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There is a need to uncover diagnostic and prognostic biomarkers for HIV-associated neurocognitive disorder (HAND), according to American Journal of Managed Care. HAND is a viral co-morbidity that remains common despite advancements in antiretroviral therapy. Additionally, the commentary noted that cognitive, behavioral, and motor dysfunctions, including asymptomatic neurocognitive impairment, mild neurocognitive disorder, and HIV-associated dementia, often lead to HAND in up to half of patients treated with antiretroviral therapy or who are virus infected.
The FDA program evaluating HIV drugs for use in low-resource countries is achieving its goals, but a new agency analysis finds that there is also ways the program could be made more efficient, according to Contagion Live. The analysis notes that the FDA has received 260 applications; of those, 83% were eventually approved. In addition, the analysis suggests that the amount of applications have decreased, possibly due to market saturation, a trend towards fixed-dose combinations instead of single-drug applications, and new fees the FDA is required to charge for applications.
Encouraging initial data was recently presented from an ongoing early-stage study testing their experimental therapy for multiple myeloma in patients who did not respond to prior treatments, according to Reuters. The lowest dose of the therapy, bb21217, had an overall response rate of 83% in heavily pre-treated patients with at least 3 prior lines of therapy. A CAR-T therapy, bb21217 has been found to have a safety profile consistent with the known toxicities of CAR-T therapies, regardless of dosage.
FDA Approves Bimekizumab-Bkzx as Treatment for Hidradenitis Suppurativa