A new small molecule drug intended to treat cystic fibrosis patients with the F508del gene mutation has been well tolerated in patients in a Phase 2 study, paving the way for its use as part of a triple therapy, Galapagos NV announced on 19 November.
Roche has reported positive Phase 3 results for two different antibody therapeutics putting it in a leadership position for treating both non-small cell lung cancer and haemophilia A. The cancer trial was significant because it showed the benefits of using a checkpoint inhibitor as part of a triple therapy.
Finland-based Faron Pharmaceuticals Oy is proposing to raise up to £10 million, before expenses, in a private share placement to support the late-stage development and commercialisation of its product for acute respiratory distress syndrome Traumakine.
New longer-term data from a Phase 3 trial of the drug guselkumab for plaque psoriasis has shown that patients achieved consistent rates of skin clearance following treatment at both 52 and 100 weeks, according to the developer Janssen Research & Development LLC.
A Phase 3 trial of the Bavarian Nordic A/S candidate vaccine for prostate cancer, Prostvac, has been declared futile based on the results of a preplanned interim analysis. The trial’s independent data monitoring committee is recommending the study be discontinued.
A Phase 3 trial of a candidate gene therapy for retinal disorder has been highlighted in The Lancet as a possible standard for future trials of genetic medicines. The trial was conducted by Spark Therapeutics Inc whose therapy, voretigene neparvovec, is under review at the US Food and Drug Administration.
Phase 3 trial results of canakinumab (Ilaris), a monoclonal antibody that targets interleukin 1 beta (IL-1 beta), have shown a significant 15% reduction of major cardiovascular events in people with a prior heart attack and inflammatory atherosclerosis.
Amgen Inc said that its licensed drug, Kyprolis (carfilzomib), produced a better survival benefit in a Phase 3 trial of patients with relapsed or refractory multiple myeloma than Velcade (bortezomib). The trial results were published in The Lancet Oncology on 23 August.
Regeneron Pharmaceuticals Inc has stopped development of suptavumab, a candidate antibody for the treatment of respiratory syncytial virus (RSV) in infants following the failure of a Phase 3 trial to prevent medically- attended infections.
A Phase 2a study of a drug developed by Galapagos NV for patients with idiopathic pulmonary fibrosis has halted the progression of the disease in a randomised, placebo-controlled study. Galapagos said it is making plans for a late-stage trial.