Good morning, everyone, the middle of the week has arrived, and this calls for a celebratory cup or two of stimulation. How so? Well, you made it this far, which can be an accomplishment, after all. Moreover, there is always good reason to forge ahead, given that there is so much more to do and the effort just might pay off. With this in mind, we have fired up the trusty coffee kettle. Our choice today is crème brûlée. Meanwhile, we have assembled the usual menu of tidbits for your perusal. Hope you have a smashing day, and do drop us a line when you run across something interesting. …
One of the most powerful pharmaceutical lobbying groups in Washington is launching a new seven-figure advertising blitz targeting a federal drug discount program that has ballooned in recent years, Bloomberg Law reports. The campaign set to run Wednesday by the Pharmaceutical Research and Manufacturers of America takes aim at the 340B Drug Pricing Program, a federal plan that requires manufacturers under Medicaid to provide drugs at significantly reduced prices to health providers that care for a high number of low-income and uninsured patients. In the 30-second ad, a group of administrators at a fictional nonprofit hospital manipulate the program to divert 340B benefits to the hospital instead of patients, then use the money for other perks.
The U.S. Food and Drug Administration rejection rate for cell and gene therapies was 18% from 2020 to 2024, but subsequently rose to 38% over the subsequent 15 months, STAT tells us, citing data from the Alliance for Regenerative Medicine. The numbers underscore concern expressed at the Meeting on the Med conference in Rome last week. Rejections and reversals of prior directives at the FDA division responsible for reviewing cell and gene therapies have destabilized the already shaky footing of this field. What companies previously saw and relied on as regulatory stability and collaboration has teetered. Although the industry hopes for a friendlier replacement for Vinay Prasad, who headed the division but was recently pushed out, worries about the ongoing turmoil at the FDA, including many offices being understaffed, cropped up on other panels at the conference.
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