Astellas Pharma has announced the initiation and dosing of the first patient in their SKYLIGHT1 Phase III pivotal trial for fezolinetant. The investigational oral, non-hormonal compound is being studied for the treatment of moderate-to-severe menopause related vasomotor symptoms (VMS), such as hot flashes and night sweats. The first trials of the programme will evaluate the efficacy
Pfizer and Astellas have announced results from the Phase III ARCHES trial in men with metastatic hormone-sensitive prostate cancer (HSPC), showing that Enzalutamide had significantly improved radiographic progression-free survival, paving the way for an application to expand the drug’s use. The results, which are for the drug in combination with androgen deprivation therapy, show a
Final results of a Phase II study of quizartinib were presented at the American Society of Hematology meeting in Atlanta which suggest that drug could be a good option to treat patients with treatment-resistant acute myeloid leukaemia (AML). In the clinical study, the majority of participants carried a mutation in a gene called FLT3-ITD. The
Astellas and partner Optimer Pharmaceuticals announced yesterday that regulators in Europe have given the green light to their antibiotic Dificlir. The European Commission has approved Dificlir (fidaxomicin) for the treatment of Clostridium Difficile infections (CDI) in adults, which can cause severe diarrhoea. The approval is based on two Phase III trials which compared Dificlir with
