Tag: Business and Industry

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

November 30, 2020todi0

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 […]

Johnson & Johnson initiates second global Phase 3 clinical trial of its Janssen COVID-19 vaccine candidate

November 26, 2020todi0

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. In addition to the single-dose regimen ENSEMBLE […]

Lilly’s neutralizing antibody bamlanivimab (LY-CoV555) receives interim authorization from Health Canada as a treatment for COVID-19

November 24, 2020todi0

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 […]

AZD1222 vaccine met primary efficacy endpoint in preventing COVID-19

November 23, 2020todi0

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 […]

Pfizer and BioNTech to submit Emergency Use Authorization request today to the U.S. FDA for COVID-19 vaccine

November 20, 2020todi0

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 […]

Pfizer and BioNTech conclude Phase 3 study of COVID-19 vaccine candidate, meeting all primary efficacy endpoints

November 18, 2020todi0

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. Analysis of the data indicates a vaccine efficacy rate of 95% (p0.0001) in participants without prior SARS-CoV-2 […]

Moderna’s COVID-19 vaccine candidate meets its primary efficacy endpoint in the first interim analysis of the Phase 3 COVE study

November 16, 2020todi0

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 […]

Swissmedic begins rolling review of Moderna’s mRNA vaccine against COVID-19 (mRNA-1273)

November 13, 2020todi0

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. This announcement follows positive results from a preclinical viral challenge study of mRNA-1273 and […]

Lilly’s neutralizing antibody bamlanivimab (LY-CoV555) receives FDA emergency use authorization for the treatment of recently diagnosed COVID-19

November 13, 2020todi0

The U.S. Food and Drug Administration (FDA) granted Emergency Use Authorization (EUA) for Eli Lilly and Company’s (NYSE: LLY) investigational neutralizing antibody bamlanivimab (LY-CoV555) 700 mg. Bamlanivimab is authorized for the treatment of mild to moderate COVID-19 in adults and pediatric patients 12 years and older with a positive COVID-19 test, who are at high […]

Medicago and GSK announce start of Phase 2/3 clinical trials of adjuvanted COVID-19 vaccine candidate

November 12, 2020todi0

Medicago, a biopharmaceutical company headquartered in Quebec City, and GSK have announced the start of Phase 2/3 clinical trials of its plant-derived vaccine candidate for COVID-19 to evaluate its efficacy, safety, and immunogenicity. Based on the positive Phase 1 results, Medicago has decided to launch the Phase 2/3 clinical trial with GSK’s pandemic adjuvant. Nathalie […]