The US Food and Drug Administration, FDA, approves the single tablet combination macitentan/tadalafil for pulmonary arterial hypertension, March 22, 2024

On March 22, 2024 the Food and Drug Administration (FDA), the US drug regulatory authority, approved the single-tablet macitentan/tadalafil combination (Opsynvi) for pulmonary arterial hypertension. The application to the FDA was submitted by the Janssen Pharmaceutical Companies of Johnson & Johnson on May 30, 2023. The FDA approval is based on the results of the […]

The US Food and Drug Administration, FDA, approves the single tablet combination macitentan/tadalafil for pulmonary arterial hypertension, March 22, 2024 Read Post »

The Phase 3 clinical trial to evaluate the safety and efficacy of oral inhalation of seralutinib for pulmonary arterial hypertension is enrolling

The PROSERA Phase 3, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of the oral Inhalation of seralutinib for the treatment of pulmonary arterial hypertension is currently enrolling. The PROSERA study’s objective is to understand the effect of seralutinib on specific pathways in the body that lead to the inflammation, proliferation and fibrosis

The Phase 3 clinical trial to evaluate the safety and efficacy of oral inhalation of seralutinib for pulmonary arterial hypertension is enrolling Read Post »

“Breathe in, speak out”, an online platform developed by J&J Innovative Medicine to provide information and support to pulmonary arterial hypertension patients

The “Breathe In, Speak Out” online platform provides access to a range of pulmonary arterial hypertension focused information, resources and links to support networks to help patients manage their disease more effectively. Read more at this link on the Johnsson & Johsson Innovative Medicine website

“Breathe in, speak out”, an online platform developed by J&J Innovative Medicine to provide information and support to pulmonary arterial hypertension patients Read Post »

Phase 1 clinical trial on a treprostinil skin patch for pulmonary arterial hypertension due to start shortly

Corsair Pharma has developed a proprietary transdermal patch intended to provide consistent blood levels of treprostinil, a drug currently administered via a 24/7 infusion pump (sub-cutaneous or intra-venous, see this link for more details), by delivering an inactive prodrug, which crosses the skin, enters the blood, and converts rapidly to treprostinil in the liver. Since

Phase 1 clinical trial on a treprostinil skin patch for pulmonary arterial hypertension due to start shortly Read Post »

PHA Europe held its Annual Pulmonary Hypertension European Conference (APHEC) on November 8-12, 2023, featuring representatives of the scientific, patient, and health care communities

The European Association for Pulmonary Hypertension, PHA Europe, held its Annual European Pulmonary Hypertension Conference (APHEC) in Barcelona from 8-12 November 2023 in Castelledefels, Barcelona (Spain). The conference featured presentations by distinguished members of the scientific community (Prof. Adam Torbicki, Poland; Prof. Jean-Luc Vachiéry, Belgium; Prof Joanna Pepke-Zabka, UK; Prof. Jimmy Ford, USA; Prof. Dr.

PHA Europe held its Annual Pulmonary Hypertension European Conference (APHEC) on November 8-12, 2023, featuring representatives of the scientific, patient, and health care communities Read Post »

KEROS Therapeutics announces launch of a Phase 2 trial, TROPOS, to assess the effectiveness of KER-012 as add-on treatment in pulmonary arterial hypertension

Keros Therapeutics has announced that the U.S. Food and Drug Administration (FDA) has cleared its investigational new drug application to conduct a Phase 2 clinical trial of KER-012, TROPOS, in combination with background therapy in patients with pulmonary arterial hypertension. KER-012 KER-012 is designed to normalize blood vessel thickness and heart function in pulmonary hypertension.

KEROS Therapeutics announces launch of a Phase 2 trial, TROPOS, to assess the effectiveness of KER-012 as add-on treatment in pulmonary arterial hypertension Read Post »

Update on Merck Phase 2/3 INSIGNIA-PAH clinical trial investigating inhaled treatment MK-5475 in pulmonary arterial hypertension

Merck’s investigational inhaled soluble guanylate cyclase (sGC) stimulator MK-5475 was well-tolerated and showed promise among adults with pulmonary arterial hypertension (PAH) in a Phase 1 clinical trial (see our article on this topic at this link). Merck is sponsoring a Phase 2/3 study. Learn more about the INSIGNIA-PAH trial at this link on the Merck website

Update on Merck Phase 2/3 INSIGNIA-PAH clinical trial investigating inhaled treatment MK-5475 in pulmonary arterial hypertension Read Post »

EVOLVE, a study by United Therapeutics to evaluate real-world use of next generation pumps for Remodulin was enrolling, August 15, 2023

The aim of the EVOLVE study is to observe and assess drug administration activities, time spent on drug administration activities, and patient-reported outcomes (PROs) including quality of life, treatment satisfaction, and patient perception of devices related to use of United Therapeutics Corporation (UTC)-developed next-generation infusion pumps to administer Remodulin in patients with pulmonary arterial hypertension.

