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Co-founders of uBiome are charged with securities fraud
The SEC yesterday charged the co-founders of uBiome with defrauding its investors out of $60 million.
Jessica Richman, the former chief executive officer of the disgraced microbiome testing company, and Zachary Apte, its former chief scientific officer, “painted a false picture of uBiome as a rapidly growing company” with strong revenue prospects, the SEC stated in its complaint. The reality, it added, was the operation was a “sham,” which depended on “duping doctors into ordering unnecessary tests” that ultimately led insurers to “claw back their previous reimbursement payments to uBiome.”
The company, which raised about $100 million from venture investors, filed for bankruptcy in September 2019 — about four months after it was raided by the FBI.
Read more.
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Has Europe lost the plot with Covid-19 vaccines?
Can the latest treatment for Alzheimer’s disease. succeed where so many others failed? And why don’t biotech companies just come clean when things go wrong?
We discuss all that and more this week on “The Readout LOUD,” STAT’s biotech podcast. First we unpack the crisis of confidence facing AstraZeneca's Covid-19 vaccine in Europe with Alison Buttenheim, a University Pennsylvania professor who studies vaccine acceptance. Then, we explain the latest data on an Alzheimer's disease treatment from Eli Lilly and why it has polarized experts in the field. Finally, we make a modest proposal to the biotech industry: Give honesty a chance.
Listen here.
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Actigraphy in action: The use of actigraphy endpoints in clinical trials is expanding
In clinical research, the accessibility and use of actigraphy and physical activity tracking devices have dramatically increased, giving researchers and sponsors more opportunities to practice patient-centric drug development. To support actigraphy measures, many trials are gathering dense data remotely via wearable technology seen to improve patient experiences, simplify study designs, and offer objective data on traditionally subjective patient reported outcomes like pain. Understand the benefits of actigraphy.
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EMA gives AstraZeneca shot the go-ahead
Side effects from AstraZeneca’s Covid-19 vaccine have triggered alarm across Europe, but the European Medicines Agency has officially deemed that its benefits far outweigh any risks. The health agency conducted an analysis of the shot and found it didn’t increase the risk of blood clots — a decision that may smooth the company’s efforts to deploy this vaccine more broadly.
Countries including Germany, France, and Italy have recently suspended use of the AstraZeneca vaccine after reports emerged that some recipients had developed rare blood clots and even died. Although the EMA is giving the inoculation the green light, the agency’s executive director said regulators “still cannot rule out definitively a link.”
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CRISPR’s #1
Well, Walter Isaacson’s tome on the advent of CRISPR gene editing is, anyway. His book “The Code Breaker” just debuted in the No. 1 slot on the New York Times nonfiction bestseller list.
Isaacson chatted recently with STAT’s Pat Skerrett — and discussed the awesome power that gene editing technology can wield for or against humanity.
“We have to go step by step, hand in hand because the slopes are less slippery that way,” Isaacson said. “We have to figure out the promise of CRISPR — we shouldn’t flinch from it the way some people do about genetically modified organisms — but also defy the peril part of it.”
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More reads
- Antibiotic stewardship may be improving at U.S. hospitals, but new targets are still needed. (STAT)
- AmerisourceBergen say-on-pay proposal squeaks by amid outrage over CEO compensation. (STAT)
- How the wave of telehealth SPACs during the pandemic could create a ‘perfect storm’ for investors. (STAT)
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Thanks for reading! More next week,
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