👉🏻 ANSM Gives Green Light to Therapeutic Phage Production by Lyon University Hospitals
The Lyon University Hospitals (Hospices Civils de Lyon, HCL) have received approval from the French National Agency for Medicines and Health Products Safety (ANSM) for the first hospital-based GMP-compliant therapeutic phage bioproduction facility in Europe, enabling the conduct of clinical trials. Four anti-Staphylococcus aureus phages, covering 90% of the strains responsible for human infections, will make up the first product range, expected to be available from autumn 2026. Supported by the France 2030 investment plan, the project is expected to lead to the creation of a national therapeutic phage institution, modeled on the French Blood Establishment (EFS).
👉🏻 Nantes Strengthens Its Biotech Hub with the Acquisition of a Former Valneva Site
Nantes Métropole is set to acquire the 4,000 m² site vacated by vaccine manufacturer Valneva in Saint-Herblain for €6.2 million, following the company’s relocation to Lyon. The deal is expected to be finalized in September 2026, with marketing of the available space starting shortly thereafter. The site will become part of the Saint-Herblain Biopark, where Framatome Healthcare and IBA announced in 2025 the establishment of an Astatine-211 production facility for nuclear medicine cancer treatments. “The buildings are in very good condition and ready for immediate use,” Anthony Descloziers, Vice-President of Nantes Métropole in charge of economic development, told Ouest-France.
👉🏻 Biotech Act Sparks Debate Among European Ministers Over Patent Protection
Meeting in Luxembourg on June 16, EU Health Ministers revealed significant differences regarding a key provision of the Biotech Act: the granting of an additional year of patent protection through Supplementary Protection Certificates (SPCs). Under the proposal, this extension would be conditional on conducting clinical trials in at least two EU countries and carrying out one manufacturing step within the European Union. However, several countries, including Malta, Estonia, and Poland, have raised concerns that the measure could delay access to biosimilars and increase pressure on healthcare budgets. Ireland, which takes over the EU Council Presidency in July, intends to accelerate negotiations by focusing first on the clinical trials component of the legislation.