Pulmonary arterial hypertension (PAH) is a condition involving high blood pressure and structural changes in the walls of the pulmonary arteries, which are the blood vessels that connect the right side of the heart to the lungs. Affecting people of all ages and ethnic backgrounds - but most commonly found in young women of child-bearing years - the disease has historically been chronic and incurable, with a poor survival rate. PAH is often not diagnosed in a timely manner because its early symptoms can be confused with those of many other pulmonary and respiratory conditions. Symptoms include shortness of breath, extreme fatigue, dizziness, fainting, swollen ankles and legs and chest pain (especially during physical activity). With proper diagnosis, there are currently several therapies to alleviate symptoms and improve quality of life for PAH patients. The key is to find a PAH specialist and pursue immediate treatment.
Repairing small, seemingly benign holes in a child's heart may be more clinically important than previously thought, as dysfunction could be lurking out of sight. These are the findings from a study conducted by doctors and researchers at Nationwide Children's Hospital and the Ohio State University Medical Center examining a subset of the most common form of congenital heart disease, ventricular septal defect.
The use of stem cells for research and their possible application in the treatment of disease are hotly debated topics. In a special issue of Translational Research published this month an international group of medical experts presents an in-depth and balanced view of the rapidly evolving field of stem cell research and considers the potential of harnessing stem cells for therapy of human diseases including cardiovascular diseases, renal failure, neurologic disorders, gastrointestinal diseases, pulmonary diseases, neoplastic diseases, and type 1 diabetes mellitus.
A disease that has no cure in young children and adults is getting closer attention, thanks to a University of Colorado Denver Bioengineering assistant professor and a five year National Heart Lung and Blood Institute/National Institutes of Health grant. Kendall Hunter, PhD, will perform research to improve the diagnosis and prognosis of pulmonary arterial hypertension in children and adults with approximately $700,000 over a five-year period.
Pfizer Inc. and FoldRx Pharmaceuticals, Inc., a privately held drug discovery and clinical development company, today announced that they have entered into an agreement under which Pfizer will acquire FoldRx.
Actelion Pharmaceuticals US, Inc., today announced that the U.S. Food and Drug Administration has approved the brand name VELETRI® for the company's epoprostenol for injection therapy. VELETRI has been commercially available since April 2010 as Epoprostenol for Injection for the treatment of moderate to severe pulmonary arterial hypertension (PAH) and PAH associated with the scleroderma spectrum of disease. Actelion plans to release VELETRI-labeled product by early fourth quarter of 2010.
An Ohio Federal Court of Appeals ruling issued yesterday is reinstating the late victim's claim that the recalled diet drug Redux (commonly called fen-phen) linked to her death should never have been marketed to the American people by Wyeth due in part to its pre-approval concerns about potentially lethal side effects.
Ikaria, Inc. announced today that its INOMAX® DS drug-delivery systems in the United States are being voluntarily recalled due to the potential failure of a pressure switch which may have an impact on the administration of INOMAX® (nitric oxide) for inhalation to patients. This potential failure was identified by Ikaria as part of its ongoing quality monitoring and review processes. This class I recall is being conducted with the knowledge of the U.S. Food and Drug Administration (FDA). All INOMAX DS systems in Canada also are being voluntarily recalled.
Merck reported that two pivotal Phase III registration studies for boceprevir, its investigational oral hepatitis C protease inhibitor, have been completed and met the primary endpoints: in both studies in patients with chronic hepatitis C virus (HCV) genotype 1 infection, the addition of boceprevir to treatment with PEGINTRON® and REBETOL® significantly increased the number of patients who achieved sustained virologic response, compared to control groups that received Peg/riba plus placebo.
Millennium: The Takeda Oncology Company today reported new correlative science data from the pivotal PINNACLE trial of VELCADE (bortezomib) in patients with relapsed/refractory mantle cell lymphoma. The data, derived from an analysis of archived tumor samples, tested pre-specified biomarkers for their association with time to progression and response to treatment with VELCADE in patients with relapsed MCL.
