The European Medicines Agency (EMA) has published a new booklet on the safety monitoring of medicines in the European Union. It provides an overview of how the European Medicines Agency and European Union Member States work to ensure that medicines used across Europe remain safe throughout their lifecycle. The booklet is published on a new […]
Tacrolimus (FK506), discovered in 1984 from Japanese soil fungus, revolutionized organ transplantation. Dr. Thomas Starzl’s pioneering work at the University of Pittsburgh demonstrated dramatic improvements over cyclosporine: liver graft survival increased from 65.5% to 86.2%, with rejection rates dropping to 1-2%. The Food and Drug Administration (FDA) approval followed for liver (1994), kidney (1997), and
The two main highlights of this edition are the report of the UK Pulmonary Hypertension survey on what symptoms affect patients most (pages 9-12) and the association’s 25th anniversary celebrations in Birmingham (pages 16-18). For the survey there were 232 responses from patients and 35 responses from caregivers. KEY FINDINGS – THE PATIENT VIEW MOST
Pulmonary hypertension associated with congenital heart disease (PAH-CHD) is one of the most common causes of pulmonary hypertension in children. Patients fall into different subgroups, each requiring specific treatment approaches. According to an article recently published in the Expert Review of Respiratory Medicine current management is clear for two groups: The challenge The management of
Pulmonary arterial hypertension patients face unique challenges in lung transplantation. Unlike patients with other lung diseases, they often have relatively normal lung function tests but are in critical condition due to heart failure. This means they receive low priority scores in the standard Lung Allocation Score (LAS) system, which was designed primarily for patients with
Access to specialized care may differ between urban and rural patients, potentially influencing outcomes. A study conducted at the at the University of Utah Pulmonary Hypertension Center compared 263 pulmonary arterial hypertension patients from urban versus rural areas treated in the period 2020-2024. Similar at baseline: Important differences emerged: Conclusion: Despite similar care delivery and
CM5480 is an experimental therapy being developed by Calcimedica, a US clinical-stage biopharmaceutical company. The findings of a new study titled “Combination of Orai1 inhibitor CM5480 with specific therapy mitigates pulmonary hypertension and its cardiac dysfunction” reveals that CM5480 was helpful in rat models when used on its own and provided additional benefits when combined
A modified Delphi consensus was conducted by the Pulmonary Vascular Research Institute (PVRI) Lung Transplantation Workstream, involving 29 international experts on pulmonary arterial hypertension (PAH) and lung transplantation. The process generated consensus ( mean scores >_2.5 on Likert scale ) across 141 out of 223 statements relating to when to refer pulmonary arterial hypertension patients
The Council of Europe’s EDQM (European Directorate for the Quality of Medicines and HealthCare) Newsletter Transplant provides regular updates on transplantation-related developments across Europe. It covers policy, regulation, quality standards, and best practices related to organ donation, allocation, and transplant safety, ensuring harmonisation across European Union member states. Additionally, the newsletter shares news on scientific
Vallerie McLaughlin, MD, the Kim A. Eagle M.D. Endowed Professor of Cardiovascular Medicine and Professor of Internal Medicine at the University of Michigan Medical School, presented the results of a pooled analysis of the PULSAR, STELLAR, and ZENITH trials of sotatercept in pulmonary arterial hypertension at the 2025 American Heart Association Scientific Sessions, held in
Cereno Scientific has submitted the clinical trial protocol for the planned global Phase IIb trial of its lead drug candidate CS1 to the U.S. Food and Drug Administration (FDA). CS1 is an oral histone deacetylase inhibitor (HDACi) intended as a disease-modifying therapy for pulmonary arterial hypertension (PAH), working through epigenetic modulation to target underlying mechanisms
The first clinical site is now active for a global Phase 3 study that will evaluate Gossamer Bio’s therapy candidate seralutinib for people with pulmonary hypertension associated with interstitial lung disease (PH-ILD). The study, titled SERANATA, aims to enroll around 480 patients aged 18 to 80, randomised to receive either 90 mg or 120 mg
A study titled “Single‑Tablet Combination Therapy of Macitentan/Tadalafil for Patients with Pulmonary Arterial Hypertension: Qualitative Interview Study” interviewed 26 pulmonary arterial hypertension patients and 18 doctors from the A DUE clinical trial, who tested the single-pill combination therapy (macitentan+tadalafil) versus taking multiple pills daily. Both patients and doctors agreed that taking one pill daily instead
Tacrolimus therapeutic drug monitoring is challenging due to high inter- and intra-patient variability. A prospective randomized controlled trial was conducted by researchers at the University Hospital in Leuven, Belgium, on 293 de novo kidney transplant recipients during the first 14 days post-transplant. A fully automated Model-informed precision dosing (MIPD) application (1) was integrated into the
Right heart catheterization (RHC) is an invasive diagnostic procedure used to measure pressures and blood flow in the right side of the heart and pulmonary arteries. It’s considered the gold standard for diagnosing and assessing pulmonary hypertension and other cardiovascular conditions. This video by the UK Pulmonary Hypertension Association PHA UK with Dr Charlie Elliott,
Kristine Sørensen founder of the Global Health Literacy Academy, President of the International Health Literacy Association, and Executive Chair of Health Literacy Europe, brings extensive expertise to the field of health literacy. She currently serves as a visiting lecturer at Bielefeld University in Germany, MCI School of Management in Innsbruck, Austria, and the Centre of
A recent article in Healio news by Isabella Hornick summarises a study titled “Exploring the potential benefits of GLP-1 receptor agonists in pulmonary arterial hypertension: Insights from a large database study”, which was presented at the CHEST Annual Meeting October 19-22, 2025 in Chicago. GLP-1 receptor agonists (Glucagon-Like Peptide-1) are commonly used for diabetes and
A 2025 study published in the Journal of Market Access & Health Policy explores the evolving role of digital health technologies in shaping patient experiences and healthcare delivery. The authors used a mixed-methods approach including a survey of 20 Digital Health Technology developers, and qualitative research with 29 industry representatives from startups to multinational companies
A study on the importance of phenotyping patients with mild pulmonary hypertension was publslhed on the Open Heart journal on October 10, 2025. They found that most patients with mild precapillary pulmonary hypertension have underlying comorbidities rather than early-stage pulmonary arterial hypertension. Stroke volume index emerged as the key independent predictor of prognosis. Survival was
A poster presented by the French Pulmonary Hypertension association HTaPFrance was displayed at the RARE 2025 Congress on October 8, 2025– see photo below with HTaPFrance President Maggy Surace. The poster presents data from a questionnaire that was sent to patients’ families and to the patients. It summarizes the section “Understanding the disease at the
