Tags : Adults

MedTech

Otsuka and Click Initiate Digital Study in Adults with Major

Shots: Otsuka and Click have reported the initiation of the Mirai study which is a fully remote clinical trial to investigate the effectiveness of digital therapeutics in reducing depressive symptoms in adults diagnosed with MDD who are on antidepressant monotherapy. The study will enroll ~540 patients globally The trial will run fully remotely utilizing the […]Read More

Regulatory

ViiV Healthcare’s Rukobia (fostemsavir) Receives Marketing Authorization for the Treatment

Shots: The MAA is based on P-III BRIGHTE study assessing Rukobia (600mg, bid) + OBT vs PBO in 371 HTE adults living with multidrug-resistant HIV. Participants were enrolled in either a randomized or nonrandomized cohort In the randomized cohort, 60% achieved undetectable HIV viral load and clinically meaningful improvements to CD4+ T-cell count @96wks., HIV-1 […]Read More

MedTech Regulatory

Abbott’s FreeStyle Libre 2 Receives Health Canada’s Approval for Adults

Shots: Abbott’s next-generation, sensor-based glucose monitoring technology, FreeStyle Libre 2, received Health Canada’s approval for adults & children with diabetes The system continuously measures glucose data every minute with customizable, optional real-time alarms to alert users when their glucose is high/low without scanning The technology sustains performance for ~14days, providing trends, insights & actionable data […]Read More