U.S. Executive Orders Shine Spotlight on India’s Life Sciences Industry
Three recent U.S. Executive Orders have significant consequences for India with its outsized role in global generic drug supply. The policy changes offer both opportunity and increased scrutiny for Indian drug manufacturers. Arif Noorani and Ryan Tan discuss proactive steps manufacturers can take.
2025 Boston Life Sciences Roundtable
The 5th Annual Boston Life Sciences Roundtable, “Navigating New Frontiers,” brought together legal experts, industry leaders, and innovators for an afternoon of thought-provoking discussion, strategic networking, and forward-looking perspectives on the latest trends and hot topics shaping the industry. Discussions ranged from recent changes at the FDA to strategies on how to de-risk supply chains from recently imposed tariffs to new AI technologies and pathways for products, and creative approaches to funding sources and deal structures amid ongoing regulatory and geopolitical uncertainty, writes Mia Harris.
UK Windsor Framework Enters Into Force
Recent UK regulatory developments of potential interest to international life sciences companies include: reforms aimed at speeding up medicines approvals and market access, global firsts with respect to certain orphan drug and cancer diagnostic approvals, and updates on unified packaging and labeling across the UK. Article authored by Dr. Chris Boyle and Dr. Kwabena Tenkorang.
Unauthorized Drug Importation by Alternative Funding Programs: What Pharmaceutical Companies Need to Know and Options on How to Respond
Some entities known as Alternative Funding Programs (AFPs) are engaged in the unauthorized importation of specialty drugs into the United States and may pose a growing threat to the U.S. drug supply. Article authored by Benjamin B. Correa and Kathy P. Lee.
Referral Payments Targeted in New Special Fraud Alert
A Special Fraud Alert has been issued by the U.S. Department of Health and Human Services, Office of Inspector General (HHS-OIG), warning that certain marketing arrangements relating to Medicare Advantage beneficiary referrals could potentially result in “abusive arrangements.” Jon Zucker explains.
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.
