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Drugs in the Pipeline

Benralizumab Reduces OCS Use in Severe Asthma Trial

Findings from a phase 3b trial showed that a majority of patients with severe eosinophilic asthma treated with benralizumab (Fasenra; AstraZeneca), an interleukin-5 antagonist, were able to eliminate or reduce oral corticosteroid (OCS) use. The open-label, single-arm PONENTE trial assessed the efficacy and safety of reducing OCS use after initiating treatment with benralizumab in nearly…
Drugs in the Pipeline

Voclosporin NDA for Lupus Nephritis Submitted to FDA

The New Drug Application (NDA) for voclosporin (Aurinia Pharmaceuticals) has been submitted to the Food and Drug Administration (FDA) for the treatment for lupus nephritis.
News

Dupixent Approval Expanded to Pediatric Patients With Atopic Dermatitis

The FDA has expanded the approval of Dupixent® (dupilumab; Regeneron and Sanofi) to include patients aged 6 to 11 years with moderate to severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.
News

NIH Treatment Guidelines for COVID-19 Released

Recommendations on the management of coronavirus disease 2019 (COVID-19) were recently released by the National Institutes of Health (NIH) to help guide clinicians caring for patients with COVID-19.
Safety Alerts and Recalls

Certain Blister Packages of Sandimmune, Neoral Not Child Resistant

Certain blister packages of Sandimmune (cyclosporine capsules) and Neoral (cyclosporine capsules) may not meet child-resistant packaging requirements, according to manufacturer Novartis.  The Company announced that it is working with the Consumer Product Safety Commission to address the packaging issue. In a press statement, Novartis stressed that there are no quality or efficacy issues with the…