Shots: The approval was based on the clinical program including two P-III TULIP & P-II MUSE trials evaluated the efficacy and safety of Saphnelo vs PBO in 362 & 305 […]readmore
Tags : MHLW
Regulatory
Regeneron’s Ronapreve Antibody Cocktail (casirivimab and imdevimab) Receives MHLW’s Approval
Shots: The approval is based on the results from a P-III trial evaluating Ronapreve (casirivimab and imdevimab) in high-risk non-hospitalized patients with COVID-19 The results showed a reduction in the […]readmore
Shots: The filing is based on the results from the P-III IMpower010 study assessing Tecentriq (1200mg, IV) vs BSC in 1,005 patients in a ratio (1:1) with Stage IB-IIIA NSCLC, […]readmore
Shots: The approval is based on the results from two studies i.e. FIREFISH & SUNFISH. The FIREFISH study involves assessing Evrysdi (dry syrup, 60mg) in infants with symptomatic Type 1 […]readmore
Shots: The approval is based on the P-III VICTORIA trial involves assessing Verquvo (2.5mg, 5mg & 10mg) in patients with CHF, published in NEJM in Mar’20. The therapy is being […]readmore
Shots: The MHLW has approved Acuvue Theravision with Ketotifen as the first combination contact lens that provides vision correction and an antihistamine drug to relieve symptoms for people experiencing itchy […]readmore
Shots: The approval is based on results from P- Ib/II GO29365 study assessing Polivy (IV, 30 & 140mg) + BR vs BR alone in 80 DLBCL patients and P-II JO40762/P-DRIVE […]readmore
Shots: The approval is based on the P-III NAVIGATE trial in adult and adolescent patients and P- I/II pediatric SCOUT trial involves assessing Vitrakvi for NTRK fusion-positive advanced or recurrent […]readmore
Shots: The approval is based on the P-II FIGHT-202 study that involves assessing Pemazyre (13.5mg, qd, on a 21-day cycle) in adults aged ≥18yrs. with previously treated, LA/m- cholangiocarcinoma with […]readmore
Shots: The submission is based on P-III HELP study evaluating lanadelumab (300mg, q2w & q4w) vs PBO in 125 patients with HAE attack for 26wks. It also based on P-III […]readmore