FDA Approves IV Formulation of Tpoxx for Smallpox
The IV formulation is designed to provide an alternative option for patients who are unable to swallow the oral capsules.
Smallpox
Vials Found in Lab Contained Vaccine, Not Smallpox Virus: CDC
Federal officials were alerted that the vials were found by a laboratory worker while cleaning out a freezer in the facility
Vials With Smallpox Labels Found at Vaccine Lab in Pennsylvania: CDC
Vials were found by a laboratory worker while cleaning out a freezer in a facility that conducts vaccine research
FDA Approves Tembexa for Smallpox Treatment
The treatment was approved under the FDA’s Animal Rule which allows findings from animal efficacy studies to determine the approval for a drug when feasible or ethical studies in humans cannot be conducted.
TPOXX Approved for the Treatment of Human Smallpox Disease
The approval was supported by findings from 12 clinical trials of TPOXX with more than 700 healthy volunteers that showed no drug-related serious adverse events.
FDA Grant Orphan Drug Status to Brincidofovir for Smallpox
Brincidofovir is the Company’s lead candidate, a nucleotide analog that has antiviral activity against variola virus, which causes smallpox.
Review: Treatment Recommendations for Biological Disasters
The Centers for Disease Control and Prevention (CDC) classifies key biological agents into three categories: A, B, and C.
Treatment for Smallpox Gets FDA Priority Review
The treatment was developed under the FDA’s ‘Animal Rule’; where efficacy is determined in animal studies and human studies determine safety and appropriate dosing. The FDA have stated a target action date for TPOXX of August 8, 2018.
