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.
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If New COVID-19 Vaccine Recommendations Land In the United States, Do They Make Sound?
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.
Rexulti On Track To Add Claim For Alzheimer’s Dementia Agitation Following US Panel Nod
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.
US FDA Holds First Hybrid Meeting With Industry
A Type A meeting was held in-person with a virtual contingent, the FDA clarified to the Pink Sheet. Several other meeting requests received were eligible, but did not seek an in-person session.