Supplemental Filings: Pink Sheet’s Notebook on Elon vs. FDA, Audio vs. Video, and More
Califf tweaks his misinformation stump speech, FDA adds to the Twitter COVID vaccine confusion with a tweet to Elon Musk, generic firms are schooled on the difference between a teleconference and a video conference, and other observations from Pink Sheet reporters’ notebooks.
You may also be interested in...
Six is the fewest number of voting experts for a drug or biologic advisory committee dating back to at least 2015, according to the Pink Sheet Performance Tracker. Agency issued two conflict-of-interest waivers for the meeting, one of which was to a site principal investigator on lecanemab and aducanumab studies but who is no longer participating in the Leqembi review.
CDC’s director signs off on FDA’s proposed updates to COVID-19 vaccines, marking the country’s second attempt to simplify the administration schedule in a effort to increase vaccine uptake. There’s little evidence that this latest strategy shift will be any more successful.
Nine of 10 advisory committee members voted favorably for an expansion of brexpiprazole’s label, but some said Otsuka/Lundbeck’s atypical antipsychotic may not be appropriate first-line treatment for patients with mild symptoms or for use in individuals with acute, severe agitation.