Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Hyperfine Research, Novaerus, Perkinelmer, Perspectum.
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.”
Reports of multiple new variants of the SARS-CoV-2 virus have emerged, raising questions about the efficacy of vaccines, but also regarding the utility of diagnostic and other tests. The U.S. FDA’s Tim Stenzel said single-target tests are thus at a greater risk of returning a false negative result, adding that these developers “should consider this carefully” in surveillance of their tests.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: New test beats biopsy for transplant rejection; NICE eyes digital health HTAs; MHRA moves on the hazards of bedrails; TGA zeroes in on tests for COVID-19; HHS posts rule for agency enforcement action.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Excalibur Healthcare Services, Siemens Healthineers, Vestibular First.
CAJICA, Colombia – Authorities in Brazil released new efficacy data for Sinovac Biotech Ltd.'s COVID-19 vaccine Coronavac that surprised on the downside, suggesting the vaccine could be much less effective than initially indicated for preventing symptomatic infections.
LONDON – The U.K. has launched a nationwide free testing program to diagnose COVID-19 in people who are asymptomatic, in the latest attempt to stem the tide of infection. Through the program, all local authorities will provide rapid testing using lateral flow devices. In addition, companies will be provided with free tests to set up workplace screening. Initially, the focus of both strands will be on getting people who cannot work from home to come forward for regular checks.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Biomerica, Cognito Therapeutics, Cytosorbents, Jud Care, Medskin Solutions Dr. Suwelack, Microvention, Ortho, Quanterix, Therapixel.