Poor Sleep, Burnout Increase COVID-19 Risk in Health Care Workers
Longer sleep duration linked to reduced odds of COVID-19; sleep problems, burnout linked to increased odds
Mood Disorders
Dexmedetomidine Oral Thin Film NDA Submitted for FDA Review
The NDA submission is supported by data from the double-blind, placebo-controlled, parallel group phase 3 SERENITY I and II studies.
Antidepressants Not Tied to Increased Intracerebral Hemorrhage Risk
Selective serotonin reuptake inhibitors are not associated with higher risk for intracerebral hemorrhage
Lumateperone sNDAs Submitted for Bipolar Depression Indication
The sNDA submissions are supported by data from 2 global randomized, double-blind, placebo-controlled phase 3 studies.
FDA Issues Complete Response Letter for Olanzapine/Samidorphan
While the CRL did not raise clinical concerns, the Agency noted that certain conditions related to the tablet coating process needed to be resolved.
FDA Committees Vote on Novel Therapy for Schizophrenia, Bipolar I Disorder
ALKS 3831 is composed of samidorphan, a mu-opioid receptor antagonist, which is co-formulated with the established antipsychotic agent, olanzapine, in a single bilayer tablet.
Mortality Risk Up With Newer Antipsychotic Use for Depression
Risk up for nonelderly adults with augmentation with newer antipsychotic versus second antidepressant.
USPSTF Finds Evidence Lacking for Vitamin D Screening
Current evidence inadequate to determine benefits and harms of screening for vitamin D deficiency
Telepsychology Use Up 12-Fold in the US During Pandemic
However, adoption of telepsychology has varied according to individual and practice characteristics
Confirmatory Testing No Longer Needed for 23andMe’s CYP2C19 Report
The 510(k) clearance allows for modification of the labeling of the previously authorized pharmacogenetics report.
