Top of the morning to you. And a steamy one, it is. In fact, there is more steam rising from the grounds of the Pharmalot campus than from our ritual cup of stimulation. But this is to be expected at this time of year, yes? In any event, there is work to be done, so as always, we have assembled a few items of interest for you. After all, the world keeps spinning no matter what the thermometer says. Hope you have a successful day and conquer the world. And of course, do keep in touch. …
In order to approve a new Alzheimer’s treatment, the FDA is rewriting its rulebook, an enormously risky move that could accelerate public access to medicines but upend the future of drug regulation, forcing the 114-year-old agency to do the equivalent of redesigning a fighter plane in mid-flight, STAT writes. The FDA is creating a framework that could require less certain evidence of safety and efficacy for drugs beyond Alzheimer’s treatments. In doing so, it is choosing to alter many well-established processes and standards.
The FDA approval of an Alzheimer’s drug developed by Biogen (BIIB) is raising fresh questions about the financial implications for millions of families, insurers, and American taxpayers. But the drug maker is already scrambling to mitigate the fallout, STAT explains. At a wholesale price of $56,000 per year, the company greatly surpassed the $8,300 threshold that a nonprofit determined was the price at which the medication could be considered cost effective. And with a broad label, the drug could potentially be prescribed to millions of people.
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