AstraZeneca Plc said that its recently approved lung cancer drug Tagrisso (osimertinib) has achieved another milestone, showing superiority to chemotherapy in a Phase 3 trial of patients with mutated metastatic non-small cell lung cancer.
Two Phase 3 trials which were seeking to show the superiority of a new combination treatment for patients with age-related macular degeneration (AMD) compared with the use of the licenced drug Lucentis alone, have failed to show an added benefit.
ReNeuron Plc has reported positive data from a Phase 2 trial of its allogeneic cell therapy for patients disabled by a stroke and plans to apply to regulatory authorities in the US and Europe to begin a pivotal study that could lead to possible registration.
Novartis said that its chimeric antigen receptor (CAR) T cell therapy, developed jointly with the University of Pennsylvania, achieved significant disease remission in paediatric and young adult patients with B cell acute lymphoblastic leukaemia.
UK researchers have reported sequencing the whole genomes of a human donor and a patient using a hand-held device based on nanopore technology. The device was developed by Oxford Nanopore Technologies Ltd, a venture capital-backed company based in Oxford UK.
Solanezumab, a monoclonal antibody that was being tested in patients with mild dementia due to Alzheimer’s disease, won’t be submitted for registration following the drug’s failure to meet its primary endpoint in a Phase 3 trial, Eli Lilly and Company announced on 23 November.
Juno Therapeutics Inc of the US suspended a trial of its chimeric antigen receptor (CAR) T cell therapy for leukaemia for a second time on 23 November following the deaths of two patients from cerebral edema.
Ablynx NV is poised to consult regulatory authorities in the US and Europe on plans for the Phase 3 development of its biologic for rheumatoid arthritis vobarilizumab. The Belgium-based company will also initiate discussions with potential partners for the drug.
Recruitment for Phase 3 clinical trials of AstraZeneca’s treatment for head and neck cancer, both mono and combination therapies, has been suspended by the US regulator because of bleeding by some of the patients, the UK company disclosed on 27 October.
Patients with head and neck cancer who were treated with nivolumab experienced a better quality of life than those treated with chemotherapy, according to an outcomes study released on 9 October at the European Society for Medical Oncology congress in Copenhagen.