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Valneva commences manufacturing of its inactivated, adjuvanted COVID-19 vaccine, completes Phase 1/2 study recruitment

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28 January 2021
ValnevaValneva SE, a specialty vaccine company focused on prevention of infectious diseases with significant unmet medical need, today announced it has commenced production of its inactivated, adjuvanted COVID-19 vaccine candidate in parallel to the ongoing clinical studies, in order to optimize the timeline for potential deliveries of the vaccine. The Phase 1/2 clinical study is now fully enrolled and is expected to report initial results in April 2021.
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Pfizer and BioNTech publish results of study showing COVID-19 vaccine elicits antibodies that neutralize pseudovirus bearing the SARS-CoV-2 U.K. strain spike protein

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20 January 2021
BioNTechToday, Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) announced results from an in vitro study that provides additional data on the capability of sera from individuals immunized with the Pfizer-BioNTech COVID-19 vaccine BNT162b2 to neutralize the SARS-CoV-2 U.K. strain, also known as B.1.1.7 lineage or VOC 202012/01. The results were published on the preprint server bioRxiv and submitted to a peer-reviewed journal.
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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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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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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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More Pharma News ...

  1. Novavax announces initiation of PREVENT-19 pivotal Phase 3 efficacy trial of COVID-19 vaccine in the United States and Mexico
  2. Valneva initiates Phase 1/2 clinical study of inactivated, adjuvanted COVID-19 vaccine candidate
  3. Moderna announces first participants dosed in Phase 2/3 study of COVID-19 vaccine candidate in adolescents
  4. 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
  5. Moderna's COVID-19 vaccine candidate meets its primary efficacy endpoint in the first interim analysis of the Phase 3 COVE study
  6. Swissmedic begins rolling review of Moderna's mRNA vaccine against COVID-19 (mRNA-1273)
  7. The Sputnik V COVID-19 vaccine efficacy amounted to 92% in Phase III clinical trials
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Build the future of health through collaboration & innovation

Business & Industry

  • Novartis signs initial agreement with CureVac to manufacture COVID-19 vaccine candidate
  • AstraZeneca advances mass global rollout of COVID-19 vaccine through COVAX
  • Abbott researchers find rare group of people with controlled HIV who could be a key to unlocking cure
  • Pfizer and BioNTech initiate a study as part of broad development plan to evaluate COVID-19 booster and new vaccine variants
  • Sanofi and GSK initiate new Phase 2 study of their adjuvanted recombinant protein-based COVID-19 vaccine candidate

Research & Development

  • New evidence COVID-19 antibodies, vaccines less effective against variants
  • Vaccine development software shows promise in influenza effort, could help defeat coronavirus
  • Researchers discover SARS-CoV-2 inhibitors
  • Nanoparticle-delivered COVID-19 vaccine candidate shows promise in preclinical studies
  • First COVID-19 COVAX vaccine doses administered in Africa
  • Assessing a compound's activity, not just its structure, could accelerate drug discovery
  • Arthritis drugs may reduce mortality and time in ICU for sickest COVID patients

Conferences & Events

  • Scientists urge for investment now in highly potent vaccines to prevent the next pandemic
  • 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

Regulatory Affairs

  • FDA issues Emergency Use Authorization for third COVID-19 vaccine
  • FDA Authorizes Monoclonal Antibodies for Treatment of COVID-19
  • 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
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