News
Tocilizumab Shortage Prompts Temporary REMS Change for CAR T-Cell Therapy
Shortly after an EUA was issued, Genentech announced that tocilizumab (marketed under the brand name Actemra) was in shortage.
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Drugs in the Pipeline
Baricitinib Alone Authorized for COVID-19 Under Revised EUA
The update was based on data from the COV-BARRIER study.
News
FDA Authorizes Emergency Use of Actemra for COVID-19
The EUA was issued based on 4 randomized controlled clinical trials that evaluated the efficacy and safety of Actemra in more than 5500 hospitalized patients with COVID-19.
Drugs in the Pipeline
Mixed Results for Baricitinib in Trial of Hospitalized COVID-19 Patients
Findings showed that the trial did not meet statistical significance on the primary endpoint.
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.
News
Fluvoxamine Evaluated in Patients With Mild COVID-19
The study, which was fully remote and contactless, aimed to evaluate whether early treatment with fluvoxamine reduced the likelihood of clinical deterioration and disease severity in patients with mild COVID-19 illness.
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.
