Drugs in the Pipeline, News
The EUA was granted based on data from the phase 3 ACTT-2 trial, which was conducted by the NIAID.
Drugs in the Pipeline, News
The FDA has approved the Investigational New Drug (IND) application for the phase 2a study of opaganib (RedHill Biopharma) in patients with confirmed moderate to severe SARS-CoV-2 infection.
Drugs in the Pipeline
The placebo-controlled ACTT 3 trial will evaluate the efficacy and safety of remdesivir in combination with interferon beta-1a in more than 1000 hospitalized COVID-19 patients.
News
The approval was based on data from the phase 3 ACTT-2 and COV-BARRIER studies.
Drugs in the Pipeline
Both randomized, placebo-controlled trials are expected to enroll approximately 1000 hospitalized patients.
Drugs in the Pipeline
Findings showed that the trial did not meet statistical significance on the primary endpoint.
Drugs in the Pipeline
Following clearance of an Investigational New Drug Application by the Food and Drug Administration, ViralClear announced that a phase 2 study evaluating merimepodib oral solution for the treatment of coronavirus disease 2019 (COVID-19) will be initiated.
News
The FDA approved Veklury (remdesivir; Gilead Sciences) for the treatment of COVID-19 in patients aged ≥12 years (weighing ≥40kg) requiring hospitalization.
Drugs in the Pipeline
The ACTT-2 study began on May 8 and included more than 1000 patients.
Drugs in the Pipeline
The sBLA is supported by data from 4 randomized, controlled studies that evaluated tocilizumab for the treatment of COVID-19 in more than 5500 hospitalized patients.