Rise and shine. Another busy day is on the way. Indeed, the official to-do list is brimming with tasks and reminders. On the bright side, there is a shiny sun and a cool breeze wafting about the Pharmalot campus, where the official mascot and a loyal playmate are enjoying the moment. As for us, yes, we are downing still more cups of stimulation to steel ourselves for what today may bring. Our choice today is maple bourbon. No doubt, you may relate. So please join us, or grab a bottle of water, if you prefer. Meanwhile, here are some items of interest. Have a great day, everyone. …
The U.S. Food and Drug Administration agreed to review a treatment for a rare, genetically defined form of ALS developed by Biogen, even though results from a clinical trial failed to show a definitive benefit for patients, STAT writes. Biogen said the agency accepted its application for the drug, called tofersen, and that it will undergo a priority review with an approval decision expected by Jan. 25. Biogen is seeking approval at a time when the FDA has been the target of lobbying from ALS patients and advocates who have accused the agency of being too rigid and slow to approve new medicines for the fatal neuromuscular disease.