We’re reading about Moderna setback, CVS playing hardball with Gilead

Top of the morning to you, and a fine one it is. Blue skies and comfortable breezes are enveloping the Pharmalot campus, where the official mascots are dozing after chasing varmints. As for us, we are engaged in the usual rituals — firing up the coffee kettle in order to brew a cup of stimulation (the choice today is peppermint mocha) and foraging for items of interest. On that note, here are a few tidbits to help you get started on your journey today, which we hope will be meaningful and productive. Meanwhile, do keep in touch — we enjoy secret dossiers and saucy tips.…

Moderna disclosed that its experimental vaccine for cytomegalovirus, a cause of disability in newborns, failed in a Phase 3 trial, a significant setback for a company already facing pressure from Wall Street and the federal government, STAT writes. The CMV vaccine had been its lead program prior to the Covid-19 pandemic, and the company repeatedly said it could bring in between $2 billion and $5 billion in peak annual sales, although analysts polled by Visible Alpha forecast peak sales of $1.6 billion for the product. The company had made big claims about the vaccine, and the failure of the study to meet its primary endpoint is likely to be interpreted as a miss for either Moderna’s mRNA technology, its clinical development prowess, or both. Sales of its Covid shots have slumped and Moderna has found itself in the crosshairs of a U.S. health secretary hostile to vaccines. 

Instead of sharing the names of the medications coming from errant foreign factories, the U.S. Food and Drug Administration routinely blacked them out on inspections, keeping the information secret from the public, ProPublica explains. That decision prevented doctors, pharmacists, and patients from knowing whether the drugs they counted on were tainted by manufacturing failures — and potentially ineffective or unsafe. There is no specific requirement that the FDA block out drug names on inspection reports about foreign facilities. Still, the agency preemptively kept that information hidden, invoking a cautious interpretation of a law that requires the government to protect trade secrets. The FDA told ProPublica that divulging drug names on its inspection reports would violate federal law that protects confidential commercial information. The agency said it only releases the information with approval from drug companies or in cases where companies have already made the details public.