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Morning! Today, we discuss the maneuverings of two interesting women in biotech: Verily alum Amy Abernethy and 23andMe CEO Anne Wojcicki. Also, we explore the dangers of off-brand GLP-1s, and see FDA advisers vote in favor of a Niemann-Pick drug.
The danger of alternate GLP-1 sources
Shortages of GLP-1 drugs have prompted patients to rely on risky sources for these medicines, like illegal online pharmacies that don’t require prescriptions. A new JAMA paper found that semaglutide from such sites can be contaminated with bacteria, and contain far more of the drug than labeled.
The FDA has previously issued warnings about compounded GLP-1s, but that hasn’t dissuaded patients from pursuing non-branded versions of these drugs. That said, the supply of drugs like Zepbound and Wegovy is expected to soon improve, which might help temper this trend.
“It’s just a very, very risky business, going online and buying this product,” one of the study’s authors told STAT’s Katie Palmer. “Just because it’s online and accessible and it can be sold without a prescription, does not mean it’s authentic.”
An update on Amy Abernethy’s new company
From STAT’s Matt Herper: It’s been almost nine months since STAT reported that Amy Abernethy, a former FDA official, was leaving Verily Life Sciences to start a new effort aimed at improving the technological infrastructure behind clinical trials. That effort, backed by Lyda Hill Philanthropies, now has a name: Highlander Health, according to Abernethy’s LinkedIn page and bios of her at industry events she has attended.
One such bio describes Highlander as “an organization focused on advancing evidence generation for the new era of medical innovation.” That’s right in line with what Abernethy has said before — and the issues around that infrastructure are vast. Contacted by STAT, Abernethy didn’t have new details to share, but did confirm the name relates to the famous movie about an immortal warrior from the Scottish Highlands.
FDA ad comm favors Zevra’s Niemann-Pick drug
An FDA advisory committee voted 11-5 in favor of arimoclomol, a small molecule drug made by Zevra Therapeutics to treat Niemann-Pick disease type C — a rare, inherited lysosomal storage disorder that causes organ and nervous system degeneration. Regulators will decide whether or not to approve arimoclomol by Sept 21.
The FDA rejected arimoclomol in 2021 and asked Orphazyme — which owned right to the drug at the time — to submit additional data. Now owned by Zevra, the drug is meant to stabilize lysosomal protein folding within cells — which can help prevent the buildup of cholesterol and other lipids that end up causing severe damage in this degenerative disease.
Shares for Zevra jumped more than 40% in after-market trading Friday following the panel vote.
Board foils CEO’s plan to privatize 23andMe
23andMe CEO Anne Wojcicki’s efforts to take the company private were rejected by the company’s board, for now.
In a public letter, a special committee of the board said Wojcicki’s proposal didn’t offer a premium to the current stock price, and didn’t have committed financing from other investors. It also asked Wojcicki to withdraw her opposition to alternative transactions so that it could potentially draw interest from other buyers. That said, the committee is allowing Wojcicki time to revise her proposal and find solid investors, STAT’s Matt Herper writes.
More reads
- U.S. FDA says all doses of Lilly’s weight loss and diabetes drug are now available, Reuters
- Medicare scrambles to keep prescription drug plan premiums stable ahead of elections, STAT
- New antibiotic kills flesh-eating bacteria in preclinical study, FierceBiotech