Pfizer Inc said that its kinase inhibitor, palbociclib, significantly improved progression-free survival in a Phase 2 study of women with advanced breast cancer. A global Phase 3 trial of the drug is currently enrolling patients.
Janssen Research and Development LLC is to allow healthcare professionals and researchers access to anonymised data from its clinical trials, under an agreement negotiated with the Yale School of Medicine in the US.
Cytos Biotechnology AG of Switzerland said an influenza vaccine that it is co-developing with Singapore’s Agency for Science, Technology and Research has met its primary endpoint for immunogenicity in a Phase 1 study in Asian volunteers.
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.