Rise and shine, another busy day is on the way. However, this is also shaping up as a beautiful day as well, despite expectations of still more heat. The skies are clear and sunny, the birds are chirping, and the official mascots are capturing creatures on the Pharmalot campus this morning. This calls for celebration with a cup of stimulation, and we are opening a new package of blueberry muffin for the occasion. What is upon us right now, however, is our ever-growing to-do list. Sound familiar? So here are some items of interest. Have a great day, everyone. …
The U.S. Food and Drug Administration rejected Novo Nordisk’s weekly insulin for treating diabetes in a rare setback for the company, STAT tells us. The agency sent the drugmaker a complete response letter, saying it needs more information on the drug’s manufacturing process, as well as more data on how well it performs in people with type 1 diabetes. Novo said it does not expect to be able to fulfill the requests during 2024, delaying the program for several months at least. This comes after the FDA in May convened a group of advisers to discuss the drug, called icodec. The panel voted against approval in type 1 patients, raising concerns about the risk of dangerously low blood sugar in that population.
The U.S. Federal Trade Commission plans to sue the three largest pharmacy benefit managers over their negotiating tactics for various medicines, including insulin, that pushed patients toward higher-priced treatments, STAT writes, citing a source familiar with the matter. The step comes after the agency this week released a scathing report that found the three largest PBMs — Express Scripts, Caremark, and OptumRx — processed nearly 80% of the roughly 6.6 billion prescriptions that were dispensed by U.S. pharmacies in 2023. The FTC said its findings were interim, though, because some companies did not provide all of the requested information, and threatened further action.
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