Results Announced in Phase 3 Trial of Ruxolitinib in COVID-19 Associated ARDS
Patients were randomized to receive either ruxolitinib 5mg twice daily (BID) plus standard of care (SoC), ruxolitinib 15mg BID plus SoC or placebo plus SoC.
All articles by Steve Duffy
Tocilizumab Gains New Indication for Systemic Sclerosis-Associated Interstitial Lung Disease
The FDA has approved Actemra® (tocilizumab; Genentech) subcutaneous injection for slowing the rate of decline in pulmonary function in SSc-ILD.
First OTC Molecular COVID-19 Test Receives EUA for At-Home Use
The test correctly identified 96% of positive samples from individuals known to have symptoms and 100% of positive samples from individuals without symptoms.
Novel Device for Sleep Apnea, Snoring Receives FDA Approval
The eXciteOSA device is used while the individual is awake and provides electrical muscle stimulation through a mouthpiece that sits around the tongue.
NIH: Study Will Identify Most Promising Therapies for COVID-19
So far, the therapies scheduled to be part of the trial are risankizumab, an interleukin-23 antagonist, and lenzilumab, an anti-human granulocyte macrophage-colony stimulating factor monoclonal antibody.
US Makes Deal With Pfizer, BioNTech for 100 Million COVID-19 Vaccine Doses
The US Department of Health and Human Services and the Department of Defense have agreed to receive 100 million doses of BNT162, a vaccine for SARS-CoV-2, once the manufacturers obtains approval or emergency use authorization from the FDA.
Validation Study Data Released for Some COVID-19 Antibody Tests
The analysis included results from 2 tests that have received EUA: the SARS-CoV-2 ELISA test (Euroimmun) and the COVID-19 IgG/IgM Rapid Test Cassette (Healgen).
First Study Investigating Antibody Treatment for COVID-19 Begins
The first patients have been dosed in a phase 1 trial evaluating a potential antibody therapy designed to treat coronavirus disease 2019. These patients received treatment at major medical centers in the US, including NYU Grossman School of Medicine and Cedars-Sinai in Los Angeles.
Digital Health Tool Propeller Cleared for Use With Symbicort Inhaler
The FDA has cleared the Propeller Health digital platform to connect with the Symbicort® Inhaler, a corticosteroid and long-acting beta-2 agonist indicated for the treatment of asthma and COPD.
LabCorp Expands Access to COVID-19 At-Home Collection Test Kit
LabCorp has expanded access to its at-home collection test kit to individuals nationwide who have symptoms consistent with coronavirus disease 2019 and those without symptoms who may have been exposed to the virus.
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