United States: Life Sciences, Biotechnology & Nanotechnology

Ankura's comprehensive insights hub showcases cutting-edge analysis across cybersecurity threats, life sciences transactions, regulatory compliance, and corporate governance. Explore how emerging malware campaigns, building envelope litigation patterns, and evolving valuation landscapes are reshaping risk management and strategic decision-making for enterprises worldwide.

The U.S. Food and Drug Administration has released its proposed eighth commitment letter for the Prescription Drug User Fee Act (PDUFA VIII), covering fiscal years 2028 through 2032, with significant changes to drug review processes, manufacturing facility oversight, and user fee structures.

Moderna's mRNA-1010 seasonal influenza vaccine has received FDA approval for adults 50 years and older, marking a significant milestone in mRNA vaccine technology. The approval follows a unanimous recommendation from FDA's advisory committee supporting the vaccine's benefit-risk profile across both middle-aged and senior adult populations.

The U.S. Government Accountability Office has released a comprehensive report examining the potential and pitfalls of using genetically engineered microbes to clean up waste. The analysis identifies critical obstacles including insufficient testing infrastructure, regulatory uncertainties, and public acceptance challenges that currently hinder the development and deployment of this biotechnology. GAO presents thirteen policy options for policymakers to consider, addressing goals ranging from demonstrating s

The United States Patent and Trademark Office has launched a mandatory pilot program that fundamentally changes how certain PCT national stage applications are processed, introducing a new decision point that could significantly impact patent term adjustment and examination strategy. Selected applicants must choose between proceeding with examination, delaying for 12 months with PTA consequences, or abandoning their applications based on international phase work products.

How are AI-washing risks reshaping digital health M&A due diligence, and what regulatory developments across the U.S., EU, and UK are defining the future of AI-enabled clinical trials, medical devices, and health data governance? This comprehensive update examines the intersection of artificial intelligence, digital health innovation, and evolving compliance frameworks that are transforming healthcare delivery and investment strategies.

Representative Rich McCormick introduces legislation to establish a dedicated biotechnology leadership position within the U.S. Department of State, responding to recommendations from the National Security Commission on Emerging Biotechnology. The bill aims to coordinate America's international biotechnology strategy and counter strategic rivals in this critical arena of global competition.

The Organisation for Economic Co-operation and Development (OECD) has published the Developments in Delegations on the Safety of Manufactured Nanomaterials and Advanced Materials — Tour de Table: July 2024 — June 2025...

Recent UPC decisions in Promosome v BioNTech and Gilead v AMMS clarify critical aspects of patent validity practice, including enablement requirements for novelty, the framework for assessing inventive step...