The Roche group’s new kinase inhibitor for metastatic melanoma, Zelboraf (vemurafenib), has been given a positive opinion by the European Medicines Agency, following its approval by the US Food and Drug Administration in August.
In another set-back for developers of potential stroke treatments, Sygnis Pharma AG said its Phase 2 study of a growth factor for acute ischaemic stroke failed to meet its primary and secondary endpoints. The product is a recombinant version of granulocyte colony-stimulating factor (G-CSF).
Neovacs SA of France has completed the recruitment of patients for the first phase of a multicentre Phase 2 trial of its immunotherapy for Crohn’s disease. The primary objective will be to evaluate the ability of the therapy to induce clinical remission.
GE Healthcare and the engineering and construction company, M+W Group GmbH, have identified capacity-building in biomanufacturing as a market opportunity in the Third World and have announced a new alliance to exploit the opportunity.
4SC AG of Germany said that it is spinning off its discovery activities into a new wholly-owned subsidiary in order to make its early research programmes more visible to the financial markets and to potential pharmaceutical company licensees.
Ablynx NV has started a Phase 1 study in healthy volunteers of an antibody-derived therapeutic protein for the treatment of respiratory syncytial viral infections. To date, there is only one approved antibody therapeutic for this disease.
Cytos Biotechnology Ltd said that it has received the support of bondholders to restructure its outstanding convertible debt with the result that it can continue as a going concern. The refinancing affected CHF 1.225 million of debt.
Since 2003, the European Medicines Agency and the US Food and Drug Administration have been working actively behind the scenes to coordinate decision-making. This doesn’t mean issuing the same opinions on new products. But it does mean sharing intelligence, and taking a common approach to problem-solving.
Researchers from University College London and colleagues have reported the successful administration of a gene therapy to patients with haemophilia B. The study appears in the 10 December New England Journal of Medicine.
A team of European researchers has reported the successful transplantation of a synthetic trachea into a patient with tracheal cancer using a scaffold which was seeded with the patient’s own stem cells.