Shots: The P-II Vivacity-MG study involves assessing the safety, tolerability, efficacy, PK, PD, and immunogenicity of nipocalimab in addition to SoC vs PBO in a ratio (1:1:1:1:1) in 68 patients with gMG The 1EPs of the study include safety, tolerability, and efficacy assessed by (MG-ADL) ADL score. The 2EPs includes the efficacy as measured by […]Read More
Shots: The approval is based on data from the P-III IKEMA study evaluating Sarclisa + carfilzomib and dexamethasone (Kd) vs Kd alone in 302 patients with relapsed MM across 69 centers spanning 16 countries Results: mPFS (not reached vs 19.15 mos.) at the time of the pre-planned interim analysis, reduction in the risk of disease […]Read More
Shots: The DSMB has recommended that the VIR-7831 arm of the trial be closed to enrollment while the data mature. The recommendation was based on pre-planned safety & efficacy data review of the first 300 patients hospitalized with COVID-19 enrolled in ACTIV-3 The companies will continue discussions with the NIH to further assess the potential […]Read More
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
Shots: The sNDA filing is based on P-III ADVANCE trial data, assessing Otezla (30 mg, bid) vs PBO in 595 patients in a ratio (1:1) with mild-to-moderate plaque psoriasis The P-III ADVANCE study results: @16wks., improvement in its 1EPs of sPGA score; achieve 2EPs i.e, 75% improvement in BSA, change in PASI score Otezla is […]Read More
Shots: The approval is based on the P-III study that involves assessing Panzyga (IVIg) in 142 patients with CIDP. The study evaluated more than one maintenance dosing option while the efficacy, safety, and tolerability were observed during 7 maintenance infusions @3wks. intervals over a 6mos. period The study met 1EPs i.e. 80% of patients achieved […]Read More
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
Shots: The approval is based on pivotal TRANSCEND NHL 001 (017001) study assessing Breyanzi in 268 patients with 3L+R/R LBCL including patients with a broad range of histologies and high-risk disease. Breyanzi was administered in the inpatient & outpatient settings Results: ORR (73%); CR (54%); PR (19%); mDOR (16.7mos.) in all responders; patients with best […]Read More
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
Shots: The approval is based on P-III POLYP 1 & 2 trials assessing Xolair vs PBO in 138 & 127 adult patients with nasal polyps who had an inadequate response to nasal corticosteroids respectively Results: @24wks. improvement in NPS (-1.1 vs 0.1 & -0.9 vs -0.3); improvement in NCS (-0.9 vs -0.4 & -0.7 vs […]Read More
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