The presence of antibodies in a patient means that they likely had COVID-19 at some point and may suggest they have some degree of immunity. Source: Devices & Diagnostics Letter

The device should be available in Europe, Australia and New Zealand in June. Source: Devices & Diagnostics Letter

The company is involving local Japanese medical institutions in its project, beginning with Yokohama’s Kanagawa Cardiovascular and Respiratory Center. Source: Devices & Diagnostics Letter

In an emergency final guidance released yesterday, the FDA agency said it is temporarily relaxing its regulations for repackaging and combining units of propofol during the COVID-19 pandemic. Source: Devices…

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) is relaxing some GMP requirements to help manufacturers overcome challenges during the COVID-19 pandemic. Source: Devices & Diagnostics Letter

Results from a Chinese trial of Gilead’s antiviral remdesivir show no benefit in COVID-19 patients, according to data accidentally posted on the World Health Organization’s (WHO) website. Source: Devices &…

Johnson & Johnson is partnering with Emergent Biosolutions to scale up manufacturing of a COVID-19 vaccine. Source: Devices & Diagnostics Letter

Dynavax used the adjuvant in its FDA-approved hepatitis B vaccine. Source: Devices & Diagnostics Letter

MenQuadfi will be available in a ready-to-use liquid formulation to allow healthcare providers to avoid vaccine reconstitution. Source: Devices & Diagnostics Letter

The FDA previously granted the drug priority review, breakthrough therapy and fast- track designations. Source: Devices & Diagnostics Letter