The COVPN is part of “Operation Warp Speed”, a partnership led by the Department of Health and Human Services to accelerate the development, manufacturing, and distribution of COVID-19 vaccines, therapeutics, and diagnostics.
Siltuximab is currently marketed under the trade name Sylvant and is indicated for the treatment of multicentric Castleman’s disease.
A phase 3 trial evaluating sarilumab, an interleukin-6 antagonist, in patients with COVID-19 requiring mechanical ventilation did not meet its primary and key secondary end points.
Pfizer and BioNTech SE announced positive preliminary results from the phase 1/2 study evaluating the safety, tolerability, and immunogenicity of escalating doses of the vaccine candidate BNT162b1 against COVID-19.
The FDA has granted Fast Track designation to RLF-100 (Aviptadil; NeuroRx and Relief Therapeutics) for the treatment of acute lung injury/acute respiratory distress syndrome associated with coronavirus disease 2019.
A phase 1 study evaluating the safety, reactogenicity and immunogenicity of SCB-2019, a vaccine candidate for coronavirus disease 2019 (COVID-19), has been initiated by Clover Biopharmaceuticals.
GlaxoSmithKline Consumer Healthcare announced the voluntary recall of 2 lots of Children’s Robitussin® Honey Cough and Chest Congestion DM and 1 lot of Children’s Dimetapp® Cold and Cough due to the inclusion of incorrect dosing cups.
The accelerated approval was based on data from a prospectively-planned retrospective analysis of 10 cohorts of patients with various previously treated unresectable or metastatic solid tumors with TMB-H who were enrolled in the open-label phase 2 KEYNOTE-158 trial.
The FDA recently issued an Emergency Use Authorization for the use of Propoven 2% Emulsion as a result of the continued shortage of propofol which is needed for ventilating COVID-19 patients.
Regeneron has initiated its first human clinical trials evaluating an investigational antiviral antibody cocktail, REGN-COV2, for the prevention and treatment of coronavirus disease 2019.
