Tag: PAH

Occlutech’s Atrial Flow Regulator (AFR) Receives U.S. FDA Breakthrough Device Designation

SCHAFFHAUSEN, Switzerland, Dec. 18, 2020 /PRNewswire/ — Occlutech, a privately-held company, announced today that the US Food and Drug Administration (FDA) has granted the company a Breakthrough Device designation for its first-in-class, implantable Atrial Flow Regulator (AFR) for Pulmonary Arterial Hypertension (PAH). PAH […]

Acceleron Presents New Data from the PULSAR Phase 2 Trial, Preclinical Research on Sotatercept in Pulmonary Arterial Hypertension (PAH) at the 2020 American Heart Association (AHA) Scientific Sessions

– Treatment with sotatercept in the ongoing PULSAR Phase 2 trial was associated with improvements in cardiac and pulmonary function at week 24 – – Presentation of echocardiography data from the PULSAR trial received AHA’s “Cardiopulmonary Best Abstract” Award – […]

Janssen Submits New Drug Application (NDA) to U.S. FDA for UPTRAVI® (selexipag) Injection for Intravenous Use to Treat Pulmonary Arterial Hypertension (PAH)

SOUTH SAN FRANCISCO, Calif., Sept. 30, 2020 /PRNewswire/ — The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for UPTRAVI® (selexipag) as an injection for intravenous (IV) use for the treatment […]

Bayer Phase IV Study Met its Primary Endpoint in PAH Patients Who Had Transitioned to Adempas® (riociguat) After Insufficient Response to PDE5 Inhibitors

Data presented as a late-breaker during a virtual ALERT session at the annual meeting of the European Respiratory Society Outcomes from the randomized, controlled, open-label REPLACE study included results from 226 patients with pulmonary arterial hypertension (PAH) WHIPPANY, N.J.–(BUSINESS WIRE)–Bayer […]

Liquidia Releases Exploratory Endpoint Data from INSPIRE Study at the American Thoracic Society (ATS) Annual Meeting

New data from INSPIRE LIQ861 safety and tolerability study in pulmonary arterial hypertension (PAH) patients demonstrate positive trends in exploratory endpoints, including quality of life (QoL) RESEARCH TRIANGLE PARK, N.C., Aug. 05, 2020 (GLOBE NEWSWIRE) — Liquidia Technologies, Inc. (NASDAQ: […]

United Therapeutics Announces Additional Results From FREEDOM-EV Study Showing The Hemodynamic And Risk Status Reduction Benefits Of Orenitram Treatment In Patients With Pulmonary Arterial Hypertension

– Orenitram demonstrated improvement in hemodynamic parameters and risk status, important indicators of long-term outcomes in PAH patients, in presentations at recent scientific conferences – Separately, total PAH-related patient healthcare costs are 67% higher for selexipag in article published in […]

Acceleron Announces Sotatercept Achieved Primary and Secondary Endpoints in the PULSAR Phase 2 Placebo-Controlled Trial in Patients with Pulmonary Arterial Hypertension

– The PULSAR trial achieved its primary endpoint: a statistically significant reduction in pulmonary vascular resistance – – The trial also achieved statistically significant improvements in the key secondary endpoint of six-minute walk distance (6MWD) and other secondary endpoints, including […]

Acceleron Receives FDA Orphan Drug Designation for Sotatercept in Pulmonary Arterial Hypertension

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Acceleron Pharma Inc. (NASDAQ:XLRN), a leading biopharmaceutical company in the discovery and development of TGF-beta superfamily therapeutics to treat serious and rare diseases, today announced that the United States Food and Drug Administration (FDA) has granted Orphan Drug […]

Altavant Sciences to Present Data Supporting Planned Phase 2 Clinical Program for Rodatristat Ethyl in Patients with Pulmonary Arterial Hypertension at PVRI World Congress

BASEL, Switzerland and DURHAM, N.C., Jan. 31, 2019 /PRNewswire/ — Altavant Sciences, a company in the Roivant family focused on clinical development of novel therapies for pulmonary arterial hypertension (PAH) and other indications, will present its latest nonclinical and clinical data at the Pulmonary Vascular […]

Arena Pharmaceuticals Announces Closing of Global License Agreement with United Therapeutics for Ralinepag

SAN DIEGO, Jan. 24, 2019 /PRNewswire/ — Arena Pharmaceuticals, Inc. (Nasdaq: ARNA) today announced the closing of the global license agreement with United Therapeutics Corporation (Nasdaq: UTHR) for the Arena-discovered, Phase 3 investigational drug candidate ralinepag, a next-generation, oral, selective and potent prostacyclin receptor agonist for […]