In this edition we examine how market volatility and a looming patent cliff are affecting corporate development activity and explore the creative deal structures that are emerging to mitigate risk and support continued innovation. 

We analyze how President Trump’s policy agenda—and the approach of U.S. Health Secretary Robert F. Kennedy Jr.—are influencing federal regulation and the work of the U.S. Food and Drug Administration.  

We take stock of legal and regulatory developments in Europe and explain the consequences of a shift in approach to merger reviews, closer FDI scrutiny and recent antitrust rulings by the European Court of Justice. We also look at what the future holds for pharma companies and their divested consumer healthcare divisions following a string of separation deals.  

Elsewhere we examine the rise of artificial intelligence and ask how we can devise regulatory frameworks that deliver the greatest health improvements while addressing AI’s complex challenges; assess the evolving U.S. regulatory landscape around medical devices and wearables and their associated privacy and cyber risks; and highlight a landmark decision from the EU's UPC Court of Appeal, which has for the first time in the pharma sector granted a provisional injunction for imminent patent infringement.