Advances in genetic testing and personalized medicine are creating new opportunities for individualized, or “N-of-1,” therapies. As emerging companies explore scalable business models for these treatments, they face evolving regulatory, legal, and ethical considerations that will shape their development and commercialization.
https://goodlifesci.sidley.com/wp-content/uploads/sites/6/2025/05/MN-24012_FCA-Blog-Imagery-Refresh-B_25.jpg606833Torrey Copehttps://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/03/sidleyLogo-e1643922598198.pngTorrey Cope2026-11-13 13:56:242026-11-13 15:51:57What Does It Take to Build a Business Around a Single Patient? Emerging “N-of-1” Models and the Regulatory Road Ahead
On October 26, 2026, the U.S. Treasury Department published proposed regulations (new 31 C.F.R. Part 851) in the Federal Register implementing the Comprehensive Outbound Investment National Security Act (COINS Act). The proposed regulations would prohibit investments by U.S. persons in Chinese biotechnology companies involved in the development or production of small molecules, biologics, vaccines, cell and gene therapies, and their delivery mechanisms where a biological system is used to modify, enhance, produce, or control them. The regulations also prohibit U.S. persons from establishing joint ventures with Chinese partners to conduct such activities. For companies that in-license drug candidates from Chinese biotechs, the license itself remains permitted, but several deal features that are now market practice (licensor equity, NewCos, profit-share collaborations, and certain governance terms) would carry real risk. Comments are due December 7, 2026. The rule is not yet effective. The “effective date” referenced below is the date of the entry into force of the new regulations, which is likely to be close to the end of the first quarter of 2027.
https://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/03/sidleyLogo-e1643922598198.png00Lila Hopehttps://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/03/sidleyLogo-e1643922598198.pngLila Hope2026-11-13 10:24:132026-11-13 10:24:13Treasury Proposes to Prohibit U.S. Investment in Chinese Biotech: What It Means for China Licensing Deals
PFAS, or per- and polyfluoroalkyl substances – which are widely used across industries and in life sciences applications, from cosmetics and food-contact-material to medical devices and pharmaceuticals – have become an increasing focus of regulatory scrutiny across Europe. In the EU, broad legislative measures aim at restricting the manufacture, placing on the market, and use of PFAS across a wide range of industries, resulting in industry and policy consequences. In contrast, the United Kingdom is considering more targeted regulatory approaches, signaling a potential divergence from the EU framework. The life sciences sector is particularly affected by these developments, given its historic reliance on PFAS in discovery, development, manufacturing, packaging, delivery, and safe use of medicines and healthcare products. These substances are often used for safety and performance reasons, e.g., in diagnostic assays and implantable medical devices, and play a key role in many pharmaceutical manufacturing processes. While carve-outs are likely to apply for certain uses, a broad legislative measure will undoubtfully have sweeping consequences for the life sciences industry. This blog post examines the evolving European regulatory landscape and considers the implications of forthcoming PFAS restrictions for businesses operating in the life sciences sector in Europe.
https://goodlifesci.sidley.com/wp-content/uploads/sites/6/2025/05/MN-24012_FCA-Blog-Imagery-Refresh-B_33.jpg606833Josefine Sommerhttps://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/03/sidleyLogo-e1643922598198.pngJosefine Sommer2026-10-27 10:18:272026-10-27 12:41:53The Growing PFAS Focus in Europe and the UK – Strategies for Life Sciences Companies
The EU’s targeted revision of the medical device and in vitro diagnostics framework has entered a more active phase, with nearly 800 amendments tabled in Parliament in July 2026 and the Council’s examination continuing in parallel. The revision would ease certification bottlenecks by removing the five-year cap on certificate validity, scaling notified body involvement to device risk, and letting lower-risk software move down to self-certified Class I. It would also loosen clinical evidence requirements, create fast-track pathways for orphan and breakthrough devices, and regulate AI-enabled devices primarily under the MDR/IVDR rather than the AI Act. This post summarizes the key aspects of the proposed revision, the prospects for their adoption, the issues still in play, and what manufacturers and investors should plan for.
https://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/03/sidleyLogo-e1643922598198.png00Josefine Sommerhttps://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/03/sidleyLogo-e1643922598198.pngJosefine Sommer2026-10-16 03:03:292026-10-16 15:41:34A More Competitive MedTech Landscape in the EU? What the MDR/IVDR Revision Could Mean for MedTech Manufacturers and Investors
Sally Wagner Partin and Sharon Flanagan look at the results of Sidley’s latest survey of contingent value rights (“CVRs”), analyzing recent trends in life sciences public M&A and finding a record share of deals using a CVR, particularly in biopharma and also increasingly in medical devices.