Merck announced a non-exclusive license agreement with Laboratory Corporation of America Holdings for the commercialization of a genetic test that may help predict the response of patients with Hepatitis C virus infection to peginterferon alpha-based therapy.
The Children's Hospital and the University of Colorado Hospital have finalized an agreement to jointly establish a center for advanced maternal fetal medicine offering state-of-the-art care for high-risk pregnant women and their babies. The two leading academic medical centers have individually provided such services for more than three decades, and by building on already existing adult and pediatric expertise, they together will be able to provide unparalleled care and treatment for the region's most at-risk moms and babies.
Lantheus Medical Imaging, Inc., a worldwide leader in diagnostic medical imaging, today announced the launch of its ultrasound contrast imaging agent, DEFINITY® Vial For (Perflutren Lipid Microsphere) Injectable Suspension, in India. The company has signed a multi-year agreement with Mumbai-based J.B. Chemicals & Pharmaceuticals, Ltd. for the distribution and marketing of DEFINITY® in the Indian marketplace.
GE Healthcare Medical Diagnostics today announced the market reintroduction of Optison™ (Perflutren Protein-Type A Microspheres Injectable Suspension, USP), a diagnostic ultrasound contrast agent for use in select echocardiograms. Optison is indicated for use in patients with suboptimal echocardiograms to opacify the left ventricle and to improve the delineation of the left ventricular endocardial borders. The safety and efficacy of Optison with exercise stress or pharmacologic stress testing have not been established.
The Pulmonary Hypertension Association (PHA) and Actelion Pharmaceuticals US, Inc., today announced Dr. Vallerie McLaughlin of the University of Michigan Health System as the recipient of the annual PHA Award of Excellence in Pulmonary Arterial Hypertension (PAH) Care. As part of the award, the University of Michigan System will receive a grant in the amount of $50,000 to support continued excellence in care for patients with PAH.
LifeVantage Corporation, the maker of Protandim®, a patented, science-based solution to oxidative stress, announced today that a peer-reviewed manuscript was published in the Journal of Dietary Supplements examining the beneficial effects of Protandim® on a mouse model of Duchenne Muscular Dystrophy (DMD), an X-linked inherited disease affecting one in 3,500 males.
W. L. Gore & Associates (Gore) today announced that Instituto Nacional De Cardiologia in Mexico City, Mexico, is the first hospital in the country to use the GORE® HELEX Septal Occluder for the transcatheter closure of an atrial septal defect (ASD). Department Chief, Dr. Carlos Zabal and Dr. Jose Garcia Montes of the Instituto Nacional de Cardiologia, in Mexico City, achieved the milestone procedure in March, 2010.
Lantheus Medical Imaging, Inc., a worldwide leader in diagnostic medical imaging, today announced new data from a Phase 4, open-label safety study evaluating the effect of DEFINITY® Vial For (Perflutren Lipid Microsphere) Injectable Suspension, an echocardiography contrast agent, on pulmonary and systemic artery hemodynamics in patients with either normal or increased baseline pulmonary artery pressure.
Alexion Pharmaceuticals, Inc. today announced new research evaluating the substantial disease burden of paroxysmal nocturnal hemoglobinuria, an ultra-rare blood disorder, in patients worldwide. The International PNH Registry, involving 580 patients from 99 sites in 14 countries as of May 2010, found that the debilitating symptoms and life-threatening complications of PNH are similar across patient populations around the world.
Bayer HealthCare Pharmaceuticals, Inc. today announced that the study "Riociguat for chronic thromboembolic pulmonary hypertension and pulmonary arterial hypertension: a phase II study" was published online this week by the European Respiratory Journal. Results of this study to assess the safety, tolerability and the feasibility of individual dose titration of riociguat were previously presented at the 2009 International Conference of the American Thoracic Society.
Pulmo BioTech Inc. has announced that early indications are that its PulmoBind product candidate has the potential for early diagnosis of Pulmonary Hypertension in the pediatric population. PH is a potentially life threatening and crippling disease; it is also very hard to diagnose.
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