Worldwide: Food, Drugs, Healthcare, Life Sciences

The UK's medicines regulator is proposing fundamental changes to how gene therapy products are defined, shifting from origin-based classifications to mechanism-driven frameworks. This consultation raises critical questions about where regulatory boundaries will be drawn for synthetic biology, genome editing platforms, and engineered cell therapies as biotechnology advances beyond traditional biological manufacturing.

A mother shares the heartbreaking story of her 22-year-old daughter's death from ketamine addiction, revealing how recreational drug use spiraled into a debilitating condition called ketamine bladder that caused chronic pain and ultimately led to fatal complications. The case exposes critical gaps in healthcare support for ketamine addiction and raises urgent questions about education, treatment pathways, and the accessibility of this Class B substance.

June 2026 – In case Kfv.VI.37.810/2025/27, the Hungarian Supreme Court (the “Supreme Court”) reviewed an administrative dispute concerning the marketing authorisation of a generic medicinal product.