The European Medicines Agency (EMA) has welcomed the provisional political agreement on the EU Critical Medicines Act, an initiative designed to enhance the availability, production, and supply of critical medicines throughout the European Union. This agreement represents a key a...

Neuropsychiatry treatment innovations continue to reshape care for complex conditions. At the recent APA and ASCP meetings, Johnson & Johnson presented new portfolio and pipeline data focused on major depressive disorder, treatment-resistant depression, and schizophrenia — offering p...

The public assessment report for Hympavzi (marstacimab) in Portugal concludes that the product offers no added therapeutic value relative to recombinant factor VIII concentrates and emicizumab in patients aged 12 years and older weighing at least 35 kg with severe hemophilia A without factor VIII...

Decision-makers in England, the Netherlands, and Spain consistently identify administrative burden, outcome measurement, and data collection as the foremost obstacles to adopting managed entry agreements ATMPs. These challenges emerge most acutely when hybrid or outcome-based agreements are consi...

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: ...