Shots: The updated label includes P-III DECLARE-TIMI 58 study that assesses the effect of Forxiga vs PBO on CV outcomes in 17000+ patients with T2D at risk of CV events also assessed key renal 2EPs, across 882 sites in 33 countries The study demonstrated that Forxiga achieved a significant reduction in the composite EP of […]Read More
Shots: The EC has approved label update which is based on Phase III DECLARE-TIMI 58 study results assessing Forxiga vs PBO on CV outcomes in 17,000 patients with T2D at risk of CV events across 33 countries The P-III DECLARE-TIMI 58 study results: reduction in hospitalization for heart failure/CV deaths, safe and effective with no […]Read More
The EU label update is based on the study examining the stability of Imraldi formulation at room temp. (25 ± 2 ˚C and 60 ± 5% relative humidity), post storing in refrigerated conditions (2-8 ˚C) for 36 mos. The separate three batches were tested at 0/2/4 wks. for solution appearance, pH, protein concentration, purity, particulates, […]Read More
Shots: The approval is based on P-III KEYNOTE-042 trial results assessing Keytruda (200mg, q3w) vs CT in 1274 patients in ratio (1:1) with 1L stage III whose tumors expressed PD-L1 with TPS ≥1% and who had not received prior systemic treatment for metastatic NSCLC P-III KEYNOTE-042 study results: @ TPS ≥1%, TPS ≥50% mOS (16.7, […]Read More
Shots: The approval is based on the results of ongoing P-III ARRIVAL study assessing Kalydeco in patients who have either of 10 mutations in the CFTR gene (G551D, G178R, S549N, S549R, G551S, G1244E, S1251N, S1255P, G1349D or R117H) Results: mean sweat chloride level @ 24 wks. 33.8 mmol/L; mean absolute change -73.5 mmol/L; presented at […]Read More
Shots: Approval is based on KEYNOTE-189, Ph III study where Keytruda combined with ALIMTA and Pt. CT showed improved results vs CT KEYNOTE-189 (Keytruda +pemetrexed and Pt. CT vs CT alone): mPFS (8.8 vs 4.9mos); ORR (48% vs 19%); mDOR (11.2 vs 7.8mos); reducing death risk by half Keytruda was first approved in 2017 in […]Read More
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