Shire Plc of Ireland said that two pivotal Phase 3 studies of the central nervous system drug Vyvanse (lisdexamfetamine dimesylate) have failed to show efficacy in patients with major depressive disorder (MDD).
Amgen Inc and Merck & Co Inc have announced plans to collaborate on the development of a new combination therapy for advanced melanoma. This will combine Amgen’s oncolytic virus product with Merck’s PD-1 inhibitor.
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.