Good morning, everyone, and how are you today? The sun is trying to peek through a muggy haze descending this morning on the Pharmalot campus, where the official mascot is hunting for rabbits, and assorted birds and bugs can be heard in the distance. As for us, we are immersed in our usual routine of foraging for interesting items and brewing cups of stimulation. It is, after all, another busy day. No doubt, it is the same for you. So here are some tidbits to help you along. Hope today proves successful, and keep in touch. …
The Food and Drug Administration has changed the prescribing label for the controversial Biogen (BIIB) Alzheimer’s drug and narrowed its recommended use to patients with milder forms of the disease, STAT reports. Biogen and the FDA described the Aduhelm label update as a clarification meant to better reflect data from clinical trials. But the move will also be seen as the FDA yielding to outside criticism that the recent approval — just one month ago — was overly permissive.
In his most explicit appeal to date, W0rld Health Organization Director General Tedros Adhanom Ghebreyesus called upon the leaders in Covid-19 mRNA vaccine manufacturing – Pfizer (PFE)/BioNTech (BNTX) and Moderna (MRNA) — to “share their know-how” in vaccine manufacturing with more manufacturers, particularly in low- and middle-income countries, Health Policy Watch tells us. He noted that a new manufacturing hub is being built in South Africa, “but this could be accelerated by companies openly sharing technology and know-how.”
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