Hello, everyone. Damian Garde here, filling in for Ed Silverman once more as the working week wends to its middle. May your day of meetings, deadlines, and questionably necessary video calls be that much brighter with the light of the weekend now in sight. In the meantime, here’s your regular array of tidbits to get the day started, and, as always, do stay in touch. …
The European Union published some long-awaited details on its proposed overhaul of pharmaceutical regulations, Reuters tells us, setting up a fight with drugmakers over the biggest potential reforms in decades. The EU’s changes are meant to ensure all Europeans have access to new medicines, ending the wide disparities in availability and cost between member states. The drug industry argues the proposed reforms go too far, warning that strict regulations will lead companies to invest their resources elsewhere.
The FDA granted conditional approval to Biogen’s treatment for a rare, genetic form of ALS, basing its decision on preliminary evidence that may also speed the development of future medicines for the neurodegenerative disease, STAT reports. The drug, a monthly spinal injection called Qalsody, is intended to treat people with ALS caused by inherited mutations in a gene called SOD1. Biogen estimates approximately 330 people in the U.S. have this form of ALS, with 120 new cases each year. Globally, SOD1 mutations are responsible for approximately 2% of all ALS cases.
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