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.
https://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/03/sidleyLogo-e1643922598198.png00Dr. Chris Boylehttps://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/03/sidleyLogo-e1643922598198.pngDr. Chris Boyle2025-12-10 11:08:362025-12-10 11:11:42What the U.S.–UK Drug Pricing Agreement Reveals About How MFN Drug Policy Could Impact the UK and EU
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.
https://goodlifesci.sidley.com/wp-content/uploads/sites/6/2025/05/MN-24014_GoodLifeSci-Blog-Imagery-Refresh29.jpg606833Sam Newmanhttps://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/03/sidleyLogo-e1643922598198.pngSam Newman2025-11-18 09:03:522025-11-18 09:55:19Navigating an Uncertain Market Amidst Cautious Optimism: Steps Biotech Companies Can Take to Hedge Against Financial Fluctuations
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.
https://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/03/sidleyLogo-e1643922598198.png00Lara Mehrabanhttps://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/03/sidleyLogo-e1643922598198.pngLara Mehraban2025-10-29 09:03:292025-10-28 15:49:10SEC Remains Focused on Public Disclosures Made By Life Sciences Companies
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.
https://goodlifesci.sidley.com/wp-content/uploads/sites/6/2025/09/AdobeStock_521493531.png400600Josefine Sommerhttps://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/03/sidleyLogo-e1643922598198.pngJosefine Sommer2025-09-23 09:04:362025-09-23 10:57:31Navigating the European Health Data Space Regulation: What Life Sciences Companies Need to Know About Secondary Use Implementation (Now) – A Tracking Tool (September 2025)
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.
https://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/03/sidleyLogo-e1643922598198.png00Meng Dinghttps://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/03/sidleyLogo-e1643922598198.pngMeng Ding2025-09-11 11:35:212025-09-11 11:35:21Now Is The Right Time For A Hong Kong Biotech Listing
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.
https://goodlifesci.sidley.com/wp-content/uploads/sites/6/2025/05/MN-24012_FCA-Blog-Imagery-Refresh-B_10.jpg606833Maarten Meulenbelthttps://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/03/sidleyLogo-e1643922598198.pngMaarten Meulenbelt2025-08-28 11:28:502025-08-28 15:07:55EU Pharma Review: Trilogue negotiations under the shadow of U.S. MFN pricing
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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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.
Dr. Chris Boyle
London
cboyle@sidley.com
Meenakshi Datta
Chicago
mdatta@sidley.com
Maarten Meulenbelt
Brussels
mmeulenbelt@sidley.com
Zina Chatzidimitriadou
London
zchatzidimitriadou@sidley.com
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.
(more…)
Sam Newman
Century City
sam.newman@sidley.com
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.
Lara Mehraban
New York
lmehraban@sidley.com
Ike Adams
Washington, D.C.
iadams@sidley.com
Martha O. Tabor
New York
martha.tabor@sidley.com
Ada G. Dovell
New York
adovell@sidley.com
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.
Josefine Sommer
Brussels
josefine.sommer@sidley.com
Francesca Blythe
London
fblythe@sidley.com
Belinda Baum
Brussels
belinda.baum@sidley.com
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.
Meng Ding
Hong Kong
meng.ding@sidley.com
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.
Maarten Meulenbelt
Brussels
mmeulenbelt@sidley.com
Josefine Sommer
Brussels
josefine.sommer@sidley.com
Dr. Chris Boyle
London
cboyle@sidley.com
Zina Chatzidimitriadou
London
zchatzidimitriadou@sidley.com
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.
Torrey Cope
Washington, D.C.
tcope@sidley.com
Anna-Shari Melin
Munich
amelin@sidley.com
Andrew James
Washington, D.C.
andrew.james@sidley.com
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