Archive for August 2020

Mylan has launched the product in 120mg and 240mg delayed-release capsule forms. Source: Devices & Diagnostics Letter

The diagnostic runs on real-time PCR detection systems, including Applied Biosystems’ QuantStudio 5 and Bio-Rad’s CFX96. Source: Devices & Diagnostics Letter

President Trump is lashing out at the FDA’s decision to hold off issuing an Emergency Use Authorization (EUA) for using convalescent plasma to treat COVID-19 patients. Source: Devices & Diagnostics Letter

The company expects to release software updates late next year that will fix the problem. Source: Devices & Diagnostics Letter

German vaccine maker CureVac and the European Union (EU) are close to finalizing a supply deal for the company’s COVID-19 vaccine candidate that will stock the EU with hundreds of millions of doses. Source: Devices & Diagnostics Letter

The company said it plans to produce 2 million tests in September, increasing to 10 million tests in December. Source: Devices & Diagnostics Letter

Sinopharm has announced that it will launch another phase 3 trial of its experimental COVID-19 vaccine candidate, this time in Peru, following a greenlight from the Peruvian health regulator. Source: Devices & Diagnostics Letter

Johnson & Johnson (J&J) expects to begin the largest late-stage trial for a COVID-19 vaccine candidate to date early next month if results from its early-stage studies pan out. Source: Devices & Diagnostics Letter

The software can be used with scanners made by Siemens or other manufacturers. Source: Devices & Diagnostics Letter