03:07 , Feb 4, 2017 |  BioCentury  |  Strategy

Actelion, take two

After surviving takeover attempts, an investor mutiny and a make-or-break gamble on Opsumit macitentan, Actelion Ltd. co-founder and CEO Jean-Paul Clozel finally took a deal management couldn’t refuse. Johnson & Johnson’s proposed $30 billion acquisition provides...
07:00 , May 19, 2014 |  BioCentury  |  Regulation

Beyond vasodilators in PAH

At last week's FDA patient-focused drug development meeting, pulmonary arterial hypertension patients credited marketed vasodilators with saving their lives, but said dyspnea and fatigue are still crippling. Clinicians say targeting the underlying inflammatory and fibrotic...
07:00 , Jul 29, 2013 |  BC Week In Review  |  Company News

Actelion sales and marketing update

Actelion disclosed in its 1H13 earnings that at the end of 2Q13 it launched 0.5 and 1.5 mg epoprostenol as Epoprostenol ACT in Japan to treat pulmonary arterial hypertension (PAH). The formulation of the...
07:00 , Jul 29, 2013 |  BC Week In Review  |  Clinical News

Veletri epoprostenol regulatory update

Actelion disclosed in its 1H13 earnings that Veletri epoprostenol was approved in the Netherlands and the U.K. under the EU's decentralized procedure to treat pulmonary arterial hypertension (PAH). The formulation of the prostacyclin analog is...
08:00 , Feb 25, 2013 |  BC Week In Review  |  Clinical News

Veletri regulatory update

Actelion said Japan's Ministry of Health, Labor and Welfare (MHLW) approved a second-generation formulation of 0.5 and 1.5 mg epoprostenol as Epoprostenol "ACT" to treat pulmonary arterial hypertension (PAH). Actelion, which plans to launch the...
07:00 , Oct 29, 2012 |  BC Week In Review  |  Company News

Actelion sales and marketing update

Actelion disclosed in its 3Q12 earnings that in October it launched a second-generation formulation of Veletri epoprostenol in the U.S. to treat pulmonary arterial hypertension (PAH) to improve exercise capacity. FDA approved the prostacyclin...
07:00 , Jul 9, 2012 |  BC Week In Review  |  Clinical News

Veletri epoprostenol regulatory update

FDA approved an sNDA for a second generation formulation of Veletri epoprostenol to treat pulmonary arterial hypertension (PAH) to improve exercise capacity. Actelion plans to launch the prostacyclin analog this quarter. Veletri was initially approved...
07:00 , Oct 10, 2011 |  BioCentury  |  Product Development

Gleevec in PAH

Phase III data for Novartis AG's Gleevec imatinib show potential for the tyrosine kinase inhibitor in late-stage pulmonary arterial hypertension. But its second-generation TKI Tasigna nilotinib could do even better and has more patent life. Gleevec...
07:00 , Aug 1, 2011 |  BC Week In Review  |  Clinical News

Veletri epoprostenol regulatory update

Actelion disclosed in its 1H11 earnings that it withdrew an application in France for Veletri epoprostenol to treat pulmonary arterial hypertension (PAH) in order to seek approval of a second generation product. By year end,...
07:00 , Oct 11, 2010 |  BC Week In Review  |  Clinical News

Veletri epoprostenol regulatory update

FDA approved additional conditions for preparation and storage of Veletri epoprostenol to treat moderate to severe pulmonary arterial hypertension (PAH) and PAH associated with the scleroderma spectrum of disease. Patients may prepare medication up to...