The Readout Damian Garde & Meghana Keshavan

The political spending of pharma, analyzed

Drug makers and their trade groups have cut checks to 356 lawmakers — more than two-thirds of Congress — ahead of this year’s election, according to a sweeping new analysis. It's a barrage of spending, and it comes as the industry is working to rehabilitate its image in Washington by battling Covid-19. 

“It’s less about a particular deliverable and more about creating a relationship,” one political analyst told STAT. “And, maybe, greasing the skids on a particular issue for which a company has great concern or sees great opportunity. On Covid, it’s certainly both — these corporations are being called to the aid of a country in crisis.”

STAT’s Lev Facher and Kaitlyn Bartley have assembled a comprehensive guide to how pharmaceutical dollars have been distributed among politicians during this election season thus far.

Read more.

Biologics labs have been closed, perhaps too long

Government research labs have slowly been reopening, but those focused on biologics have been staying shuttered longer than the rest, STAT’s Nicholas Florko writes. The FDA told its staff last month that it’ll keep these labs, which research vaccine and gene therapy safety and efficacy, closed until there are fewer than 10 Covid-19 cases per 100,000 people in the region. 

Some scientists argue that this is overkill — and that scientists will take the appropriate safety precautions. “You’ve gotta open up labs,  you have to let scientists get back in again,” said Ashish Jha, a Harvard researcher who created the metrics the FDA uses for its reopening protocol.

FDA scientists who are still restricted from returning to work find the scenario distressing and demoralizing. “We just want to make a contribution to protecting the public health,” one FDA scientist told STAT.

Read more.

A success for Seres

Seres finally is seeing some success for its C. difficile treatment that works by tinkering with the microbiome. About 11% of patients who took Seres’ drug, which is a pill filled with bacteria, had a recurrence a C. difficile infection — compared to 41% among those who didn’t take the drug.

This data represent a major comeback for Seres: Four years ago, the company reported a devastating — and unexpected — clinical trial failure that dropped its stock from $34 a share to less than $5. The company has since revised its screening protocols for trial participants, to try and ensure they indeed have C. difficile infections — and that may have helped tipped the balance in a positive direction. 

Read more.

PDUFA timelines are still on track

The Covid-19 pandemic hasn't slowed FDA review timelines, as Mizuho points out in a client note. The agency continues to churn out NDA and BLA reviews on time, or even ahead of PDUFA deadline.

Mizuho has compiled a list of companies, and their respective drugs up for approval, in a handy document here

“We believe this is encouraging in light of Covid-19,” the Japanese banking firm said. “While companies may be impacted from a commercial and clinical development standpoint to various degrees, there appears to be minimal impact on regulatory review timelines.” 

More reads

  • This company boasted to Trump about its Covid-19 vaccine. Experts are skeptical (New York Times)
  • FDA approves first oral treatment for a rare muscle-destroying disease. (STAT)
  • Why Bill Gates thinks U.S. testing is not improving. (CNN

Thanks for reading! More tomorrow,


Monday, August 10, 2020


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