Moderna announces first participants dosed in Phase 2/3 study of COVID-19 vaccine candidate in adolescents
- Details
- 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 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.
Pfizer and BioNTech achieve Health Canada authorization for their vaccine to combat COVID-19
- Details
- Category: Pfizer
Pfizer Canada and BioNTech SE (Nasdaq: BNTX) today announced that Health Canada has granted Authorization under Interim Order for the emergency use of their mRNA COVID-19 vaccine (BNT162b2). The distribution of the vaccine in Canada will be prioritized according to the populations identified in guidance from the National Advisory Committee on Immunizations (NACI).
AZD1222 Oxford Phase III trials interim analysis results published in The Lancet
- Details
- Category: AstraZeneca
Results of an interim analysis of the Phase III programme conducted by Oxford University with AZD1222, peer-reviewed and published in The Lancet today, demonstrated that the vaccine is safe and effective at preventing symptomatic COVID-19 and that it protects against severe disease and hospitalisation. The interim analysis for efficacy was based on 11,636 participants accruing 131 symptomatic infections from the Phase III UK and Brazil trials conducted by Oxford University.
Lilly announces 650,000 additional doses of neutralizing antibody bamlanivimab (LY-CoV555) purchased by U.S. government to treat COVID-19
- Details
- Category: Eli Lilly and Company
The U.S. government has purchased 650,000 additional doses of Eli Lilly and Company's (NYSE: LLY) neutralizing antibody bamlanivimab (LY-CoV555) 700 mg. The purchase agreement is for $812.5 million and the doses will be delivered through January 31, 2021, with at least 350,000 of the additional doses delivered in December 2020.
Johnson & Johnson announces initiation of rolling submission for its single-dose Janssen COVID-19 vaccine candidate with the European Medicines Agency
- Details
- Category: Johnson & Johnson
Janssen-Cilag International N.V., part of the Janssen Pharmaceutical Companies of Johnson & Johnson, has initiated a rolling submission with the European Medicines Agency (EMA) for its investigational single-dose vaccine candidate for the prevention of COVID-19.
The EMA's Committee for Medicinal Products for Human Use (CHMP) enabled a rolling review of the investigational single-dose Janssen COVID-19 vaccine candidate based principally on positive non-clinical data showing that the vaccine candidate elicits a robust immune response, as demonstrated by neutralizing antibodies.
Pfizer and BioNTech achieve first authorization in the world for a vaccine to combat COVID-19
- Details
- Category: Pfizer
Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) announced today that the Medicines & Healthcare Products Regulatory Agency (MHRA) in the U.K. has granted a temporary authorization for emergency use for their COVID-19 mRNA vaccine (BNT162b2), against COVID-19. This constitutes the first Emergency Use Authorization following a worldwide Phase 3 trial of a vaccine to help fight the pandemic.
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
- Details
- 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 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%.
More Pharma News ...
- Johnson & Johnson initiates second global Phase 3 clinical trial of its Janssen COVID-19 vaccine candidate
- Lilly's neutralizing antibody bamlanivimab (LY-CoV555) receives interim authorization from Health Canada as a treatment for COVID-19
- AZD1222 vaccine met primary efficacy endpoint in preventing COVID-19
- Pfizer and BioNTech to submit Emergency Use Authorization request today to the U.S. FDA for COVID-19 vaccine
- Pfizer and BioNTech conclude Phase 3 study of COVID-19 vaccine candidate, meeting all 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
- Swissmedic begins rolling review of Moderna's mRNA vaccine against COVID-19 (mRNA-1273)