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 clear blue skies and chilly breezes greeting us today. 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 strawberry creme, a pantry favorite. Please feel free to join us. Remember, no prescription is required and no rebates are involved. 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. …
The U.S. Food and Drug Administration has delayed reviews of two drugs chosen for the Trump administration’s new fast-track program after agency scientists flagged safety and efficacy concerns, including the death of a patient while taking one of the medicines, Reuters reports. FDA reviewers pushed back by two weeks an experimental Disc Medicine drug for a rare blood disorder following concerns about trial data and its risk for abuse. They also stalled review of Sanofi’s Tzield for late-stage type 1 diabetes by more than a month over adverse event reports, including two related to seizure and blood clotting and one death. Unveiled in June, the FDA Commissioner’s National Priority Voucher Program promised decisions in one or two months on a limited number of drugs deemed critical to public health or national security, or if they were manufactured in the U.S. or offered at low prices. That would cut four to six months off the fastest priority approval process. The delays were not previously reported.
In the latest fracas over the burgeoning market for weight loss drugs, a compounding pharmacy has filed a lawsuit accusing Eli Lilly and Novo Nordisk of using anticompetitive tactics to prevent it from serving patients, STAT writes. Strive Specialties claimed the drugmakers entered into exclusive agreements with telehealth providers, which were then barred from working with compounders; interfered with relationships that compounders have with payment processors and social media platforms; and regularly disparaged compounded medicines as illegal or unsafe. In doing so, Lilly and Novo Nordisk “unlawfully restricted competition and directly harmed patients in the U.S. As a result, patients are forced to pay inflated prices and suffer reduced access to [the] medicines, particularly personalized versions of those medicines,” Strive argued in its lawsuit.Continue to STAT+ to read the full story…