The European Medicines Agency has launched a review of guidelines for the testing of new medicines in volunteers following the death of one person and the hospitalisation of five others in France in January. The case is the most serious incident to come to light since 2006 when an experimental immunotherapy seriously injured six volunteers in a first-in-human study the UK.
A Phase 2b trial of elsiglutide, a peptide drug designed to prevent diarrhoea in patients undergoing chemotherapy, has failed to meet its primary endpoint even though there was some evidence of patient benefit.
A review of the safety of Zydelig (idelalisib) as a combination cancer agent is ongoing, with a report expected to be made to the Committee for Medicinal Products for Human Use (CHMP) in June, according to the European Medicines Agency.
Ablynx NV has reported positive top line results from a first-in-infant study of its therapeutic protein for respiratory syncytial virus (RSV), a leading cause of lower respiratory tract disease in infants and young children. The results were reported on 3 May.
A Phase 2b/3 trial of the monoclonal antibody bimagrumab failed to meet its primary endpoint, which was based on a six-minute walking test, in patients with the muscle wasting disease sporatic inclusion body myositis, according to MorphoSys AG.
A Phase 3 development programme for the prospective osteoarthritis drug fulranumab has been stopped early by Janssen Research & Development because of a change in strategic priorities. The decision was not based on any safety issues, the company said.
Following a review of its staff disciplinary board, the Karolinska Institutet (KI) announced on 23 March that it had dismissed Paolo Macchiarini, a surgeon who is the focus of an investigation over alleged misconduct involving a novel trachea replacement procedure.
The failure of the anti-platelet agent Brilinta (ticagrelor) to perform better than aspirin in a late-stage stroke trial has dashed expectations, at least for the time being, of expanding the approved indications for the drug.
A new once daily formulation of the HIV-1 medicine Isentress (raltegravir) has shown statistical non-inferiority to the marketed version of the same drug, paving the way for possible registration in both the US and Europe, according to Merck & Co. Inc.
Romosozumab, a monoclonal antibody that targets the protein sclerostin, has reduced the incidence of new spinal fractures in postmenopausal women with osteoporosis, according to results from a new Phase 3 study. The data were reported by UCB SA and Amgen Inc on 22 February.