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The Readout Damian Garde & Meghana Keshavan

The YouTube ‘hit job’ making its way through biotech circles

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(YouTube)

In a short film that invokes Chernobyl, Homer Simpson, and the aesthetics of early-2000s video-editing software, someone is trying to tarnish the reputation of Jacobus Pharmaceuticals.

As STAT’s Ed Silverman reports, earlier this month, a YouTube account called “Bad Pharma Exposed” posted a roughly six-minute video pointing out that Jacobus’s New Jersey manufacturing plant is right next to a decommissioned nuclear reactor. Then there’s some ominous music, animated text, and snippets from old FDA inspection reports, all making the case that Jacobus’s drugs might not be safe.

The video, which one analyst called “a well-done hit job,” doesn’t break any new ground on Jacobus. But the timing is curious. Jacobus made headlines back in 2019 when it won FDA approval for a drug that treats the rare disease LEMS. Before that, Catalyst Pharmaceuticals had the only approved LEMS treatment, a drug that costs $375,000 or more. Catalyst has since sued the FDA, claiming it “arbitrarily and capriciously” approved the Jacobus drug, which sells for less than half the price. A federal judge has promised to rule on the lawsuit.

Read more

How the brains behind YCombinator are trying to speed up Covid-19 studies

Sam Altman, who ran the startup accelerator YCombinator until last year, wanted to help fight the novel coronavirus outbreak. To Silicon Valley VC, that means funding biotech companies. But in meeting after meeting, founders mentioned the same stumbling block: Running clinical trials is a costly, time-consuming endeavor that makes developing drugs during a pandemic exceedingly difficult.

Altman’s answer is Project Covalence, a collaboration meant to speed up the process by using technology to recruit patients from afar, evaluate them remotely, and collect samples. As STAT’s Matthew Herper reports, the effort brings in TrialSpark, a health tech startup, and Mark Fishman, a Harvard Professor who was the founding president of the Novartis Institutes for Biomedical Research. The goal is collapse the standard timeframe for clinical trials.

“We're pushing ourselves … to think about things for Covid differently, more urgently,” Fishman said. “You know, this is not your standard trial. It has to be done quickly, but it has to be done well. And you've seen already the problems of trials being done or reported in a slipshod fashion.”

Read more.

There’s an FDA-sanctioned video game now

After years of development and a few months of uncertainty, the FDA has given the green light to EndeavorRx, a video game meant to treat ADHD and the first digital therapeutic to pass regulatory muster in the U.S.

As STAT’s Rebecca Robbins reports, the game, developed by Boston-based Akili Interactive Labs, targets children between the ages of 8 and 12 who have an ADHD diagnosis and have demonstrated an issue with attention. EndeavorRx rewards players for completing various tasks designed to activate and strengthen certain neural networks in the brain. It’s a far more ambitious application of technology than the many apps designed to help patients manage their conditions, and its approval is a landmark moment for the health tech sector.

It’s also just the beginning of Akili’s story. Now the company has to convince doctors to prescribe it, insurers to pay for it, and patients to stick to it. The company’s success or failure will be closely watched by a nascent industry.

Read more.

Momenta’s neuromuscular drug looks competitive in Phase 2

Momenta Pharmaceuticals’ treatment for the rare neuromuscular disease myasthenia gravis posted impressive results in a mid-stage study, improving the company’s odds of competing with a more advanced rival.

As STAT’s Adam Feuerstein reports, Momenta’s drug improved symptoms for 52% of patients with generalized myasthenia gravis, beating the 15% seen with placebo. Momenta tested four different doses of its treatment in the Phase 2 study, and it’s likely to use a monthly dose in its next study, which would support FDA approval.

The news, which sent Momenta’s share price up about 15% yesterday, suggests the company has a shot against Argenx, a Belgian drug maker whose myasthenia gravis treatment could be up for approval later this year.

Read more.

More reads

  • FDA revokes emergency use ruling for hydroxychloroquine, the drug touted by Trump as a Covid-19 therapy. (STAT)
  • Germany stakes its claim over Curevac. (Evaluate Vantage)
  • ‘We have a job to do’: Cancer patients and their doctors carry on with clinical trials during Covid-19. (STAT)
  • Can existing live vaccines prevent COVID-19? (Science)

Thanks for reading! Until tomorrow,

Tuesday, June 16, 2020

STAT

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