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 »

Proposed revision of EU pharmaceutical laws, released on April 26, 2023, will contribute to making the EU regulatory framework more patient-centred

On Wednesday April 26, 2023, the European Commission adopted a proposal for a new Directive and a new Regulation, which revise and replace the existing general pharmaceutical legislation. The EU Commission’s proposed revisions include proposals to update the EU’s Regulations on Orphan Medicinal Products and Paediatric Medicines, which are very important to Europe’s population of

Proposed revision of EU pharmaceutical laws, released on April 26, 2023, will contribute to making the EU regulatory framework more patient-centred Read Post »

“Eroi anonimi” (“Anonymous heroes”), an Italian online platform aimed at raising awareness about the importance of organ donation in the general population

“Eroi anonimi” (“Anonymous heroes”) is an Italian online platform aimed at the promotion of organ donation among the general population. The slogan of this awareness initiative is “You can be a hero even without superpowers”. The platform features information about the importance of organ donation, on the different procedures that are used in Italy to

“Eroi anonimi” (“Anonymous heroes”), an Italian online platform aimed at raising awareness about the importance of organ donation in the general population Read Post »

The Pulmonary Arterial Hypertension (PAH) “Companion Program”, an initiative to support patients developed by Janssen

Janssen’s Pulmonary Arterial Hypertension (PAH) Companion Program connects patients to a trained PAH Companion who provides one-on-one educational support to help with prescribed Janssen PAH medication. The company specifies that the program is intended to supplement understanding of the prescribed therapy, and does not provide medical advice or replace a treatment plan from the patient’s doctor, nurse,

The Pulmonary Arterial Hypertension (PAH) “Companion Program”, an initiative to support patients developed by Janssen 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 »

“The Added Value of Patient Engagement in Early Dialogue at the European Medicines Agency (EMA): Scientific Advice as a Case Study”, Frontiers in Medicine

  ABSTRACT The European Medicines Agency provides Scientific Advice to medicines developers and patient input has been an integral part of this process for many years. As end users of medicines, patients bring their perspectives to many different processes along EMA’s regulatory pathway, complementing the scientific expertise. While the value of including patients has been

“The Added Value of Patient Engagement in Early Dialogue at the European Medicines Agency (EMA): Scientific Advice as a Case Study”, Frontiers in Medicine 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 »

The EU Clinical Trials Regulation came into force 31st of January 2022

The European Union (EU) pharmaceutical legislation known as the Clinical Trials Regulation comes into force today, the 31st of January 2022. It aims to ensure the EU offers an attractive and favourable environment for carrying out clinical research on a large scale, with high standards of public transparency and safety for clinical trial participants. Prior to

The EU Clinical Trials Regulation came into force 31st of January 2022 Read Post »

TRANSLATE »
Scroll to Top