Shots: The approval of Breztri Aerosphere (budesonide/glycopyrronium/ formoterol fumarate) is based on P-III KRONOS study results assessing PT010 vs Bevespi Aerosphere & PT009 in patients with COPD, resulted in improvement […]readmore
Tags : MHLW
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 […]readmore
Shots: The approval follows CCT-001 study assessing Entyvio (vedolizumab, 300 mg) vs PBO in 157 patients with moderately to severely active CD, along with an additional data from GEMINI 2 […]readmore
Shots: The submission is based on METEOR, CABOSUN and Takeda’s bridging study. METEOR & CABOSUN studies result assessing Cabometyx vs everolimus & sunitinib in patients with RCC + prior treated […]readmore
Shots: The MHLW’s ODD follows P-II/III (FIREFISH, SUNFISH) study assessing Risdiplam in patients with spinal muscular atrophy (SMA) in Japan Chugai & Roche collaborated for the clinical development Risdiplam, first […]readmore
Regulatory
AstraZeneca’s Forxiga (dapagliflozin) Receives MHLW’s Approval for Type-1 Diabetes (T1D)
Shots: The approval is based on P-III DEPICT & D1695C00001 study results assessing Forxiga (5/10 mg) vs PBO in patients with T1D inadequately controlled by insulin for 28 to 52 […]readmore
Shots: The approval is based on P-III ESAX-HTN study assessing esaxerenone vs eplerenone for 12wks. in patients with essential hypertension, 1EP as SBP / DBP In 2006, Exelixis and Daiichi […]readmore
Shots: The approval from Japanese Ministry of Health is based on two P-III study FRAME & BRIDGE assessing Evenity (210mg) vs PBO in 7,180 & 245 postmenopausal women with osteoporosis & […]readmore