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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…
Drugs in the Pipeline

Oral Tyrosine Kinase Inhibitor Effective in Severe Asthma Trial

Treatment with masitinib, a selective tyrosine kinase inhibitor, significantly reduces the rate of severe asthma exacerbations in patients with severe asthma uncontrolled by oral corticosteroids, according to data from a phase 3 study.
Drugs in the Pipeline

Baricitinib Added to Topical Steroids Beneficial in Atopic Dermatitis Trial

Adding baricitinib to topical corticosteroids significantly improved disease severity in adult patients with moderate to severe atopic dermatitis, according to top-line results from BREEZE-AD7 study. The phase 3 study included 300 patients who had been diagnosed with moderate to severe atopic dermatitis for at least 12 months and had an inadequate response to topical medications.…