Phase 3 Study Evaluating Ravulizumab for COVID-19 Paused
The open-label, controlled study enrolled adults hospitalized with COVID-19 and severe pneumonia, acute lung injury or acute respiratory distress syndrome.
Respiratory Diseases/Disorders
Perception of Not Returning to Full Health Common After COVID-19
47 percent experience fatigue, with no correlation between any measures of persistent disease and initial disease severity
Locally-Delivered Sitaxsentan Designated Orphan Drug for Systemic Sclerosis
TMB-003 is a locally delivered formulation of sitaxsentan, a highly selective endothelin receptor antagonist.
Priority Review Granted to Novel Pneumococcal Conjugate Vaccine V114
The V114 vaccine candidate consists of pneumococcal polysaccharides from 15 serotypes, including serotypes 22F and 33F, which are associated with invasive pneumococcal disease.
Early High-Titer Plasma Reduces Progression of COVID-19
Early administration of high-titer convalescent plasma against SARS-CoV-2 reduces progression in mildly ill older adults
Case Series Describes Use of Icosapent Ethyl for COVID-19 Pneumonia
The authors described the cases of 3 patients with moderate to severe COVID-19 pneumonia who were treated with 2g of icosapent ethyl administered twice daily via a nasogastric tube.
Opdivo No Longer FDA-Approved for Small Cell Lung Cancer
In 2018, the FDA granted accelerated approval to Opdivo for SCLC based on data from the phase 1/2 CheckMate -032 trial.
Lorlatinib Under Review for Previously Untreated ALK-Positive NSCLC
The sNDA is supported by data from the phase 3 CROWN study comparing lorlatinib to Xalkori in 296 adults with advanced ALK-positive NSCLC.
FDA Expands Use of Three Cystic Fibrosis Medications
The full list of CFTR gene mutations for Trikafta, Symdeko and Kalydeco can be found in the updated prescribing information for each respective product.
No Benefit With Ruxolitinib for COVID-19 Associated Cytokine Storm
The global, double-blind, placebo-controlled RUXCOVID study compared ruxolitinib to placebo, in addition to standard of care, in 432 patients aged 12 years and older with COVID-19 associated cytokine storm.
