We’re reading about Prasad leaving FDA, a pause on NIH spending

We’re reading about Prasad leaving FDA, a pause on NIH spending


Good morning, everyone, and welcome to the middle of the week. Congratulations on making it this far, and remember there are only a few more days until the weekend arrives. So keep plugging away. After all, what are the alternatives? While you ponder the possibilities, we invite you to join us for a delightful cup of stimulation. Our choice today is marshmallow magic. What makes this so magical? We shall leave that to your imagination. But remember that no prescription is required — so no rebate calculations are involved. Meanwhile, here is the latest menu of tidbits to help you on your way. Have a wonderful day and please do stay in touch. …

Vinay Prasad, a top official at the U.S. Food and Drug Administration, has suddenly departed after a series of controversial decisions about a treatment for boys with Duchenne muscular dystrophy and criticism from conservatives, STAT tells us. Prasad was the head of the FDA division that regulates vaccines, gene therapies, and blood products, as well as the agency’s chief medical and scientific officer, making him a top adviser to Commissioner Marty Makary. His sudden exit comes amid escalating tensions and blowback involving a regulatory dispute with Sarepta Therapeutics, the maker of a gene therapy for Duchenne muscular dystrophy. The FDA forced Sarepta to halt shipments of the treatment, called Elevidys, following a series of patient deaths. He faced scathing opinion pieces in the conservative press and was also a target of conservative influencer Laura Loomer, who called him a “leftist saboteur” and said his regulatory philosophy was “fundamentally anti-Trump.” 

Merck is embarking on a multi-year cost-savings plan, which includes cuts to its workforce and real-estate footprint, as it looks to redirect resources toward new product launches, The Wall Street Journal notes. The plan comes as the company logged lower revenue and sales in its latest quarter and narrowed its full-year guidance. Merck expects the cuts to result in $3 billion in annual cost savings by the end of 2027, which it plans to reinvest to support new products as well as its pipeline across multiple therapeutic areas. As part of the effort, Merck will eliminate certain administrative, sales, and research-and-development positions. The company did not disclose how many workers would be affected, but said it would continue to hire employees in new roles across strategic growth areas of its business. Merck will also reduce its global real-estate footprint and continue to optimize its manufacturing network. Sales of Keytruda, which accounts for about half of revenue, grew by 9%, to $7.96 billion. The main U.S. patent for the cancer drug expires in 2028, opening the door for lower-cost versions to weigh on sales.

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