FDA Issues Guidance for COVID-19 Vaccine Development
The FDA has issued guidance to assist in the development and licensure of vaccines for the prevention of COVID-19.
All articles by Diana Ernst, RPh
NICHD Study to Examine Drugs Used to Treat Pediatric COVID-19 Patients
Unlike a clinical trial with a control group, the study will focus on collecting data in order to identify appropriate and safe doses; it will not be evaluating the best treatment for COVID-19.
Merck Collaborating on Novel COVID-19 Vaccine, Oral Antiviral
The vaccine candidate is currently in preclinical development with clinical studies expected to begin later this year.
Early Data Show Potential Benefit of Acalabrutinib in Severe COVID-19
Acalabrutinib, a Bruton tyrosine kinase (BTK) inhibitor, appears to reduce respiratory distress as well as the hyperinflammatory immune response associated with coronavirus disease 2019.
NIH Trial Investigating Hydroxychloroquine Plus Azithromycin for COVID-19 Begins
The phase 2b trial is expected to include roughly 2000 participants with confirmed SARS-CoV-2 who are experiencing fever, cough, and/or shortness of breath.
Pomalyst Gets Accelerated Approval for Kaposi Sarcoma
This indication was granted accelerated approval based on overall response rate (ORR) and continued approval may be contingent upon confirmatory trial results.
Investigational T Cell Therapy Gets Fast-Tracked for Mucosal Pemphigus Vulgaris
The FDA has granted Fast Track designation to DSG3-CAART (desmoglein 3 chimeric autoantibody receptor T cell therapy; Cabaletta Bio), a potential treatment for mucosal pemphigus vulgaris.
FDA Issues Safety Alert Regarding Use of Hydroxychloroquine, Chloroquine for COVID-19
The Agency is warning the public that the use of these agents should be limited to clinical trial settings or for treating certain hospitalized patients under the Emergency Use Authorization.
Trial Evaluating Ruxolitinib for COVID-19 Associated Cytokine Storm Initiated
A phase 3 trial evaluating ruxolitinib (Jakafi; Incyte) for the treatment of coronavirus disease 2019 (COVID-19)-associated cytokine storm is being initiated in patients 12 years of age and older.
Scalp Psoriasis Study Data Added to Otezla Labeling
The labeling for Otezla (apremilast; Amgen) has been updated to include safety and efficacy information related to the treatment of patients with moderate to severe plaque psoriasis of the scalp.
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