FDA: Paperwork Not Filed Before Covid Microbiome Drug Tested On Humans
Kaleido Biosciences has been warned by the Food and Drug Administration that it broke paperwork procedure in clinical tests of a microbiome therapeutic aimed at treating covid. In other news, miniature brain-like structures have been grown in the lab to boost Parkinson's disease research.
FDA Dings Kaleido For Testing A Microbiome Drug Without Proper Paperwork
The Food and Drug Administration is warning Lexington, Mass.-based Kaleido Biosciences that it shouldn’t have tested one of its microbiome therapeutics in humans without filing the paperwork the agency requires to begin clinical trials. The FDA’s warning letter, published in late August and reported first by Endpoints, focuses only on a microbiome therapeutic that Kaleido was testing as a Covid-19 treatment. (Sheridan, 9/7)
In other pharmaceutical and research news —
Lab-Grown Mini Brains Mimic Parkinson’s Disease, Researchers Say
Researchers have grown miniature brains in laboratory dishes to mirror Parkinson’s disease, learn how it progresses and study new treatments, Duke-NUS Medical School announced Tuesday, in what was reported as a first-time feat. Parkinson’s disease is a neurodegenerative disorder without a cure, and which gradually causes movement-related issues, like tremors and rigidity, per the Parkinson’s Foundation. (Rivas, 9/7)
To Find New Antibiotics, Will Technology Overtake Underwater Exploration?
Choppy, windswept waves slap at the hull as our boat nears the last known location of the Lucerne, a schooner that sank to the bottom of Lake Superior in 1886. The wreck, just off a narrow sand peninsula jutting from the northern tip of Wisconsin, doubles as a suspected habitat for an elusive freshwater sponge called Eunapius fragilis. Finding these tiny aquatic organisms is the reason a trio of young scientists have set off with a local divemaster. The hunch is these sponges could be a source for new chemical molecules, which, in turn, could be the basis for new antibiotics. (Smith, 9/8)
Inside Verily’s Make-Or-Break Push To Turn Its Ideas Into Profitable Products
It’s a make or break moment for Verily, as the sprawling Google offshoot rapidly accelerates its strategy to take its most promising products and turn them into tools that not only transform medicine, but also drive profit. In recent months, the company has assembled an all-star team of executives to bring its software and data tools to the market. They include Amy Abernethy, formerly a top data and informatics leader at the Food and Drug Administration, and Stephen Gillett, previously an executive at Best Buy and Starbucks who is now Verily’s chief operating officer. (Brodwin and Ross, 9/8)