Sanofi SA has received European regulatory assurance of the fitness of a manufacturing plant in Framingham, Massachusetts, signaling progress towards the restoration of global supplies of its treatment for Fabry disease, Fabrazyme.
Pfizer Inc and its partner, Medivation Inc are stopping a Phase 3 trial of the Alzheimer’s disease compound, Dimebon (latrepirdine), because it didn’t achieve statistical significance for either of its two co-primary endpoints.
Wilex AG has reported the successful completion of a Phase 1 study in volunteers of a small molecule inhibitor of the MEK signalling pathway. MEK inhibition is being studied by a number of companies and institutions as a potential anti-cancer agent.
Clavis Pharma ASA has announced a delay in the start of a Phase 3 study of its new treatment for acute myeloid leukaemia (AML). Separately, the Norwegian oncology company said it has raised NOK 163 in a private share placement with investors.
Evotec AG has announced a second strategic alliance with Harvard University, this time to discover and develop biomarkers and treatments for kidney disease. This follows an earlier deal to develop diabetes therapies targeting beta cell regeneration.
Vernalis Plc has announced the start of a new three-year collaboration with the privately-owned French company, Les Laboratoires Servier, to discover potential oncology drugs using a new, undisclosed target. Financial terms were not disclosed.
Just six months after approving Adcetris (brentuximab vedotin), the US Food and Drug Administration has announced that the developer, Seattle Genetics Inc, will be tightening the drug’s label to warn against the rare PML brain infection.
Novartis Pharmaceuticals said it plans to eliminate about 1,960 positions in the US ahead of the loss of patent protection for valsartan, and the cessation of a Phase 3 study for a new indication for aliskiren. The stoppage of the trial has triggered a regulatory safety review.
AstraZeneca Plc has announced a three-year collaboration with the healthcare data company, IMS Health, to study the use of drugs in medical practice in order to identify market gaps and inform future decisions on discovery and development.
Sanofi SA and two US venture capital companies have reached an agreement to create a new biotechnology company that will use proprietary genomic technology to discover drugs from natural substances that are hidden within micro-organisms.