Tags : Adult

Novartis’ Enerzair Breezhaler Receives the EC’s Approval as a Maintenance

Shots: The approval is based on P-III IRIDIUM study assessing Enerzair Breezhaler (qd) vs Atectura Breezhaler (QMF149; IND/MF) in 3092 patients in the ratio (1:1:1:1) whose asthma is uncontrolled with LABA/ICS SOC treatment which resulted in improvement of ACQ-7 score @26wks., reductions in asthma exacerbation rates were observed in moderate-to-severe and safety profile was consistent […]Read More

Astellas Reports Results of Roxadustat in P-III DOLOMITES Study to

Shots: The P-III study involves assessing of Roxadustat (N=323) vs darbepoetin alfa (N=293) evaluating its safety and efficacy in (N=616) adult anemia patients with stage 3–5 chronic kidney disease (CKD) The study meet its 1EPs & 2EPs also demonstrated superiority, showing correction of hemoglobin levels during the first 24 wks. (89.5% vs 78.0%), decrease in […]Read More

Roche’s Rozlytrek (entrectinib) Receives MHLW’s Approval for NTRK Fusion-Positive Advanced

Shots: The approval is based on P-II STARTRK-2, P-I STARTRK-1, P-I ALKA-372-001 & P-I/II STARTRK-NG studies results assessing Rozlytrek in adults & pediatric patients with NTRK fusion-positive solid tumors, across 10 different tumor types, including CNS metastases solid tumors across 15 countries in 150+ clinical studies respectively   The P-II STARTRK-2 study demonstrated that Rozlytrek […]Read More