The U.S. Food and Drug Administration (FDA) has agreed to review an application seeking approval of sotatercept as a treatment for adults with pulmonary arterial hypertension (PAH). The FDA has given the application priority review, shortening the review time from the usual 10 months to six months. A decision…
Note: This story was updated Jan. 30, 2024, to correct the approved indications of available treprostinil formulations. Amid ongoing litigation, the U.S. Food and Drug Administration (FDA) has agreed to review an application from Liquidia that seeks to extend the approval of Yutrepia — an inhaled dry powder…
Corsair Pharma has secured $23 million in financing to support clinical testing of a skin patch for the delivery of treprostinil to treat pulmonary arterial hypertension (PAH), the company announced. The transdermal patch is intended to provide continuous and consistent levels of treprostinil, similar to those achieved with…
Treatment with VU6047534, an experimental therapy that blocks the activity of a specific type of serotonin receptor, reduced strain on the heart in a mouse model of pulmonary arterial hypertension (PAH) in a new study. The study, “Development of a Peripherally Restricted 5-HT2B Partial Agonist for Treatment…
A joint initiative between a Singapore-based medical technology company and Duke University is aiming to develop and commercialize artificial intelligence, or AI, tools for echocardiography — using ultrasounds to visualize the heart. Researchers from Us2.ai, the first new company created from an 11-country cardiovascular research platform, have teamed up…
Gradient Denervation Technologies has raised €14 million (around $14.9 million) in funding to support the clinical development and testing of an ultrasound-based catheter device for the treatment of pulmonary hypertension (PH). The minimally invasive catheter device is designed for use in the pulmonary arteries. It delivers therapeutic ultrasound…
An inhaled formulation of imatinib in development by Aerami Therapeutics to treat pulmonary arterial hypertension (PAH), was safe and well tolerated with few systemic side effects among healthy adults in a Phase 1 trial. AER-901, which is delivered via a smart, breath-activated nebulizer, also showed a distinct absorption…
Treatment with sotatercept in addition to standard pulmonary arterial hypertension (PAH) therapies significantly improved measures of heart health for adults with the disease, according to a new analysis of the STELLAR trial. Results from the Phase 3 trial had already shown the therapy enhanced walking abilities in the participants…
Treatment with treprostinil improved the risk profile in people with inoperable or persistent severe chronic thromboembolic pulmonary hypertension (CTEPH). The risk profile was assessed using a risk score established to predict a response to treatment and survival in people with pulmonary arterial hypertension (PAH), the most common type…
A Phase 3 clinical trial testing high-dose Opsumit (macitentan) in people with chronic thromboembolic pulmonary hypertension (CTEPH) has ended early after an analysis showed the treatment is unlikely to help patients. The announcement was made in a press release from Janssen, the company that markets Opsumit. Opsumit…
The protein LTBP1 is active at high levels in pulmonary arterial hypertension (PAH) and may be a diagnostic marker and therapeutic target in the disease, a new study indicates. “Our study suggests that LTBP1 is involved in the development of PAH and serves as a potential diagnostic and therapeutic…
AI Therapeutics has begun dosing in a clinical trial testing inhaled LAM-001, a potential disease-modifying therapy for pulmonary arterial hypertension (PAH). The 24-week, open-label Phase 2 study (NCT05798923) is recruiting 15 adults at Brigham and Women’s Hospital in Boston, Massachusetts. All participants should have advanced PAH…
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