Alivegen’s ALG-801 given orphan drug designation for the treatment of pulmonary arterial hypertension, Pulmonary Hypertension News, January 8, 2025

ALG-801 is a next-generation ligand trap targeting type IIA/IIB activin receptors that selectively sequesters a specific set of molecules that activate the Smad2/3 pathway, known to be involved in pulmonary arterial hypertension. Smad2/3 is implicated in the growth of pulmonary artery smooth muscle cells, which contributes to blood vessel remodeling, essentially structural alterations, and narrowing […]

Alivegen’s ALG-801 given orphan drug designation for the treatment of pulmonary arterial hypertension, Pulmonary Hypertension News, January 8, 2025 Read Post »

Positive scientific advice from the US Food and Drug Administration (FDA) for a Phase 2 clinical trial of tiprelestat in pulmonary arterial hypertension

Tiakis Biotech has received positive scientific advice from the US Food and Drug Administration (FDA) for a planned Phase 2 ATHENA clinical trial of tiprelestat in pulmonary arterial hypertension. The therapy has been granted orphan designation in the U.S. and in Europe for pulmonary arterial hypertension. Dr. Roham Zamanian, Professor of Medicine at Stanford University and

Positive scientific advice from the US Food and Drug Administration (FDA) for a Phase 2 clinical trial of tiprelestat in pulmonary arterial hypertension Read Post »

Results of the INSIGNIA-PAH study on MK-5475, an inhaled soluble guanylate cyclase stimulator for pulmonary arterial hypertension, published on the ERS Respiratory Journal, Vol 64 Issue 3, 2024

MK-5475 is an experimental soluble guanylate cyclase stimulator which is administered via dry powder inhalation and is designed to potentially mitigate the side effects associated with systemic vasodilation. The results of the INSIGNIA-PAH study published in the Respiratory Journal suggest that MK-5475 reduced pulmonary vascular resistance (PVR) and was well tolerated in patients with pulmonary

Results of the INSIGNIA-PAH study on MK-5475, an inhaled soluble guanylate cyclase stimulator for pulmonary arterial hypertension, published on the ERS Respiratory Journal, Vol 64 Issue 3, 2024 Read Post »

Single tablet combination macitentan and tadalafil for pulmonary arterial hypertension (PAH) receives EU Commission approval, September 30, 2024

Janssen-Cilag International NV, a Johnson & Johnson company, announced on September September 30, 2024, that the European Commission has approved Yuvanci®, a single tablet macitentan 10 mg and tadalafil 40 mg combination therapy for the long-term treatment of adult pulmonary arterial hypertension patients in WHO Functional Class II-III, who are treated with macitentan and tadalafil

Single tablet combination macitentan and tadalafil for pulmonary arterial hypertension (PAH) receives EU Commission approval, September 30, 2024 Read Post »

Cereno Scientific announces positive topline results of Phase IIa trial with lead candidate CS1 in pulmonary arterial hypertension, September 27, 2024

CS1 is a HDAC, Histone Deacetylase inhibitor, that works through epigenetic modulation and is being developed by Cereno Scientific as a disease modifying treatment for pulmonary arterial hypertension. CS1 targets the root cause of the disease, aiming to reverse the pathological vascular remodeling of the small lung arteries. The Phase IIa trial evaluated the safety,

Cereno Scientific announces positive topline results of Phase IIa trial with lead candidate CS1 in pulmonary arterial hypertension, September 27, 2024 Read Post »

Merck receives European Commission Approval for WINREVAIR™ (sotatercept) for the treatment of pulmonary arterial hypertension, August 26, 2024

Merck, known as MSD outside of the US and Canada, announced on August 26, 2024 that the European Commission has approved WINREVAIR™ (sotatercept), in combination with other pulmonary arterial hypertension (PAH) therapies, for the treatment of pulmonary arterial hypertension in adult patients with World Health Organization (WHO) Functional Class (FC) II to III, to improve

Merck receives European Commission Approval for WINREVAIR™ (sotatercept) for the treatment of pulmonary arterial hypertension, August 26, 2024 Read Post »

U.S. Food and Drug Administration (FDA) grants tentative approval of YUTREPIA™ (treprostinil) inhalation powder for pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD)

Liquidia Corporation announced on August 20, 2024, that the US Food and Drug Administration (FDA) has granted tentative approval for YUTREPIA™ (treprostinil) inhalation powder to treat pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD). The approval is supported by the Phase 3 INSPIRE trial, which demonstrated YUTREPIA’s safety and tolerability.

U.S. Food and Drug Administration (FDA) grants tentative approval of YUTREPIA™ (treprostinil) inhalation powder for pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD) Read Post »

Practical management of oral treprostinil in patients with pulmonary arterial hypertension: Lessons from ADAPT, EXPEDITE, and expert consensus, “Respiratory Medicine”

Oral treprostinil is a prostacyclin analogue approved to treat pulmonary arterial hypertension (PAH). A study analysing the practical management of oral treprostinil in patients with pulmonary arterial hypertension has been published on “Respiratory Medicine” Volume 231, 107734, September 2024. The article is based on results of the ADAPT and EXPEDITE trials and expert consensus. The

Practical management of oral treprostinil in patients with pulmonary arterial hypertension: Lessons from ADAPT, EXPEDITE, and expert consensus, “Respiratory Medicine” Read Post »

