The US Food and Drug Administration has approved the first diagnostic that will enable healthcare professionals to determine whether a patient taking the multiple sclerosis drug, Tysabri (natalizumab), faces a risk of the brain infection, PML.
Novartis’s new treatment for Cushing’s disease, a rare hormonal disorder, has received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use.
The European Medicines Agency has announced the start of a safety review of the Novartis treatment for multiple sclerosis, Gilenya (fingolimod), less than a year after the drug was authorised for marketing in the European Union.
4SC AG has reported new data showing that its lead oncology compound, resminostat, an HDAC inhibitor, met its primary endpoint in a Phase 2 study of patients with advanced liver cancer. The results were reported on 19 January.
The US Food and Drug Administration has turned down a new treatment for type 2 diabetes, dapagliflozin, the drug’s co-developers, AstraZeneca Plc and Bristol-Myers Squibb Company announced. The drug inhibits sodium-glucose transport proteins known as SGLT2.
In the wake of its acquisition of Nycomed A/S, and in order to increase productivity, Takeda Pharmaceutical Company Ltd is to embark on a five-year restructuring that will result in job losses of 2,800 globally, of which 2,100 will be in Europe.
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.