Will the EU Become the Most Attractive Place for Life Sciences? How the EU Woos Biotech
The European Commission made a lofty commitment in its recently published Life Sciences Strategy to position the EU as the world’s most attractive place for life sciences by 2030. To succeed with this vision, EU lawmakers must ensure that these efforts will truly cut red tape and accelerate innovation rather than simply adding new layers of regulation. They must also ensure that these efforts are not undermined by other legislative changes affecting the EU’s biotech industry.
EU Critical Medicines Act Seeks to Enhance Supply and Access Requirements
The European Commission has proposed a new Critical Medicines Act aimed at reinforcing the security of supply and ensuring the availability of critical medicines and medicines of common interest across the EU. The Act introduces new obligations for pharmaceutical companies such as enhanced supply chain transparency, mandatory stockpiling, and regular reporting obligations. At the same time, it creates opportunities for investment and funding to expand EU-based manufacturing, diversify supply chains, and foster innovation. By shifting procurement practices to include award criteria beyond price considerations by prioritizing quality, supply security, and EU production, the Act aims to address vulnerabilities in the current supply system and reduce reliance on third countries. However, to avoid becoming another layer of red tape for industry, a final Critical Medicines Act must carefully balance new regulatory requirements with the need to maintain competitiveness and support a resilient, innovative pharmaceutical sector.
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.
“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.
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.
Life Sciences Companies See New Path Open for Challenging FDA Decisions
A U.S. Supreme Court ruling which overturned the famous Chevron ruling by deciding courts should not defer to an agency’s interpretation of the law is likely to usher in a new era of both opportunity and risk for life sciences companies seeking to review FDA decisions. Michael Varrone explains.
