Johnson & Johnson (J&J) aims to add a fourth cardiac business to its portfolio in less than two years with the acquisition of V-Wave Ltd., which makes the Ventura interatrial shunt system for the treatment of heart failure. J&J will pay $600 million up front and an additional $1.1 billion contingent on meeting specified regulatory and commercial milestones. The deal is slated to close before the end of the year. Read More
The New York Times published an article on Aug. 20 about potential conflicts of interest on the part of Jeff Shuren, former director of the Center for Devices & Radiological Health (CDRH), arguing that Shuren may have failed to recuse himself in matters in which his wife, a regulatory attorney, represented a medical device maker. Read More
Andera Partners involvement in a string of recent deals in the cardiovascular space demonstrates the ongoing appetite for devices to treat heart diseases, Olivier Litzka, a partner at Andera Partners told BioWorld. Read More
The U.S. Government Accountability Office’s report on FDA oversight of medical devices acknowledges that the agency has made strides in its efforts to develop surveillance systems to track adverse events, but there are shortcomings. Read More
“There are hundreds of strains of bird flu, and most of them don’t infect humans, or even mammals,” Stephen Cusack told BioWorld. “There are two main reasons for that.” To be able to cause an infection, a virus “has to be able to get into the cell, and for that it needs a receptor,” Cusack said. For influenza viruses, those receptors are hemagglutinin receptors, and they differ in subtle but important ways between birds and mammals. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Alife Health, Bioaro, Implantica, Lucid, Neuromod Devices. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Guard Medical, SI-Bone. Read More
