13.05.2013 - Swiss Novartis AG has gained authorisation from the FDA to market its IL-2beta blocker Ilaris in childhood arthritis.
The market approval of Novartis’ immune system blocker canakinumab comes only two weeks after the FDA has cleared Roche’s first-in-class IL-6 receptor blocker Actemra (tocilizumab) for the treatment of active systemic juvenile idiopathic arthritis (SJIA) in children aged 2 years and older.
SJIA is a rare, debilitating form of arthritis in children that worsens over time and affects approximately 30 in 100,000 children. The approval of the Novartis once monthly subcutaneously administered human monoclonal antibody was based on two Phase III trials. The first one showed that 84% of patients treated achieved ACR30 versus 10% in the placebo arm at day 15. In an open-label part of the other study, 92 of 128 patients attempted corticosteroid tapering. 57 were able to reduce their use of corticosteroids, and 42 completely discontinued corticosteroids.
Roche had reported that 83% of patients that took its monthly intravenously administered IL 6 receptor antagonist tocilizumab as monotherapy achieved an ACR 30 response at week 16 compared to baseline. Additionally, Actemra-treated children experienced significantly fewer disease flares (26%) compared to placebo-treated patients (48%).
17.04.2014 The European Parliament has given green light to the second Innovative Medicines Initiative with the aim to advance pharmacological research and development, particularly in areas of unmet medical need.
11.04.2014 There is no evidence that neuraminidase inhibitors Tamiflu and Relenza prevent complications of influenza or reduce hospital admissions. In addition, it is unclear whether they can stop the spread of influenza in case of outbreaks, says a report by the Cochrane Collaboration.
09.04.2014 Roche is extending its involvement in the area of point-of-care diagnostics by taking over US company Iquum. In the field of epigenetics, the Swiss pharma company has started a cooperation with the Spanish company Oryzon.
08.04.2014 The Swiss Biotech Report 2014 presented in Zurich sees an encouraging upturn in the country's biotech scene. However, the acceptance of the mass immigration initiative poses a significant threat.
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