Adding I.V. sildenafil – the active ingredient in Viagra – to inhaled nitric oxide (iNO) therapy for newborns with persistent pulmonary hypertension (PPHN) failed to achieve a statistically significant reduction in treatment failure rates or time on iNO vs. iNO alone in the first part of a phase III study sponsored by Pfizer Inc.
Boston startup Beta Bionics Inc. is headed into a pair of ambitious pivotal trials in 2020: one starting for an autonomous bionic pancreas device with insulin only and another to follow for a bihormonal version that also includes glucagon. These are expected to offer more precise, easy-to-use blood glucose maintenance for type 1 diabetes patients.
NEW ORLEANS – The Apple Heart study has accumulated data from more than 400,000 participants in its evaluation of the ability of an algorithm to detect abnormalities that may be indicative of atrial fibrillation (AF), although the enrollment came up short of the target of half a million users. Nonetheless, Mintu Turakhia, a cardiologist at Stanford, Calif.-based Stanford University, said that while the study has some significant limitations, "we now have a footprint for evaluating technology such as this, and how to do this in an appropriate and scalable way."
LONDON – Themis Bioscience GmbH has announced positive phase II results for its vaccine against Chikungunya virus, as it moves to complete an IPO later this week to raise up to €55 million (US$62.6 million) to fund the launch of a pivotal phase III trial.