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Valneva in advanced discussions with European Commission to supply up to 60 million doses of inactivated, adjuvanted COVID-19 vaccine candidate

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Business
13 January 2021
ValnevaValneva SE, a specialty vaccine company focused on prevention of infectious diseases with significant unmet medical need, announced it is in advanced discussions with the European Commission (EC) for the supply of up to 60 million doses of its COVID-19 vaccine, VLA2001. VLA2001 is currently the only inactivated vaccine candidate in clinical trials against COVID-19 in Europe.
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An in vitro study shows Pfizer-BioNTech COVID-19 vaccine elicits antibodies that neutralize SARS-CoV-2 with a mutation associated with rapid transmission

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Business
08 January 2021
BioNTechPfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced results from an in vitro study conducted by Pfizer and the University of Texas Medical Branch (UTMB) that shows the antibodies from people who have received the Pfizer-BioNTech COVID-19 vaccine effectively neutralize SARS-CoV-2 with a key mutation that is also found in two highly transmissible strains.
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European Commission authorizes COVID-19 vaccine Moderna in Europe

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07 January 2021
Moderna, Inc.Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, announced that the European Commission has granted a conditional marketing authorization (CMA) for COVID-19 Vaccine Moderna, allowing vaccination programs using the Moderna vaccine to be rolled out across the European Union.
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China grants conditional market approval for Sinopharm CNBG's COVID-19 vaccine

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06 January 2021
The inactivated COVID-19 vaccine developed by Beijing Institute of Biological Products of Sinopharm CNBG has been granted conditional registration by the NMPA of China, Chinese equivalent of FDA, according to a press conference of the State Council Joint Prevention and Control Mechanism on December 31, 2020,
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Moderna provides COVID-19 vaccine supply update

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05 January 2021
Moderna, Inc.Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, provided a supply update for the Moderna COVID-19 Vaccine, increasing its base-case global production estimate from 500 to 600 million doses for 2021. Moderna said it is continuing to invest and add staff to build up to potentially 1 billion doses for 2021.
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Novavax announces initiation of PREVENT-19 pivotal Phase 3 efficacy trial of COVID-19 vaccine in the United States and Mexico

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28 December 2020
Novavax, Inc.Novavax, Inc. (Nasdaq: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced initiation of PREVENT-19, its pivotal Phase 3 study in the United States and Mexico to evaluate the efficacy, safety and immunogenicity of NVX-CoV2373, the Company's COVID-19 vaccine candidate.
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Valneva initiates Phase 1/2 clinical study of inactivated, adjuvanted COVID-19 vaccine candidate

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Business
16 December 2020
ValnevaValneva SE, a specialty vaccine company focused on prevention against diseases with major unmet needs, today announced the initiation of a Phase 1/2 clinical study for its inactivated, adjuvanted COVID-19 vaccine candidate, VLA2001.

VLA2001 leverages the manufacturing platform of Valneva's licensed Japanese encephalitis vaccine, IXIARO® and is the first publicly announced inactivated vaccine against COVID-19 to commence clinical development in Europe.

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More Pharma News ...

  1. Moderna announces first participants dosed in Phase 2/3 study of COVID-19 vaccine candidate in adolescents
  2. Moderna announces primary efficacy analysis in Phase 3 COVE study for its COVID-19 vaccine candidate and filing today with U.S. FDA for Emergency Use Authorization
  3. Moderna's COVID-19 vaccine candidate meets its primary efficacy endpoint in the first interim analysis of the Phase 3 COVE study
  4. Swissmedic begins rolling review of Moderna's mRNA vaccine against COVID-19 (mRNA-1273)
  5. The Sputnik V COVID-19 vaccine efficacy amounted to 92% in Phase III clinical trials
  6. Novavax COVID-19 vaccine granted Fast Track Designation by U.S. FDA
  7. Novavax announces facility expansion to support global vaccine development
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Business & Industry

  • Vir Biotechnology and GSK announce NHS-supported AGILE study to evaluate VIR-7832 in the early treatment of COVID-19
  • Bayer transforms pharma business through breakthrough innovation in healthcare
  • Valneva in advanced discussions with European Commission to supply up to 60 million doses of inactivated, adjuvanted COVID-19 vaccine candidate
  • An in vitro study shows Pfizer-BioNTech COVID-19 vaccine elicits antibodies that neutralize SARS-CoV-2 with a mutation associated with rapid transmission
  • European Commission authorizes COVID-19 vaccine Moderna in Europe

Research & Development

  • New England Journal of Medicine publishes COVID-19 treatment trial results
  • Scientists identify 'immune cop' that detects SARS-CoV-2
  • New findings help explain how COVID-19 overpowers the immune system
  • New virtual screening strategy identifies existing drug that inhibits COVID-19 virus
  • Sustained cellular immune dysregulation in individuals recovering from COVID-19
  • How SARS-CoV-2 interacts with cells
  • Neutralizing antibodies protect against severe COVID-19

Conferences & Events

  • CPhI Worldwide to return in 2021
  • Reuters Events' Cell & Gene Therapy USA
  • Total health: Build a better healthcare system
  • Don't fall for the 'next best action' trap
  • Locking down shape-shifting spike protein aids development of COVID-19 vaccine
  • COVID-19 vaccine innovation could dramatically speed up worldwide production
  • Wearable Injectors and Connected Devices Conference 2020

Regulatory Affairs

  • EMA receives application for conditional marketing authorisation of COVID-19 Vaccine AstraZeneca
  • FDA takes additional action in fight against COVID-19 by issuing Emergency Use Authorization for second COVID-19 vaccine
  • Update on assessment of the BioNTech and Pfizer BNT162b2 vaccine marketing authorisation application
  • FDA takes key action in fight against COVID-19 by issuing Emergency Use Authorization for first COVID-19 vaccine
  • EMA receives application for conditional marketing authorisation of COVID-19 mRNA vaccine BNT162b2
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