How Life Sciences Companies Can Respond To DOJ’s Focus on Clinical Trial Fraud
For the past two years, clinical trial fraud has been a key enforcement area for the U.S. Department of Justice’s (DOJ) Consumer Protection Branch (CPB). David Ludlow and Julea Lipiz set out considerations for life sciences companies to help mitigate scrutiny of their trial results and related products.
The AI Revolution and the FDA: Becky Wood and Deeona Gaskin’s Fireside Chat with Former FDA Commissioner Dr. Scott Gottlieb
AI tools are already advancing patient care by opening up new avenues for drug and product discovery, evaluation, and pharmacovigilance. But they also raise regulatory challenges as our panelists discuss.
Risks and Benefits of Generative AI for Pharma Supply Chain Management
As the life sciences sector grapples with complex challenges around sustainability and Environmental and Social Governance (ESG) compliance, Generative AI (GenAI) is emerging as a potentially powerful tool for enhancing efficiency and sustainability. Michele Tagliaferri, Eva von Mühlenen, and Anna-Shari Melin explain. (more…)
European Court of Justice Judgment Relating to Orphan Market Exclusivity
In a recent judgment, the Court of Justice of the European Union (CJEU) has shed light on the scope of the ‘clinical superiority’ criteria providing for a derogation to orphan market exclusivity which is key to protect the orphan molecule from competition for the period of market exclusivity (10 or 12 years as the case may be). Marie Manley, Chris Boyle, and Alix Vermulst examine the impact of this judgment on pharmaceutical companies.
As U.S. Biosecure Act Passes the House, Four Things Biotechs Can Do to Prepare
The U.S. Senate may still reject the U.S. BIOSECURE Act , but the House of Representatives has now passed a version of the bill. Biotechs in both the P.R.C. and the U.S. therefore need to prepare for the new environment which it heralds. Michael Borden, Andrew Shoyer, and Ruchun Ji set out five steps to take now.
How, When, and If the U.S. BIOSECURE Act Is Likely to Become Law
Both U.S. and P.R.C.-based biotechs are anxiously watching attempts to pass the U.S. BIOSECURE Act into law. Michael Borden and Andrew Shoyer explain what this month’s developments mean, and why the legislation, even with so much attention and publicity, may never actually become law.
EU Investigation Into PRC Public Procurement for MedTech May Impact EU Market Access for PRC Companies
Concerns about the PRC’s medical devices procurement practices have led the EU to launch an investigation which could lead to the EU subjecting PRC companies, including MedTech companies, to market access restrictions in the EU. Sven De Knop, Lei Li and Maryanne Kamau explain.
Key Regulatory and Compliance Considerations for Early-Stage Life Sciences Companies and Their Investors
Early-stage life sciences companies and the investors that back them are laser-focused on evidenced-based development and approval hurdles. However, even at early stages, failure to adequately prioritize more nuanced regulatory and compliance issues can have a significant impact on exit value and create potential liability for investors and acquirers. Geoffrey Levin, Torrey Cope, Marie Manley, Donielle McCutcheon, Andrew Shoyer, Michele Tagliaferri, and Julea Lipiz highlight eight key areas for focus.
China’s Generative AI Measures Could Affect Life Sciences Companies That Make Apps
Those medtech companies which embed AI into an app allowing healthcare professionals or patients to ask questions and to receive a response will probably need to comply with China’s new Interim Measures for the Management of Generative Artificial Intelligence Services (the “Measures”). Lianying Wang explains.
New EU Subsidies Rules Likely to Catch Global Life Sciences Companies
Given their extensive involvement in public procurement contracting, life sciences companies are likely to be heavily impacted by the EU’s Foreign Subsidies Regulation (the “FSR”), which has the potential to hold up tender awards over competition concerns. Michele Tagliaferri and Alessandra Moroni explain.
