The US Food and Drug Administration has approved a new carbapenem antibiotic from GSK Plc to treat complicated urinary tract infections – the first oral treatment of its kind for the disease. The authorisation, announced on 17 June, is for Utebzi (tebipenem pivoxil), a broad-spectrum carbapenem antibiotic of the beta-lactam class. The treatment will be available as a tablet, in addition to its availability as an in-hospital intravenous therapy.
A new study on the economic impact of pharmaceutical innovation in Europe shows sustained benefits across society, according to EFPIA, the European industry federation. Data from the study, released on 22 June, shows that between 2014 and 2024 Europe’s investment of €11.67 billion in new medicines returned more than five times the amount in social, economic and hospital cost savings – equating to €66 billion in total. This figure includes more than €9 billion in direct hospital savings. Key findings include:
The US Food and Drug Administration issued new draft guidance on 29 May about how companies can reduce the use of animals in drug testing – this time for cancer medicines. Entitled, Oncology Pharmaceuticals: Streamlined Nonclinical Safety Studies for Biologics and Conjugated Products, the guidance recommends new criteria for general toxicology studies, including when animal testing may be unnecessary because there is no binding or pharmacologic activity.
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