Sidley Global Life Sciences

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.

Sidley represented Sagard Healthcare Partners in providing up to US$250 million in non-dilutive financings to Nuvation Bio, a global biopharmaceutical company tackling some of the greatest unmet needs in oncology. The transaction comprises a royalty interest financing of US$150 million and a senior term loan of up to US$100 million. The Sidley team was led by partners Asher Rubin, Adriana Tibbitts, and Angela Fontana. Read more here: https://bit.ly/4koXXTD.?

Join the Women’s Life Sciences Network on Tuesday, May 20 in Brussels for their next event held on the occasion of the EU Pharmaceutical Law Forum. The event will feature a moderated discussion with Rainer Becker (Director, DG SANTE, European Commission) on pharmaceutical legislation and policy. Learn more and register here: https://bit.ly/4bwvBTy.

On February 21, 2025, President Trump issued a memorandum on “America First Investment Policy,” which outlines his plans to use foreign investment policy to further decouple the United States from certain “foreign adversaries,” most notably China. The memorandum proposes strengthening restrictions on inbound investment from China and outbound investment to Chinese technology companies. Read here for our five key takeaways: https://bit.ly/4bsWozL.

In the U.S., development-stage biotech companies find themselves facing challenging clinical trial scenarios involving payments to investigators, study sites, and physician employees and consultants advising on trial design. Read below for our key compliance tips to address several common issues faced by companies designing or executing clinical trials.

Sidley is representing Clearlake Capital Group in its significant majority growth investment in ModMed. The company, currently backed by Warburg Pincus, is a developer of AI-powered medical practice technology, including electronic health records, practice management, revenue cycle management, patient engagement, payment processing, and native AI integrations. The Sidley team is being led by partners Mehdi Khodadad and Mark Castiglia. Read more here: https://bit.ly/41szV1c.

On February 28, 2025, the U.S. Department of Health and Human Services (HHS) rescinded a longstanding memo, referred to as the “Richardson Waiver,” pursuant to which the Department voluntarily agreed to use notice-and-comment rulemaking procedures for regulations related to public benefits. The rescission could have significant impacts on the pace and legal vulnerability of the Trump administration’s policy and regulatory changes. Read our insights below.

In recent years, the FDA has communicated a focus on advancing the development of cell and gene therapies (CGT), mirroring the industry’s optimism that these therapies can potentially offer durable and targeted treatment options. In this Cell & Gene article, Sidley’s Emily Marden and Kelly Cho share their insights on significant FDA regulatory considerations for CGTs in 2024 and offer a preview of potential developments for 2025. Read the full article here: https://bit.ly/4hXi1dX.

Join Sidley’s Global Life Sciences team with Breakthrough Properties and Symbiotic Capital at Breakthrough’s Torrey Heights campus in San Diego on March 5 for “Regulatory Know-How for Development & Growth-Stage Life Sciences Innovators.” This program is designed for legal professionals and executives to provide a foundation in FDA, healthcare, and securities issues arising in development stage companies. Speakers will include: Greg Bowman, Senior Director, Leasing, Breakthrough Properties; Josh Bradley, Senior Managing Director and Co-Founder, Symbiotic Capital; Mike Brown, Executive Vice President and Chief, Legal Officer, Dexcom; Aneta Ferguson, JD, Senior Vice President and General Counsel, Adverum Biotechnologies; Michael Mueller, General Counsel, Sidewinder Therapeutics, Inc. Learn more and register here: https://bit.ly/3WGEbbS .

Thank you to everyone who joined us last week in Brussels for our Digital Health App’ero and annual Life Sciences College. Co-hosted with EUCOPE - European Confederation of Pharmaceutical Entrepreneurs, attendees engaged in in-depth discussions with regulators from the European Commission, investors, and thought leaders on topics ranging from #AI and the future of #healthcare to the regulatory landscape in the #lifesciences industry.