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The Readout Damian Garde & Meghana Keshavan

Are we ever getting a permanent FDA commissioner?

When can we stop wearing masks outside? And is curing disease a good business?

We cover all that and more this week on “The Readout LOUD,” STAT’s biotech podcast. First, Northwestern University epidemiologist Mercedes Carnethon joins us to weigh in on the nation’s latest Covid-19 debate: Is it OK to go maskless outdoors? Then, STAT Washington correspondent Nicholas Florko calls in to talk about why the Biden administration is waiting so long to nominate an FDA commissioner and how that indecision could have real consequences. Later, we discuss the scientific promise of novel treatments for sickle cell disease — and the industry’s growing concern that they might not be as lucrative as once thought. And, naturally, we recap the latest news in the Covid-19 vaccine rollout.

Listen here.

Parsing Al Sandrock

Like some Oracle of Alzheimer’s, every word uttered by Biogen R&D chief Al Sandrock was maniacally scrutinized yesterday during the company’s earnings conference. Analysts and investors are desperate for any hints about what might happen to Biogen’s Alzheimer’s drug aducanumab as the FDA review winds down to the June 7 approval decision deadline.

So, things got a bit nutty when Sandrock, responding to a question related to the need for patients to undergo MRIs for safety monitoring, said, “Exactly how many we’ll need will obviously depend on our discussions if we get to them, or when we get to them in terms of the label, which we don’t have yet.”

Wall Streeters immediately freaked out because Sandrock’s choice of words — “if we get to them” — suggested that perhaps Biogen and the FDA had not started to discuss a possible aducanumab label. And that might mean the FDA is leaning toward rejecting the drug. And Sandrock using those words on the conference call might mean Biogen is telegraphing reduced confidence in its most important drug. 

Or, not. Biogen later tried to walk back Sandrock’s response, insisting investors were reading way too much into the statement. Whether  aducanumab patients will require MRIs depends on the drug’s label, and that won’t be known until the drug is approved, Biogen said. 

The stock still fell 4%.

A patient community reels after Pfizer discontinues a drug

For patients with a rare condition known as aphakic glaucoma, which causes intraocular pressure to dramatically rise, a decades-old eye drop made by Pfizer has been life-altering. But starting next week, that medication will be unavailable; Pfizer has announced it will stop producing it because “a complex chain of external partners” is “increasingly unstable.”

As STAT’s Ed Silverman reports, that decision has caused great alarm among the small group of patients who depend on the drops.

“They’re scared and anxious and desperate. It’s a very intense concern. And you have a big, multinational, multibillion-dollar company that arbitrarily says it won’t make it anymore. I think it’s understandable from a Pfizer perspective. But there are things Pfizer could do to look good – make more drug or fund research to prevent the disease from recurring.”

Read more.

Things could get worse for Emergent

Emergent Biosolutions, whose contract manufacturing revenue quintupled in 2020 thanks to Covid-19, was always going to struggle to keep that pace of growth. But after weeks of negative press and now a scathing FDA inspection report, Emergent’s core business could be coming unglued, too.

The company’s mounting problems led the analysts at Cowen to lower their valuation of the company by about 32% yesterday, citing the firm’s embarrassing problems producing Johnson & Johnson’s Covid-19 vaccine, the damning implications of that FDA review, and an upcoming congressional hearing that’s sure to highlight Emergent’s name in the news for unenviable reasons. All of that is going to make winning new manufacturing contracts exceedingly difficult, Cowen figures.

It could also spill over to Emergent’s other major revenue driver: selling biodefense products to the federal government. The U.S. is still under contract to stockpile the company’s anthrax vaccine, but if it decides to scale back its relationship with Emergent or look elsewhere entirely, the company would be in dire straits. Making matters worse, Emergent relies heavily on sales of the overdose treatment Narcan, which is likely to face generic competition from global giant Teva Pharmaceutical in the next 12 months, putting even more pressure on the company’s contract manufacturing business.

More reads

  • Could a souped-up version of existing Covid-19 tests be our shortcut to tracking variants? (STAT)
  • Homegrown Indian Covid vaccine already in use shows 78% efficacy. (Bloomberg)
  • VC firm of Moderna chairman dumped $1.4 billion of stock in two months. (Forbes)
  • In mouse experiments, scientists unlock the key to scar-free skin healing. (STAT)

Thanks for reading! Until next week,

Friday, April 23, 2021

STAT

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