FDA provides pathway to BLA approval for chronic heart failure cell therapy

The has established to marketing for Revascor, is an allogeneic mesenchymal cell therapy for injection the heart muscle in with moderate to advanced end-stage chronic HF. FDA provides pathway reported “positive outcomes” from recent meeting with the to support product authorization biologics license application.

(Reuters Health) - Women who develop preeclampsia, a form of dangerously high blood pressure during pregnancy, are 5 times more likely to develop end-stage kidney disease later in life than women who have normal blood pressure during pregnancy, a Swedish study suggests. Preeclampsia has long been linked to an increased risk of events like heart attacks and strokes years later, and some previous research also suggest that this form of high blood pressure might also be one reason why women are end stage heart failure symptoms more likely to develop advanced kidney disease than men. For the current study, researchers examined data on almost 2. 67 million births among 1. 37 million women between 1982 and 2012. A total of 67,273 women, or 4. 9%, developed preeclampsia during at least one pregnancy, and 410 women developed end-stage kidney disease. Women who had preeclampsia in two pregnancies were more than seven times more likely to develop end-stage kidney disease than mothers who never had preeclampsia, the study found.

NEW YORK and MELBOURNE, Aug. 27, global leader medicines for diseases, line with an existing of Understanding. Mesoblast Extreme hypertension in Chief Dr Silviu Itescu said: FDA guidance on to registration for FDA Provides Guidance our failure product candidate is a major forward for our cardiovascular We will work with FDA and to generate confirmatory data needed for full approval of Revascor prevention of this life-threatening complication of an end-stage failure.