Hello, everyone, and how are you today? Cloudy skies are hovering this morning over the Pharmalot campus, where things have settled down now that the short person has left for gainful employment and the official mascot has assumed his formal snoozing position. As for us, we are dutifully concocting a few needed cups of stimulation as we dig in for another busy day. No doubt, you can relate. So time to get cracking. As always, we have assembled some items of interest. So hoist your own cup to a successful day, and drop us a line when something interesting arises. …
The Centers for Medicare & Medicaid Services announced plans to start a process that could limit access to the controversial new Alzheimer’s drug from Biogen (BIIB) — the first signals from the agency about what will be an enormously consequential decision for Biogen, the Medicare program itself, and people with the disease, STAT writes. The process, called a National Coverage Determination analysis, ensures that coverage for the drug is uniform across the country instead of leaving decisions to regional contractors.
Two powerful House Democrats demanded documents from Biogen about the approval process, marketing, and pricing of its Alzheimer’s drug, STAT tells us. The request references a STAT investigation that found Biogen had an off-the-books meeting with a key Food and Drug Administration official ahead of the approval, and that the back-channel relationship between the agency and the company started earlier and was far more extensive than disclosed.
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