News

LungFit PH NO therapy device wins marketing approval in Australia

LungFit PH, a device developed by Beyond Air for administering nitric oxide (NO) therapy, has received marketing approval from the Australian Therapeutic Goods Administration (TGA), which will allow the company to market the device as a Class IIb medical device. NO causes blood vessels to relax and widen, lowering…

Winrevair regimen balances efficacy, safety in PAH: Analysis

The dosing regimen for Winrevair (sotatercept-csrk) is optimal for balancing efficacy and safety in adults with pulmonary arterial hypertension (PAH), an analysis of clinical trial data shows. This regimen is “well-justified based on the totality of the observed safety and efficacy data from Phase 2 and Phase 3…

Weight-based Uptravi dosing appropriate for PAH children: Study

Body weight-adjusted Uptravi (selexipag) dosing for children and adolescents with pulmonary arterial hypertension (PAH) resulted in exposure to the treatment’s active ingredient comparable to that in adults with PAH, a study showed. The study assessed the treatment’s pharmacokinetics — its…

Phase 2 trial of tiprelestat for PAH receives FDA advice

The U.S. Food and Drug Administration (FDA) has provided Tiakis Biotech with advice for a planned Phase 2 clinical trial testing tiprelestat for pulmonary arterial hypertension (PAH). The ATHENA trial, which will assess the treatment’s safety and efficacy, is expected to enroll 90 patients, randomly assigned to receive…

Alivegen’s ALG-801 named FDA orphan drug for PAH

The U.S. Food and Drug Administration (FDA) has granted orphan drug designation to ALG-801, Alivegen’s experimental treatment for pulmonary arterial hypertension (PAH). That designation aims to support the development of therapies for rare diseases, or those affecting fewer than 200,000 people in the U.S. It comes with certain…

CS1 expanded access program for PAH now covers 10 patients

Cereno Scientific said it has enrolled nine additional people with pulmonary arterial hypertension (PAH) in its expanded access program (EAP) for investigational therapy CS1, bringing the total number of patients in the program to 10. The patients will continue receiving CS1 after completing a Phase 2a clinical trial.

Study IDs metabolites, genes as potential diagnostic markers in PAH

Using in-depth analyses and machine learning, scientists have identified several molecules and genes involved in metabolism that may be diagnostic markers of pulmonary arterial hypertension (PAH). Specifically, their research found five small molecules, or metabolites, and three metabolism-related genes that are tied to a PAH diagnosis. All were “identified…

Oxygen-sensing protein a potential therapeutic target in PAH: Study

An oxygen-sensing protein called hypoxia-inducible factor-1alpha, or HIF-1alpha, may contribute to worsening pulmonary arterial hypertension (PAH) and is a possible therapeutic target for people with this rare type of pulmonary hypertension, a study by Chinese scientists found. According to the researchers, HIF-1alpha may worsen PAH by increasing the uptake…