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
Lenzilumab is an investigational anti-human granulocyte macrophage-colony stimulating factor monoclonal antibody.
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
Both randomized, placebo-controlled trials are expected to enroll approximately 1000 hospitalized patients.
Drugs in the Pipeline
The ACTT-2 study began on May 8 and included more than 1000 patients.
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.
Drugs in the Pipeline
The FDA has approved Octapharma’s Investigational New Drug Application allowing the Company to initiate a phase 3 trial of Octagam® (immune globulin intravenous [human]) in patients with COVID-19 with severe disease progression.
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.
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.
News
The Food and Drug Administration has approved the supplemental New Drug Application (sNDA) for Mycamine (micafungin for injection; Astellas Pharma) for the treatment of candidemia, acute disseminated candidiasis, Candida peritonitis and abscesses without meningoencephalitis and/or ocular dissemination in pediatric patients aged <4 months.