The US Food and Drug Administration is expected to tell Roche by 17 December 2010 whether it will be able to approve the company’s two applications for Avastin (bevacizumab) to treat advanced HER2-negative breast cancer with chemotherapy.
The US Food and Drug Administration has announced a safety review of the diabetes drug, Actos (pioglitazone), on the basis of preliminary data on bladder cancer from a 10-year observational study of the drug. Takeda Pharmaceuticals is the manufacturer.
Novartis Europharm Ltd has withdrawn its application to market the hypertension treatment, Rasival (aliskiren and valsartan) in Europe, according to the European Medicines Agency. At the time of withdrawal, it was under review by the CHMP.
The Food and Drug Administration has approved a new treatment for gout, Krystexxa (pegloticase), an enzyme that lowers uric acid levels by metabolising it into a harmless chemical excreted in urine. The developer is Savient Pharmaceuticals Inc.
Novartis International AG said that the Russian health authority has approved its oral therapy for the treatment of relapsing, remitting multiple sclerosis, Gilenya (fingolimod). Earlier, Russia approved a competing MS drug from Merck Serono.
Regulators meeting in London on 2 and 3 September 2010 agreed that procedures in place to assess the current generation of nanomedicines are adequate. But as nanotechnology advances, adaptations will be necessary.
In the realm of nanotechnology, size matters. But exactly what is meant by ‘nanoscale’ and ‘nanomedicine’ is still open for discussion. This was one of the themes to emerge from the first day of a two-day workshop on nanotechnology which is being hosted by the European Medicines Agency in London.
The US Food and Drug Administration has issued its second ‘complete response letter’ to the AstraZeneca unit, MedImmune, rejecting its application to market motavizumab, a new monoclonal antibody for respiratory syncytial virus disease.
The US Food and Drug Administration has approved a new treatment for high blood pressure from Novartis which combines the renin inhibitor, aliskiren, with the calcium channel blocker, amlodipine, in a single pill.
The US Food and Drug Administration has granted priority review status to belimumab, a potential treatment for systemic lupus erythematosus, according to the drug’s co-developers, GlaxoSmithKline Plc and Human Genome Sciences Inc.