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.
The Union of AI and Drug Discovery and Development Requires New Thinking for Structuring and Negotiating Strategic Transactions, and a Rigorous Analysis of Applicable Regulatory Considerations
The use of artificial intelligence and machine learning (AI/ML) in drug discovery and development is well established and here to stay. With AI tools developing the potential to impact virtually every stage of the life sciences product life cycle, the FDA continues to refine its framework for the use of AI to support regulatory decision-making. On April 7, the FDA ended its consultation period on two draft guidance documents, one containing recommendations on the use of AI to support FDA regulatory decision-making and another providing a “comprehensive approach” to the management of risk throughout the total product life cycle of AI-enabled devices. We also saw, in January of this year, the U.S. administration issue the Executive Order Removing Barriers to American Leadership in Artificial Intelligence. These developments, and potential developments, need to be carefully taken into account by life sciences companies that are considering transacting with an AI/ML tool provider.
Securities Litigation Against Life Sciences Companies: 2024
Securities class actions against life sciences companies are mostly second-order problems. The first-order problem is a business or regulatory setback that, when disclosed by the company or a third party, triggers a stock price decline. Following the decline, plaintiffs’ class-action attorneys search the company’s previous public statements and seek to identify inconsistencies between past positive comments and the current negative development. In most cases, plaintiffs’ attorneys then seek to show that any arguable inconsistency amounts to fraud—that is, they will claim that the earlier statement was knowingly or recklessly false or misleading. When the challenged statement appears in a public offering document (that is, a registration statement or prospectus), plaintiffs need only show that the statement was materially false or misleading, not that it was made with scienter or caused their losses.
“Refreshed” UK-wide Innovative Licensing and Access Pathway (ILAP) Applications Now Open
Commercial and pre-commercial developers of potentially transformative medicines or drug-device combination products can now utilize a unique accelerated regulatory pathway in the UK. Article authored by Marie Manley and Victoria Kerr. (more…)
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.
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.
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.
