Government Regulation

Expanded QSBS Benefits: What Biotech Founders Need to Know After the “One Big Beautiful Bill” Act

July 30, 2025 | Posted by Eric B. Sloan; Matt Donnelly; Kamia Williams; Bree Gong; Topic(s): Government Regulation; Tax; Trends and Insights

Why this matters for biotech start-ups

Raising capital for drug discovery often pushes early-stage biotech companies above the gross asset limit for qualifying for the U.S. federal income tax benefits associated with qualified small business stock (“QSBS”). The law commonly referred to as the One Big Beautiful Bill Act (the “OBBBA”), signed into law on July 4, 2025, lets founders and other investors greater access these tax savings—potentially reducing their tax bill by millions when the company is sold.

Getting Ready for Your Q2 Quarterly Reports: Trends in Biopharmaceutical Disclosures from Q1 Quarterly Reports

July 28, 2025 | Posted by Aaron K. Briggs; Branden C. Berns; Melanie E. Neary; Xuan Hong Tran; Topic(s): Government Regulation; International Trade; SEC Disclosure; Trends and Insights

Earlier this year, the new Presidential Administration introduced a series of policies, legislative proposals and regulatory actions that have impacted the business and regulatory environment and contributed to a climate of uncertainty—particularly in the biopharmaceutical sector. These developments gave companies much to address in their first quarter 10-Q filings. To shed light on how biopharmaceutical companies addressed these developments, we conducted a survey of the Q1 Quarterly Reports of the top 100 biopharmaceutical companies. Our analysis revealed that most companies are actively assessing the potential impact of these changes, with more than two-thirds (68%) of companies updating their risk factors and more than half (53%) updating their Management’s Discussion & Analysis (MD&A) accordingly. Below is a summary of the key disclosure changes, with a focus on topics of heightened relevance to the industry—including tariffs, changes in laws related to Medicaid or Medicare, federal workforce disruptions and other issues such as the Section 232 investigation and the Section 340B Drug Pricing Program.

Potential Impacts of Most-Favored-Nation Executive Order on Ex-US License Agreements

July 15, 2025 | Posted by Ryan A. Murr; Branden C. Berns; Melanie E. Neary; Topic(s): FDA; Government Regulation; License Agreements; Trends and Insights

Introduction

On May 12, 2025, President Donald Trump signed an Executive Order titled “Delivering Most-Favored-Nation Prescription Drug Pricing to American Patients”. This order aims to address the perceived imbalance where the United States funds a significant portion of global pharmaceutical profits and pays high prices, while drug manufacturers offer deep discounts to access foreign markets, subsidizing those lower prices through higher prices in the United States. The stated purpose of the Executive Order is to ensure that Americans are not forced to pay almost three times more for the same medicines and have access to the most-favored-nation (MFN) price.

Trump Administration Revives Possibility of MFN Drug Pricing: Key Implications for the Life Sciences Industry

May 15, 2025 | Posted by Rachel E. Baron; Wynne Leahy; Carlo Felizardo; Jonathan M. Phillips; John D.W. Partridge; Katlin McKelvie; Topic(s): FDA; Government Regulation; Trends and Insights

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.”

Navigating the Impact of Emergency Tariffs on Biotech Manufacturing with Chinese Counterparties

March 10, 2025 | Posted by Samantha Sewall; Lindsay Bernsen Wardlaw; Adam M. Smith; Branden C. Berns; Topic(s): Government Regulation; International Trade; Manufacturing; Trends and Insights

The recent imposition of emergency tariffs on products from China and Hong Kong has raised significant concerns for biotech companies, particularly those considering or currently engaged in manufacturing contracts with Chinese entities. This post aims to provide an overview of the recent emergency tariffs targeting China and their potential implications for the biotech industry.

FDA in Flux: What Life Science Companies Should Expect as the Agency Undergoes Staffing Changes

March 4, 2025 | Posted by Katlin McKelvie; Carlo Felizardo; Topic(s): FDA; Government Regulation; Trends and Insights

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.