Top of the morning to you, and a fine one it is, although we concede this may depend on your tolerance for frigid temperatures. Nonetheless, blue skies and a shiny sun are enveloping the Pharmalot campus, where the official mascots are hunting wildlife and we are engaged in the usual rituals — firing up the coffee kettle in order to brew a cup of stimulation (the choice today, hazelnut mocha) and foraging for items of interest. On that note, here are a few tidbits to help you get started on your journey today, which we hope will be meaningful and productive. Meanwhile, do keep in touch — we enjoy secret dossiers and saucy tips. …
After nearly a decade of machine learning innovation in the drug industry, the U.S. Food and Drug Administration published its first draft guidance on the use of artificial intelligence in the development of drugs and biological products, STAT tells us. The guidance comes as drug regulatory submissions citing AI have increased exponentially. As of last October, the agency had received more than 500 drug submissions with AI components going back to 2016, with a large number in the areas of oncology, neurology, and gastroenterology. The guidance does not, however, capture how AI is being used in drug discovery, the process of identifying and designing molecules, or in operational efficiency. The brief, 20-page document, instead, focuses on AI models used to produce data that supports regulatory decision-making about the safety, effectiveness, or quality of drugs. That could include anything from modeling to cut down on animal-based toxicology studies to developing AI-based clinical trial endpoints to evaluating adverse events after the FDA approves a drug.
The widespread use of pharmaceuticals in America is introducing even more toxic “forever chemicals” into the environment through wastewater and large municipal wastewater treatment plants are not capable of fully filtering them out, The Washington Post writes, citing a new study. The plants’ inability to remove compounds known as organofluorines from wastewater before they enter drinking water supplies becomes even more pronounced during droughts and could affect up to 23 million people. Most of the compounds came from commonly prescribed medications including antidepressants and statins. Oganofluorines — a group that includes per- and polyfluoroalkyl substances, or PFAS — were found in wastewater in eight large municipal treatment plants. The wastewater continued to contain high concentrations of organofluorines and other compounds that meet the definition of PFAS even after treatment.
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