What the U.S.–UK Drug Pricing Agreement Reveals About How MFN Drug Policy Could Impact the UK and EU

The new U.S.–UK agreement in principle on pharmaceutical pricing offers more than tariff relief and adjusted UK drug pricing and reimbursement measures – it provides an early window into how U.S. Most Favored Nation (MFN) policies may interact with UK and EU policy to shape drug pricing, launch strategies, and investment across Europe. Sidley’s transatlantic team breaks down what this means for manufacturers and explains why the continued focus on MFN and other drug pricing policy initiatives that is anticipated through the first half of 2026 is likely to be of major significance to manufacturers both in the U.S. and in Europe.

Navigating an Uncertain Market Amidst Cautious Optimism: Steps Biotech Companies Can Take to Hedge Against Financial Fluctuations

As global markets continue to contend with a complex mix of macroeconomic pressures, development-stage biotech companies are being urged to proactively strengthen their financial resilience. The ability to anticipate and respond to liquidity challenges has become a defining factor in determining which companies emerge from this period of volatility with momentum and stability.

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SEC Remains Focused on Public Disclosures Made By Life Sciences Companies

On September 5, 2025, the U.S. Securities and Exchange Commission (SEC) announced a US$1.25 million settlement with biopharmaceutical company, FibroGen, Inc. (FibroGen), finding that FibroGen made false and misleading statements regarding the results of cardiovascular safety analyses of FibroGen’s anemia drug candidate, Roxadustat.

Navigating the European Health Data Space Regulation: What Life Sciences Companies Need to Know About Secondary Use Implementation (Now) – A Tracking Tool (September 2025)

The European Health Data Space Regulation took effect on March 26, 2025. While its key requirements regarding the secondary use of health data will not apply until March 2029, these provisions are set to bring about substantial changes for life sciences companies operating within the EU. This blog marks the beginning of a dedicated series of blogs exploring the implementation of the EHDS Regulation, with a particular focus on secondary use obligations. Our aim is to keep life sciences organizations informed about the latest EHDS Regulation developments, by offering an overview of relevant publications, consultations, and guidance on emerging best practices.

Now Is The Right Time For A Hong Kong Biotech Listing

Hong Kong has recently emerged as the number one IPO venue globally, and one of the sectors driving this is biotech. For China-based biotechs looking to float, Hong Kong is a natural destination. But biotechs based anywhere in the world may wish to ride the current wave, as Meng Ding explains.

EU Pharma Review: Trilogue negotiations under the shadow of U.S. MFN pricing

The coming months will be crucial for the so-called “Pharma Package”, the largest revision of EU pharmaceutical law since 1965. So-called “trilogue” negotiations are being held between the European Commission (“Commission”), the European Parliament (“Parliament”) and the Council of the European Union (“Council”), based on documents showing their positions (see draft Pharmaceutical Directive (“PD”) and draft Pharmaceutical Regulation (“PR”) published on 17 June 2025). Will the Pharma Package make the EU more competitive as has been claimed, despite reducing and ‘modulating’ IP rights and regulatory exclusivities? The stakes are high. For one of the proposals being considered (obliging companies to launch in all EU Member States), the stakes have been raised further by the growing risk that the U.S. administration will use prices in certain EU Member States as a “Most Favored Nation” (“MFN”) benchmark for U.S. prices. Maarten Meulenbelt, Josefine Sommer, Chris Boyle and Zina Chatzidimitriadou discuss the EU institutions’ trilogue positions in the context of broader legal, economic and political changes.

Key Steps Toward Using Artificial Intelligence in Pharmacovigilance – Sidley Insights on the Recent CIOMS Draft Report

The Council for International Organizations of Medical Sciences Working Group XIV (CIOMS) has produced a draft report (the Draft Report) on the use of artificial intelligence (AI) in pharmacovigilance (PV). Torrey Cope, Anna Melin, and Andrew James provide insights on how life sciences companies can take steps to implement key concepts from the Draft Report.

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