Don’t expect clarity when it comes to remdesivir data

Some time this week, Gilead Sciences will disclose clinical data on remdesivir, the Covid-19 treatment whose future is unhyperbolically important to the fate of the world. But the data, from an open-label trial, will be far from definitive.

As STAT’s Matthew Herper and Adam Feuerstein report, Gilead’s trial has no placebo control, meaning all patients are getting remdesivir for either five or 10 days. That means “the overall study itself has little or no scientific value,” said Steven Nissen, the chief academic officer at the Cleveland Clinic.

Experts said it’ll be impossible to say whether remdesivir works until placebo-controlled trials, now underway, produce results. But on that point about the fate of the world, every glimmer of data on Gilead’s drug has shifted global markets, and data from the open-label study, no matter the caveats, are sure to do the same.

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How is the pandemic affecting the business of biopharma?

We’re going to get some clues this week, when a few of the industry’s biggest companies report their first-quarter earnings numbers.

Merck, Gilead Sciences, Novartis, Pfizer, and GlaxoSmithKline are among the firm’s that will present their financials this week. Analysts don’t expect major disruptions to first-quarter numbers, as the coronavirus crisis didn’t fully set in in the U.S. until March. But Wall Street will be listening closely for statements about how the rest of 2020 might shake out and when executives think business might return to something resembling normal.

As an addition, you can expect that the question-and-answer session of Gilead’s Thursday conference call will be focused on the Covid-19 treatment remdesivir, just as Pfizer, Amgen, AstraZeneca, and GSK are sure to discuss their efforts to find treatments and vaccines for the novel coronavirus.

America doesn’t make antibiotics anymore. That could be a problem

The U.S.’s inconsistent response to the coronavirus pandemic has only underlined concerns that the country is unprepared for the microbial threats of the future. And antibiotics, essential to fighting bacterial infection, are made almost universally outside its borders.

As Gardiner Harris and Alex Palmer of The Wire report, China manufactures about 80% of the world’s antibiotics, a situation that grew out of cheap labor, rapid industrialization, and U.S. government inactivity.

Now, with China and the U.S. in a yearslong economic standoff, experts worry that the next political flareup or spike in antibiotic demand could be disastrous. As Rosemary Gibson, a senior adviser at the Hastings Center, warned, “If China shut the door on exports of medicines and their key ingredients and raw materials, U.S. hospitals and military hospitals and clinics would cease to function within months, if not days.”

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Regeneron's future in oncology is that much brighter

Back in 2018, when Regeneron Pharmaceuticals won approval for the cancer treatment Libtayo, it was fair to wonder whether the world really needed a sixth so-called checkpoint inhibitor. But data released at a medical meeting this week suggest that Regeneron’s come-from-behind plan is working.

As STAT’s Matthew Herper reports, Libtayo extended the survival of previously untreated patients with non-small cell lung cancer in a study stopped early because the drug was so effective. Of the five approved checkpoint inhibitors, only Merck’s market-leading Keytruda has succeeded in such a study.

Libtayo still has a long way to go before it can challenge Merck’s drug, which made $11 billion last year. But the company’s strategy, which hinges on developing combination therapies that make Libtayo more effective, is working so far.

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