On May 12, 2025, President Trump signed an Executive Order (“EO” or “Order”) “Delivering Most-Favored-Nation Prescription Drug Pricing to American Patients” aimed at significantly reducing U.S. prescription drug prices by aligning them with the lowest prices paid by other developed nations. According to the EO, drug manufacturers “deeply discount their products to access foreign markets and subsidize that decrease through enormously high prices in the United States.” Seeking to rectify this “egregious imbalance,” the EO announced the following policy: “Americans must therefore have access to the most-favored-nation price for these products… [and] should drug manufacturers fail to offer American consumers the most-favored-nation lowest price, [the] Administration will take additional aggressive action.”
Gibson Dunn and BCLT Host a Webcast Series on Royalty Finance, the UCC, and Issues of Recharacterization
Gibson Dunn has partnered with the UC Berkeley Center for Law & Technology on a three-part webcast series that discusses issues originally raised in a Law 360 article on royalty financing written by partners Todd Trattner and Ryan Murr.
In the series, partners Todd Trattner, Ryan Murr, Jin Hee Kim, and Jeffrey Krause and associates Kali Jelen, Anthony Hajj, and Michael Farag provide an in-depth exploration of royalty finance, the treatment of synthetics under the UCC, and the risks of a sale of a synthetic royalty being recharacterized as a loan in bankruptcy.
The series is designed to educate biotechnology stakeholders (investors, entrepreneurs, companies, and their attorneys) on best practices for monetizing and investing in a synthetic royalty so that they can embark on such transactions with greater certainty.
To access the series, visit:
- Panel 1 – Royalty Finance: Structures, Trends and Synthetics
- Panel 2 – Synthetic Royalty Financings and the UCC
- Panel 3 – Synthetic Royalty Financings: Risks of Recharacterizing a True Sale (available May 20)
You can watch the series for free using the code “BCLT-GD” at checkout.
“Deal Lawyers Download” Podcast: Shell Companies and Reverse Mergers
Listen to Ryan Murr, Branden Berns, and James Moloney discuss reverse mergers and how recent actions by the SEC have influenced the ways that reverse mergers are structured and the implications of those actions for those companies considering a reverse merger on the “Deal Lawyers Download” podcast produced by DealLawyers.com.
Listen here (subscription required).
Missed PDUFA Targets: Context, Concerns, and the Case of Stealth BioTherapeutics
The FDA’s commitment to timely drug approvals under the Prescription Drug User Fee Act (PDUFA) has been a cornerstone of its regulatory framework. Historically, the agency has maintained a high success rate in meeting its PDUFA goals; however, a handful of delays will typically occur each year for largely idiosyncratic reasons. Since 2021, when the FDA experienced delays due to challenges during the COVID-19 pandemic, the FDA has generally met or exceeded 90% of its review performance goals for new drug applications (NDAs) and biologics license applications (BLAs). However, recent regulatory upheaval at the FDA has prompted discussions of a potential decline in the previously reliable response rates and the implications for biotech companies and patients awaiting new therapies.
Impact of Current and Proposed Tariffs on Pharmaceutical Products
Pharmaceutical products from China continue to be subject to the fentanyl-related emergency tariffs (20%) and are expected to be subject to national security tariffs to be announced under Section 232 of the Trade Expansion Act of 1962, despite the recently announced “exemption” from the so-called “reciprocal tariffs” announced on April 2, 2025. We expect the Section 232 investigation to move quickly, and we advise companies to take prompt proactive steps to assess the tariff impacts. Our trade team stands ready to assist clients in navigating the fast-developing tariff landscape.
FDA’s Roadmap to Reducing Preclinical Animal Safety Studies: Six Things to Know
On April 10, 2025, the U.S. Food and Drug Administration (FDA) announced a new initiative to explore ways to reduce preclinical animal safety studies for human drugs and biological products, beginning with an approach to allowing the use of “New Approach Methodologies” (NAMs) in lieu of animal testing for eligible investigational monoclonal antibodies.[1] The agency’s plan marks a significant departure from decades of agency practice, in which life sciences companies developing novel therapeutic products typically have conducted a number of safety studies, including pharmacological and toxicological studies, in various species before progressing to the clinical phase. Below are six key points for life sciences companies to know about FDA’s plans to incorporate NAMs into preclinical evaluations for human drugs and biologics.
Tariffs and Royalties in License Agreements: Key Considerations for Life Science Companies
Recent shifts in international trade policies have led to the imposition of new tariffs prompting life science companies to reassess their license agreements to understand the potential impact of these new tariffs on royalty calculations under such agreements.
FDA’s User Fee Programs at a Crossroads: User Fee Deadlines and Funding at Risk
Gibson Dunn is closely monitoring developments and is prepared to help companies consider and address the implications of potential changes to FDA’s funding structure and authorities, including through regulatory counseling, agency and legislative engagement, and litigation.
Following recent mass layoffs at the Food and Drug Administration and growing criticism from senior administration officials of FDA’s user fee funding programs, the life sciences industry can expect significant changes to both FDA’s ability to meet medical product user fee deadlines and the future of the user fee programs more broadly.
The Current Landscape of Reverse Mergers: An In-Depth Analysis and Q&A
Branden Berns and Ryan Murr are the authors of “The Current Landscape of Reverse Mergers: An In-Depth Analysis and Q&A” [PDF] published by DealLawyers.com on April 2, 2025.
Royalty Report: Royalty Finance Transactions in the Life Sciences 2020-2024
This Royalty Report provides an analysis of publicly reported royalty finance transactions for the last five years (2020 to 2024) in the life sciences sector, focusing on both traditional and synthetic royalty transactions. Traditional royalty transactions encompass monetizations of royalties under existing license agreements. Synthetic royalty transactions involve the sale of a portion of future product sales, rather than the sale of an existing future royalty entitlement.