Shots:MHLW has approved Blenrep + BorDex & PomDex in MM pts with ≥1 prior therapy; review ongoing in the US (PDUFA: Jul 23, 2025), EU, Canada, China (PR for DREAMM-7), & Switzerland (with PR for DREAMM-8)Approval was based on P-III (DREAMM-7 & DREAMM-8) trials assessing Blenrep (2.5mg/kg, IV, Q3W) + BorDex vs Darzalex + BorDex in 494…
Shots:Japan's MHLW has granted conditional & time-limited approval to Elevidys for DMD pts (3–8yrs.) with no exon 8/9 deletions in the DMD gene & who are negative for anti-AAVrh74 AbsApproval was based on extensive clinical data, incl. 2yr. global P-III (EMBARK) trial showing motor function benefits vs external controls; Part 2 data was…
Shots:Japan’s MHLW has received MAA for Eylea 8mg (114.3mg/ml for injection) to treat pts with macular edema following RVO (central, branch & hemiretinal) supported by the P-III (QUASAR) trial; regulatory filings are ongoing in other marketsIn the trial, Eylea 8mg (Q8W after 3 or 5 monthly doses) met its 1EP at 36wks. with…
Shots: PharmaShots’ Designation Report provides a concise overview of the latest drug designations granted by major regulatory authorities, including the FDA, EMA, MHLW, and NMPA The March 2025 report covers designations granted to 37 drugs and 3 medical devices, spanning 11 small molecules, 10 biologics, 10 cell and gene therapies & 3 medical devices among…
Shots:Kaken Pharmaceutical has entered into a licensing agreement with KalVista Pharmaceuticals to obtain commercialization rights of sebetralstat in JapanAs per the deal, KalVista will receive $11M upfront & $13M in regulatory (expected in early 2026) & commercial milestones, along with Japan NHI price-based royalties, with royalty rate as sales % approximately in the…
Shots:Japan’s MHLW has approved Dupixent to treat COPD in adults whose disease is inadequately controlled with existing therapyApproval was based on P-III (BOREAS) trial assessing Dupixent + SoC vs PBO in uncontrolled COPD adults with elevated blood eosinophils, which showed reduced exacerbations & improved lung function; data from BORUS & its replicate P-III (NOTUS)…
Shots:Japan’s MHLW has approved Beyonttra to treat ATTR-CM in adult pts based on P-III (ATTRibute-CM) study assessing Beyonttra (BID, oral) vs PBO (n=632) in ATTR-CM pts; commercialization to begin in H1’25Trial showed 42% decrease in composite ACM & recurrent CVH events, plus 50% reduction in cumulative frequency of CVH events at 30mos., with pts…
Shots: PharmaShots’ Designation Report provides a concise overview of the latest drug designations granted by major regulatory authorities, including the FDA, EMA, MHLW, and NMPA The February 2025 report covers designations granted to 53 drugs and 4 medical devices, spanning 16 small molecules, 14 biologics, 18 cell and gene therapies & 4 medical devices among…
Shots:The US FDA has accepted sNDA & granted priority review to finerenone for HF pts having a left ventricular ejection fraction (LVEF) of ≥40%, i.e. mildly reduced (HFmrEF) or preserved LVEF (HFpEF), with approval expected in Q3’25. Awaits authorization in China, EU & Japan, with global applications planned
Application was backed by P-III…
Shots:The EC has approved Imfinzi monotx. for the treatment of LS-SCLC adults whose disease has not progressed after receiving Pt-based CRT; regulatory review underway in Japan & other regions
Approval was based on P-III (ADRIATIC) trial (n=730) assessing Imfinzi (1500mg, IV, Q4W) with or without Imjudo (75mg, IV, Q4W × 4 cycles) followed by…

