We just published Gibson Dunn’s 2026 Royalty Finance Market Update — a comprehensive analysis of 133 life sciences royalty transactions from 2020 through 2025, totaling $32.7 billion in aggregate value. A few findings stood out to us as genuinely worth flagging for practitioners in the space.
One and Done: FDA’s New Single-Trial Default and What It Means for Drug Developers, Investors, and Counsel
On February 18, 2026, FDA Commissioner Martin Makary and Vinay Prasad, then-Chief Medical and Scientific Officer and Director of the Center for Biologics Evaluation and Research, published a landmark policy announcement in the New England Journal of Medicine that a single adequate and well-controlled pivotal trial — supplemented by confirmatory evidence — is now the FDA’s default standard for approving novel drugs.[1] The agency’s longstanding practice of requiring two pivotal trials has not been a statutory mandate since 1997: at that time, Congress amended the Federal Food, Drug, and Cosmetic Act to provide that data from one adequate and well-controlled trial and confirmatory evidence can constitute ‘substantial evidence’ of effectiveness.[2] In some therapeutic areas, such as in oncology and rare disease, FDA increasingly has approved drugs on the basis of a single clinical trial, but, as a matter of general agency policy, two trials have been the baseline norm for decades.[3] That norm has now changed.
MFN Drug Pricing in 2026: Voluntary Deals Are Giving Way to Mandatory Rules — Five Things Life Sciences Companies Need to Know
What began as a series of demand letters in July 2025 has evolved into something significantly more consequential. By February 2026, sixteen of the seventeen largest pharmaceutical manufacturers have signed Most-Favored-Nation (MFN) pricing agreements with the Trump administration, which commit them to Medicaid price parity, MFN pricing on new product launches, and participation in TrumpRx.gov in exchange for three-year tariff immunity and improved regulatory positioning. But as those voluntary deals settle, the Centers for Medicare & Medicaid Services (CMS) has moved to make MFN pricing mandatory for Medicare through two new models: GLOBE (Medicare Part B) and GUARD (Medicare Part D), both published in the Federal Register on December 23, 2025, with a public comment period that closed on February 23, 2026.
2026 Life Sciences Industry Outlook: Collaborations and Licensing
Welcome to Part 4 of our 2026 Life Sciences Industry Outlook series. Today, we’re looking at life sciences collaborations and licensing activity in 2025 and what it may signal for 2026.
2025 life sciences licensing activity remained resilient and increasingly sophisticated, with stable deal volume, heightened structural customization, and growing geopolitical and technology-driven considerations shaping how biotechs and large pharmaceutical companies approach partnerships heading into 2026.
2026 Life Sciences Industry Outlook: Royalty Finance
Welcome to Part 3 of our 2026 Life Sciences Industry Outlook series. Today, we are turning to royalty finance transactions in the life sciences industry in 2025 and what to expect in 2026.
Once again, 2025 marked a year of meaningful growth for royalty finance, underscoring the continued evolution of royalty monetization transactions from niche alternatives into established components of the corporate finance toolkit within the life sciences sector. Aggregate transaction value across leading market participants increased to a record level of approximately $6.5 billion, up from approximately $5.7 billion in 2024. While $6.5 billion remains modest when compared with traditional equity or debt markets, the growth trajectory is notable. As recently as the early 2000s, annual aggregate royalty finance transaction value was estimated at less than $200 million per year, highlighting the extent to which royalty financing has relatively quickly become a mainstream funding solution for biopharmaceutical companies.
Introducing Our 2026 Life Sciences Industry Outlook Series
As the life sciences industry kicks off the new year and convenes at the JP Morgan Healthcare Conference this week, we are launching a weeklong Biotech Briefings series highlighting key insights from our 2026 Life Sciences Industry Outlook. Following a pivotal year in which deal activity accelerated and capital markets reopened selectively, the industry enters 2026 with cautious optimism—and a sharper focus on execution.
Throughout the week, we will explore the trends shaping life sciences dealmaking and financing in the year ahead, with posts focused on mergers and acquisitions, capital markets, royalty finance, collaborations and licensing, and the evolving regulatory environment. Together, these perspectives reflect a market characterized by renewed strategic conviction, disciplined capital deployment, and increasing structural sophistication.
We look forward to sharing our views on what biotech executives, investors, and strategic partners should be watching as 2026 unfolds.
Trump’s 100% Pharma Tariffs: Manageable for Large Pharma; Challenging for Biotechs
On September 25, 2025, President Trump announced 100% tariffs on imported branded or patented pharmaceuticals, effective October 1, 2025, unless the importing company is building U.S. manufacturing capacity (defined in President Trump’s announcement as “breaking ground and/or under construction”). The policy is being advanced under Section 232 “national security” authority.
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.
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
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.
Delaware Court of Chancery Opines on the Meaning of “Commercially Reasonable Efforts” in a Pharmaceutical Earn-Out Provision
Observations and drafting suggestions for CRE terms in merger agreements, licenses, and royalty purchase agreements.
On April 30, 2024, the Delaware Court of Chancery held that the buyer in a life sciences merger and its successor had not breached their contractual obligations under an earn-out provision to use commercially reasonable efforts (“CRE”) to achieve regulatory approvals for a pharmaceutical product. In Himawan, et al. v. Cephalon, Inc., et al., Vice Chancellor Glasscock found that the merger agreement’s definition of CRE for purposes of the earn-out provision, which referred to the efforts of a company with substantially the same resources and expertise as the buyer, required the Court to analyze whether a reasonable actor faced with the circumstances would continue to pursue the development of a drug that had failed to meet one of its co-primary endpoints in an earlier clinical trial.[1]
Life Sciences Review and Outlook – 2024
This update provides a recap of 2023 highlights for capital markets, M&A activity, royalty finance transactions and clinical funding arrangements, along with expectations for 2024.
The past five years have been particularly tumultuous in the biopharma sector. Strong capital markets and M&A activity into early 2020 were whipsawed during the pandemic, with equity valuations climbing significantly through early 2021 before dropping dramatically through the fourth quarter of 2023.