Insights

New York – August 19, 2025: Crowell & Moring represented Halda Therapeutics in a strategic research collaboration, worth over $1 billion in total potential value, with VantAI to discover next-generation RIPTAC (Regulated Induced Proximity Targeting Chimeras) medicines.

Washington – June 3, 2025: Crowell & Moring LLP and Faber Daeufer & Itrato have combined to provide companies, academic research institutions, and investors in the life sciences ecosystem with integrated and industry-leading transactional, regulatory, intellectual property, and litigation counsel distinguished by deep industry, trade, and government experience in the U.S. and Europe.  

On December 16, 2025, the European Commission published its proposal for a regulation establishing a European Biotech Act to strengthen the EU's biotechnology and biomanufacturing sectors with a primary focus on health.

The European Commission has proposed targeted amendments to the Medical Devices Regulation 2017/745 (MDR) and the In-Vitro Diagnostic Medical Devices Regulation 2017/746 (IVDR). The amendments are intended to simplify the rules, reduce the administrative burden, and enhance the predictability and cost-efficiency of notified body certification, while maintaining high public health and patient safety standards.

On December 11, 2025, the Council of the European Union and the European Parliament reached provisional agreement on the long-awaited “Pharma Package,” (see the announcement here). The Pharma Package is a comprehensive and major overhaul of the EU legislative framework for pharmaceuticals, which replaces the more than 20-year-old Directive 2001/83 and Regulation 726/2004 and incorporates (and updates) the separate regulations on orphan and pediatric medicines (Regulations 141/2000 and 1901/2006 respectively).

The landscape of AI governance and regulation is shifting. Following the release of the White House’s “America’s AI Action Plan” in July 2025 and the President’s signing of related Executive Orders, the White House has emphasized (at least rhetorically) a preference for innovation, adoption, and deregulation. But that does not tell the entire story. The Administration remains committed to exercising a heavy hand in AI, including by banning the U.S. government’s procurement of so-called “woke AI,” intervening in the development of data centers and the export of the AI technology stack, imposing an export fee for certain semiconductors to China, and assuming a stake in a U.S. semiconductor company. State legislatures are also racing to implement their own regulations, particularly around AI’s use in critical areas, such as healthcare, labor and employment, and data privacy. The many sources of regulation raise the specter of a fragmented compliance environment for businesses. This webinar will delve into the Administration’s AI strategy, going beyond the headlines to analyze: