SwitzerlandSwitzerland

Roche runs for EU application of subcutaneous Herceptin

26.03.2012

Basel/Vienna - Following promising results from a Phase III study, Roche has submitted a regulatory application to EMA for subcutaneous Herceptin (trastuzumab) to treat HER2-positive breast cancer. Roche said subcutaneous administration of Herceptin is less invasive and more convenient to patients, as it takes approximately five minutes instead of 30-90 minutes with the approved intravenous (IV) administration. The regulatory application is based on data from the Phase III HannaH trial presented on March 23 the at the European Breast Cancer meeting in Vienna. Subcutaneous Herceptin produced a complete pathologic response rate, the co-primary endpoints of pharmacokinetics and efficacy met their pre-specified criteria. The drug concentration in the blood measured just before surgery was at least as high for the SC as for the IV formulation (69.0 and 51.8 µg/mL, respectively). This is important in order to demonstrate comparable efficacy. In addition, efficacy, determined by pCR, in patients treated in the SC arm was in the same range as in patients who received the IV formulation (45.4 percent and 40.7 percent, respectively). Subcutaneous Herceptin is formulated using Enhanze recombinant human hyaluronidase (rHuPH20) drug delivery technology from Halozyme Therapeutics Inc.

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...

SwitzerlandSwitzerland

11.11.2011

Ghent/Geneva - Ablynx rides the biotech rollercoaster. Only days after US-pharma company Pfizer pulled out of a rheumatoid arthritis pact, the Belgian bipharmaceutical outfit expanded its relationship with Merck Serono. Ablynx...

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