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Kura Oncology and Kyowa Kirin
NEWS

Kura Oncology and Kyowa Kirin Report the US FDA’s Approval Komzifti (Ziftomenib) for NPM1-Mutated Acute Myeloid Leukemia (AML)

Shots: The US FDA has granted full approval to Komzifti (QD, PO) to treat adults with r/r AML with NPM1 mutation who have no satisfactory alternative treatment options before the PDUFA date of Nov 30, 2025 Approval was backed by P-I/II (KOMET-001) trial in 112 r/r NPM1-mutant AML pts, showing 21.4% CR + CRh with a median…
November 14, 2025

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NEWS

Boehringer Ingelheim Licenses an Autoimmune Disease Therapy from Kyowa Kirin for ~$744.4M

Shots: BI has licensed a pre-clinical small molecule program from Kyowa Kirin to develop it as a potential treatment for autoimmune diseases As per the deal, BI will receive exclusive rights to develop the small molecule program globally, expanding BI’s inflammatory pipeline In contrast, Kyowa Kirin will receive up to €640M (~$744.4M), incl. an upfront payment, development,…
October 30, 2025

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NEWS

Amgen and Kyowa Kirin Report Topline P-III (ASCEND) Study Results of Rocatinlimab in Moderate to Severe Atopic Dermatitis

Shots: The P-III (ASCEND) trial evaluated rocatinlimab (150 or 300mg, Q4W/Q8W) in ~2,600 atopic dermatitis pts who completed 24wks. in ROCKET trial program & continued for 32wks. in ASCEND, which will evaluate long-term safety & efficacy up to 104wks. Trial showed a favorable long-term safety profile (1EP) with low discontinuation rates due to AEs, consistent…
September 9, 2025

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PharmaShots Interview Abdul Mullick, CEO at Kyowa Kirin Shares Insights on the Launch of a Virtual Exhibition to Highlight Issues of Rare Disease, X-linked Hypophosphataemia
VIEWPOINTS

PharmaShots Interview: Abdul Mullick, CEO at Kyowa Kirin Shares Insights on the Launch of a Virtual Exhibition to Highlight Issues of Rare Disease, X-linked Hypophosphataemia

Shots: Abdul spoke about the launch of a digital exhibition ‘Shine a light’ to raise awareness about rare diseases Abdul also emphasized the significance of this awareness campaign for the patients who were unaware of X-linked Hypophosphataemia(XLH) The interview provides a profound understanding of Kyowa Kirin's initiatives to help patients suffering from XLH Smriti: Can we…
July 27, 2022

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Insights+ Key Biosimilars Events of June 2020
INSIGHTS+

Insights+ Key Biosimilars Events of June 2020

Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency Mylan with its partners Lupin and Biocon received MAA for Nepexto (biosimilar, etanercept) in EU and the US FDA's Approval for Semglee (biosimilar, insulin glargine) respectively Our team at PharmaShots has summarized 15 key events of the…
July 3, 2020

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