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FDA grants Orphan Drug Designation to IONIS-HTTRx
5 January 2016 | By Victoria White
IONIS-HTTRx is a Gen. 2.0+ antisense drug in development for the treatment of Huntington's disease...
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FDA approves Roche’s Alecensa for ALK-positive NSCLC
14 December 2015 | By Victoria White
Alecensa (alectinib) is approved for patients whose disease has worsened after, or who could not tolerate treatment with Xalkori (crizotinib)...
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Roche and Upsher-Smith to develop VAP-1 inhibitor
1 December 2015 | By Victoria White
The novel, oral small molecule inhibitor of VAP-1 is a cell-adhesion molecule that may be effective in the treatment of inflammatory diseases...
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EC approves Cotellic plus Zelboraf in advanced melanoma
25 November 2015 | By Victoria White
The approval is based on data that showed Cotellic plus Zelboraf helped people with previously untreated BRAF V600 mutation-positive advanced melanoma live for more than a year without their disease worsening...
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Kadcyla ‘price remains too high’, says NICE
17 November 2015 | By Victoria White
NICE has published final draft guidance not recommending the use of Kadcyla as a treatment for a type of advanced breast cancer because the price is too high...
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FDA approves Tagrisso for non-small cell lung cancer
13 November 2015 | By Victoria White
Tagrisso (AZD9291) is the only approved medicine indicated for patients with metastatic EGFR T790M mutation-positive non-small cell lung cancer...
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Roche restructures its manufacturing network for small molecules
13 November 2015 | By Victoria White
Roche plans to restructure its manufacturing network for small molecules to address current underutilisation as a result of its evolving portfolio...
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FDA approves Cotellic plus Zelboraf in advanced melanoma
11 November 2015 | By Victoria White
The approval is for the treatment of people with BRAF V600E or V600K mutation-positive unresectable or metastatic melanoma...
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SMC accepts Keytruda as a treatment option for advanced melanoma
10 November 2015 | By Victoria White
The SMC also announced positive recommendations for Roche’s Avastin (bevacizumab) and Daiichi Sankyo’s Lixiana (edoxaban)...
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Ocrelizumab signficantly reduces disability progression in MS in studies
9 October 2015 | By Victoria White
Roche’s Chief Medical Officer said the results of the pivotal trials have the potential to transform the treatment of MS...
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Cotellic Zelboraf combo demonstrates significant overall survival results
6 October 2015 | By Victoria White
Results from a Phase III study show that Cotellic plus Zelboraf helped people with advanced melanoma live significantly longer compared to Zelboraf alone...
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Esbriet data show benefits of long-term treatment in IPF
29 September 2015 | By Victoria White
A pooled analysis from two Phase III studies showed a 38% reduction in risk of death in IPF patients who stayed on Esbriet treatment up to two years...
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Ocrelizumab first medicine to show efficacy in PPMS
28 September 2015 | By Victoria White
Roche's study met its primary endpoint, showing treatment with ocrelizumab significantly reduced the progression of clinical disability...
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CHMP recommends Cotellic and Zelboraf combo in advanced melanoma
25 September 2015 | By Victoria White
The CHMP’s recommendation is based primarily on results of a Phase III study that showed that people who received the combination of Cotellic and Zelboraf lived over a year without their disease worsening...
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Roche’s IPF drug Esbriet approved in Switzerland
23 September 2015 | By Victoria White
In a Phase III study, significantly more patients who received Esbriet showed delayed progression of idiopathic pulmonary fibrosis (IPF) than those who received placebo...
