In this edition we examine how current market volatility and a looming patent cliff are affecting corporate development activity.  

Our team explores some of the creative deal structures that are emerging to better share risk, support continued innovation and allow the sector’s leading players to access enabling technologies such as CRISPR-based gene editing and antibody-drug conjugate linkers.  

Next, 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 broader work of the U.S. Food and Drug Administration.  

We then take stock of legal and regulatory developments in Europe and explain the consequences of a shift in approach to merger reviews, closer FDI scrutiny at member state level, and recent antitrust rulings by the European Court of Justice.  

Our fourth article examines what the future holds for pharma companies and their divested consumer healthcare divisions following a string of separation deals.  

Next, we look at the sector’s use of artificial intelligence and ask how life sciences professionals, policymakers, software companies and lawyers can devise frameworks that deliver the greatest health improvements while addressing AI’s complex legal and ethical challenges. 

In our sixth article we clarify the complex and evolving U.S. regulatory framework around medical devices and wearables. We also explore their associated privacy and cyber risks – and explain the responsibilities of developers and end-users. 

Finally, we 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.