13.02.2013 - The FDA has rejected market authorization of Novo Nordisk’s long-acting insulin Tresiba and demands a complete new cardiovascular safety study.
The FDA asked the Danish insulin-maker to complete a cardiovascular safety study of the long-acting insulin in 7,500 patients before granting market authorisation. The decision on Tresiba comes just a few weeks after the European Medicines Agency had given the green light for the once daily insulin degludec.
Most analysts don't expect Novo to have databefore 2016, offering market leader Sanofi more years to sell its blockbuster Lantus without a challenge from Tresiba. Sanofi made about 20% of its revenues with Lantus (US$6.6bn) last year – more than 50% of the global diabetes market. The FDA's complete response letter also caught Novo's related Ryzodeg in the regulatory net, which was also backed by the expert panel.
25.04.2014 Crispr Therapeutics has raised $25m in a series A investment. With the money, the newly formed Swiss biopharma company plans on translating its gene editing technology into medicines for genetic diseases.
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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