Vir Biotechnology and GSK announce start of NIH-sponsored ACTIV-3 trial evaluating VIR-7831 in hospitalised adults with COVID-19
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- Category: GlaxoSmithKline
Vir Biotechnology, Inc. (Nasdaq: VIR) and GlaxoSmithKline plc (LSE/NYSE: GSK) today announced that the first patient has been dosed in a new sub-trial of the National Institutes of Health's (NIH) Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) Program Phase 3 clinical trial.
Valneva initiates Phase 1/2 clinical study of inactivated, adjuvanted COVID-19 vaccine candidate
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- Category: Business
Valneva 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.
Pfizer and BioNTech celebrate historic first authorization in the U.S. of vaccine to prevent COVID-19
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- Category: Pfizer
Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) announced that the U.S. Food and Drug Administration (FDA) has authorized the emergency use of the mRNA vaccine, BNT162b2, against COVID-19 in individuals 16 years of age or older. The vaccine is now authorized under an Emergency Use Authorization (EUA) while Pfizer and BioNTech gather additional data and prepare to file a planned Biologics License Application (BLA) with the FDA for a possible full regulatory approval in 2021.
Novartis provides update on RUXCOVID study of ruxolitinib for hospitalized patients with COVID-19
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- Category: Novartis
Novartis today announced that the Phase III RUXCOVID study evaluating ruxolitinib on top of standard of care (SoC) therapy compared to SoC treatment alone in patients with COVID-19 did not meet its primary endpoint(1). Initial data show there was no statistically significant reduction in the proportion of patients on ruxolitinib plus SoC therapy who experienced severe complications, including death, respiratory failure requiring mechanical ventilation or admission to the intensive care unit (ICU) by Day 29, compared to SoC alone(1).
Sanofi and GSK announce a delay in their adjuvanted recombinant protein-based COVID-19 vaccine programme to improve immune response in the elderly
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- Category: GlaxoSmithKline
Sanofi and GSK announce a delay in their adjuvanted recombinant protein-based COVID-19 vaccine program to improve immune response in older adults. Phase 1/2 study interim results showed an immune response comparable to patients who recovered from COVID-19 in adults aged 18 to 49 years, but a low immune response in older adults likely due to an insufficient concentration of the antigen.
Pfizer and BioNTech receive FDA Advisory Committee vote supporting potential first Emergency Use Authorization for vaccine to combat COVID-19 in the U.S.
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- Category: Pfizer
Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) announced that the U.S. Food and Drug Administration's (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted 17 to 4 in support of the FDA granting Emergency Use Authorization (EUA) for the companies’ COVID-19 mRNA vaccine (BNT162b2). There is one member of the Committee whose vote is not included in the 17 to 4 vote decision.
Pfizer and BioNTech announce publication of results from landmark Phase 3 trial of BNT162b2 COVID-19 vaccine candidate in The New England Journal of Medicine
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- Category: Pfizer
Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced that the New England Journal of Medicine has published safety and final efficacy results from the pivotal Phase 3 trial of BNT162b2, their mRNA-based COVID-19 vaccine candidate. In the trial of 43,448 participants, who were 16 years and older, 21,720 of whom received BNT162b2 and 21,728 placebo, the two-dose regimen of 30 μg BNT162b2, which was given 21 days apart, was well-tolerated and demonstrated vaccine efficacy of 95% against COVID-19.
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- Johnson & Johnson announces initiation of rolling submission for its single-dose Janssen COVID-19 vaccine candidate with the European Medicines Agency
- Pfizer and BioNTech achieve first authorization in the world for a vaccine to combat COVID-19
- 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