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Kalvista & Kaken

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…

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Sanofi & Regeneron

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)…

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BridgeBio

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…

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New Drug Designations - February 2025

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…

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Astrazeneca

AstraZeneca Reports the EC’s Approval of Imfinzi to Treat Limited-Stage Small Cell Lung Cancer (LS-SCLC)

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…

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New Drug Designations - January 2025

New Drug Designations – January 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 January 2025 report covers designations granted to 53 drugs and 9 medical devices, spanning 18 small molecules, 13 biologics, 13 cell and gene therapies & 9 medical devices among…

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Astellas

Japan’s MHLW Receives NDA for Conditional Approval of Astellas’ Avacincaptad Pegol to Treat Geographic Atrophy

Shots: Japan’s MHLW has received NDA for conditional approval of avacincaptad pegol (ACP) to treat geographic atrophy (GA) secondary to AMD Submission was backed by the P-II/III (GATHER1) & P-III (GATHER2) trials assessing safety & efficacy of ACP (2mg, Q1M, intravitreal) in pts with GA secondary to AMD Data from both trials showed reduced…

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New Drug Designations - December 2024

New Drug Designations – December 2024

Shots:   PharmaShots' designation report provides a concise overview of the latest drug designations by major regulatory authorities, including the FDA, EMA, MHLW and NMPA   The December 2024 report covers designations granted to 43 drugs and 3 devices, encompassing 13 small molecules, 10 biologics, 7 cell and gene therapies & 3 medical devices among others  Significant…

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