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The Readout Damian Garde & Meghana Keshavan

Vaccine experts have some questions about Moderna’s coronavirus data

On Monday, Moderna issued a press release worth about $5 billion in market value, describing the early results of its investigational vaccine for the novel coronavirus. The market reaction was joyous. But experts left to parse the company’s statements found plenty of vagaries, plot holes, and open questions.

As STAT’s Helen Branswell reports, Moderna’s press release offers scientists little in the way off determining whether its vaccine might actually protect people from infection. And, curiously, the company’s partners at the federal government have been mostly silent.

Read more.

Meanwhile, to STAT’s Adam Feuerstein, Moderna’s reticence when it comes to disclosure is unbecoming of a serious player in biotech. The company’s information-light statement was followed hours later by a $1.3 billion stock offering. That’s business as usual in the penny-stock corners of biotech, not firms with the scale and ambition of Moderna, Feuerstein writes.

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The CEO Trump picked for emergency generics has a checkered résumé

The coronavirus pandemic has threatened the supply chain of much-needed generic medicines. So the federal government is paying a drug company to help prevent a crisis. But the man in charge of that company didn’t exactly win over industry watchdogs at his last gig.

As STAT’s Ed Silverman reports, the company on the receiving end of a $354 million award is led by Eric Edwards, a founder and former executive at Kaleo. Back in 2018, a Senate subcommittee report found that Kaleo raised the price of its Evzio opioid overdose antidote by more than 600% between 2014 and 2017, costing taxpayers more than $142 million. And the company’s efforts to compete with the controversially expensive EpiPen led to a Senate probe in 2017.

“Maybe this company is the best one for the job, but it does raise eyebrows,” said Holly Fernandez Lynch, an assistant professor of medical ethics at the Perelman School of Medicine at the University of Pennsylvania. “One would hope that CEOs who behave in a way that is not in the public interest are not rewarded by the federal government a couple of years later.”

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Suddenly everything is biotech

Speaking of the reaction to Moderna’s preliminary vaccine data, it goes well beyond Moderna. The aforementioned Monday press release sent the Dow Jones Industrial Average up more than 900 points for its best day since early April. And then yesterday, as experts weighed in with unaddressed concerns, the Dow gave about a third of that back.

That kind of fluctuation is familiar to biotech investors, but because the fate of global economies is now entwined with when — and whether — the drug industry can come up with an answer for Covid-19, the Moderna situation might be a preview of the months to come. 

Every positive biotech headline, however preliminary, is now a positive for airlines, hotel chains, and any other sector imperiled by the pandemic. Over the next few weeks, we’re likely going to see more data on Gilead Sciences’ remdesivir and early-stage results from vaccine developers around the world. If the Moderna experience is any indication, it’s going to be volatile.

What do we do with all this Covid-19 data?

As scientists pick apart the effects of the novel coronavirus in hopes of learning how to stop it, they’re left to grapple with a deluge of conflicting data from flawed studies. The FDA, with the help of some modern technology, wants to help.

As STAT’s Matthew Herper reports, the agency is working with Aetion, a New York health tech startup that specializes in real-world evidence, to compile data from government, academia, and industry into something useful for researchers trying to get a handle on Covid-19.

The idea is to take information collected by insurance companies, in electronic health records, and in other places in medicine to help prioritize which potential medicines merit further study and which patients might get the most benefit from them.

“It really helps you zero in on the work that you should be doing, quickly, to resolve whether or not identified treatments bear out in clinical trials,” said Amy Abernethy, the FDA’s principal deputy commissioner.

Read more.

More reads

  • Amid conflict-of-interest criticisms, top FDA officials recuse themselves from Covid-19 vaccine approvals. (STAT Plus)
  • AI-powered biotech can help deploy a vaccine in record time. (Wired)
  • Gilead ups its donation of the Covid-19 drug remdesivir for U.S. hospitals. (STAT)
  • How a California biotech briefly tripled its value by hyping a Covid-19 ‘cure.' (Endpoints)

Thanks for reading! Until tomorrow,

Wednesday, May 20, 2020

STAT

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