SwitzerlandSwitzerland

Positive opinion on personalised skin cancer medicine

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 diagnostic test should be granted full marketing authorisation as a monotherapy for the treatment of adult patients with BRAF V600 mutation-positive unresectable or metastatic melanoma. “The CHMP recommendation to approve Zelboraf represents an important milestone for people with metastatic melanoma who until recently had limited treatment options,” said Hal Barron, chief medical officer and head of Global Product Development at Roche. Metastatic melanoma is the deadliest and most aggressive form of skin cancer with less than one in four people expected to be alive 12 months after their diagnosis. Earlier this year, Zelboraf became the first and only FDA and Swissmedic approved personalised medicine for people with BRAF V600 mutation-positive inoperable or metastatic melanoma that is shown to improve survival. The cobas 4800 BRAF V600 Mutation Test, co-developed by Roche, was approved simultaneously with Zelboraf in the US and CE-marked in the EU where it is commercially available. Zelboraf is designed to target and inhibit mutated forms of the BRAF protein found in about half of all cases of melanoma. Roche expects the corresponding European Commission decision on the Marketing Authorization of Zelboraf in February 2012.

SwitzerlandSwitzerland

30.03.2012

Basel/Hinxton (UK) – Two European teams have created huge repositories of cancer genomics data that help predict drug response. Swiss Novartis and the Boston-based Broad Institute have combined data obtained from large-scale...

SwitzerlandSwitzerland

27.03.2012

London/Lausanne – The global private equity firm Celtic Therapeutic L.L.L.P. believes in the power of antibody-drug conjugates (ADCs). It is investing $50m in a new Switzerland-based company called ADC Therapeutics Sarl which...

SwitzerlandSwitzerland

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...

SwitzerlandSwitzerland

09.03.2012

After the US Food & Drug Administration forced Swiss generics giant Sandoz AG to update its production facilities in Quebec, there are now fears that supplies of some medicines could grow tight in Canada. The regulatory authority...

SwitzerlandSwitzerland

08.03.2012

The hepatitis C space has seen a string of large deals in the last weeks that include a US$11bn buyout of Pharmasset by Gilead. Now Novartis is also trying to get in the game with the purchase of a global exclusive licence from...

SwitzerlandSwitzerland

06.03.2012

Allschwil – Swiss Actelion Ltd. has strengthened its commercial offerings by securing rights in certain countries to Auxilium’s biotech drug Xiaflex for treating tissue buildup under the skin. The US pharma is to receive US$10m...

SwitzerlandSwitzerland

06.03.2012

Zug – Life Sciences specialist HBM partners has raised €90m in the first close of its HBM BioCapital II fund, which will invest in revenue-generating companies in the pharmaceuticals, medical device and diagnostics sectors....

SwitzerlandSwitzerland

05.03.2012

Stans – Mondobiotech, a drug discovery company in troubled waters, could soon be under Italian ownership: The Swiss biotech announced it has entered into exclusive negotiations with Milan-based provider of pharmaceutical and...

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No liability assumed, Date: 01.08.2014


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