Merck scientists have published a landmark paper in Science describing a novel biocatalytic method for the large-scale synthesis of enlicitide decanoate, an investigational oral PCSK9 inhibitors. The approach employs a tailored suite of enzymes to assemble this complex macrocyclic peptide through...

The European Medicines Agency is convening a two-day multistakeholder workshop to collect expert contributions that will inform the development of Annex 22 guidance on AI in GMP Manufacturing. Date: 30 June – 1 July 2026 Format: Hybrid The event features: ...

Advanced Therapy Medicinal Products (ATMPs) offer transformative options for rare and previously untreatable conditions, yet their high upfront costs, uncertain durability, and single-arm trial data create major reimbursement barriers. The 2026 pre-proof study by Greco et al. shows that developer...

MEA Adoption Challenges continue to limit the practical use of Managed Entry Agreements for Advanced Therapy Medicinal Products across Europe. The 2026 pre-proof paper by Greco et al. draws on interviews with HTA bodies and payers in England, the Netherlands, and Spain to show that hybrid agreeme...

A recently published visualization from Zorginstituut Nederland illustrates the intricate pathways through which an elderly individual with progressive dementia, such as Mrs. Mahabier, encounters multiple statutory frameworks, care providers, and administrative entities as her needs evolve. It de...

South Africa’s Draft General Public Procurement Regulations, 2026 establish a comprehensive framework that prioritises transparency, accountability and value for money in all public contracts under procurement regulations South Africa. For pharmaceutical, biotech and medtech companies bidding on ...