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The Readout Damian Garde & Meghana Keshavan

We don't know who's going to be president in January

And it may stay that way for a while. But in terms of things pertinent to this newsletter, last night produced a handful of definitive results.

Rep. Donna Shalala, who served as health and human services secretary under President Clinton, lost her Miami-area seat, leaving Democrats without a notable voice on health care. And in Minnesota, drug pricing activist Quinn Nystrom, who based her campaign on fighting the escalating cost of insulin, lost to incumbent Republican Rep. Pete Stauber.

What remains unclear this morning is the balance of power in Congress, which will be key to matters of drug pricing and health care policy, regardless of who’s president. Democrats look likely to retain their majority in the House, but Republicans could manage to chip away at the advantage. Meanwhile, the Senate remains entirely up in the air, with six races still too close to call.

November is going to be big for Covid-19 medicines

Now that Election Day has finally come and gone, we can turn our attention to the fact that, over the next few weeks, we’re in for potentially world-changing data on medicines for Covid-19.

Any day now, partners Pfizer and BioNTech will conduct the first interim analysis of their pivotal Covid-19 vaccine trial, and if the results are resoundingly positive — or conclusively negative — the companies will tell us about it. The same could be true of Moderna, which has promised to take an interim look at its similar vaccine study some time in November.

On the therapeutics front, both Regeneron Pharmaceuticals and Eli Lilly have asked the FDA to grant emergency use authorizations for their Covid-19 antibody treatments. Either could arrive imminently, as is the case for preliminary data from ongoing trials. 

A great many people, including the author of this newsletter, are guilty of framing the development of Covid-19 medicines in the context of the election, which, as Pfizer CEO Albert Bourla put it last week, was always “an artificial milestone” in the timeline of vaccine development. Now that it’s over, we can look forward to some actual data.

The biggest questions headed into earnings

On top of everything else, this week inaugurates the crowded part of earnings season in biotech, and some of the sector’s biggest companies are likely to face probing questions about their futures.

  • BioMarin Pharmaceutical, which reports Thursday afternoon, is in an interesting spot with the FDA. The agency rejected its gene therapy for hemophilia A, which came as a shock, and recent news suggests the agency might have some concerns about the company’s treatment for the most common form of dwarfism. Expect there to be some inquiries.
  • Regeneron Pharmaceuticals, which will discuss earnings Thursday morning, is in the process of figuring out just which Covid-19 patients benefit most from its antibody therapy, with recent data implying that the treatment doesn’t work in the advanced stages of the disease. That, plus the timing of a potential approval, should be a dominant topic.
  • Bristol Myers Squibb, on deck for Thursday, has been the subject of fascination for former Celgene shareholders, who are entitled to a cash payout if certain drugs win approval on a fixed timeline. The latest scrutiny applies to a Washington manufacturing facility and whether it’s in good standing with the FDA. Bristol Myers management might not delve into details, but you can be certain the question will be asked.

The (other) big Alzheimer’s news this week

During the wall-to-wall coverage of Biogen’s controversial treatment for Alzheimer’s disease, spare a thought for one from Roche and AC Immune, which will be the subject of a less-watched but similarly weighty presentation.

On Friday, the two companies will present detailed data from a negative trial involving semorinemab, a drug that targets tangles of tau proteins in the brain. We know the treatment failed to beat placebo when it came to slowing the rate of cognitive decline, but we’re going to learn just how much of an effect it had on tau.

Post-mortem presentations on failed trials might not be the most alluring way to spend a Friday morning, but the details of semorinemab could be important. There are, according to AlzForum, 24 tau-targeting medicines in development. If Roche and AC Immune’s drug had a negligible effect on tau, there’s hope that a more potent therapy could yet show a benefit. If semorinemab did its job in the brain but still failed on the measure of cognition, the whole tau hypothesis would take a blow.

More reads

  • Critics say new NIH policy on scientific data sharing falls short. (STAT+)
  • Bahrain latest country to vaccinate frontline workers with Covid-19 shot. (Reuters)
  • An ‘innocent bystander’ in the booming biotech investor world is writing a blank check for $100 million. Who’s going to cash it? (Endpoints)
  • Ubiquitous hand sanitizers and grousing about masks: Snapshots from around the nation of voting in a pandemic. (STAT)

Thanks for reading! Until tomorrow,

Wednesday, November 4, 2020

STAT

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