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,
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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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…
Delaware Supreme Court Makes Earnouts Less Risky For Buyers Earnout Decision Partially Reversed Because Buyer Did Not Have to Pursue an Alternative Regulatory Pathway
Earnouts are a common feature of life sciences deals, and a 2024 Chancery Court decision had increased the financial risk for buyers agreeing to an earnout. However, the Delaware Supreme Court’s partial reversal of Johnson & Johnson v. Fortis Advisors…
EU Pharma Package: Sharp New Tools With Limited Protections
Last week, concluding a seven-year process, the Council of the European Union and the European Parliament agreed on the EU Pharma Package consisting of a new Pharmaceutical Directive and Pharmaceutical Regulation. The Package introduces pivotal changes to the EU pharmaceutical…
U.S. Drug Pricing Year in Review: Reflections on 2025 and Getting Ready for 2026
Federal drug pricing pressures intensified in 2025 with the second Trump administration. This Update reviews the year’s pivotal shifts and outlines what manufacturers should expect as they prepare for a more complex 2026.
The post U.S. Drug Pricing Year in…
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…
Navigating an Uncertain Market Amidst Cautious Optimism: Steps Biotech Companies Can Take to Hedge Against Financial Fluctuations
By Sam Newman
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…
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…
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…
Now Is The Right Time For A Hong Kong Biotech Listing
By Meng Ding
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…