In an apparently unprecedented situation, a committee of the European Union member states which advises the European Commission on the granting or refusal of marketing authorisations, has reached an impasse over the gene therapy, Glybera.
After two earlier rejections, a once-weekly treatment for type 2 diabetes, Bydureon (exenatide extended-release), has received clearance from the US Food and Drug Administration. The sponsors are Amylin Pharmaceuticals Inc and Alkermes Plc.
The US Food and Drug Administration has approved Inlyta (axitinib) for the treatment of advanced renal cell carcinoma, the seventh drug to be authorised for this indication since 2005, the agency said. The developer is Pfizer Inc.
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.