications Now Open" below.

Sidley’s Securities Class Actions in the Life Sciences Sector report addresses developments in securities class actions brought against life sciences companies in 2024. In this publication, we provide an overview and analysis of trends in federal district court and appellate decisions in these cases, provide summaries of the 49 decisions surveyed, and catalog the new securities class action complaints filed against life sciences companies last year. Read the full report here: https://bit.ly/4l5LIeP.

Some entities known as Alternative Funding Programs (AFPs) are engaged in the unauthorized importation of specialty drugs into the United States and may pose a growing threat to the U.S. drug supply. Article authored by Benjamin Correa and Kathy Lee. Read more on "Unauthorized Drug Importation by Alternative Funding Programs: What Pharmaceutical Companies Need to Know and Options on How to Respond."

The U.S. Department of Health and Human Services has issued a revised Statement of Organization for the Office of the General Counsel (HHS-OGC). The update repeats previously announced changes but also includes subtle changes designed to consolidate and expand HHS-OGC’s authority, especially with respect to matters currently opined upon by lawyers advising the HHS Office of Inspector General. Read our insights below.

Sidley has received a Band 1 practice area ranking for Life Sciences: EU (Belgium) in Chambers Europe 2025. Additionally, partners Maurits Lugard and Maarten Meulenbelt maintained their Band 2 rankings in Life Sciences: EU (Belgium), senior advisor Eva von Mühlenen, LL.M. received a new Band 3 ranking in Life Sciences (Switzerland), and partner Josefine Liv Sommer was ranked an “Up and Coming” lawyer for Life Sciences: EU (Belgium). Our pioneering Global Life Sciences practice comprises an experienced team of approximately 200 lawyers across numerous legal disciplines in our offices around the world, advising on the full scope of regulatory, compliance and enforcement, litigation and transactional matters. Learn more about our practice here: https://bit.ly/3lsR8Eu. #ChambersEurope2025.

Sidley partner Robert Darwin recently moderated a panel on “Market Spotlight: How is Innovation from China and Asia Reshaping Global Biopharma?” at BIO-Europe Spring 2025 in Milan. Joined by Novartis’ Jesús Baena, Novo Nordisk’s Tomas Landh, Pappas Capital’s William Pay, and Johnson & Johnson’s Nerida Scott, the panel explored the rise of cutting-edge therapies, groundbreaking research, and transformative business models originating from Asia, examining how these trends are driving partnerships, altering the competitive landscape, and accelerating access to innovation.

Thank you to everyone who joined us in San Diego this week for our Global Life Sciences event focused on key early-stage and emerging growth regulatory issues and how to tackle them. A special thank you to our distinguished speakers – Himani Bhalla, CFA, Greg Bowman, Mike Brown, Aneta Ferguson, JD, and Michael Mueller – for sharing their invaluable expertise and perspectives. Thank you as well to the Sidley team – including Torrey Cope, Meenakshi Datta, Sharon Flanagan, Carlton Fleming, Cindy Lovering, James Lu, Jon Olsen, and Adam Welland – for their thought-provoking sessions and engaging discussions.