The US Food and Drug Administration (FDA) grants orphan drug designation to ZMA001, a monoclonal antibody being developed as a first-in-class treatment for pulmonary arterial hypertension

The US Food and Drug Administration (FDA) has granted orphan drug designation to ZMA001,a first-in-class therapeutic monoclonal antibody designed to control or inhibit inflammation responses in pulmonary blood vessels. ZMA001 could potentially improve both the survival rates and the quality of life of patients by addressing the underlying cause of pulmonary arterial hypertension. The placebo-controlled

The US Food and Drug Administration (FDA) grants orphan drug designation to ZMA001, a monoclonal antibody being developed as a first-in-class treatment for pulmonary arterial hypertension Read Post »

Selexipag in patients with pulmonary arterial hypertension associated with connective tissue disease (PAH-CTD): Real-world experience from the EXPOSURE study, Pulmonary Circulation, July 28 2024

Selexipag shows promise for treating pulmonary arterial hypertension associated with connective tissue disease (CTD). The ongoing EXPOSURE (EUPAS19085) study sheds light on the real-world management of PAH-CTD patients in Europe and Canada. For more detailed insights, check out the full study results at this link on PubMed Citation Gaine S, Escribano-Subias P, Muller A, Fernandes

Selexipag in patients with pulmonary arterial hypertension associated with connective tissue disease (PAH-CTD): Real-world experience from the EXPOSURE study, Pulmonary Circulation, July 28 2024 Read Post »

The UK Pulmonary Hypertension Association Chair, Dr Iain Armstrong, explains what happens next with sotatercept and what will be considered when it comes to making decisions for the UK

The first-in-class pulmonary arterial hypertension drug sotatercept was approved in March 2024 by the Food and Drug Administration (FDA) in the USA and the approval of the European Medicines Agency (EMA) is expected in the next few months. The UK Pulmonary Hypertension Association, PHA UK, has put together a short video, with its Chair Dr

The UK Pulmonary Hypertension Association Chair, Dr Iain Armstrong, explains what happens next with sotatercept and what will be considered when it comes to making decisions for the UK Read Post »

Food and Drug Administration (FDA) tentatively approves generic selexipag by injection for the treatment of pulmonary arterial hypertension, “Pulmonary Hypertension News, July 15, 2024

A recent article in “Pulmonary Hypertension News” reports on the tentative approval of Alembic Pharmaceuticals’ generic selexipag as pulmonary arterial hypertension treatment for pulmonary arterial hypertension. Alembic’s generic selexipag contains the same chemical substance as an approved treatment, Uptravi for injection, sold by Johnson & Johnson. Selexipag is a prostacyclin receptor agonist that leads to

Food and Drug Administration (FDA) tentatively approves generic selexipag by injection for the treatment of pulmonary arterial hypertension, “Pulmonary Hypertension News, July 15, 2024 Read Post »

Aerovate Therapeutics announces that its pulmonary arterial hypertension candidate AV-101 failed to meet its primary endpoint in the Phase IIb portion of the IMPAHCT trial

Aerovate Therapeutics has announced that its pulmonary arterial hypertension (PAH) candidate AV-101 failed to meet its primary endpoint in the Phase IIb portion of the IMPAHCT trial. The Phase IIb portion of the IMPAHCT trial aimed to assess three different doses of AV-101, a novel dry powder inhaled formulation of imatinib. The primary endpoint tested

Aerovate Therapeutics announces that its pulmonary arterial hypertension candidate AV-101 failed to meet its primary endpoint in the Phase IIb portion of the IMPAHCT trial Read Post »

The Committee for Human Medicinal Products (CHMP) of the European Medicines Agency (EMA) has recommended granting a marketing authorisation for Winrevair (sotatercept)

On 28 June 2024 the European Medicines Agency has issued a press release to say that the CHMP (human medicines committee) has recommended granting a marketing authorisation in the European Union (EU) for Winrevair (sotatercept) to treat adult patients with pulmonary arterial hypertension (PAH), in combination with other specific PAH therapies, to improve exercise capacity. This is the first step

The Committee for Human Medicinal Products (CHMP) of the European Medicines Agency (EMA) has recommended granting a marketing authorisation for Winrevair (sotatercept) Read Post »

Impact of insurance restrictions on pulmonary arterial hypertension (PAH) therapies in the US, “Managed Healthcare Executive”, June 21, 2024

An article by Jared Kaltwasser, in Managed Healthcare executive in its latest issue, sheds light on the growing restrictions imposed by commercial insurers on treatments for pulmonary arterial hypertension. An examination of 17 major insurance plans from 2017 to 2022 showed a sharp increase in policies with at least one restriction, jumping from 38% to

Impact of insurance restrictions on pulmonary arterial hypertension (PAH) therapies in the US, “Managed Healthcare Executive”, June 21, 2024 Read Post »

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

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) Read Post »

“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

“Outnumber PAH” a new campaign launched by Merck to spread awareness and empower people with pulmonary arterial hypertension Read Post »

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

United Therapeutics has been granted a patent for a method to treat pulmonary arterial hypertension (PAH) by administering endothelial progenitor cells treated with prostacyclin Read Post »

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

The US Food and Drug Administration, FDA, approves sotatercept, Merck’s new drug for pulmonary arterial hypertension, March 26, 2024 Read Post »

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