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 »

The US Food and Drug Administration (FDA) issues guidance to medical product sponsors to ensure greater inclusivity in clinical trials, June 26, 2024

The U.S. Food and Drug Administration (FDA) has issued a draft guidance titled “Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies.” This guidance is aimed at assisting medical product sponsors in submitting “Diversity Action Plans” for certain clinical studies. These plans are designed to enhance the enrollment of historically

The US Food and Drug Administration (FDA) issues guidance to medical product sponsors to ensure greater inclusivity in clinical trials, June 26, 2024 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 »

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

Gas-filled balloon implanted in main pulmonary artery to alleviate right ventricle workload tested in pulmonary hypertension Read Post »

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 »

Kick-off meeting of the EU Joint Action JARDIN on the integration of European Reference Networks (ERNs) into national health systems 

The European Reference Networks (ERNs) are virtual networks involving healthcare providers across Europe. They aim to facilitate discussion on complex or rare diseases and conditions that require highly specialised treatment, and concentrated knowledge and resources. 24 ERNs are working on a range of thematic issues, including ERN-Lung, the European Reference Center for Rare Lung Diseases, which

Kick-off meeting of the EU Joint Action JARDIN on the integration of European Reference Networks (ERNs) into national health systems  Read Post »

2023 Italian pulmonary hypertension awareness campaign wins “Best Patient Advocacy Digital Campaign of the Year”!

The 2023 awareness campaign “Viaggio alla scoperta della PAH” (A trip to discover pulmonary arterial hypertension), has won the Life Sciences Excellence award for the “Best Patient Advocacy Digital Campaign of the Year”! A very important recognition for this collaborative effort by AIPI Italian Pulmonary Hypertension Association, AMIP Associazione Malati Ipertensione Polmonare, GILS – Gruppo Italiano per la

2023 Italian pulmonary hypertension awareness campaign wins “Best Patient Advocacy Digital Campaign of the Year”! 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 »

Two part video series on Patient Reported Outcome Measures (PROMs): what they are and how to collect and use them, by Leem France

Les Entreprises du Médicament, Leem, is the French industry association which represents drug companies operating in France. During the course of November 2023 Leem organised a two-part video series on Patient Reported Outcome Measures. Round Table 1- 06/11/2023 – PROMs, PREMs, Patient Surveys: What are we talking about and for what purposes? Moderator: Dr. Thomas

Two part video series on Patient Reported Outcome Measures (PROMs): what they are and how to collect and use them, by Leem France Read Post »

The European Medicines Agency (EMA) has issued a call for patient representatives to join the Committee for Orphan Medicinal Products (COMP)

The European Commission has launched a call for expressions of interest to represent patients’ organisations in European Medicines Agency’s (EMA) Committee for Orphan Medicinal Products (COMP). This is a very important opportunity for patients to have a role in the approval of orphan medicinal products! The call aims to fill three positions nominated by the

The European Medicines Agency (EMA) has issued a call for patient representatives to join the Committee for Orphan Medicinal Products (COMP) 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 »

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