Europe
The European Medicines Agency is set to adopt opinions on whether marketing approval should be granted to five new products, including three orphans. A decision is also due on a previously-rejected Alzheimer’s drug that was under re-examination.
Cambrex is accelerating API capacity expansion across the US and Europe, advancing a $120m Iowa project and a $30m Milan upgrade as it builds scale in complex chemistries, peptides and high-potency manufacturing amid rising reshoring demand.
“In a very siloed organization made up of a jigsaw of different companies, no one was thinking enterprise first,” says Perrigo CEO Patrick Lockwood-Taylor. “The fundamentals of running operations, brand-building, innovation, they are now as they were.”
The first multinational clinical trial approval under the EU’s 70‑day fast-track pilot pathway is expected by the end of April 2026.
In an effort to streamline AI rules for high-risk systems and improve competitiveness, two European Parliament committees agreed amendments to the EU AI Act that will allow medtech companies to avoid double certification with notified bodies. A plenary vote takes place in late March.
Formycon expects its aflibercept biosimilar to enter European markets from the end of spring, as commercial paths also open up in Latin America and Asia Pacific countries.
Digitalization is expected to reform the European pharmaceutical industry. But it will also change perceptions towards technology and current regulatory skillsets.
The final week of February saw the AAM hold its Access! 2026 annual conference in Miami and Medicines for Europe hold its annual regulatory and scientific affairs conference in Amsterdam. Generics Bulletin was there at both events and our reporters discuss the key takeaways in our latest podcast.
Certain short-term EU market improvement measures are expected to be in place this month, said the European Commission, which has challenged device industry stakeholders for input and advice as the EU’s late-2025 bundle of device regulatory improvements begins to take shape.
EU data protection bodies back clinical trial harmonization under the draft Biotech Act, but insist on strong safeguards for sensitive health data.
Outlook Therapeutics gave little detail about its next steps following a meeting with the US FDA, but said it was evaluating regulatory options toward approval. Meanwhile, expansion in Europe continues with a fresh Swiss commercial distribution deal.
A new survey of French healthcare professionals reveals concerns that France is increasingly being excluded from major international clinical studies.