Russian application of Sputnik V vaccine for WHO vaccine prequalification among the first applications submitted
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- Category: Business

Novavax provides Phase 3 COVID-19 vaccine clinical development update
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Johnson & Johnson prepares to resume Phase 3 ENSEMBLE Trial of its Janssen COVID-19 vaccine candidate in the U.S.
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- Category: Johnson & Johnson

The independent Data Safety and Monitoring Board (DSMB) overseeing the ENSEMBLE study has recommended resuming trial recruitment. Following consultation with the U.S. Food and Drug Administration (FDA), preparations to resume the trial in the United States, including submissions for approval by the Institutional Review Boards, are now underway.
Moderna announces supply agreement with the Ministry of Public Health to supply Qatar with mRNA vaccine against COVID-19 (mRNA-1273)
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FDA authorises restart of the COVID-19 AZD1222 vaccine US Phase III trial
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- Category: AstraZeneca

The Food and Drug Administration (FDA) authorised the restart in the US, following the resumption of trials in other countries in recent weeks. The FDA reviewed all safety data from trials globally and concluded it was safe to resume the trial.
CureVac reports positive preclinical data for its COVID-19 vaccine candidate, CVnCoV
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Moderna completes enrollment of Phase 3 COVE study of mRNA vaccine against COVID-19 (mRNA-1273)
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More Pharma News ...
- Sanofi and Translate Bio mRNA COVID-19 vaccine candidate induced high antibody levels in preclinical studies
- Regeneron's REGN-COV2 antibody cocktail reduced viral levels and improved symptoms in non-hospitalized COVID-19 patients
- Gilead Sciences signs joint procurement agreement with the European Commission for Veklury® (remdesivir)
- COVID-19 Long-Acting AntiBody (LAAB) combination AZD7442 rapidly advances into Phase III clinical trials
- Johnson & Johnson announces European Commission approval of agreement to supply 200 million doses of Janssen's COVID-19 vaccine candidate
- Vir Biotechnology and GSK announce global expansion to Phase 3 of COMET-ICE study evaluating VIR-7831 for the treatment of COVID-19
- BioNTech and Pfizer initiate rolling submission to European Medicines Agency for SARS-CoV-2 vaccine candidate BNT162b2