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The Readout Damian Garde & Meghana Keshavan

Merck’s vaccine candidate fails

Merck is dropping out of the Covid-19 vaccine race. It announced this morning that it will stop developing both formulations of a vaccine it was working on after trial participants failed to generate a strong immune response to either. 

It's a stunning setback for one of the world’s top vaccine makers — and increases the stakes for other companies that have their own Covid-19 vaccine readouts coming up, notably Johnson & Johnson and NovaVax.

Merck plans to continue development of two Covid-19 therapeutics. And the International AIDS Vaccine Initiative, which had partnered with Merck on the Covid-19 shots, will continue work on at least one of the Merck vaccines — to see if a different administration route, such as oral or intranasal, might improve its efficacy.

Read more.

Aurinia’s kidney drug wins approval, becomes potential blockbuster

As expected, Aurinia Pharmaceuticals has won FDA approval for its drug Lupkynis, aimed at treating lupus nephritis. There have been few options, to date, to treat this severe autoimmune kidney disease, so it’s welcome news for the patient community.

But it's also welcome news for the company and its investors, given the nature of the approval, STAT’s Adam Feuerstein writes. The  FDA allowed Aurinia to include proprietary dosing instructions in its prescribing label, strengthening and extending the drug’s patent protection.

Read more.

Colchicine may be promising for Covid-19. Or maybe not.

New research suggests that colchicine, a cheap and widely accessible drug used to treat gout, may reduce the likelihood that a person with Covid-19 will be hospitalized. Scientists at the Montreal Heart Institute found the rate of hospitalization or death to be 21% lower among patients who took colchicine. 

But the data, as STAT’s Matthew Herper writes, were only detailed in a press release, which also said the results were not statistically significant — but were very nearly so. Outside experts are hopeful but cautioned that it’s too early to draw conclusions about colchicine and Covid-19.

“How many therapies looked like they had promising topline results and look what happened?” UCSF cardiologist Ethan Weiss said — citing Gilead’s remdesivir, which has generated heaps of conflicting results. “Let’s see what the actual results look like and then we can have a conversation.”

Read more.

An endorsement for FDA commissioner

The Biden administration is earnestly seeking out a new FDA commissioner — a process that’s critically important in the wake of Covid-19. And there’s no better candidate than Joshua Sharfstein, a physician at Johns Hopkins University, say two academics who study the regulatory agency.

Sharfstein served at the FDA as a principal deputy commissioner during the Obama administration, and has always been a champion of modernization and transparency at the agency. And, importantly, Sharfstein has demonstrated that he’s unwilling to bend to political pressure — an attribute that hasn’t been the strong suit of the current commissioner, they argue. 

Read more.

More reads

  • AstraZeneca vaccine supply to EU cut 60%. (Reuters)
  • PhRMA sues to block Trump administration 340B rule. (STAT)
  • Covid-19 vaccine basics: Why the rollout is so slow, when it will pick up, and who can get it. (STAT)

Thanks for reading! More tomorrow,

Damian

Monday, January 25, 2021

STAT

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