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Bayer Wins Panel Backing for Pulmonary Hypertension Drug
Bayer AG (BAYN)’s experimental lung drug won the backing of U.S. regulatory advisers to treat two forms of pulmonary hypertension. Bayer’s riociguat should be approved for the condition that can eventually lead to fatal heart failure, a panel of advisers to the Food and Drug Administration voted 11-0 today at a meeting in Silver Spring, Maryland. The pill would be the first to treat pulmonary hypertension that lasts six months or longer often ca…
FDA experts give Bayer's riociguat unanimous backing for lung disease
An FDA panel of outside experts has contributed a round of thumbs-up for Bayer's new drug for pulmonary arterial hypertension, to be sold as Adempas, sending the pharma giant on what appears to be another victory lap in the lead-up to a likely approval. The group voted unanimously in favor of riociguat, both for PAH as well as chronic pulmonary thromboembolic hypertension. And while the FDA doesn't have to accept the recommendation, it's quite…
Bayer Lung Drug Should Be Approved at Low Dose, FDA Says
Bayer AG (BAYN)’s experimental treatment for two forms of pulmonary hypertension is being recommended for approval by U.S. regulatory staff at a lower dose than what the company sought. Bayer’s riociguat improved the distance patients can walk during a six-minute test in clinical trials, Food and Drug Administration staff said today in a report ahead of a meeting of agency advisers Aug. 6. The pill would be the first to treat pulmonary hypertens…
How Transplanted Pig Lungs Could Save Human Patients
Martine Rothblatt, the founder and CEO of the Maryland-based drug company United Therapeutics, entered the orphan drug business to develop pharmaceutical treatments for pulmonary arterial hypertension (PAH), a rare but deadly heart disease. Rothblatt spoke with PopMech about the art and science of xenotransplantation—transplanting organs from one species to another. Q: You're working on xenotransplantation, the moving of organs of one species …
Inhalable gene therapy may help pulmonary arterial hypertension patients
The deadly condition known as pulmonary arterial hypertension (PAH), which afflicts up to 150,000 Americans each year, may be reversible by using an inhalable gene therapy, report an international team of researchers led by investigators at the Cardiovascular Research Center at Icahn School of Medicine at Mount Sinai. In their new study, reported in the July 30 issue of the journal Circulation, scientists demonstrated that gene therapy adminis…
D-Link Sponsors 6th Annual “Swing 4 the Cure” Golf Tournament
Funds Raised to Benefit Pulmonary Hypertension Association (PHA) Research FOUNTAIN VALLEY, Calif. -- D-Link today announced it is sponsoring the “Swing 4 the Cure Wojo PH Golf Classic” on Monday, July 29, 2013. The annual charity golf tournament raises money to help support the ongoing research of the Pulmonary Hypertension Association (PHA), and will be held at the Aliso Viejo Country Club in Aliso Viejo, Calif. “We are very excited to hav…
Gene mutations linked to fatal lung disease
A new genetic cause of a rare and fatal lung disease has been identified by US researchers. The Columbia University Medical Center team found that mutations on the gene KCNK3 are linked to pulmonary arterial hypertension, which is high blood pressure in the lungs. The mutations in the gene appear to affect potassium channels in the pulmonary artery, a mechanism not previously linked to pulmonary arterial hypertension, according to the study…
New Genetic Cause of Pulmonary Hypertension Identified
NEW YORK, NY (July 25, 2013) — Columbia University Medical Center (CUMC) scientists have identified new genetic mutations that can cause pulmonary arterial hypertension (PAH), a rare fatal disease characterized by high blood pressure in the lungs. The mutations, found in the gene KCNK3, appear to affect potassium channels in the pulmonary artery, a mechanism not previously linked to the condition. Cell culture studies showed that the mutations' e…
Novel Pulmonary Hypertension Drug From Bayer Shows Modest Promise In Phase 3 Trials
A new drug appears to have promising– but not game-changing– effects in people with two forms of pulmonary hypertension. Riociguat, a soluble guanylate cyclase stimulator under development by Bayer, is thought to have vasodilating, antiproliferative and antifibrotic effects. Ball-and-stick model of the riociguat molecule... Results of two phase 3 placebo-controlled trials were published today in the New England Journal of Medicine. CHEST-1 …
A Common Stem Cell For The Heart And Lungs Reveals Intricacies Of Life On Land
A common stem cell in the heart and lung systems may explain the evolution of life — and related disease — on land. BY MATTHEW MIENTKA | JUL 22, 2013 11:51 AM EDT EMAIL PRINT 4 TEXT SIZE TEXT SIZE TEXT SIZE Tagsevolution The discovery of a common embryonic stem cell in the cardiopulmonary system may help to explain the evolution of life on land, as well as the pathology of pulmonary hypertension — a disease affecting both the lungs a…
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