The U.S. Food and Drug Administration (FDA), a vast government bureaucracy, employs about 17,500 people and had a budget of $5.7 billion in 2019. Yet even with its enormous resources, the FDA these days relies more and more on patients to…
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Switching from injectable treprostinil or epoprostenol to a combination therapy including inhaled treprostinil appears to be safe, well tolerated, and effective for a select group of patients with clinically stable pulmonary arterial hypertension (PAH), a study suggests. The study, “Ambulatory Transition from Parenteral Prostanoid…
The biopharmaceutical PhaseBio announced positive results from a case study involving a patient with pulmonary arterial hypertension (PAH) who received treatment with PB1046, a new therapy using the company’s proprietary technology platform. PB1046…
The gleaming new Dutch headquarters of the European Medicines Agency (EMA), fronting Domenico Scarlattilaan in Amsterdam’s suburban Zuidas business district, finally opened for business last month — just over two years after the European Union decided to relocate the EMA to the Netherlands in the wake of Brexit.
Seeking to further advance research into treatments for pulmonary hypertension (PH), the nonprofit Team PHenomenal Hope is now accepting submissions for its research award program. Called the PHenomenal Impact Fund for Global PH Research, the program supports investigations in basic or translational science, clinical research, and clinical…
Liquidia Technologies is requesting U.S. Food and Drug Administration (FDA) approval of LIQ861, an inhaled dry powder formulation of the vasodilator treprostinil, to treat pulmonary arterial hypertension (PAH). The request came in the form of a new drug application (NDA) to the agency. LIQ861…
Treatment with sotatercept (ACE-011) eased heart strain and improved exercise capacity in individuals with pulmonary arterial hypertension (PAH) participating in the Phase 2 PULSAR trial, according to Acceleron Pharma, the therapy’s manufacturer. Sotatercept is an investigational compound designed to bind and entrap proteins…
A new generic version of Actelion’s Tracleer (bosentan), developed by Alembic Pharmaceuticals, has been approved by the U.S. Food and Drug Administration (FDA) for treating pulmonary arterial hypertension (PAH). The approval comes after Alembic submitted an abbreviated new drug application (ANDA) for generic bosentan tablets. ANDA is an application for…
The newly founded Pulmonary Wellness Foundation recently launched its interactive online 2020 Lecture Series, covering an array of topics related to respiratory health for patients, caregivers, family members, and clinicians. The free webinars are presented at 7 p.m. EST every Wednesday by the nonprofit and its founder, cardiopulmonary…
Measuring the levels of the N‐terminal pro B-type natriuretic peptide (NT-proBNP) — a validated and widely accepted prognostic marker of pulmonary hypertension (PH) — in the urine of babies born prematurely is feasible, and may facilitate the screening of PH, a study suggests. The study, “Urinary NT-proBNP as…
Minimal incisions, shorter hospital stays, and faster recovery are some of the advantages of robotic heart surgery to repair a leaky mitral valve — a risk factor for pulmonary hypertension (PH) — compared to conventional open-heart surgery, says a cardiovascular surgeon at the Mayo Clinic. Patients with…
New York cardiopulmonary physical therapist Noah Greenspan has launched the Pulmonary Wellness Foundation (PWF), a nonprofit group that provides free online information on a range of prevalent, rare and ultra-rare pulmonary diseases for those who can’t afford to pay for it. PWF specifically targets patients with pulmonary fibrosis,…