https://goodlifesci.sidley.com/wp-content/uploads/sites/6/2025/05/MN-24014_GoodLifeSci-Blog-Imagery-Refresh11.jpg606833Sally Wagner Partinhttps://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/03/sidleyLogo-e1643922598198.pngSally Wagner Partin2026-10-07 10:12:022026-10-07 10:12:022025 to First-Half 2026 Marks a Breakout Time for CVRs
Momentum is building behind the European Biotech Act I. The European Parliament and the Council of the EU broadly back the competitiveness agenda, with strong cross-party support for faster clinical trials, strategic-project funding, and regulatory simplification, and Member States showing less resistance than expected. The supplementary protection certificate (SPC) extension is the main open point – and the clearest test of how far Europe will go to attract biotechnology research, development, manufacturing, and investment.
The Commission presented its proposal in December 2025 (see our initial Sidley blog post here). This update focuses on how the package has evolved since then and what the latest developments in Parliament and the Council mean for biopharmaceutical developers and investors.
https://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/03/sidleyLogo-e1643922598198.png00Josefine Sommerhttps://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/03/sidleyLogo-e1643922598198.pngJosefine Sommer2026-09-21 10:02:442026-09-29 10:17:18EU Biotech Act I: Parliament and Council back Europe’s biotech competitiveness agenda – SPC incentive now the key battleground
HHS Secretary Robert F. Kennedy Jr. recently announced that he would give CMS the authority to exclude individuals and entities from participation in federal health care programs, an authority previously held only by HHS-OIG. While the announcement has not been formalized since announced in July, the announcement signals a potentially far-reaching expansion of CMS’s enforcement powers, which in turn would have implications for healthcare providers, suppliers, manufacturers, vendors, and other industry stakeholders.
What Does It Take to Build a Business Around a Single Patient?
Emerging “N-of-1” Models and the Regulatory Road Ahead
Advances in genetic testing and personalized medicine are creating new opportunities for individualized, or “N-of-1,” therapies. As emerging companies explore scalable business models for these treatments, they face evolving regulatory, legal, and ethical considerations that will shape their development and commercialization.
Torrey Cope
Washington, D.C.
tcope@sidley.com
Jon S. Zucker
Washington D.C.
jzucker@sidley.com
Emerging “N-of-1” Models and the Regulatory Road Ahead
Treasury Proposes to Prohibit U.S. Investment in Chinese Biotech: What It Means for China Licensing Deals
On October 26, 2026, the U.S. Treasury Department published proposed regulations (new 31 C.F.R. Part 851) in the Federal Register implementing the Comprehensive Outbound Investment National Security Act (COINS Act). The proposed regulations would prohibit investments by U.S. persons in Chinese biotechnology companies involved in the development or production of small molecules, biologics, vaccines, cell and gene therapies, and their delivery mechanisms where a biological system is used to modify, enhance, produce, or control them. The regulations also prohibit U.S. persons from establishing joint ventures with Chinese partners to conduct such activities. For companies that in-license drug candidates from Chinese biotechs, the license itself remains permitted, but several deal features that are now market practice (licensor equity, NewCos, profit-share collaborations, and certain governance terms) would carry real risk. Comments are due December 7, 2026. The rule is not yet effective. The “effective date” referenced below is the date of the entry into force of the new regulations, which is likely to be close to the end of the first quarter of 2027.
(more…)
Lila Hope
Palo Alto
lila.hope@sidley.com
James Mendenhall
Washington, D.C.
jmendenhall@sidley.com
Steve M. Przesmicki
San Diego
przes@sidley.com
Asher M. Rubin
Baltimore
arubin@sidley.com
Jessica P. Sanchez
Washington, D.C.
jessica.p.sanchez@sidley.com
Lloyd Lyall
Washington, D.C.
lloyd.lyall@sidley.com
The Growing PFAS Focus in Europe and the UK – Strategies for Life Sciences Companies
PFAS, or per- and polyfluoroalkyl substances – which are widely used across industries and in life sciences applications, from cosmetics and food-contact-material to medical devices and pharmaceuticals – have become an increasing focus of regulatory scrutiny across Europe. In the EU, broad legislative measures aim at restricting the manufacture, placing on the market, and use of PFAS across a wide range of industries, resulting in industry and policy consequences. In contrast, the United Kingdom is considering more targeted regulatory approaches, signaling a potential divergence from the EU framework. The life sciences sector is particularly affected by these developments, given its historic reliance on PFAS in discovery, development, manufacturing, packaging, delivery, and safe use of medicines and healthcare products. These substances are often used for safety and performance reasons, e.g., in diagnostic assays and implantable medical devices, and play a key role in many pharmaceutical manufacturing processes. While carve-outs are likely to apply for certain uses, a broad legislative measure will undoubtfully have sweeping consequences for the life sciences industry. This blog post examines the evolving European regulatory landscape and considers the implications of forthcoming PFAS restrictions for businesses operating in the life sciences sector in Europe.
