Drugs in the Pipeline, News
FDA Issues EUA to Baricitinib Plus Remdesivir for Hospitalized COVID-19 Patients
The EUA was granted based on data from the phase 3 ACTT-2 trial, which was conducted by the NIAID.
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Drugs in the Pipeline
Lenzilumab Promising for Hospitalized Patients With COVID-19
Lenzilumab is an investigational anti-human granulocyte macrophage-colony stimulating factor monoclonal antibody.
News
FDA Approves Veklury as First Treatment for COVID-19
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
Trials Testing Convalescent Plasma for COVID-19 Expanded
Both randomized, placebo-controlled trials are expected to enroll approximately 1000 hospitalized patients.
Drugs in the Pipeline
Baricitinib Plus Remdesivir Cuts Time to Recovery for Hospitalized COVID-19 Patients
The ACTT-2 study began on May 8 and included more than 1000 patients.
Drugs in the Pipeline
NIH: Remdesivir Plus Interferon Beta-1a Being Evaluated for COVID-19
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
High Dose IVIG to Be Investigated for Severe COVID-19 in Phase 3 Trial
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
Antiviral Merimepodib to Be Investigated in Phase 2 Trial for COVID-19
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
FDA Greenlights Study to Evaluate Opaganib in Patients With Moderate to Severe COVID-19
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
Mycamine Approved for Invasive Candidiasis in Younger Patients
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.
