The beginning of the second Trump administration has been marked by significant—and often sudden—efforts to shrink the federal workforce and replace agency leadership to establish and deliver on a new set of priorities. In the past weeks, the administration has pursued a deferred resignation program,[1] terminated employees both in leadership and on probationary status,[2] and announced plans for a forthcoming government-wide reduction in force.[3] The U.S. Food and Drug Administration (FDA) has not been immune to these changes.
Introducing Biotech Briefings
Dear friends and colleagues,
We are excited to introduce Biotech Briefings, providing Gibson Dunn’s commentary and perspectives on the legal, business, and regulatory issues shaping the life sciences industry.
From groundbreaking developments in biopharma, medical devices, and diagnostics to the evolving landscape of IP, FDA and SEC regulation, Biotech Briefings delivers timely insights for companies, investors, and industry stakeholders.
Stay tuned for expert analysis on:
- Key FDA, FTC & SEC developments
- M&A, financing & strategic partnerships
- Market dynamics shaping investment & innovation
We invite you to follow along for actionable insights at the crossroads of law, business, and science.
The Gibson Dunn Life Sciences Team
Now Available: IPO Guidebook (2025 Edition)
This guidebook offers an overview of the numerous decision points, procedures and vital considerations a company should contemplate before, during and after the IPO process.
Completing an Initial Public Offering (IPO) is a significant milestone for many business owners, executives, directors and stockholders. However, the journey towards going public can be fraught with complexities and unexpected challenges. For companies seeking to raise capital, whether through an IPO or other alternatives, it is critical to understand the road ahead.
Life Sciences 2025 Outlook
The life sciences industry is entering 2025 with a largely favorable set of catalysts for the coming year, but also with some larger risks that will impact companies differently.
FDA to Require Confirmatory Trials Be “Underway” Prior to Accelerated Approval, Per New Draft Guidance
Life sciences companies interested in pursuing accelerated approval should ensure they have a thorough understanding of the complex regulatory landscape and engage in early discussions with FDA regarding their drug development programs.
Executive Email Can Expose Public Companies to Securities Fraud Claim
Pizzuto v. Homology Meds., Inc., No. 1:23-CV-10858, 2024 WL 1436025
(D. Mass. Mar. 31, 2024)
Case Highlight
In a securities fraud action earlier this year, an executive’s statement made in an email to a single research analyst was alleged to be false or misleading. In Pizzuto v. Homology Meds (“Pizzuto”), plaintiffs brought a securities class action complaint against Homology Medicines Inc. (“Homology”), a biopharmaceutical company, alleging that the company’s statements regarding the safety and efficacy of its gene therapy treatment were false and misleading.
Webcast: M&A Insights: Earn-Outs, New HSR and Investment Rules, and Fraud Liability
Join us for a 45-minute briefing covering several M&A practice topics. The program is part of a series of quarterly webcasts designed to provide quick insights into emerging issues and practical advice on how to manage common M&A problems. Steve Glover, a partner in the firm’s Global M&A Practice Group, acts as moderator.
Webcast: IPO and Public Company Readiness: Advance Planning for 2025 and 2026 IPOs – Corporate Governance and ESG Considerations
Please join us for a briefing where we explore corporate governance and ESG considerations in preparing for an Initial Public Offering (IPO) and becoming a public company. We delve into state-of-the-art corporate governance policies and practices that companies should implement in connection with the IPO process, ensuring alignment with market practices and evolving trends. Attendees will gain insights into investor and proxy advisor expectations, key issues under Delaware law and stock exchange listing standards.
Federal Circuit Decision in Allergan v. MSN
On August 13, 2024, the Federal Circuit issued a precedential decision on the issue of obviousness-type double patenting (ODP) and patent-term adjustment (PTA) in Allergan USA, Inc. et al., v. MSN Laboratories Private Ltd., et al., No. 24-1061 (Fed. Cir. Aug. 13, 2024). While the decision also addressed other issues, this update focuses on summarizing the Court’s holding on the ODP issue.
FDA Issues Overdue Guidance on Diversity Action Plans in Drug and Device Clinical Trials – What You Need to Know
This update provides key takeaways on the new draft guidance and Diversity Action Plan requirements, including when the new requirements will go into effect, the types of clinical studies that require submission of a Diversity Action Plan, whether FDA intends to issue waivers for the requirements, and the consequences of failure to submit a Diversity Action Plan.