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STAT+: Pharmalittle: Weβre reading about FDA rejecting a Moderna vaccine, compounding in the crosshairs and more
Hello, everyone, and welcome to the middle of the week. Congratulations on making it this far. It is an accomplishment, after all. The next step is toβ¦ keep going. And why not? Just consider the alternatives. On that optimistic note, please join us for a needed cup or three of stimulation. Our choice today is coconut rum. Meanwhile, here are some items of interest to get you going. Have a wonderful day and do drop us a line when you hear something juicy β¦
The U.S. Food and Drug Administration refused to review Modernaβs application for a new influenza vaccine, a surprise decision that couldΒ raise concerns about the agencyβs posture toward drug companies and the Trump administrationβs policies on vaccines, STAT writes. Moderna, revealing the rejection, took the unusual step of releasing the letter it had received from Vinay Prasad, who heads the FDAβs biologics division. They also issued a strongly worded statement from its chief executive officer Stephane Bancel, who said the decision βdoes not further our shared goal of enhancing Americaβs leadership in developing innovative medicines.β At the heart of the dispute is what existing influenza vaccine Moderna should have used as a control when testing the efficacy of its new shot, which utilizes the same mRNA technology the company used in its Covid-19 vaccine.
The recent moves by the Trump administration against Hims & Hers might only be the start of a crackdown on compounding, STAT explains. In recent days, the Food and Drug Administration issued a warning, the Department of Health & Human Services asked the Department of Justice to open an investigation and, meanwhile, Novo Nordisk filed a patent infringement lawsuit against the company. But while compounded weight-loss drugs proliferated during recent shortages and continued to remain available, the flurry of developments underscores growing unease among regulators with mass-marketed compounded drugs sold by national, vertically integrated telehealth platforms. The FDA has so far focused publicly on misleading marketing, but signs that it may scrutinize compounding practices themselves have the industry on edge, given how many telehealth companies rely on compounded versions of everything from acne treatments to libido drugs.
Continue to STAT+ to read the full storyβ¦
Β© Alex Hogan/STAT
