SwitzerlandSwitzerland

Actelion receives recommendation to file for US market approval

14.01.2010

Allschwil – The FDA's Endocrinologic and Metabolic Drugs Advisory Committee has recommended (10 for, 3 against) approval for Actelion’s miglustat for the treatment of children and adults with Niemann-Pick Type C disease(NP-C), a fat storage disease that is accompanied by progressive neurological manifestations. The decision is based on extensive results from clinical trials in related lysosomal storage disorders. Since last year Zavesca(R) has already been available for European patients with NP-C disease. The drug is also indicated in the US, the EU, and other countries for the oral treatment of adult patients with mild to moderate type 1 Gaucher disease for whom enzyme replacement therapy is unsuitable, or when it is not a therapeutic option. The FDA decision for the supplemental new drug application is expected for March 2010.

SwitzerlandSwitzerland

21.02.2012

Basel/Berkeley – Europe enters into the age of personalised medicine. The European Commission has approved the melanoma drug Zelboraf. While the compound was developed by US-based Plexxikon Inc., owned by Daiichi Sankyo Group,...

SwitzerlandSwitzerland

26.01.2012

Basel – The rumours started just before Christmas. Roche wants Illumina. Just how dearly, has just become clear. The Swiss drugmaker made a $5.7b hostile bid for Illumina, the current market leader in Next-Generation sequencing....

SwitzerlandSwitzerland

23.01.2012

Basel – Good and bad news for Swiss drugmaker Novartis. First a look on the bright side: Signifor, for the treatment of Cushing's disease, is on its final stretch to approval. The Committee for Medicinal Products for Human Use...

SwitzerlandSwitzerland

19.12.2011

Basel - It is a further push for Roche's ambitions in medicine concerning the treatment of skin cancer: The European Committee for Medicinal Products for Human Use (CHMP) has recommended that the drug Zelboraf and its companion...

SwitzerlandSwitzerland

17.12.2011

Allschwil – Europe’s largest stand-alone biotech company Actelion Ltd. is receiving an injection of fresh capital. Under the guidance of the two biggest Swiss banks – UBS and Credit Suisse – the Swiss company will be issued a...

SwitzerlandSwitzerland

14.12.2011

Stans – Due to the current financial market conditions and the lack of significant progress with currently available options, Swiss drug developer Mondobiotech says it will be implementing restructuring measures. Together with...

SwitzerlandSwitzerland

14.12.2011

Geneva – There's is life in Swiss biotechnology beyond big pharma. Genentech has launched a First-in-Human study with anti-IL-17, an antibody made by the Swiss biotechnology company NovImmune. The fully human monoclonal antibody,...

SwitzerlandSwitzerland

22.11.2011

Basel – The FDA has withdrawn the accelerated approval for Roche's Avastin (bevacizumab) to treat metastasising breast cancer. The US regulatory authority had originally granted accelerated approval for Avastin's use in treating...

SwitzerlandSwitzerland

16.11.2011

Basel/Hervel – It may be the end of Novartis' lucky streak in osteoporosis. While the once a year osteoporosis injection Aclasta (a bisphosphonate) sells well, the Swiss pharma company had to break disastrous news from a...

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