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
GoodLifeSci
GoodLifeSci, published by Sidley Austin LLP, focuses on legal developments and regulatory issues affecting the life sciences sector. The blog covers topics such as pharmaceutical and biotech company compliance, drug pricing policies in the U.S. and internationally, securities and disclosure regulations impacting life sciences firms, and corporate governance matters relevant to the industry. It also addresses emerging regulatory frameworks like the European Health Data Space Regulation and provides insights on litigation trends, market challenges, and strategic considerations for life sciences companies navigating complex legal and financial environments.
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Latest from GoodLifeSci
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…
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…
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…
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…
When AI Changes The Deal: Seven AI-related Considerations for Life Sciences M&A Dealmakers
Sally Wagner Partin, Sharon R. Flanagan, and Torrey Cope consider how AI is reshaping drug development, particularly at the stages of target and compound identification, and set out the implications of those changes for valuation, diligence, risk, milestone design, and…
Is my product a medical device? EU Court judgment clarifies that the test includes objective function and intended purpose, and provides guidance relevant to software and AI-enabled tools
The recent judgment of the Court of Justice of the European Union (CJEU or the Court) in Case C-427/24, Diagramm Halbach clarifies the key principles for determining whether a product falls within the definition of a medical device and will…
UK Looks To Modernize Medicines And Medical Device Regulation In The Era Of AI
A landmark program designed to deepen the regulatory partnership between the UK and the U.S., a regulatory ‘sandbox’ for AI as a medical device, evidence-gathering on AI regulation in healthcare, a consultation on a draft Rare Disease Therapies Regulatory Framework…
CMS’ CY 2027 OPPS and PFS Proposed Rules Include Major Changes to Reimbursement for 340B Hospitals, Data Reporting, and Digital Health
In July 2026, the Centers for Medicare & Medicaid Services (CMS or Agency) published two of their annual proposed rules: the CY 2027 Hospital Outpatient Prospective Payment System and Ambulatory Surgical Center Proposed Rule (OPPS-ASC Proposed Rule) and the CY…
AI Collaborations – From Strategic License to Strategic Acquisition
Artificial intelligence continues to reshape healthcare delivery, particularly in diagnostics, imaging, and care coordination. For established healthcare platforms seeking to integrate innovative capabilities, effective transactions are not always single-step acquisitions. Phased relationships, beginning with commercial alignment and structured with the…