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Readying for the drug pricing law, SQZ and Synlogic layoffs, & an Alzheimer's turnaround?

  

 

The Readout

Morning, it's Meghana. Medicare's working hard with industry to iron out the details of the new drug pricing law, Alzheimer's researchers are finally feeling a modicum of excitement, and some companies with cool technology are laying off staff.

Medicare to pharma: Let's 📞

It will be a few years before the new drug pricing law is used to crack down on some drug prices, but Medicare is looking to work closely with the industry to help shape how the law is rolled out.

Starting Dec. 13, Medicare officials will host monthly, hour-long calls with drug manufacturers to discuss the law. "The December 13 call will include an overview of what’s to come with the implementation of the new law, as well as invite manufacturers to provide feedback on the manufacturer agreement and data elements for Medicare drug price negotiation," according to a new memo from top Medicare official Meena Seshamani.

These monthly calls will come as Medicare continues to hire people to handle the government's new power — and as the industry mulls litigation that would block the reforms.

An inflection point for Alzheimer’s research?

There hasn’t been much cause for optimism in the Alzheimer’s research community — considering the recent series of high-profile flops, capped by Aduhelm’s stunning downfall last year. Now, however, the vibe seems ... pretty positive. A packed audience at the Clinical Trials in Alzheimer’s Disease meeting burst into applause when Eisai presented data on lecanemab that showed a modest benefit for the neurodegenerative disease.

“It’s a big difference” compared to prior CTAD meetings, one Alzheimer’s exec told STAT. “Before, there was really nothing — basic science and failures, basically.”

Some consider this moment a turning point for the field — a time when drugs like lecanemab will finally provide some grist for Alzheimer’s researchers to build upon.

Read more.

The first FDA-approved fecal microbiome drug

A big Alzheimer’s treatment data reveal. And a stinging defeat for Big Pharma's lobbying arm. We cover all these topics and more on this week's episode of “The Readout LOUD,” STAT’s biotech podcast.

STAT Washington correspondent Rachel Cohrs joins us to explain how PhRMA, the all-powerful lobbying group, lost its edge in a fight over drug-pricing negotiation. Damian gives us the inside scoop on CTAD, the big Alzheimer's disease research conference, where Eisai and Biogen presented groundbreaking data on their treatment called lecanemab. We also discuss the FDA approval of a microbiome drug for the treatment of a bowel disorder and the potential for a big acquisition of Horizon Therapeutics.

Listen here.

Two MIT spinouts laying off staff to stay afloat

Waters are choppy for early stage companies with dazzling, but unproven, technology. Yesterday, SQZ Biotechnologies lost its founder and CEO, slashing its workforce by 60% as it pivots to a new approach. And Synlogic, a startup launched by MIT’s Jim Collins and Tim Lu, are also cutting 25% of their staff to “optimize” their operations. Both are working to prolong their cash reserves to get through to critical readouts, Endpoints points out. Both companies’ shares have dropped dramatically in the process, however.

SQZ was the brainchild of graduate students working in Robert Langer’s lab at MIT, and was developing a way to loosen cell membranes by squeezing them so they can deliver therapeutic payloads. It’s now working on a next-gen version of an antigen presenting cell-based therapy, with aims of getting a Phase 1/2 readout by the middle of next year. It’s unclear whether this will impact the company’s $1.3 billion deal with Roche.

Synlogic, meanwhile, plans to focus more intently on its lead programs. SYNB1353, one of the synthetic biology company’s more advanced drugs, hit its proof of mechanism endpoints in a Phase 1 study, and the company plans to push forward.

More reads

  • With early data and a possible advantage, Amgen enters the obesity drug race, STAT
  • Roivant, Pfizer team up on inflammatory drug disease, Reuters
  • Elon Musk hopes to test a brain implant in humans next year, New York Times

Thanks for reading! Until tomorrow,

@megkesh
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Friday, December 2, 2022

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