SwitzerlandSwitzerland

FDA says no to Avastin for breast cancer

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Basel – The FDA has withdrawn the accelerated approval for Roche's Avastin (bevacizumab) to treat metastasising breast cancer.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 breast cancer in 2008 when the drug's manufacturer Genentech submitted a study showing that Avastin extended progression-free survival. However, subsequent studies failed to confirm the initial findings, and in December 2010, following a hearing, the FDA's Center for Drug Evaluation and Research (CDER) recommended withdrawal of the drug for treating breast cancer. Genentech appealed the decision, and another hearing was held in June, at which time CDER again recommended withdrawal. FDA Commissioner Margaret Hamburg encouraged Roche's biotech daugther Genentech Inc. to continue to study the drug in the indication to identify patients who may benefit. Genentech plans to start a Phase III trial in 2012 of Avastin plus paclitaxel in previously untreated metastatic breast cancer. The trial will evaluate a potential predictive biomarker and will measure progression-free survival. At a June FDA hearing, Genentech proposed to conduct a confirmatory trial that would evaluate co-primary endpoints of PFS in the overall population and in a subgroup expressing high levels of VEGF-A, Avastin's target. Genentech markets Avastin in the U.S. and Roche sells it elsewhere. The drug is approved in the U.S. for metastatic colorectal cancer (mCRC), non-small cell lung cancer (NSCLC), renal cell carcinoma (RCC) and glioblastoma multiforme (GBM). The approval of Avastin for treating breast cancer patients in Europe remains unaffected.

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

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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