Sanofi SA has received FDA approval of its plant in Framingham, Massachusetts with the result that it can start restoring supplies of its treatment for Fabry disease. The FDA approval follows earlier approval by the European Medicines Agency.
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.
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.
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.
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.
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.
After regaining rights to the broad-spectrum antibiotic, ceftobiprole, Basilea Pharmaceutica Ltd has announced plans to file a European marketing authorisation application in the second half. Talks with the FDA are ongoing about a US filing.