Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Chromacode, Dyad Medical, Medtronic.
LONDON – Oxford University spinout Oxdx Ltd. has raised £2.6 million (US$3.6 million) in pre-seed funding to advance development of a technology for directly identifying infectious pathogens without the need to purify, culture or amplify samples first. The instant testing method uses a mixture of a single universal reagent, high resolution microscopy and machine learning, to identify specific species and strains of bacteria, viruses and other pathogens within minutes.
It's neither a retrovirus nor an opportunistic infection. But of course, SARS-CoV-2 has a prominent place at the table at the 2022 Conference on Retroviruses and Opportunistic Infections (CROI) –
starting with the fact that COVID-19 has again forced the conference to go virtual.
The overwhelming focus of research into the cellular immune response to SARS-CoV-2 has been investigating the reaction of vaccinated people, in an effort to establish correlates of protection required to fight off infection. But with a majority in many African and Asian countries still unvaccinated, it also is important to understand the natural cellular immune response, and to track the emergence of SARS-CoV-2 variants with the potential to escape immunity in these populations.
Xanadu Bio, a Yale University spinout developing an intranasal SARS-CoV-2 mRNA vaccine booster, has secured an exclusive license from the school for a polymeric nanoparticle delivery platform to support the project. The delivery tech could potentially have future applications for influenza, respiratory syncytial virus and even cystic fibrosis.
LONDON – The first human challenge study of SARS-CoV-2 infection has reported initial results, showing it is safe to infect healthy volunteers with the virus in controlled conditions, and paving the way for the model to be used to accelerate clinical trials of COVID-19 vaccines, antivirals and diagnostics.
During the most infectious COVID-19 month since the pandemic began, January recorded an increase of 82.3 million confirmed cases worldwide, an amount that is fourfold the average monthly increase over the past year. It comes at a time when the highly transmissible omicron variant continues to circulate, bolstered by a new subvariant, BA.2, which is outcompeting its predecessor. Meanwhile, regulatory agencies are authorizing antivirals, swapping monoclonal antibodies based on their efficacy against omicron, and approving new vaccine options, including Novavax Inc.’s protein-based vaccine Nuvaxovid (NVX-CoV2373).
LONDON – A new SARS-CoV-2 sub-variant is showing signs of outcompeting the omicron variant that was first reported in South Africa in late November 2021, and within a month had taken over from its delta predecessor, accounting for 98.8 % of sequenced cases worldwide, as of Jan.25.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Maxim Biomedical.