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NEWS

GSK Reports the MHLW’s sNDA Acceptance of Arexvy to Prevent Respiratory Syncytial Virus (RSV) Disease

Shots: Japan’s MHLW has accepted sNDA of Arexvy RSV vaccine for adults aged 18-49yrs. at increased risk, expanding its use beyond those aged ≥50yrs. Submission was based on P-IIIb trial (n=1458) assessing non-inferiority & safety of Arexvy RSV vaccine in individuals (18-49yrs.; n=426) compared to adults (≥60yrs.; n=429); an additional cohort (18-49yrs.; n=603) was followed for…
June 20, 2025

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INSIGHTS+

New Drug Designations – April 2025  

Shots:     PharmaShots’ Designation Report provides a concise overview of the latest drug designations granted by major regulatory authorities, including the FDA, EMA, MHLW, Health Canada and NMPA   The April 2025 report covers designations granted to 36 drugs and 6 medical devices, spanning 14 small molecules, 3 biologics, 11 cell and gene therapies & 6 medical devices among…
May 27, 2025

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Sarepta Therapeutics
NEWS

Sarepta Therapeutics Reports the MHLW’s Conditional & Time-Limited Approval of Elevidys for Duchenne Muscular Dystrophy (DMD)

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 Abs Approval was based on extensive clinical data, incl. 2yr. global P-III (EMBARK) trial showing motor function benefits vs external controls; Part 2 data was…
May 14, 2025

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Insight+_Ridhi Rastogi
INSIGHTS+

New Drug Designations – March 2025 

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…
April 29, 2025

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Kalvista & Kaken
NEWS

KalVista Pharmaceuticals Partners with Kaken Pharmaceutical to Commercialize Sebetralstat in Japan

Shots: Kaken Pharmaceutical has entered into a licensing agreement with KalVista Pharmaceuticals to obtain commercialization rights of sebetralstat in Japan As 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…
April 9, 2025

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Sanofi & Regeneron
NEWS

Sanofi and Regeneron’s Dupixent Receives the MHLW’s Approval to Treat Chronic Obstructive Pulmonary Disease (COPD)

Shots: Japan’s MHLW has approved Dupixent to treat COPD in adults whose disease is inadequately controlled with existing therapy Approval 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)…
March 28, 2025

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BridgeBio
NEWS

BridgeBio Receives the MHLW’s Approval for Beyonttra (Acoramidis) for Transthyretin-Mediated Amyloidosis Cardiomyopathy (ATTR-CM)

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 H1’25 Trial showed 42% decrease in composite ACM & recurrent CVH events, plus 50% reduction in cumulative frequency of CVH events at 30mos., with pts…
March 28, 2025

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New Drug Designations - February 2025
INSIGHTS+

New Drug Designations – February 2025

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…
March 25, 2025

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