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Catch up on coronavirus stories and special reports, curated by Mike Allen everyday

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Photo: Budrul Chukrut/SOPA Images/LightRocket via Getty Images

When an experimental coronavirus treatment received a special designation from the Food and Drug Administration on Monday, it came as a surprise to the government's top health care officials — including the FDA commissioner.

Why it matters: Top officials aren't normally involved in everyday regulatory decisions. But this particular designation was particularly controversial, as critics quickly questioned whether it was giving an unfair financial advantage to one drugmaker in the midst of a pandemic.

Background: Pharmaceutical company Gilead Sciences is running clinical trials to test whether one of its drugs, called remdesivir, is an effective treatment against the novel coronavirus.

  • On Monday, the FDA granted remdesivir status as an "orphan" drug.
  • Orphan status is reserved for drugs that treat rare diseases. It gives their developers lucrative perks, such as an extended monopoly and tax credits.
  • At the time of the designation, fewer than 200,000 people had been diagnosed with the coronavirus in the U.S., which is the legal threshold for an orphan drug. But the virus is obviously spreading fast, and experts say it could eventually afflict a huge percentage of Americans.

The intrigue: Health and Human Services Secretary Alex Azar, FDA commissioner Stephen Hahn and Janet Woodcock, who leads the FDA office in charge of new drugs, weren't aware ahead of time that remdesivir was receiving orphan status, according to multiple sources familiar with the situation.

Gilead said yesterday that it was asking the FDA to rescind the orphan designation.

Go deeper: Over 100 drugs are in testing in the race to treat coronavirus

Go deeper

Mike Allen, author of AM
5 hours ago - World

Courage vs. coddling with China

Peng Shuai of China serves during the China Open in Beijing in 2017. Photo: Andy Wong/AP

The women's professional tennis tour suspended tournaments in China Wednesday out of concern for Peng Shuai, on the same day that a top business voice made excuses for Beijing.

Why it matters: Ahead of February's Winter Olympics in Beijing, some sports figures are taking on the regime — while Big Business shrinks from confrontation with the world's second-largest economy.

5 hours ago - Sports

What to know about the first MLB lockout since 1995

Illustration: Shoshana Gordon/Axios

Hope you enjoyed the recent flurry of free-agent activity, because it's likely the last non-lockout-related MLB news for a while.

Driving the news: The owners locked out the players after the collective bargaining agreement expired at midnight last night, leading to MLB's ninth work stoppage — and first since 1995.

Biden extends mask mandates for travelers into 2022

President Biden delivers remarks at the White House on Dec. 1. Photo: Anna Moneymaker via Getty Images

President Biden will announce new testing protocols for international travelers on Thursday and extend masking requirements through March as the U.S. prepares to fight the Omicron variant this winter, according to senior administration officials.

Driving the news: The U.S. will tighten pre-departure testing protocols starting early next week by requiring all inbound international travelers to take COVID-19 tests within one day of their departure rather than three.