Roche has announced the failure of two studies in a large Phase 3 programme which is investigating the efficacy of bitopertin, a glycine reuptake inhibitor, in schizophrenia. The company said it will wait for data from the remaining studies before deciding its next steps.
Avillion LLP, a company set up by two venture capital groups to undertake late-stage clinical development on behalf of third parties, has signed a deal with Pfizer Inc to conduct a Phase 3 trial of the US company’s leukaemia drug bosutinib.
A Phase 3 study of an experimental treatment for chronic lymphocytic leukaemia and small lymphocytic lymphoma has been stopped early on efficacy grounds. The treatment, Imbruvica (ibrutinib) has been developed by Janssen Research & Development LLC.
Europe’s political leaders have reached an agreement on a new set of rules for conducting clinical trials in the EU. A key feature of the new legislation will be the introduction of a single authorisation procedure for all trials instead of multiple procedures at present.
Cubist Pharmaceuticals Inc said that top-line results from a Phase 3 trial of its antibiotic candidate ceftolozane/tazobactam in complicated intra-abdominal infections met its primary endpoint of statistical non-inferiority compared with meropenem.
Oxford BioTherapeutics Ltd and its Italian partner the Menarini Group, have announced the start of preparations for a human trial of the first of their five prospective antibody-based therapies for cancer. The target indication is acute myeloid leukaemia (AML).
Novartis has released new data on its experimental T-cell immunotherapy which shows that 14 out of 22 paediatric patients with acute lymphoblastic leukaemia (ALL) achieved complete and sustained remissions of their disease.
Scancell Holdngs Plc said that its lead cancer vaccine that targets dendritic cells has generated a disease-specific immune response in a Phase 1/2 study of patients with late-stage melanoma. There were no reports of serious drug-related side effects.
GlaxoSmithKline Plc and its partner, Theravance Inc, have announced positive Phase 3 results in asthma for their combination corticosteroid and long-acting beta2 agonist, Breo Ellipta. The companies plan to discuss an asthma filing with the FDA.
Eli Lilly and Company said that its experimental add-on therapy for depression, edivoxetine, failed to meet the primary endpoint of three Phase 3 studies and that it is ending development of the drug. This will result in a fourth quarter charge of $15 million.