The Readout Damian Garde & Meghana Keshavan

Happy Moderna vaccine day

Today, starting at 9 a.m. ET, a bunch of vaccine experts are going to dig into the data supporting Moderna’s Covid-19 vaccine, all of which is a prelude to the FDA’s decision to grant it an emergency use authorization. We at STAT will be posting live updates all day, which you can find here. In the meantime, here’s your guide to the meeting.

How to watch along: Unlike past FDA hearings, which were broadcast on the agency’s creaky internal video platform, this one will be easy to view. You can stream it live on YouTube, Twitter, and Facebook, which should preclude the bandwidth issues that have made prior FDA meetings impossible for some to view.

Will there be drama? If the positive FDA review released this week is any indication, there’s widespread enthusiasm about the demonstrated efficacy of this vaccine. And, because Moderna is seeking authorization only for people over 18, we won’t see a repeat of last week’s discussion over whether Pfizer and BioNTech’s vaccine is suitable for younger teens. But that doesn’t mean the panel will be without nits to pick. For one, Moderna’s vaccine appears to lead to more — and more severe — side effects than its counterpart, and the panelists will likely have a lot to say about the potential risk for allergic reactions, which have been observed with Pfizer’s vaccine.

Be sure to follow our coverage throughout the day.

The loudest critic of Trump’s new drug pricing policy is a tiny biotech with one product

President Trump’s plan to tie what the U.S. pays for pricey injectable drugs to what other countries pay has rankled a great many in the pharmaceutical industry, but perhaps none more than Coherus Biosciences, a tiny company with exactly one approved medicine.

As STAT’s Nicholas Florko reports, Coherus has spent the past three weeks having roughly a dozen conversations with Trump administration officials, inserting itself into the ongoing lawsuit against the policy, and filed sharply worded comments on the regulation, which wouldn’t take effect until Jan. 1.

That’s because the so-called most-favored nation policy poses an existential threat to Coherus, whose sole product, a biosimilar version of Amgen’s Neulasta, would see its federal reimbursement cut by 20% immediately and about 95% within four years. And the implementation would be unfair and anticompetitive, according to Coherus, as Pfizer, Novartis, and Viatris all make competing biosimilars, but none is included in Trump’s plan.

Read more.

Can a diabetes drug treat Alzheimer’s?

Novo Nordisk intends to find out. 

Next year, Novo plans to see whether semaglutide, a daily pill proven to lower blood sugar and spur weight loss, can slow cognitive decline for patients with early-stage Alzheimer’s disease. The Phase 3 study, slated for the first half of 2021, would enroll about 3,700 people and treat them with either semaglutide or placebo for roughly two years.

Why, you might wonder, would a major drug company go straight to Phase 3 with a diabetes drug that has never been studied in Alzheimer’s? Novo’s answer: GLP-1, semaglutide’s biological target, has demonstrated a positive relationship with memory and neuro-inflammation in animal studies. And in a trio of outcomes studies involving nearly 16,000 patients, there were 47 people who developed dementia, and only 15 of them were taking a GLP-1 treatment, which made for a statistically significant (albeit entirely post-hoc) difference.

The idea added about $8 billion to Novo’s market value, suggesting investors think it’s worth a shot. It’ll be a long time before anyone knows for sure, as Novo expects the study to take three or four years to complete.

An ‘undruggable’ cancer faces its first drug

An Amgen medicine aimed at a type of cancer long considered undruggable is now in the hands of the FDA, as the company filed for what would be a groundbreaking approval.

The treatment, sotorasib, targets a mutated protein called KRAS, which is present on a multitude of cancers but, due to its smooth outer surface, has to date stymied drug development. Sotorasib broke that mold with promising data in lung cancer, charting a 35% response rate for patients who have no other options.

If the FDA approves sotorasib, it would mark a coup for the field of oncology, which has toiled for years to find medicines that might latch onto KRAS proteins. It would also be good news for Mirati Therapeutics, whose rival treatment, adagrasib, has generated similarly positive data and is likely to go before the FDA next year.

More reads

  • Pfizer decision to turn off temperature sensors forced scramble to ensure Covid-19 vaccines kept ultra-cold. (STAT)
  • AstraZeneca makes tough unblinding call, grappling with a vaccine rollout that threatens to impair their embattled Phase 3. (Endpoints)
  • In a stem cell experiment that seemingly failed, scientists see a possible way to prevent a devastating disease. (STAT+)

Thanks for reading! Until tomorrow,

Thursday, December 17, 2020


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