Devices & Diagnostics Letter
J&J to Start Largest Phase 3 Vaccine Trial Yet in September
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
Read MoreSinopharm to Begin Phase 3 Trial of its COVID-19 Vaccine Candidate in Peru
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
Read MoreLumiraDx Rapid COVID-19 Test Authorized for Emergency Use
The company said it plans to produce 2 million tests in September, increasing to 10 million tests in December. Source: Devices & Diagnostics Letter
Read MoreEU, CureVac Near Advanced Purchase Agreement for COVID-19 Vaccine
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
Read MoreSmiths Medical Pulls Infusion Pumps, Citing Software Error
The company expects to release software updates late next year that will fix the problem. Source: Devices & Diagnostics Letter
Read MoreTrump Criticizes FDA Delay of Convalescent Plasma EUA
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
Read MoreOpGen Earns CE Mark for COVID-19 Diagnostic
The diagnostic runs on real-time PCR detection systems, including Applied Biosystems’ QuantStudio 5 and Bio-Rad’s CFX96. Source: Devices & Diagnostics Letter
Read MoreMylan’s Generic Version of Biogen’s MS Drug Gets FDA Approval
Mylan has launched the product in 120mg and 240mg delayed-release capsule forms. Source: Devices & Diagnostics Letter
Read MoreU.S. to Pay Nearly $2 Billion for Pfizer-BioNTech COVID-19 Vaccine
HHS and the Department of Defense have signed their largest deal to date under Operation Warp Speed — a $1.95 billion contract with Pfizer and BioNTech for large-scale production and nationwide delivery of 100 million doses of their COVID-19 vaccine. Source: Devices & Diagnostics Letter
Read MoreGlenmark’s Favipiravir Shows Promise for COVID-19 Patients
India-based Glenmark Pharmaceuticals says its antiviral favipiravir has shown promise as a COVID-19 treatment in mild to moderate patients. Source: Devices & Diagnostics Letter
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