The US Food and Drug Administration has put a clinical hold on a Phase 2 trial of a new immunotherapy developed by Juno Therapeutics Inc after two patients died in early July. A third patient had previously died at the end of May.
Ablynx NV said that its experimental compound for rheumatoid arthritis, vobarilizumab, was very effective with less frequent administration than tocilizumab when tested as a monotherapy in patients with moderate to severe rheumatoid arthritis.
A pioneering cell therapy designed to treat patients with congestive heart failure did not meet its primary endpoint in a Phase 3 European trial. But the developer, Celyad SA, said a subgroup did show statistical significance.
Researchers from the University of Aberdeen have called attention to a possible new link between Alzheimer’s disease and diabetes in a study published in the journal Diabetologia.
The share price of Circassia Pharmaceuticals Plc fell by 64.85% to 95 pence in mid-morning trading on 20 June following the announcement that its phase-3 trial of its cat allergy drug failed to meet its primary endpoint.
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.