EVOLVE, a study by United Therapeutics to evaluate real-world use of next generation pumps for Remodulin was enrolling, August 15, 2023 Read Post »

Aerami Therapeutics prepares for initiation of uniPHied, a Phase 2 study trial of AER-901, inhaled imatinib, in pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD), June 1, 2023

Aerami Therapeutics has announced new additions to its management team as the company prepares for the imminent initiation of the planned “uniPHied” Phase 2 trial of AER-901 (inhaled imatinib), in pulmonary hypertension associated with interstitial lung disease (PH-ILD) and pulmonary arterial hypertension (PAH). AER-901 is a drug-device combination delivered via a high-performance, handheld nebulizer that

Aerami Therapeutics prepares for initiation of uniPHied, a Phase 2 study trial of AER-901, inhaled imatinib, in pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD), June 1, 2023 Read Post »

ARTISAN Phase 4 study to assess effect of early and rapid treprostinil therapy in mean pulmonary artery pressure (mPAP) reduction and reverse right ventricle remodeling in pulmonary arterial hypertension patients, June 3, 2023

ARTISAN (Afterload Reduction To Improve Right Ventricular Structure And Function) is a Phase 4, Prospective, Multi-center, Single-Arm Study to assess the effect of early and rapid treprostinil therapy to reduce mean pulmonary artery pressure (mPAP, improve right ventricular (RV) function, and reverse RV remodeling, in patients with pulmonary arterial hypertension (PAH). Estimated enrolment is 50

ARTISAN Phase 4 study to assess effect of early and rapid treprostinil therapy in mean pulmonary artery pressure (mPAP) reduction and reverse right ventricle remodeling in pulmonary arterial hypertension patients, June 3, 2023 Read Post »

Zambon Pharma completes enrolment in Phase 3 clinical trial evaluating new inhaled treatment for the treatment of Bronchiolitis Obliterans Syndrome (BOS) following single or double lung transplant, May 1, 2023

Zambon, a multinational pharmaceutical company, announced today that it has completed enrollment in its two pivotal Phase 3 studies. The trials are designed to evaluate the safety and efficacy of Liposomal Cyclosporine A for Inhalation (L-CsA-i) for the treatment of BOS in adults following single lung (BOSTON-1) or double lung (BOSTON-2) transplantation.  BOS is a

Zambon Pharma completes enrolment in Phase 3 clinical trial evaluating new inhaled treatment for the treatment of Bronchiolitis Obliterans Syndrome (BOS) following single or double lung transplant, May 1, 2023 Read Post »

PHantasticals, an initiative to increase awareness of pulmonary hypertension among patients, caregivers and the general public, unveils its new website on World Pulmonary Hypertension Day 2023, May 5

PHantasticals is an awareness raising initiative promoted by Ferrer. It is addressed to patients, caregivers and society large. The website features testimonials from patients and health care professionals as well as useful infographics on pulmonary hypertension (PH), pulmonary arterial hypertension (PAH), and pulmonary hypertension due to Interstitial Lung Disease (PH-ILD) Learn more on the PHantasticals

PHantasticals, an initiative to increase awareness of pulmonary hypertension among patients, caregivers and the general public, unveils its new website on World Pulmonary Hypertension Day 2023, May 5 Read Post »

Study evaluating a digital health system (PAHcare™) for routine care of patients with pulmonary arterial hypertension

The PAHcare™ medical device being assessed in this clinical investigation has been approved in Europe as a Class I investigation medical device as per Medical Devices Directive (93/42/EEC) for its use by pulmonary arterial hypertension patients (26 March 2021, reference number 1291298). The authors say this is the first study that will examine the effects

Study evaluating a digital health system (PAHcare™) for routine care of patients with pulmonary arterial hypertension Read Post »

EURORDIS, the European Rare Disease Organisation, and EFPIA, the European Federation of Pharmaceutical Industries and Associations issue Joint Statement on how to improve patient access to medicines

The EURORDIS-EFPIA Joint Statement on proposals to improve patient access to medicines was published on June 15 2022. As the EURORDIS-EFPIA press release reads “This is the first time that EURORDIS-Rare Diseases Europe, as a patient organisation, has come together with the pharmaceutical industry’s European organisation in such a structured dialogue. Discussions focused on how

EURORDIS, the European Rare Disease Organisation, and EFPIA, the European Federation of Pharmaceutical Industries and Associations issue Joint Statement on how to improve patient access to medicines Read Post »

June 9, 2022: Patient engagement in drug development, a live symposium organised by admedicum

On June 9th 2022, patient engagement experts at admedicum organized a live event in collaboration with HollandBIO and INSMED Pharmaceuticals, Inc. in Utrecht, with over 70 attendees and distinguished speakers from patient organisations, healthcare, regulatory and industry. The theme was “Patient engagement in 2030: how can patient engagement contribute towards building a new ecosystem for

June 9, 2022: Patient engagement in drug development, a live symposium organised by admedicum Read Post »

Info on treatments for pulmonary arterial hypertension, life style advice and patient stories on “The PAH Initiative”, by United Therapeutics

The PAH Initiative was established by United Therapeutics with the aim of providing knowledge and inspiration based on science and research in pulmonary arterial hypertension today. Here you can find interesting information on pulmonary arterial hypertension, treatments and life style advice as well as patient testimonials. The “Learning Library” section of the PAH initiative contains useful

Info on treatments for pulmonary arterial hypertension, life style advice and patient stories on “The PAH Initiative”, by United Therapeutics Read Post »

“PH Human”, a JanssenWithMe platform provides support resources for people with pulmonary arterial hypertension and features a number of real-life experiences from patients

PH Human, part of the JanssenWithMe digital platform, was created in partnership with the pulmonary hypertension patient community and is dedicated to supporting people with the condition. It has a particular focus on pulmonary arterial hypertension (Group 1 WHO classification of pulmonary hypertension). It helps share real-life experiences from people living with pulmonary arterial hypertension

“PH Human”, a JanssenWithMe platform provides support resources for people with pulmonary arterial hypertension and features a number of real-life experiences from patients Read Post »

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