Nuplazid Complete Response Letter For Dementia Psychosis Driven By Effectiveness Concerns In Subgroups
Acadia says the US FDA’s view has shifted from what was previously agreed upon for approval of an sNDA for pimavanserin in a broad dementia-related psychosis indication.
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Deficiencies identified by the US FDA could delay the approval of pimavanserin for hallucinations associated with dementia-related psychosis, but Acadia did not have details for investors.
Interview: CEO Jean-Paul Kress talked to Scrip about the US launch of Monjuvi, commercial expansion and the aspiration to build a European biotech that can compete in the big leagues.
Categories from asthma to high blood pressure to cancer showed reductions in new medication users in 2020, likely caused by fewer new diagnoses because of the pandemic, a report from Cigna’s Evernorth shows.