Oral Treatment for COVID-19 Gains Fast Track Designation
EDP-235 is currently being examined in a first-in-human phase 1 trial to assess safety, tolerability, and pharmacokinetics.
All articles by Steve Duffy
E-Cigarette Smoking History Tied to Increased Bladder, Lung Cancer Risk
Findings demonstrated that all smoking histories were tied to a higher prevalence of bladder and lung cancer.
FDA Grants First Full Approval to Pfizer-BioNTech COVID-19 Vaccine
The approval is indicated for individuals 16 years of age and older, however the vaccine remains available to those aged 12 years and older under the EUA.
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.
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).
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