Rise and shine, everyone, another busy day is on the way. And it is getting off to a good start here on the Pharmalot campus, where we have cool breezes and sunny skies greeting us. Who could ask for anything more? Actually, we could — it is time to reheat the coffee kettle for another cup of stimulation. Our choice today is … blueberry cobbler, a trusty standby. Please feel free to join us. Remember, no prescription is required. And now, here are your tidbits. Hope you have a productive and meaningful day, and, as always, please do keep in touch. We have adjusted our settings to accept postcards and telegrams. …
Is George Tidmarsh, the U.S. Food and Drug Administration’s top drug regulator, trying to exact revenge on a prominent Wall Street investor after a run-in with him six years ago? STAT asks. This is the question biotech investors were wagging about all Monday after Tidmarsh used his personal LinkedIn page to raise questions about the safety of voclosporin, a rather obscure drug the FDA approved in 2021 to treat patients with lupus nephritis, a type of autoimmune disease that damages the kidneys. Voclosporin has “significant toxicity,” Tidmarsh wrote in his LinkedIn post, adding that the drug “has not been shown to provide a direct clinical benefit for patients.” Aurinia Pharmaceuticals is the Canadian drugmaker that sells voclosporin under the brand name Lupkynis. Its stock price sank 16% on the Tidmarsh comments. It is highly unusual, if not unheard of, for a top FDA official to use a personal social media account to criticize a specific drug, particularly without providing evidence to back up such a claim.
The Pharmaceutical Research & Manufacturers of America plans to launch a new website in January to help patients buy prescription drugs directly from manufacturers, bypassing pharmacy benefit managers and other middlemen, Reuters says. The website, to be called AmericasMedicines.com, will allow drugmakers to list medicines available for direct purchase and connect patients with programs that offer lower prices and fewer barriers to access. The move is part of a broader push by the industry to simplify how Americans get their medicines and reduce out-of-pocket costs following mounting pressure from the Trump administration. President Trump has urged pharmaceutical companies to bring down U.S. drug prices, and in July sent letters to 17 major drugmakers demanding they slash U.S. prescription drug prices to match those paid in other developed nations. The White House has also floated the idea of a government-run website, possibly named TrumpRx, to help Americans shop for cheaper medicines.
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