The U.S. Food and Drug Administration (FDA) has approved Novitium Pharma‘s generic sildenafil for oral suspension at a dose of 10 mg/mL for the treatment of pulmonary arterial hypertension (PAH). This product, which had been designated a competitive generic therapy by the FDA, is the first…
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A combination of measures of clinical worsening may be meaningful in determining response to therapies in pediatric clinical trials, and a good gauge prognosis in children with pulmonary arterial hypertension (PAH), a registry-based study reports. Disease worsening defined by the occurrence or progression of symptoms, particularly, was found to…
The latest INSPIRE Phase 3 trial data on LIQ861 as a treatment for pulmonary arterial hypertension (PAH) support the submission of a New Drug Application (NDA) with the U.S. Food and Drug Administration. Liquidia Technologies — LIQ861’s manufacturer — announced that it expects to request a pre-NDA…
AIT Therapeutics has obtained a funding agreement that will raise $8 million through private investment in public equity (PIPE) financing to further development of its nitric oxide-based treatments for persistent pulmonary hypertension of the newborn, bronchiolitis, and nontuberculous mycobacteria. Nitric oxide (NO) is a strong vasodilator that opens blood vessels, and is…
Treatment with Revatio (sildenafil) successfully reduced symptoms of portopulmonary hypertension (PPHTN), allowing patients to undergo liver transplant safely, a case report study shows. The case report study, “Sildenafil Monotherapy to Treat Portopulmonary Hypertension Before Liver Transplant,” was published in the journal Transplantation Proceedings. Pulmonary hypertension (PH)…
AIT Therapeutics’ on-demand nitric oxide (NO) ventilator is safer for patients with pulmonary hypertension (PH), and for healthcare workers, compared with standard NO cylinders, a study shows. The study’s results were highlighted in a poster titled “On-Demand Nitric Oxide for Ventilator-Based Nitric Oxide Inhalation: A Risk-Reduction…
New data support the safety and effectiveness of TIVUS (therapeutic intra-vascular ultrasound) for patients with pulmonary arterial hypertension (PAH) on a stable treatment regimen. The data were recently presented at the annual meeting of the European Association of Percutaneous Cardiovascular Interventions (EuroPCR), in Paris. In PAH, small arteries inside…
Owlstone Medical has established a strategic collaboration with Actelion Pharmaceuticals to develop and validate a breath-based diagnostic test for different types of pulmonary hypertension (PH). Actelion Pharmaceuticals will solely fund this discovery and development program. The test will be based on Owlstone’s non-invasive method called Breath Biopsy, in…
The Pulmonary Hypertension Accelerated Bayer (PHAB) Awards, recently launched by Bayer US, will grant up to $1 million dollars for clinical research into pulmonary hypertension (PH). Spread over two years, the program, which is one of the largest industry-funded grant programs, will focus primarily on pulmonary arterial hypertension (PAH)…
RaDaR, the catchy new name for the U.S. government-run Rare Diseases Registry Program, aims to help patient advocacy groups with limited resources build their own disease registries. The site was developed by the National Center for Advancing Translational Sciences (NCATS), a division of the National Institutes of…
A type of abnormality in small blood vessels of the eyes, called retinal vascular tortuosity, may provide a non-invasive way to detect alterations in lung circulation in patients with pulmonary arterial hypertension (PAH), according to a new study. The research, “Retinal Vascular Tortuosity, a New Feature…
A new analysis of Actelion‘s GRIPHON clinical trial indicates that Uptravi (selexipag) tablets reduce the risk of disease complications or death in patients with pulmonary arterial hypertension (PAH), regardless of when treatment begins. However, its effectiveness was greater if started sooner after diagnosis. The data was presented at…
