Good morning, everyone, and welcome to another working week. We hope the weekend respite was relaxing and invigorating, because that oh-so familiar routine of deadlines, online meetings, and phone calls has predictably returned. But what can you do? The world, such as it is, continues to spin. So time to give it a nudge in a better direction by brewing cups of stimulation. Our choice today is maple bourbon, a double shot for the needy neurons. Meanwhile, here are a few items of interest to start you on your journey, which we hope is meaningful and productive. Best of luck, and do keep in touch. …
The top regulator of cancer drugs at the U.S. Food and Drug Administration interceded during the late stages of a contentious review of a skin cancer therapy from Replimune Group — actions that contributed to the treatment’s last-minute rejection despite support from others inside the agency, STAT reports. The FDA has been riven by leadership changes, staff upheaval, and internal dysfunction, all of which also played a part in the drug’s review and the decision to deny its approval. Replimune was largely caught in the middle. Richard Pazdur, director of the FDA’s Oncology Center of Excellence, and his team raised concerns about the drug’s efficacy and sought to deny its approval. On the other side of the scientific debate, FDA staff inside the Center for Biologics Evaluation and Research, the group directly overseeing the drug’s review, argued for its approval. Media reports tied the decision directly to Vinay Prasad, the head of CBER at the time. In fact, Prasad, who was ousted from his FDA leadership post last week after a series of conservative figures criticized decisions of his that blocked the approval of new medicines, played no substantive role in the Replimune decision.
Thousands of Medicare recipients will have to wait longer to get some price relief on the expensive cancer drugs they depend on for treatment, while others might not get any reprieve at all, The Wall Street Journal says. Two little-known provisions in the One Big Beautiful Bill Act will delay Medicare price negotiations for some of the biggest-selling drugs in the world, including Merck’s Keytruda, which is used to treat cancer and had $17.9 billion in U.S. sales in 2024. Other drugs, such as Johnson & Johnson’s Darzalex, will be excluded entirely. Medicare gained the power to negotiate prices on a handful of prescription drugs each year under the Inflation Reduction Act in 2022. The Big Beautiful Bill now puts new restrictions on when and which types of drugs can be negotiated. The exempting or delay of drugs from negotiations will cost Medicare at least $5 billion in missed savings over 10 years, according to estimates by the Congressional Budget Office. The true tally of the new provisions could be far higher because CBO missed certain drugs such as Keytruda. The office plans to re-evaluate its analysis.
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