News

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 is expected by March 26.

“The FDA’s acceptance of this application is an exciting milestone in our journey to bring this novel activin signaling inhibitor to patients,” Joerg Koglin, MD, PhD, senior vice president of global clinical development at Merck Research Laboratories, said in a company press release. Merck acquired exclusive rights to sotatercept in pulmonary hypertension through the acquisition of Acceleron Pharma. read more

This column describes the author’s own experiences with some prescription and over-the-counter drugs. Not everyone will have the same response to treatment. Consult your doctor before starting or stopping a therapy.

When I was in college, I always had a Ricola cough drop on hand. They littered my life. Their yellow wrappers could be found on my nightstand, in my pockets, and deep in the corners of my backpack and purses. At some point during my freshman year, I began to believe that the peppermint flavoring helped to open up my lungs. Breathing in while sucking on the menthol-laced drops affected me like Vicks VapoRub. read more

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 formulation of treprostinil — to cover pulmonary hypertension associated with interstitial lung disease (PH-ILD).

The FDA in 2021 granted Yutrepia tentative approval for the treatment of pulmonary arterial hypertension (PAH). If approved, the extension would cover the therapy also for PH-ILD, which refers to high blood pressure in the lungs that develops due to diseases that cause scarring of lung tissues. read more

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 an infusion pump. It delivers an inactive prodrug of the medication, approved to treat PAH, that can cross the skin, reach the blood, and be converted into treprostinil in the liver, the company reports. read more

Most people will admit to having at least one vice. My worst one is eating sweets — I’d rather have cake for dinner than the actual dinner itself. My husband Tim’s worst vice is nicotine.

On our first date, Tim and I walked through the streets of my hometown chatting, laughing, and having a great time. About halfway through the walk, he pulled out a cigarette to smoke. He saw my reaction and quickly said, “I’m trying to quit.”

Everything else about Tim was so great. He was a responsible boss, an Eagle Scout, good looking, and our conversation flowed so freely. He was just what I had been looking for, and nobody can be perfect. read more

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 of Pulmonary Arterial Hypertension,” was published in the Journal of the American College of Cardiology: Basic to Translational Science.

Serotonin is a signaling molecule that has many different roles throughout the body. It perhaps is best known for its activity in the brain, where it plays key roles in regulating mood. Serotonin acts by binding to protein receptors on the surface of cells, and there are several different types of serotonin receptors with specialized functions. read more

Fall has always been my favorite season. Unfortunately, San Diego doesn’t quite have the enchanting fall foliage that other places do. Instead of a vibrant cascade of leaves, it’s more like a few scattered ones and a whimsical dance of pollen floating through the air. That mix mingles here with the sunshine and swaying palm trees.

Isn’t it such a magical time? Watching the transformation reminds me that we often need to shed our leaves as we let go of things in our lives. Managing a rare disease like pulmonary hypertension (PH) is challenging, and I often need to eliminate some stressors. Like cleaning out your closet several times yearly, you also need to clean your life. read more

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 with those from Duke, a leading U.S. university, to create new AI tools that will aid in more timely, and better, diagnoses and management of heart and heart-related diseases, including pulmonary hypertension (PH). read more

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 energy to reduce nervous signals that stimulate the narrowing of these blood vessels, which can potentially lower blood pressure and alleviate PH symptoms. read more

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 profile over oral imatinib, suggesting efficient concentrations in the lung tissue and little swallowing.

These findings were presented at the 2023 European Respiratory Society (ERS) International Congress, which was held Sept. 9-13 in Milan, Italy. The talk was titled, “Low Systemic Exposure With Targeted Administration of AER-901 (Inhaled Imatinib): Results of a Phase 1 Clinical Trial.” read more