Regulators

• A European Medicines Agency (EMA) report reveals a surge in AI adoption by pharmaceutical companies across the entire drug development lifecycle. • Industry applications currently range from optimizing clinical trial site selection to the automated drafting of complex regulatory documents. • The report warns that significant "gaps remain" regarding the AI tools used for regulatory assessments, questioning if regulators are equipped to keep pace.

• The EU is introducing the Cyber Resilience Act (CRA), which establishes strict legal obligations for manufacturers regarding the security of digital products, including those utilizing AI-generated code. • A critical requirement of the act mandates that manufacturers report any actively exploited vulnerabilities to the EU’s cybersecurity agency, ENISA, within 24 hours of discovery. • This regulation matters because it removes the "AI did it" excuse, forcing companies to implement significant behavioral and process shifts in their development lifecycles to ensure accountability.

California regulators settled a lawsuit that claimed a state agency showed political bias against the rocket company and its chief executiveCalifornia regulators apologized to the SpaceX CEO, Elon Musk, this week as they settled a lawsuit that claimed a state agency showed political bias against the rocket company and its chief executive.As part of the settlement, the California Coastal Commission acknowledged its members made “improper” statements about Musk’s political beliefs at a 2024 hearing on SpaceX’s Falcon 9 launch program. Continue reading...

• House Republicans argue that financial regulators must adapt governance frameworks to keep pace with innovations in artificial intelligence, digital assets, and real-time payment systems. • Congressional financial services leaders contend that regulatory evolution is essential as these technologies reshape how Americans save, invest, and conduct transactions. • The statement reflects broader debates about regulatory modernization in response to rapid technological change in the financial sector.