Italy

Sanofi CHC names new Italy country manager; Uriach appoints head of France & Belgium; EFSA announces leadership of Scientific Committee.

After a hiatus of nearly a year, the EU can celebrate another designation under the IVD Regulation.

Stay up to date on regulatory guidelines from around the world with the Pink Sheet's Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.

OTC sales edged up at Italy's Recordati in the first half of 2024 as higher demand for GI products and supplements offset a weaker cold & flu season.

Stay up to date on regulatory guidelines from around the world with the Pink Sheet's Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.

Casgevy, the world’s first CRISPR gene editing therapy, is the second drug to be accepted onto a managed access scheme via England’s Innovative Medicines Fund, offering a new treatment for patients with transfusion-dependent beta thalassemia.

Scotland’s health technology assessment body has agreed to reimburse Chiesi’s Elfabrio for Fabry disease, mirroring the decision from several other European countries – however, France turned down the rare disease drug, while Germany questioned its benefit.

Cooper Consumer Health has closed its acquisition of Viatris' OTC business as it commits to divesting the rights to infant laxative medicine Bebegel and earwax removal product Otowaxol in certain markets.

Did Samsung Bioepis and Biogen choose early US access for their Lucentis biosimilar in exchange for postponing launch in other markets? That’s what Italy’s competition authority believes, as it investigates the biosimilar sponsors and originator companies Genentech and Novartis.

J&J says it has “exhausted all current viable avenues” to get its antidepressant nasal spray Spravato reimbursed on England’s National Health Service, after NICE decided against re-appraising the drug following numerous funding rejections.