Mar 22, 2021 | News, Regulatory
The New England Journal of Medicine published results from a study to test AstraZeneca’s vaccine’s efficacy for the South African variant of COVID-19. The clinical study was conducted in South Africa with 1,467 participants, of which 2.5% developed...
Feb 18, 2021 | Clinical Trials, e-Learning, Health, Pharmaceuticals, Regulatory
There is no doubt that clinical trials are vitally important in the drug development process. As an increasing number of clinical trials are conducted overseas, sometimes with multiple ongoing studies at once, having in-depth knowledge...
Feb 10, 2021 | News, Regulatory
Pfizer announced that it was withdrawing its application for emergency use authorization (EUA) in India for its COVID-19 vaccine. The pharmaceutical company failed to meet India’s regulatory requirements for a local immunogenicity study to ensure the safety of the...
Jan 25, 2021 | News, Regulatory
The U.S. Food and Drug Administration (FDA) announced on Friday (1/22) the first ever approval for Aurinia Pharmaceutical’s Lupkynis oral medication in combination with a background immunosuppressive therapy regimen for lupus nephritis (LN), serious chronic autoimmune...
Oct 21, 2020 | News, Regulatory
In November 2020, the clinical study for treatment of acute viral pneumonia, facilitated by Beyond Air, a medical device and pharmaceutical company, is scheduled to commence. The study will consider enrollment for anyone infected with COVID-19 and pneumonia caused by...
