Clik here to view.
Once Again FDA Rejects Oral Treprostinil For Pulmonary Arterial Hypertension
For the second time the FDA has issued a complete response letter rejecting the new drug application (NDA) of oral treprostinil for the treatment of pulmonary arterial hypertension (PAH) . The...
View ArticleClik here to view.
Candidate Therapeutic Target For Pulmonary Arterial Hypertension Identified
I don’t normally write about pre-clinical research but my friend and CardioExchange colleague John Ryan has been on a tear lately (he even won a Young Investigator award from the AHA last year) with...
View ArticleClik here to view.
Novel Pulmonary Hypertension Drug From Bayer Shows Modest Promise In Phase 3...
A new drug appears to have promising– but not game-changing– effects in people with two forms of pulmonary hypertension. Riociguat, a soluble guanylate cyclase stimulator under development by Bayer, is...
View ArticleClik here to view.
FDA Panel Recommends Approval For Pulmonary Hypertension Drug From Bayer
The FDA’s Cardiovascular and Renal Drugs Advisory Committee recommended approval for Bayer’s new pulmonary hypertension drug, riociguat. The committee voted 11-0 in favor of approving the drug for two...
View ArticleClik here to view.
New Actelion Drug Found Safe And Effective In Pulmonary Arterial...
Macitentan, a new drug for pulmonary arterial hypertension (PAH), appears to be safe and effective, but it is unclear whether it offers any significant advantages over currently available drugs. The...
View ArticleClik here to view.
New Drug For Pulmonary Hypertension Approved By FDA
The FDA today approved a new drug for pulmonary hypertension. Bayer HealthCare’s riociguat (brand name Adempas) was approved for 2 indications: The treatment of adults with persistent/recurrent chronic...
View ArticleClik here to view.
FDA Approves New Pulmonary Hypertension Drug From Actelion
The FDA today approved macitentan (Opsumit, Actelion), a new oral endothelin-receptor antagonist that is an enhanced version of the company’s bosentan (Tracleer). The drug is indicated to delay disease...
View ArticleClik here to view.
Phase 4 Actelion Study Misses Primary Endpoint
Actelion announced today that a phase 4 study with its blockbuster drug bosentan (Tracleer) had failed to meet its primary endpoint. The COMPASS-2 trial was a prospective, randomized, double-blind,...
View Article
