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.
Sanofi SA said it is stopping clinical development of the JAK2 inhibitor, fedratinib, following reports of cases consistent with Wernicke’s encephalopathy in patients participating in the trials. Wernicke’s encephalopathy is caused by biochemical lesions of the CNS and is related to vitamin B1 insufficiency.
The first of two Phase 3 studies of a new treatment for chronic coronary heart disease, darapladib, has failed to meet its primary endpoint, GlaxoSmithKline Plc said. The endpoint was time to first occurrence of any major adverse cardiovascular event.
Anergis SA of Switzerland has provided further data on its lead vaccine for birch pollen allergy which showed that the treatment increased allergen-specific antibody levels by a factor of 20, indicating an immunological response.