Ascendis Pharma A/S Announces Initiation of a Phase 1 Single Ascending Dose Study of TransCon Treprostinil

16-Jan-2015 - Ascendis Pharma A/S announced that it has initiated a Phase 1 single ascending dose study of TransCon Treprostinil in healthy volunteers. TransCon Treprostinil is being developed to treat pulmonary arterial hypertension, a life-threatening orphan disease characterized by elevated blood pressure ...

Actelion receives Health Canada approval of Opsumit

18-Nov-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 ...

Bayer’s Riociguat submitted for regulatory approval in the U.S. and EU

12-Feb-2013 - Bayer HealthCare has submitted the oral investigational drug Riociguat to treat patients with inoperable chronic thromboembolic pulmonary hypertension (CTEPH) and pulmonary arterial hypertension (PAH) for regulatory approval in the United States and in the European Union. “These regulatory ...

Actelion submits the registration dossier for macitentan to EMA

23-Nov-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 ...

Actelion submits a NDA for macitentan for the treatment of patients with pulmonary arterial hypertension

23-Oct-2012 - Actelion announced that it has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) seeking approval for macitentan (Opsumit®) for the treatment of patients with pulmonary arterial hypertension.Macitentan, a novel oral dual endothelin receptor antagonist, was ...

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

03-May-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 ...

Novartis study shows QTI571 significantly improved walking distance in patients with life-threatening pulmonary arterial hypertension

30-Sep-2011 - Novartis announced new data today from the pivotal Phase III IMPRES clinical trial showing that the investigational therapy QTI571 (imatinib) significantly improved exercise capacity in patients with pulmonary arterial hypertension (PAH) after 24 weeks compared with placebo. Evidence indicates ...

BUILD-3 study with bosentan in idiopathic pulmonary fibrosis does not meet primary endpoint

02-Mar-2010 - Actelion Ltd announced the initial results of BUILD-3, a clinical study evaluating the safety and efficacy of bosentan in patients suffering from idiopathic pulmonary fibrosis. While there was a consistent trend in favor of bosentan, the primary endpoint, reduction in morbidity/mortality, was ...

Tracleer receives label extension in the US

10-Aug-2009 - Actelion Ltd announced that the U.S. Food and Drug Administration (FDA) has approved the company's supplemental New Drug Application (sNDA) for Tracleer® (bosentan) to treat patients with mildly symptomatic WHO Functional Class II (FC II) pulmonary arterial hypertension (PAH). The U.S. FDA has ...

Actelion's PGI2 receptor agonist demonstrates efficacy in pulmonary arterial hypertension patients

Morbidity-Mortality Phase III study to be initiated before year-end

20-Jul-2009 - Actelion Ltd announced that positive data have been obtained in a Phase IIa study with its first-in-class orally active non-prostanoid PGI2 receptor agonist in pulmonary arterial hypertension (PAH) patients. In the 43 patient placebo-controlled double-blind study to assess efficacy, safety and ...