| | | |   | Hello, all. Damian Garde here. The trial of Elizabeth Holmes is over, leaving everyone with even a passing interest in tech, health care, and the intersection therein to debate what her mixed verdict means for the future. | | | How did Elizabeth Holmes beat charges of defrauding patients? Asked to make a list of victims in the Theranos scandal, most people would probably start with the patients who got shoddy medical advice from the company’s unreliable tests before eventually getting to billionaire Betsy DeVos and the rest of the wealthy individuals who invested money under false pretenses. But this week’s mixed verdict for Theranos founder Elizabeth Holmes creates a more complicated legal landscape.
As STAT’s Casey Ross reports, the Holmes verdict — guilty of defrauding investors but cleared of misleading patients — has confounded some outside observers, but legal experts have a simple explanation: Investors are clearer victims than patients. Tying Holmes to Theranos’ corporate exaggerations is easy; she was usually the one making the pitch. But the line between Holmes and patients is more circuitous, making it harder to establish that her actions directly impacted their thinking and decisions when they used Theranos’ faulty technology.
“She was convicted on the big counts,” said Erik Gordon, a business and law professor at the University of Michigan. “The big counts were the fraud committed against investors, not the counts involving the patients.”
Read more. | Pfizer and BioNTech’s next target is shingles Pfizer and BioNTech, partners behind the Covid-19 vaccine that made nearly $40 billion last year, are next turning their attention to shingles, applying the same technology in hopes of coming with a market-leading vaccine.
The companies’ expanded partnership, disclosed this morning, will see Pfizer paying BioNTech $225 million to put its mRNA know-how toward the virus that causes shingles, which infects about 1 million people each year in the U.S. Pfizer and BioNTech will split the costs of development and share any future profits. The companies expect to start clinical trials in the second half of this year.
There’s already a commercially dominant shingles vaccine on the market in the form of GlaxoSmithKline’s Shingrix, with 2021 sales estimated at more than $3 billion. If Pfizer and BioNTech are to succeeded, they’ll need to craft an mRNA vaccine that proves as effective or better while demonstrating favorable tolerability. | Gain actionable insights into the patient’s lived experience with PGHD Person-generated health data (PGHD) is rich, permissioned data gathered beyond the clinic walls to provide a more holistic view of the patient’s condition and daily life. This critical information provides both patients and clinicians actionable insights to help improve quality of life. Discover how Evidation partners with organizations to help ensure that patients get on the right treatments faster and deliver better health outcomes. | What’s next in CRISPR After a pandemic-related hiatus, the many labs focused on genome editing are poised for a big 2022.
As STAT’s Megan Molteni points out, the world of CRISPR has steadily expanded beyond the first generation of its namesake technology, now covering a host of molecular systems scientists employ to rewrite the natural world. And this year could bring major advances at the cutting edge of those technologies.
That includes a new idea for editing multiple species at the same time, cracking the complex genetic roots of common diseases, and a renewed effort to apply what works on DNA to advance the field of RNA editing.
Read more. | When going after ‘the shorts’ goes wrong Back in 2020, when an anonymous short seller accused Applied Therapeutics of misrepresenting data on its lead drug, the company called it “criminal activity,” relying on “fabricated” information to manipulate its stock price. Behind the scenes, the response was more aggressive.
As STAT’s Adam Feuerstein reports, Applied hired a lawyer to go after individual investors and hedge funds, claiming the company had gathered “significant evidence” implicating them as co-conspirators in an “illegal scheme” to disseminate “materially false and misleading information about Applied Therapeutics in an attempt to artificially lower the stock price.”
Cut to Monday and the anonymous report was vindicated. After years of claiming that the FDA had endorsed its plan to seek a fast approval of its lead drug, Applied said the agency wanted more data, news that sent its share price to an all-time low.
Read more. | More reads - Robert Califf is a fervent believer in data. At the FDA, will that be enough? STAT
- Avrobio stops work on rare disease gene therapy after unexpected study results. BioPharma Dive
- The health tech tracker for the first quarter: 13 decisive industry events and deals to watch. STAT+
- U.S. government doubles its order for Pfizer’s Covid pills. New York Times
| Thanks for reading! Until tomorrow,  | | | |
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