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OpGen Earns CE Mark for COVID-19 Diagnostic

  • Post author:Sam
  • Post published:August 20, 2020
  • Post category: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

Continue ReadingOpGen Earns CE Mark for COVID-19 Diagnostic

Mylan’s Generic Version of Biogen’s MS Drug Gets FDA Approval

  • Post author:Sam
  • Post published:August 20, 2020
  • Post category:Devices & Diagnostics Letter

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

Continue ReadingMylan’s Generic Version of Biogen’s MS Drug Gets FDA Approval

Siemens Healthineers’ MRI Software Cleared

  • Post author:Sam
  • Post published:August 20, 2020
  • Post category:Devices & Diagnostics Letter

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

Continue ReadingSiemens Healthineers’ MRI Software Cleared

J&J to Start Largest Phase 3 Vaccine Trial Yet in September

  • Post author:Sam
  • Post published:August 20, 2020
  • Post category: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:…

Continue ReadingJ&J to Start Largest Phase 3 Vaccine Trial Yet in September

Sinopharm to Begin Phase 3 Trial of its COVID-19 Vaccine Candidate in Peru

  • Post author:Sam
  • Post published:August 20, 2020
  • Post category: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:…

Continue ReadingSinopharm to Begin Phase 3 Trial of its COVID-19 Vaccine Candidate in Peru

LumiraDx Rapid COVID-19 Test Authorized for Emergency Use

  • Post author:Sam
  • Post published:August 20, 2020
  • Post category: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

Continue ReadingLumiraDx Rapid COVID-19 Test Authorized for Emergency Use

EU, CureVac Near Advanced Purchase Agreement for COVID-19 Vaccine

  • Post author:Sam
  • Post published:August 20, 2020
  • Post category: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…

Continue ReadingEU, CureVac Near Advanced Purchase Agreement for COVID-19 Vaccine

Smiths Medical Pulls Infusion Pumps, Citing Software Error

  • Post author:Sam
  • Post published:August 20, 2020
  • Post category:Devices & Diagnostics Letter

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

Continue ReadingSmiths Medical Pulls Infusion Pumps, Citing Software Error

U.S. to Pay Nearly $2 Billion for Pfizer-BioNTech COVID-19 Vaccine

  • Post author:Sam
  • Post published:July 22, 2020
  • Post category:Devices & Diagnostics Letter

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…

Continue ReadingU.S. to Pay Nearly $2 Billion for Pfizer-BioNTech COVID-19 Vaccine

Glenmark’s Favipiravir Shows Promise for COVID-19 Patients

  • Post author:Sam
  • Post published:July 22, 2020
  • Post category:Devices & Diagnostics Letter

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

Continue ReadingGlenmark’s Favipiravir Shows Promise for COVID-19 Patients
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