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NewslettersThe Capsule

Gilead just got the first FDA coronavirus treatment approval, but there are still problems

By
Sy Mukherjee
Sy Mukherjee
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By
Sy Mukherjee
Sy Mukherjee
Down Arrow Button Icon
October 22, 2020, 6:55 PM ET

Good afternoon, readers.

We’ve written extensively about the emerging therapeutics against the coronavirus. One of the earliest contenders was remdesivir, an antiviral from biotech giant Gilead. It’s not a save-all; but it did just score a coveted distinction as the first Food and Drug Administration (FDA) approved treatment to tackle COVID-19.

Up until this point, remdesivir (which will now carry the brand name Veklury) was under an “emergency use authorization” that can significantly cap its market reach. Now, according to the FDA, it’s been approved outright “for use in adult and pediatric patients 12 years of age and older and weighing at least 40 kilograms (about 88 pounds).”

“Previously authorized by the FDA for emergency use to treat COVID-19, Veklury is now the first and only approved COVID-19 treatment in the
United States.”

Gilead CEO Daniel O’Day reflected those comments in his own statements. “It is incredible to be in the position today, less than one year since the earliest case reports of the disease now known as COVID-19, of having an FDA-approved treatment in the U.S. that is available for all appropriate patients in need,” he said.

The practicality of how that will work out is a different issue. Gilead’s drug is meant for the sickest patients and those who have been hospitalized. While the approval presents progress, it’s going to take a lot more time to determine what this means for the health of Americans at large.

Gilead’s stock was up more than 3 percent after hours.

Read on for the day’s news, and see you next week.

Sy Mukherjee
sayak.mukherjee@fortune.com
@the_sy_guy

DIGITAL HEALTH

Healthcare ransomware attacks are on the rise. When someone breaches your personal health information, it's, well, personal. In our digital age it's become a growing problem and according to a new study these kinds of attacks doubled in the third quarter of 2020. And, by the way, this is big money. "The average ransom fees demanded to return data files is $1 million to $5 million per hit. University of California San Francisco paid $1.14 million to ransomware attackers in June," according to the report, which also noted that healthcare organizations were the most willing to pay ransom due to the sensitivity of their consumer base. (Becker's Health IT)

INDICATIONS

Moderna hits a major COVID vaccine goal. Upstart biotech Moderna, a company which has no approved treatments yet remains one of the main contenders for a coronavirus vaccine, has reportedly completed enrollment for its candidate. This particular vaccine is one of the four most promising potential treatments along with those from companies like Pfizer and Johnson & Johnson. (CNN)

THE BIG PICTURE

What to watch out for in tonight's presidential debate... on health care. President Donald Trump and former Vice President Joe Biden will face off in a few hours in the last debate of the election season. It's clear we have no idea how it will turn out. Such is the nature of our times. But health care may loom large, given the Trump administration's efforts to repeal the Affordable Care Act in the midst of a pandemic and a likely Supreme Court decision on that very issue in the next few months.

REQUIRED READING

76% of American CEos say they may shrink office space, by Lance Lambert

The troubles of misinfomation, by Sarah Kreps & Douglas Kriner

Brand loyalty is changing due to the pandemic, by Chris Morris

About the Author
By Sy Mukherjee
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