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Selexipag meets primary endpoint in pivotal Phase III GRIPHON outcome study

17-06-2014

Actelion Ltd announced the top-line results of the pivotal Phase III GRIPHON study in 1,156 patients with pulmonary arterial hypertension (PAH) with selexipag, the first selective oral prostacyclin IP receptor agonist. Initial analysis shows that the event-driven outcome study has met its primary ...

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Management change at Actelion

06-05-2014

Actelion Ltd announced that Roland Haefeli, Senior Vice President, Head of Investor Relations and Public Affairs (IR & PA) and member of the Extended Actelion Executive Committee (AEC) has decided to step down from his current role for personal reasons effective 05 May 2014. Roland Haefeli will ...

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Actelion receives Health Canada approval of Opsumit

18-11-2013

Actelion Ltd announced that Health Canada has granted a Notice of Compliance (NOC) approving the orally available endothelin receptor antagonist OpsumitTM(macitentan) 10mg once daily for the treatment of pulmonary arterial hypertension (PAH). Opsumit (macitentan) is indicated in Canada, for the ...

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Actelion is initiating Phase III clinical development of cadazolid in patients suffering from Clostridium difficile associated diarrhea

12-09-2013

Actelion announced that it will initiate a Phase III clinical development program to assess the efficacy and safety of cadazolid in patients with Clostridium difficile-associated diarrhea (CDAD).The Phase III program consists of two identical multi-center, randomized, double-blind studies ...

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Actelion's novel antibiotic cadazolid to move into Phase III clinical development in patients suffering from Clostridium difficile associated diarrhea

04-01-2013

Actelion announced that it has decided to move forward with Phase III clinical development of cadazolid in patients suffering from Clostridium difficile associated diarrhea (CDAD). The decision is based on the results of a therapeutic exploratory Phase II dose-finding study randomizing 84 ...

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Actelion's ponesimod successful in mid-stage trial in patients with plaque psoriasis

Ponesimod to proceed to Phase III clinical development in psoriasis

21-12-2012

Actelion announced that its selective S1P1 modulator, ponesimod, successfully met the primary endpoint - the proportion of patients with at least 75% improvement in Psoriasis Area and Severity Index (PASI) from baseline (PASI75) at week 16 - in a double blind, placebo-controlled study conducted ...

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Actelion submits the registration dossier for macitentan to EMA

23-11-2012

Actelion announced that the submission of the Marketing Authorisation Application (MAA) for macitentan (Opsumit®) for the treatment of patients with pulmonary arterial hypertension to the EMA has been accepted. The EMA will now start the formal review process.The United States Food and Drug ...

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Actelion announces cost saving initiative to be implemented by the end of 2012

Initiative could result in a reduction of up to 135 positions

13-07-2012

Actelion announced that the company has launched a cost saving initiative as an integral part of its strategy for value creation outlined in early May 2012. The initiative will ensure that the company can fully capitalize on the significant growth opportunities in its core area of expertise of ...

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Actelion's macitentan meets primary endpoint in pivotal Phase III study

03-05-2012

Actelion announced that initial analysis indicates that the pivotal, long-term, event-driven study SERAPHIN with macitentan, a novel dual endothelin receptor antagonist, in 742 patients suffering from pulmonary arterial hypertension (PAH) and treated for up to three and a half years, has met its ...

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Japan's Ministry of Health, Labour and Welfare grants approval for Actelion's miglustat for the treatment of Niemann-Pick type C disease

04-04-2012

Actelion Ltd announced that Japan's Ministry of Health, Labour and Welfare has granted approval for miglustat for the treatment of Niemann-Pick type C disease.The approval was based on the data generated for the first approval of miglustat in this indication in the European Union, as well as data ...

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