A&O Shearman shares insights on life sciences and healthcare
A&O Shearman is pleased to share highlights from its latest life sciences and healthcare insights report, providing a global legal perspective on the most pressing challenges and opportunities shaping the sector today.
In this first edition, the international team looks at how economic uncertainty and the approaching patent cliff are reshaping corporate strategy and deal-making across the industry.
The report explores innovative transaction models designed to balance risk and foster continued advancement—particularly in accessing transformative technologies like CRISPR gene editing and antibody-drug conjugate linkers.
It assessed the regulatory landscape in the U.S. under the current administration, including the influence of President Trump’s policy direction and the regulatory stance of Health Secretary Robert F. Kennedy Jr., with a focus on implications for the FDA’s evolving role.
legal and regulatory shifts in Europe. This includes changes in merger control, heightened foreign direct investment scrutiny at the national level, and significant antitrust decisions from the European Court of Justice.
The report examines the strategic future of consumer healthcare businesses spun off from major pharmaceutical firms following recent divestitures, as well as the growing integration of artificial intelligence in life sciences. It provides guidance on how stakeholders—from developers to regulators—can craft legal and ethical frameworks that maximise health outcomes while managing AI’s inherent complexities.
Additionally, the insights clarify the intricate U.S. regulatory environment surrounding medical devices and wearables, highlighting associated privacy and cybersecurity risks and the responsibilities of both manufacturers and users. Finally, the report analyses a pivotal ruling from the EU’s UPC Court of Appeal, marking a significant moment for the pharmaceutical sector by granting a provisional injunction in a case of imminent patent infringement.
