Johnson & Johnson has been looking to make a big splash in robotics. Now, its Depuy Synthes unit has made progress on this front, gaining U.S. FDA clearance for the Velys robotic-assisted solution designed for use with the Attune total knee system. The solution aims to help simplify surgeons’ existing workflow around total knee replacement.
Moncef Slaoui, chief advisor to Operation Warp Speed, the public-private partnership to hurry along a vaccine for COVID-19, cited tough going in the early days of development, as researchers met “a real challenge to engage the population.” During a panel discussion at the virtual 39th J.P. Morgan Healthcare Conference, he pointed to “a double-edged sword, to talk about what a vaccine can do, when we don’t know – and then once you know, you’re going to have to change your message.”
CAJICA, Colombia – A phase III trial for an HIV vaccine developed Janssen Vaccines & Prevention BV is finally moving forward in Latin America and elsewhere in the world after a delay of more than a year caused by slow regulatory progress and worsened by a string of COVID-19 lockdowns.
Hopes continue to rise as the COVID-19 vaccine beat goes on and Operation Warp Speed (OWS) lives up to its name, with Moderna Inc. netting another U.S. Department of Defense contract worth about $1.97 billion for another 100 million doses – an order that brings to about $6 billion the company’s government contracts for the product, which was granted emergency use authorization (EUA) earlier this month.
The latest global regulatory news, changes and updates affecting biopharma, including: HIV trial networks streamlined; Grants to advance use of RWD, RWE; GAO, National Academies, report on AI in health care; ICER not sold on roxadustat; Teva, Cephalon latest EC targets; Hungary looks to Russian vaccine.
Johnson & Johnson (J&J) said it will deliver its differentiated value propositions for patients Thursday as it provided details on its Ottava platform during its Virtual Medical Devices Update. Analysts appear to have left the meeting with a good impression. “We came away impressed with JNJ's digital surgery vision & holistic approach,” wrote Cowen’s Josh Jennings.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: J&J subsidiary agrees to settle off-label promotion allegations; FDA says ‘vulnerabilities persist’ in limited CDS programs.
LONDON – A second phase III trial of Johnson & Johnson’s adenoviral-vectored COVID-19 vaccine is starting in the U.K. this week, amid concerns the positive news from the Pfizer Inc./Biontech SE vaccine study will deter volunteers from coming forward to take part.
DUBLIN – The contest to bring a safe and effective gene therapy for X-linked retinitis pigmentosa (XLRP) to market is intensifying. Two of the three contenders with clinical-stage programs reported initial 12-month data from phase I/II trials and are now looking ahead to pivotal trials and beyond.
With the next big wave of biologic patent expirations soon to wash over the U.S. market, companies developing biosimilars are optimistic about the future. “We’re at a place where we’re seeing really strong uptake of biosimilars, which has resulted in cost savings,” Chad Pettit, executive director of marketing for Amgen Inc.’s biosimilars unit, told BioWorld.
