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  • Regulatory NewsRegulatory News

    Smallpox antiviral approved under FDA’s Animal Rule

    Though the World Health Organization declared smallpox eradicated in 1980, FDA has approved Tembexa (Chimerix,brincidofovir) as a treatment for the contagious, deadly disease caused by the variola virus.   The 4 June announcement of Tembexa’s approval noted that smallpox drug development is “an important component of the US medical countermeasures response,” since the federal government has significant concerns about the virus’ potential use as a bioweapon. Tembexa was...
  • Regulatory NewsRegulatory News

    COVID innovation lessons could be applied elsewhere

    The global urgency of the COVID-19 pandemic spurred the development of new models of vaccine and drug development. Could these innovations help with researching non-pandemic vaccines or drugs, and potentially serve as a template in other areas of medicine?   Two papers recently published in Health Affairs suggest that, yes, these innovations could be applied elsewhere if deemed successful—but it’s also important to note the shortcomings of these new models as well. ...