Lucira Covid-19 test is first to get FDA nod for home use
The authorization comes as Covid-19 testing demand threatens to swamp U.S. labs. However, it will take time for the Lucira test to become available nationwide. Read more
Medicare to cover all FDA-approved Covid-19 vaccines
CMS’ interim rule states that Medicare will cover Covid-19 vaccines approved by the FDA, including those receiving emergency use authorization, in a reversal from its usual policy. The vaccine will…
Covid-19’s digital imperative for biopharma and medtech
The disruption to biopharma and medtech businesses caused by Covid-19, from sales rep visits with doctors, product launch and clinical trial delays has underscored the need for a more digital…
Algorithm that predicts Covid-19 complications gets EUA
The FDA granted an emergency use authorization to an algorithm developed by Dascena to predict which Covid-19 patients might face unstable blood pressure or respiratory decline. Read more
DoD tests wearables’ ability to detect Covid-19 before symptoms appear
Long before the start of the Covid-19 pandemic, the U.S. Department of Defense and Royal Philips had been working on a project to detect potential outbreaks of infectious disease before…
Oxford Covid-19 vaccine is still possible this year, says AstraZeneca chief
AstraZeneca’s coronavirus vaccine could still be available by the end of the year, or early next year, according to the company’s chief executive, Pascal Soriot, despite clinical trials being paused…
Pfizer, Germany’s BioNTech release new data on Covid-19 vaccine
Early clinical trial data from a Covid-19 vaccine that is among those currently in late-stage testing have shown favorable responses among participants in terms of antibody and immune cell responses.…
Roche begins trial of Actemra/RoActemra plus remdesivir
Roche has launched a Phase III study in collaboration with Gilead to evaluate the safety and efficacy of Actemra/RoActemra (tocilizumab) in combination with remdesivir in hospitalised patients with severe COVID-19…
Roche’s COVID-19 antibody test receives FDA Emergency Use Authorization and is available in markets accepting the CE mark
The serology test has a specificity greater than 99.8% and sensitivity of 100% (14 Days post-PCR confirmation) The high specificity of the test is crucial to determine reliably if a…