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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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Business
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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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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Moderna announces first participants dosed in Phase 2/3 study of COVID-19 vaccine candidate in adolescents

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Business
10 December 2020
Moderna, Inc.Moderna Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, today announced that the first adolescent participants have been dosed in the Phase 2/3 study of mRNA-1273, the Company’s vaccine candidate against COVID-19, in adolescents ages 12 to less than 18.
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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

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30 November 2020
Moderna, Inc.Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, today announced that the primary efficacy analysis of the Phase 3 study of mRNA-1273 conducted on 196 cases confirms the high efficacy observed at the first interim analysis. The data analysis indicates a vaccine efficacy of 94.1%.
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Moderna's COVID-19 vaccine candidate meets its primary efficacy endpoint in the first interim analysis of the Phase 3 COVE study

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16 November 2020
Moderna, Inc.Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, today announced that the independent, NIH-appointed Data Safety Monitoring Board (DSMB) for the Phase 3 study of mRNA-1273, its vaccine candidate against COVID-19, has informed Moderna that the trial has met the statistical criteria pre-specified in the study protocol for efficacy, with a vaccine efficacy of 94.5%.
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Swissmedic begins rolling review of Moderna's mRNA vaccine against COVID-19 (mRNA-1273)

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13 November 2020
Moderna, Inc.Moderna, Inc., (Nasdaq: MRNA) a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, today announced that Swissmedic has started a rolling review of mRNA-1273, the Company's vaccine candidate against COVID-19.
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The Sputnik V COVID-19 vaccine efficacy amounted to 92% in Phase III clinical trials

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11 November 2020
Russian Direct Investment Fund (RDIF)The National Research Center for Epidemiology and Microbiology named after N.F. Gamaleya of the Ministry of Health of the Russian Federation (Gamaleya Center) and the Russian Direct Investment Fund (RDIF, Russia's sovereign wealth fund), announce that the Sputnik V vaccine, the world's first registered vaccine against coronavirus (registered on the 11 th of August under the emergency use authorization mechanism) created on the well-studied platform of human adenoviral vectors, demonstrated high efficacy.
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More Pharma News ...

  1. Novavax COVID-19 vaccine granted Fast Track Designation by U.S. FDA
  2. Novavax announces facility expansion to support global vaccine development
  3. RDIF and União Química file documents for registration of Sputnik V vaccine with regulator in Brazil
  4. Russian application of Sputnik V vaccine for WHO vaccine prequalification among the first applications submitted
  5. Novavax provides Phase 3 COVID-19 vaccine clinical development update
  6. Moderna announces supply agreement with the Ministry of Public Health to supply Qatar with mRNA vaccine against COVID-19 (mRNA-1273)
  7. CureVac reports positive preclinical data for its COVID-19 vaccine candidate, CVnCoV
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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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  4. U.S. government purchases additional 100 million doses of Moderna's COVID-19 vaccine

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