Gossamer Bio and Chiesi Group announce global collaboration to develop and commercialise seralutinib in pulmonary arterial hypertension (PAH) and pulmonary hypertension with interstitial lung disease (PH-ILD)
Gossamer Bio and Chiesi Group have announced a a global collaboration agreement to develop seralutinib, an inhaled investigational drug for the treatment of pulmonary arterial hypertension. Seralutinib is currently being investigated in the ongoing global Phase 3 trial, PROSERA, for pulmonary arterial hypertension. This collaboration further enhances the resources and expertise devoted to seralutinib and
“Outnumber PAH” a new campaign launched by Merck to spread awareness and empower people with pulmonary arterial hypertension
“Outnumber PAH” is a new campaign launched by Merck to spread awareness and empower pulmonary arterial hypertension patients. The website features medical information about pulmonary hypertension and sections on living with the condition, patient stories and a conversation guide. Find out more at this link
United Therapeutics has been granted a patent for a method to treat pulmonary arterial hypertension (PAH) by administering endothelial progenitor cells treated with prostacyclin
United Therapeutics has been granted a patent for a method to treat pulmonary arterial hypertension (PAH) by administering endothelial progenitor cells treated with prostacyclin Application n° US17072430, December 12, 2023, Publication Number: US11839631B2. The news was reported in the Magazine “Pharmaceutical Technology, April 4, 2024. To be followed! Read more at this link on the
The US Food and Drug Administration, FDA, approves sotatercept, Merck’s new drug for pulmonary arterial hypertension, March 26, 2024
The US Food and Drug Administration has approved sotatercept, Merck‘s new drug for pulmonary arterial hypertension. It’s commercial name is Winrevair. Read more on the FDA website at this link Sotatercept is an activin receptor type IIA-Fc (ActRIIA-Fc) fusion protein. It was evaluated as an add-on to stable background therapy for the treatment of pulmonary
Gas-filled balloon implanted in main pulmonary artery to alleviate right ventricle workload tested in pulmonary hypertension
The Aria CV Pulmonary Hypertension System is an implantable gas-filled balloon that is introduced percutaneously in the main pulmonary artery to alleviate the excessive workload on the right heart that results in right heart failure. An article published in the European Journal of Heart Failure on March 13, 2024 titled “Efficacy and safety of the
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 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
“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
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
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.
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.
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
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.
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
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
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
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
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
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