The shortage of paliperidone palmitate reported by EMA stems from manufacturing issues at a contract manufacturer supplying several marketing authorisation holders. The case shows how commercially distinct supply chains can share the same manufacturing node, raising broader questions about concentration, capacity and the availability of alternatives that can actually be activated when needed.

With the 2025 AI Observatory report, EMA and HMA capture a transformation that is already under way: artificial intelligence is being discussed with companies across increasingly broad areas of the medicinal product lifecycle and, at the same time, is being adopted by regulatory authorities to improve efficiency, document analysis and decision-making capacity. In parallel, the European AI Act, EMA/FDA guidance and the workplan on data and AI are defining a new frame of reference.

A novelty in the world of biomaterials

Genenta announces Long-Term follow-up observations in brain tumor (GBM) study with emerging survival signals

A Special Issue of MakingPharmaIndustry Magazine dedicated to the 65th AFI Symposium explores the transformations shaping the pharmaceutical supply chain in the age of artificial intelligence, across innovation, quality, regulatory affairs, research, manufacturing and new skills.

This special issue explores the impact of automation and AI on pharmaceutical production—across GxP, sustainability, and digitalization.