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Basel – The FDA has withdrawn the accelerated approval for Roche's Avastin (bevacizumab) to treat metastasising breast cancer.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

10.11.2011

Alschwil - Actelion Ltd. gets a badly needed injection of fresh capital. Under the guidance of the two biggest Swiss banks, UBS and Credit Suisse, the Swiss biopharmaceutical company takes up €171 million agreeing to pay a 4,875%...

SwitzerlandSwitzerland

18.10.2011

Basel/San Diego –Swiss drug company Roche has announced it is buying biotech-company Anadys Pharmaceuticals for US$230 million. Under the terms of the merger agreement, Roche will commence an all cash tender offer for all...

Germany, SwitzerlandSwitzerland

12.10.2011

The Swiss technology transfer organisation Unitectra is the winner of the European Biotechnica Award 2011. The specialist for technology transfer received the award from hands of Lower Saxony's Minister for Economy Jörg Bode. The...

SwitzerlandSwitzerland

01.10.2011

Liestal – Swiss Santhera AG has announced strict savings measures. Out of a total of 21 employees, almost every second is now slated to be sacked. The biotech firm is closing its department of preclinical development and scaling...

SwitzerlandSwitzerland

01.10.2011

Schlieren – Swiss biotechnology company Cytos AG has finally devised a plan to help its lead candidate into Phase II, but to achieve it, the cash-strapped company is having to slash its workforce by a whopping 85%. To ensure the...

SwitzerlandSwitzerland

01.10.2011

Geneva – Swiss biotech Addex Pharmaceuticals AG has regained all rights to its metabotropic glutamate receptor 4 (mGluR4) positive allosteric modulator (PAM) programme from Merck&Co, (known as MSD outside the United States and...

SwitzerlandSwitzerland

01.10.2011

Hamburg – When the compound EVT302 failed proof-of-concept testing in the spring of 2009, investors began backing away from Evotec AG shares. Now the selective MAO-B inhibitor is back, and has powered a leap in the company’s...

SwitzerlandSwitzerland

15.09.2011

Zurich – The FDA has posted a manufacturing warning to Lonza following an inspection of the firm's microbial production site for Eisai’s cancer drug Ontak in Hopkinton. However, analysts at Vontobel said that the impact of the...

SwitzerlandSwitzerland

30.08.2011

Schlieren - Swiss biotechnology company Cytos has devised a plan to get its lead candidate into Phase II. To achieve this, the cash strapped company will slash its workforce, as previously announced, by 85%. To ensure the...

SwitzerlandSwitzerland

22.08.2011

Liestal – Swiss Santhera Pharmaceuticals and researchers from Newcastle University have published the results from a pivotal clinical trial demonstrating that the firm’s synthetic coenzyme Q10 derivative idebenone significantly...

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