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The Readout Damian Garde & Meghana Keshavan

Aducanumab on watch

Biogen kicks off biotech’s first-quarter earnings on Thursday morning, so all ears will be hyper-tuned to whatever CEO Michel Vounatsos and R&D chief Al Sandrock say — or don’t say — about the company’s controversial Alzheimer’s drug during its conference call. 

The FDA is now well into the extra three months of the aducanumab review, so analysts and investors will want to know if Biogen has any insight into which direction the agency is leaning ahead of the June 7 approval decision deadline. Expect Biogen execs to field questions about what, if any, additional aducanumab clinical data Biogen submitted to the FDA, likely from the ongoing “EMBARK” re-dosing study. Also, if Biogen doesn’t receive a “deficiency letter” from the FDA on May 7 — 30 days before the decision deadline — does that suggest an approval is likely? 

Vounatsos and Sandrock may choose to say little or nothing about aducanumab, but that’s okay, because then everyone will shift to speculating about their “tone.” Did they sound confident while not answering questions? Or nervous?

For J&J Covid shot, a continuing pause

For the J&J Covid shot, this week will likely feel like a state of suspended animation.

Last Tuesday, the U.S. recommended a pause in the use of the Covid-19 vaccine made by Johnson & Johnson after six cases of a rare condition marked by serious blood clots combined with a lack of platelets. A panel convened by the CDC met Wednesday, but decided to delay any decision until more data are available. That panel, the Advisory Committee on Immunization Practices, will meet again Friday.

In the meantime, information will continue to trickle out about this mysterious condition, vaccine-induced thrombotic thrombocytopenia, or VITT. You can refer back to this explainer from STAT's Matthew Herper, or this Atlantic piece.

As of last Friday, J&J still said in the New England Journal of Medicine that "evidence is insufficient to establish a causal relationship." But things may be different seven days later: by then, many of the recipients of the J&J vaccine will have passed through the "danger zone" when more cases of VITT would be expected.

The case for virtual inspections

FDA drug inspections are done, by and large, in person. But Covid-19 has made that approach infeasible in most cases over the past year. By September, 85% of inspections were halted in the U.S., and 99.5% were curbed abroad. Now, there’s a push toward making virtual inspections permanent. 

Instead of visiting a manufacturing site, the thinking goes, inspectors could read up on the plant’s equipment and capabilities. “If inspectors decide to proceed, the manufacturer’s staff can carry a 360-degree camera around the plant as the inspector tells the producer where to go and when to move closer to something,” write two regulatory policy experts at George Mason University. 

Read more. 

Biopharma's mixed success with Covid-19

Although Covid-19 vaccines have largely proven themselves to be a biopharma success story, therapeutics have been more complicated. STAT’s Readout LOUD crew spoke with Josh Schimmer, an analyst with Evercore ISI, one of the earliest in the industry to note the risks Covid-19 posed for the world.

He said he has “very mixed feelings” about how biotech has performed in the pandemic’s wake. 

The vast majority of Covid-19 clinical trials, he noted, haven't led to medications targeting the virus. “We did need to throw a lot of spaghetti against the Covid window and just kind of see what was going to stick,” Schimmer said. 

Read more.

More reads

  • These countries did well with Covid. So why are they slow on vaccines? (New York Times)
  • New Zealand to donate vaccines for 800,000 to COVAX vaccine facility. (Reuters)
  • South African variant may 'break through' Pfizer vaccine protection, but vaccine highly effective, Israeli study says. (Reuters)

Thanks for reading! More tomorrow,

Damian

Monday, April 19, 2021

STAT

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