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Pfizer Withdraws Application for EUA of COVID-19 Vaccine in India

Pfizer Withdraws Application for EUA of COVID-19 Vaccine in India

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...
Pfizer and BioNTech Receive Premier COVID-19 Vaccine Authorization

Pfizer and BioNTech Receive Premier COVID-19 Vaccine Authorization

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,...
Analysis on Pfizer’s COVID-19 Vaccine Distribution Leaves Many Healthcare Workers Unprotected

Analysis on Pfizer’s COVID-19 Vaccine Distribution Leaves Many Healthcare Workers Unprotected

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...
Review of Johnson & Johnson’s COVID-19 Vaccine Underway

Review of Johnson & Johnson’s COVID-19 Vaccine Underway

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...
Pfizer Signs Multiyear Agreement to Make Gilead’s Remdesivir

Pfizer Signs Multiyear Agreement to Make Gilead’s Remdesivir

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-19. With Gilead aiming to produce enough remdesivir to treat more than 2 million patients by the end of the year, and agreeing to send...

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