Pharmalittle: We're reading about FDA drug reviews, Novartis investing $23 billion in the

Pharmalittle: We’re reading about FDA drug reviews, Novartis investing $23 billion in the

April 11, 2025

And so, another working week will soon draw to a close. Not a moment too soon, yes? This is, you may recall, our treasured signal to daydream about weekend plans. Our agenda is rather modest. We expect to promenade with the official mascots, catch up on our growing reading list, and tidy up around the castle. We also hope to hold yet another listening party with Mrs. Pharmalot, and the rotation will likely include this, this, this, this and this. And what about you? Those of you on this side of the pond still have time to file your taxes. This may be a good time to stock up on sundry goods if rising prices are concern or stash your cash under some floorboards. Or you could tune out the noise by curling up in front of the telly to binge-watch. Well, whatever you do, have a grand time. But be safe. Enjoy, and see you soon. …

U.S. Food and Drug Administration employees who review drugs and devices and inspect manufacturing plants were protected when the Trump administration fired thousands and, while the idea was to preserve some of the most important agency functions, drug reviews are likely to be affected, anyway, STAT explains. Sources said that the cuts have had a particularly big impact on the ability to convene expert advisory committees, a key part of the approval process. Another factor is that officials at the U.S. Department of Health and Human Services are slowing down the process of approving new committee members. There are no advisory committees scheduled between February and May 5, when the agency will hold a meeting related to studies about the misuse of opioids. Last year, the agency held seven meetings during that time frame. At the biologics center, incoming product submissions are already slowing down as the staff who assigned and distributed the regulatory work are gone.

Novartis plans to spend $23 billion to build and expand 10 facilities in the United States, as it grapples with renewed threats of drug import duties from the Trump administration, Reuters tells us. The company expects to build six new manufacturing plants, some of which will make raw pharmaceutical ingredients, as well as a new research and development site in San Diego. The new sites and extensions will be built over the next five years and are expected to create more than 1,000 jobs for skilled workers like engineers and scientists as well as another 3,000 support staff and construction jobs. The drugmaker said it had yet to decide where to build four of its new manufacturing plants, but that two used to produce certain cancer therapies would be built in Florida and Texas. Over the next five years, its total investment in the U.S. is expected to reach nearly $50 billion.

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