Top of the morning to you, and a fine one it is. Clear blue skies and chilly breezes are wafting across the Pharmalot campus, where the official mascots are snoozing after foraging for their breakfast. This means we are free to focus on the matters at hand — rummaging through our to-do list and making cups of stimulation. Our choice today is maple cinnamon French toast. A sweet treat. As always, we invite you to join us. Meanwhile, here is the latest menu of tidbits to help you get started yourself. We hope your day is simply smashing and that you conquer the world. And of course, do keep in touch. We have adjusted our settings to accept postcards and telegrams.…
Gilead Sciences plans to begin Phase 3 testing soon for a drug it believes could prevent HIV infection with just a single shot every year, STAT tells us. Such a medicine, if proven effective, would be the closest thing to a vaccine the HIV field has produced in four decades of research. The company plans to begin the trial next year, with an eye toward regulatory filings in late 2027. The once-a-year drug is another formulation of lenacapavir, a medicine that already made headlines this year when Gilead published data showing it could prevent HIV infections with just one shot every six months. Gilead executives revealed the 12-month formulation at an analyst day dedicated to its HIV portfolio. They said they recently completed a pharmacokinetics study — tracking how a drug behaves in the body — that gave them confidence to advance the molecule. They will present that data next year. The trial comes amid a series of rapid advancements in the field of PrEP, as drugs that prevent HIV are known. PrEP has been available for a decade in the form of a daily pill. But that can be hard for many people to take consistently, for a variety of reasons, and HIV infections have continued to surge or remain roughly flat in many places.
During 2023, drugmakers substantially raised prices on five widely used medicines without any new clinical evidence to justify the increases, leading patients and health insurers in the U.S. to spend an additional $815 million last year, STAT writes, citing a new report. The drug for which spending increased the most due to a price increase was Biktarvy, which is prescribed to treat HIV and is a franchise product for Gilead. The company raised the wholesale price by 5.9%, while the net price — after rebates and discounts are calculated — rose by 3.8%, most likely because the company offered more concessions than previously. Consequently, spending for this drug climbed by $359 million, according to the report issued by the Institute for Clinical and Economic Review, a nonprofit that assesses the cost-effectiveness of medicines. The report noted that Gilead maintained that certain important study data were “rejected” or “overlooked,” and that in at least one instance, the analysis “contradicts standard research practice.”
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