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...
Dec 14, 2020 | News, Regulatory
Pfizer and BioNTech have made history with their COVID-19 vaccine, as it is the first to enter the U.S. market after Phase 3 clinical trial results showing 95% efficacy. The mRNA vaccine is being allocated for emergency use to hospitals nationwide,...
Dec 4, 2020 | News, Regulatory
Countrywide, hospitals are preparing for the first 3.2 million shipments of Pfizer’s COVID-19 vaccine. The first round of shipments will be distributed to five government agencies before Moderna’s vaccine hits the market. State’s will have final say on...
Dec 1, 2020 | News, Regulatory
After finding that the Johnson & Johnson vaccines triggered antibody cell formation to fight COVID-19, the European Medicines Agency (EMA) began to review the drug for emergency use authorization (EUA). Meanwhile, the company’s rivals Moderna and...
Aug 7, 2020 | News, Regulatory
Pfizer announced today (8/7) that it has signed a multiyear agreement for Gilead’s remdesivir, a treatment for Covid. With Gilead aiming to produce enough remdesivir to treat more than 2 million patients by the end of the year, and agreeing to send almost the entirety...
