Johnson & Johnson initiates second global Phase 3 clinical trial of its Janssen COVID-19 vaccine candidate
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- Category: Johnson & Johnson
The Phase 3 ENSEMBLE study of the single-dose regimen of JNJ-78436735, the investigational vaccine candidate for the prevention of COVID-19 being developed by the Janssen Pharmaceutical Companies of Johnson & Johnson, continues to enroll and vaccinate study participants. ENSEMBLE is proceeding to enroll up to 60,000 participants worldwide.
Lilly's neutralizing antibody bamlanivimab (LY-CoV555) receives interim authorization from Health Canada as a treatment for COVID-19
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- Category: Eli Lilly and Company
Health Canada granted authorization under the Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19 for the use of bamlanivimab (LY-CoV555) as a treatment for adults and pediatric patients 12 years of age or older with mild to moderate COVID-19 who weigh at least 40 kg and are at high risk of progressing to severe COVID-19 illness and/or hospitalization, Eli Lilly and Company (NYSE: LLY) announced.
AZD1222 vaccine met primary efficacy endpoint in preventing COVID-19
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- Category: AstraZeneca
Positive high-level results from an interim analysis of clinical trials of AZD1222 in the UK and Brazil showed the vaccine was highly effective in preventing COVID-19, the primary endpoint, and no hospitalisations or severe cases of the disease were reported in participants receiving the vaccine. There were a total of 131 COVID-19 cases in the interim analysis.
Pfizer and BioNTech to submit Emergency Use Authorization request today to the U.S. FDA for COVID-19 vaccine
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- Category: Pfizer
Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) announced they will submit a request today to the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) of their mRNA vaccine candidate, BNT162b2 against SARS-CoV-2, which will potentially enable use of the vaccine in high-risk populations in the U.S. by the middle to end of December 2020.
Pfizer and BioNTech conclude Phase 3 study of COVID-19 vaccine candidate, meeting all primary efficacy endpoints
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- Category: Pfizer
Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced that, after conducting the final efficacy analysis in their ongoing Phase 3 study, their mRNA-based COVID-19 vaccine candidate, BNT162b2, met all of the study's primary efficacy endpoints.
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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- Category: Business
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%.
Swissmedic begins rolling review of Moderna's mRNA vaccine against COVID-19 (mRNA-1273)
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- Category: Business
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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