Coronavirus News Roundup: Gilead Sets Price for Remdesivir, New FDA and CDC Guidance Updates

July 2, 2020

Here's this week's roundup of the coronavirus-related news you should know.

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus that causes coronavirus disease 2019 (COVID-19), has infected an estimated 10,730,000 individuals worldwide, and approximately 2.7 million Americans. The latest COVID-19 related news centers around Gilead’s announcement on the price of remdesivir for COVID-19, and new FDA and CDC COVID-19 guidance.

Here’s a roundup of the latest coronavirus-related news:

Premature Testing More Likely to Result in False Negative for COVID-19

A Johns Hopkins team of investigators has found that testing infected individuals too early for COVID-19 may result in a false negative, even though they may test positive for the virus later.

The study, published in May in the Annals of Internal Medicine journal, examined 7 previously published studies that provided data on the performance of a common method called reverse transcriptase polymerase chain reaction (RT-PCR) in diagnosing COVID-19.

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FDA Guidance Provides Safety, Quality Standards for COVID-19 Vaccine Development

The FDA updated its guidance for developing and evaluating vaccine candidates to protect humans from SARS-CoV-2.

Although neither the FDA nor the scientific community can predict how quickly data will be generated from vaccine clinical trials, Marks said, the FDA is committed to “thoroughly and expeditiously evaluating” all the data.

“But make no mistake: the FDA will only approve or make available a COVID-19 vaccine if we determine that it meets the high standards that people have come to expect of the agency,” Marks added.

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CDC Updates List of Those With Highest Risk of Severe COVID-19 Illness

New evidence has prompted the CDC to update its list of demographics at highest risk for severe COVID-19, expanding the selection to further include various age groups and other medical condition factors.

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Part 2: A Conversation on Remdesivir Trial Updates

Julie Ann Justo, infectious diseases clinical pharmacist and associate professor at the University of South Carolina College of Pharmacy, discusses the latest data from Gilead's trials for Remdesivir, a potential COVID-19 treatment.

Watch the interview

Gilead Sets Price of Remdesivir for COVID-19 Treatment

Gilead Sciences has reached a decision on how much remdesivir should cost as a treatment for the novel coronavirus disease 2019 (COVID-19), according to an open letter by Daniel O’Day, chairman and CEO of Gilead. 1

According to O’Day, the manufacturer has set a price for governments of developed countries of $390 per vial, but for private insurance companies, it could be expected to be $520.

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