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
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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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…
The EU AI Act’s Machinery Exemption: Does It Extend to Surgical Robotics?
The EU’s latest AI reforms are intended to reduce regulatory duplication for products already subject to extensive sector-specific regulation. For manufacturers of surgical robotics, however, they leave unresolved how AI embedded within increasingly sophisticated surgical systems will be regulated in…
Most-Favored-Nations Drug Pricing Policy: White House Quietly Releases Report Describing Voluntary MFN Deals
On May 6, 2026, the White House Council of Economic Advisors (CEA)[1] discretely released the first report quantifying its view of the projected savings generated by the administration’s Most-Favored-Nation (MFN) drug pricing policy framework, based on existing MFN pricing agreements…
FDA’s Elsa at Eleven Months: AI-Powered Operations and One-Day Inspections Signal a New Oversight Paradigm
Recent United States Food and Drug Administration (FDA) announcements continue to highlight the agency’s increasing development and use of artificial intelligence. Earlier this month, FDA announced the launch of the latest version of Elsa – the internal AI solution it…
EU Pharma Package: Compromise Text Published – Best Efforts Required (Part 2)
After a 10-year process, the compromise text of the new EU General Pharmaceutical Legislation (GPL or Pharma Package) has been published and will soon become law. This blog post discusses the 10 most important changes for company pipelines, transition mechanisms,…
Navigating the European Health Data Space Regulation: An (Uneasy) Marriage Between EHDS and GDPR
The European Health Data Space Regulation (EHDS Regulation) took effect on March 26, 2025. Most of its secondary use provisions will apply from March 2029, and implementation at EU and Member State level will have to take place between 2027…