Remove FDA Approval Remove Hospitals Remove RNA Remove Virus
article thumbnail

Day Zero Antivirals for Future Pandemics

Codon

After the outbreak ended, it took another three years for the first Ebola vaccine by Merck to be approved. When COVID-19 emerged in 2019, by contrast, mRNA vaccines developed by Pfizer and Moderna took just 326 days from the initial sequencing of the virus to gaining approval for emergency use. Unsubscribe any time.

RNA 87
article thumbnail

FDA Approves First Rapid COVID Test for Home Use

The Pharma Data

Lab tests that look for the coronavirus’s genetic material using a technique called polymerase chain reaction (PCR) are still considered the gold standard for detecting the virus. That fragment sets off alarms in the immune system and stimulates it to attack if the real virus shows up. “I am hopeful that it works well.”

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

Months of Work Hang in the Balance as Moderna’s COVID-19 Vaccine Awaits AdComm Vote

The Pharma Data

To this point, Moderna has only submitted two months of follow-up safety data, and the FDA typically requires six months for a full approval. intends to ship just shy of six million doses of Moderna’s vaccine once the FDA approves EUA. Both vaccines have shown about 95% efficacy in preventing novel coronavirus infections.

Vaccine 52
article thumbnail

World RNA Day: What impact RNA it had on drug discovery?  

Drug Discovery World

1 August was first chosen as World RNA Day in 2018 as a play on AUG (adenine, uracil and guanine), a triple sequence of RNA (called a codon) that initiates protein synthesis by the cell. Since then, it has been observed to publicise the importance of this molecule in the generation of proteins in the body.

RNA 130
article thumbnail

FDA Takes Additional Action in Fight Against COVID-19 By Issuing Emergency Use Authorization for Second COVID-19 Vaccine

The Pharma Data

. “ With the availability of two vaccines now for the prevention of COVID-19, the FDA has taken another crucial step in the fight against this global pandemic that is causing vast numbers of hospitalizations and deaths in the United States each day,” said FDA Commissioner Stephen M. Hahn , M.D.

Vaccine 52
article thumbnail

Gilead Sciences Announces Second Quarter 2021 Financial Results

The Pharma Data

Hepatitis B virus (“HBV”) and hepatitis delta virus (“HDV”) product sales increased 8% to $237 million for the second quarter 2021 compared to the same period in 2020. Sales of Veklury are generally affected by COVID-19 related rates of infections, hospitalizations and vaccinations. Total second quarter 2021 revenue of $6.2

Science 52
article thumbnail

Moderna Announces Primary Efficacy Analysis in Phase 3 COVE Study for Its COVID-19 Vaccine Candidate and Filing Today with U.S. FDA for Emergency Use Authorization

The Pharma Data

Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, today announced that the primary efficacy analysis of the Phase 3 study of mRNA-1273 conducted on 196 cases confirms the high efficacy observed at the first interim analysis.

Vaccine 52