Until now, the ongoing push for transcatheter aortic valve replacement (TAVR) systems has primarily been for patients with high or intermediate risk of mortality due to surgery. But now Medtronic has staked a claim to using its next-gen device for this catheter-based approach in lieu of surgery for low-risk mortality patient with an FDA go-ahead for a 1,200-patient trial to treat aortic stenosis with its CoreValve Evolut R System that's slated to start this spring.
Boston Scientific won a CE mark for its Eluvia Drug-Eluting Vascular Stent System to treat peripheral artery disease (PAD) patients with narrowing of the arteries above the knee. It will launch the product immediately in the EU and has already started a pivotal trial aimed at U.S. and Asia approvals, with primary endpoint data due in early 2018.
Amgen scored promising Phase III data for its osteoporosis drug romosozumab, providing a pivotal win for the Big Biotech's late-stage pipeline and moving the drug one giant step toward an FDA filing later in the year. But some analysts were quick to note that the drug didn't perform as well as its main late-stage rival at Radius Health, triggering concerns about how well it may perform if it makes the leap to the market.
Chimerix has scuttled two Phase III studies of its antiviral brincidofovir after studying the data from the first late-stage failure, which bludgeoned its share price as the biotech sector fell out of favor with investors.
Biopharma contractor CRO Analytics raised an undisclosed sum in a Series A round to expand its business, which focuses on cloud-based technology for tracking clinical trials.
CRO INC Research is working to strengthen its ties to clinical trial sites around the world through a new program designed to cut back on variability and make the testing process more uniform.
Leading U.S. schools are failing to report their clinical trial results as just one-third are bothering to show their completed data for scrutiny.
Can Regulus still make a splash in the increasingly crowded hepatitis C drug market? The biotech says yes, backing up its case for RG-101 with interim Phase II data that showed its injection pushed a small group of patients to a 97% sustained virologic response rate after only four weeks of combination therapies using some of the top oral drugs now on the market.
Russian Health Minister Veronika Skvortsova announced that an Ebola vaccine developed in that country did well in Phase I and II trials, and will enter further testing in Guinea, Agence France-Presse reported.
Lantern aims to put mental health services and professionals at the patient's fingertips with its online and mobile programs in cognitive behavioral therapy. To help it do so, Pittsburgh-based healthcare provider and payer UPMC is leading a $17 million investment and it also will partner with the San Francisco-based startup to conduct pilot testing of its approach.