V-Wave’s new interatrial shunt — a medical device designed to reduce arterial heart pressure — has been granted breakthrough device designation by the U.S. Food and Drug Administration (FDA) for the treatment of people…
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Translate Bio is focusing its efforts on the development of new therapies targeting pulmonary diseases, including pulmonary arterial hypertension and cystic fibrosis, among others. In light of this, the company is discontinuing the development of its lead candidate MRT5201 for ornithine transcarbamylase deficiency — a metabolic…
Altavant Sciences presented its patient-centered approach to drug development, which informed the design of an ongoing Phase 2 study, at the Pulmonary Hypertension Association’s recent Annual PH Professional Network (PHPN) Symposium. The effort was detailed in the poster “A Framework for Engaging PAH Patients in…
Owlstone Medical announced that it has introduced a new ReCIVA Breath Sampler and CASPER Portable Air Supply, designed to support researchers working to identify disease biomarkers and to measure levels of known volatile organic compounds (VOCs) on a person’s breath. Confirmed biomarkers provide valuable information to both clinicians and researchers…
The Endoarterial Biopsy Catheter (EABC), a tool for performing biopsies on lung artery walls to better evaluate pulmonary arterial hypertension (PAH) in people and responses to treatment, has been designated a humanitarian use device (HUD) by the U.S. Food and Drug Administration (FDA), its maker, Vascular Biosciences,…
The U.S. Food and Drug Administration (FDA) has granted orphan drug status to sotatercept for the treatment of pulmonary arterial hypertension (PAH), according to…
The U.S. Food and Drug Administration (FDA) has agreed to review a request to approve Trevyent (treprostinil) as a treatment of pulmonary arterial hypertension (PAH), United Therapeutics announced in a press release. An FDA decision on this updated New Drug Application (NDA) for Trevyent is expected on or before…
For two-and-a-half painful years, Jerome Maharaj, 42, had no idea what was wrong with him. Born in South Africa, he came to Israel in 1996 and settled in Ma’agan, a small kibbutz near the Sea of Galilee. He got married and raised three children. Jerome Maharaj standing…
The U.S. Food and Drug Administration (FDA) has granted the designation of breakthrough device to SoniVie’s Therapeutic Intra-Vascular Ultrasound (TIVUS) System for the treatment of people with pulmonary arterial hypertension (PAH). Similar to breakthrough therapy, the designation of breakthrough device is given to medical equipment…
Only two non-invasive diagnostic tests are required to best predict the risk of adverse events in people with congenital heart disease (CHD)-associated pulmonary arterial hypertension (PAH), a new study suggests. The study, “Guideline implementation and early risk assessment in pulmonary…
Swedish men and women who have been diagnosed with idiopathic pulmonary arterial hypertension (IPAH) in recent years have similar survival rates, study says. The study, “Sex-specific differences and survival in patients with idiopathic pulmonary arterial hypertension 2008–2016,” was published in the journal ERJ Open Research. IPAH, a form of…
Targeting the pro-inflammatory TGF-β signaling pathway in specific cells of the pulmonary arteries — those with high levels of a protein called periostin — shows promise in treating pulmonary arterial hypertension (PAH), a study reports. The study, “Periostin-expressing cell-specific transforming growth factor-β inhibition in pulmonary artery prevents pulmonary arterial…