Josefine Sommer
Brussels
josefine.sommer@sidley.com
Dr. Chris Boyle
London
cboyle@sidley.com
Andrew R. Stewart
Washington, D.C.
astewart@sidley.com
Brittany A. Bolen
Washington, D.C.
bbolen@sidley.com
A More Competitive MedTech Landscape in the EU? What the MDR/IVDR Revision Could Mean for MedTech Manufacturers and Investors
The EU’s targeted revision of the medical device and in vitro diagnostics framework has entered a more active phase, with nearly 800 amendments tabled in Parliament in July 2026 and the Council’s examination continuing in parallel. The revision would ease certification bottlenecks by removing the five-year cap on certificate validity, scaling notified body involvement to device risk, and letting lower-risk software move down to self-certified Class I. It would also loosen clinical evidence requirements, create fast-track pathways for orphan and breakthrough devices, and regulate AI-enabled devices primarily under the MDR/IVDR rather than the AI Act. This post summarizes the key aspects of the proposed revision, the prospects for their adoption, the issues still in play, and what manufacturers and investors should plan for.
Josefine Sommer
Brussels
josefine.sommer@sidley.com
Michelle Gandolfo
Brussels
mgandolfo@sidley.com
Belinda Baum
Brussels
belinda.baum@sidley.com
Anna-Shari Melin
Munich
amelin@sidley.com
Eva von Mühlenen
Geneva
evonmuehlenen@sidley.com
Dr. Chris Boyle
London
cboyle@sidley.com
2025 to First-Half 2026 Marks a Breakout Time for CVRs
Sally Wagner Partin and Sharon Flanagan look at the results of Sidley’s latest survey of contingent value rights (“CVRs”), analyzing recent trends in life sciences public M&A and finding a record share of deals using a CVR, particularly in biopharma and also increasingly in medical devices.
Sally Wagner Partin
San Francisco, Palo Alto
swagnerpartin@sidley.com
Sharon Flanagan
San Francisco, Palo Alto
sflanagan@sidley.com
EU Biotech Act I: Parliament and Council back Europe’s biotech competitiveness agenda – SPC incentive now the key battleground
Momentum is building behind the European Biotech Act I. The European Parliament and the Council of the EU broadly back the competitiveness agenda, with strong cross-party support for faster clinical trials, strategic-project funding, and regulatory simplification, and Member States showing less resistance than expected. The supplementary protection certificate (SPC) extension is the main open point – and the clearest test of how far Europe will go to attract biotechnology research, development, manufacturing, and investment.
The Commission presented its proposal in December 2025 (see our initial Sidley blog post here). This update focuses on how the package has evolved since then and what the latest developments in Parliament and the Council mean for biopharmaceutical developers and investors.
Josefine Sommer
Brussels
josefine.sommer@sidley.com
Alix Vermulst
Brussels
alix.vermulst@sidley.com
Maarten Meulenbelt
Brussels
mmeulenbelt@sidley.com
Dr. Chris Boyle
London
cboyle@sidley.com
Eva von Mühlenen
Geneva
evonmuehlenen@sidley.com
HHS Secretary Announces Intent to Extend HHS-OIG Exclusion Authority to CMS, Expanding the Administration’s Anti-Fraud Campaign
HHS Secretary Robert F. Kennedy Jr. recently announced that he would give CMS the authority to exclude individuals and entities from participation in federal health care programs, an authority previously held only by HHS-OIG. While the announcement has not been formalized since announced in July, the announcement signals a potentially far-reaching expansion of CMS’s enforcement powers, which in turn would have implications for healthcare providers, suppliers, manufacturers, vendors, and other industry stakeholders.
Meenakshi Datta
Chicago
mdatta@sidley.com
Mark B. Langdon
Washington, D.C.
mlangdon@sidley.com
Donielle McCutcheon
Chicago
dmccutcheon@sidley.com
Trevor L. Wear
Chicago
twear@sidley.com
Gabrielle Feliciani
Washington, D.C.
gfeliciani@sidley.com
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