More than 4,000 actions alleging gastrointestinal injuries associated with GLP-1-based medicines are pending in a US federal multidistrict litigation (MDL). According to the latest statistics published by the US Judicial Panel on Multidistrict Litigation (JPML), 4,082 actions were pending in MDL No. 3094 as of 2 November 2026, while the total number of actions historically recorded in the MDL was 4,196. The litigation involves Novo Nordisk and Eli Lilly, whose...

Russia’s human pharmaceutical manufacturing sector is subject to several layers of regulatory oversight, including manufacturing licensing, Eurasian Economic Union (EAEU) Good Manufacturing Practice (GMP) certification and domestic and foreign GMP inspections. An analysis of three official Russian regulatory registers shows 490 manufacturing licence records, 3,286 GMP certificate records and 592 inspection register entries. The datasets provide complementary information on the scale of regulatory activity, certification status, refusal decisions and the...

The Pharmaceutical Inspection Co-operation Scheme (PIC/S) plays a central role in promoting internationally harmonised Good Manufacturing Practice (GMP) inspection standards. Through common technical guidance, the assessment of inspectorates, inspector training and regulatory cooperation, it helps authorities develop more consistent approaches to pharmaceutical manufacturing oversight. However, PIC/S is not a global regulatory authority and its membership does not establish automatic mutual recognition of GMP certificates or inspection results. Understanding this distinction...

Anthropic has acquired Mithril Medicine, a biotechnology startup developing experimental treatments for rare inherited muscular dystrophies. The acquisition, completed in July 2026 and disclosed on 27 October, marks the company's move beyond AI tools for external drug developers towards running its own drug discovery programmes. Mithril had just one full-time employee, its founder Cody Tranbarger, who used Anthropic's Claude AI assistant to manage research activities and coordinate work with 11...

Mutual Recognition Agreements (MRAs) allow pharmaceutical regulatory authorities to rely on defined elements of one another’s Good Manufacturing Practice (GMP) inspection systems. By reducing unnecessary duplication of inspections and, where applicable, batch testing, these agreements support international regulatory cooperation while maintaining oversight of medicinal product quality. However, mutual recognition is conditional. Its scope depends on the legal framework, the authorities involved, the products covered, the types of inspections concerned...