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Memo has entered into a strategic collaboration & exclusive option-to-license agreement with CSL for Memo’s recombinant polyclonal IgG technology
As per the deal, Memo will use its Dropzylla platform for cloning human antibody repertoires & polyclonal antibody expression to develop recombinant polyclonal IgG products, while CSL will obtain an option to exclusively license those…
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Genentech has reported the P-III (FENtrepid) trial data assessing fenebrutinib (QD, PO) with IV Ocrevus-matching PBO vs Ocrevus & oral fenebrutinib-matching PBO in 985 adults with PPMS
Trial met its 1EP, showing a 12% reduction in disability progression (cCDP12) with curves separating by wk. 24 & consistent benefit across subgroups & duration. The strongest effect was…
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The US FDA has granted 510(k) clearance to eyonis Lung Cancer Screening (LCS), an AI/ML-powered CADe/CADx software, to detect & diagnose lung cancer
eyonis LCS analyzes LDCT imaging to help radiologists detect & characterize pulmonary nodules, enabling earlier diagnosis; in testing it showed 93.3% sensitivity, 92.4% specificity & 99.9% NPV, minimizing false positives &…
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The US FDA has accepted sBLA & granted priority review to Hympavzi for the treatment of pts (≥6yrs.) with hemophilia A or B with inhibitors & in pts (6-11yrs.) with hemophilia A or B without inhibitors (PDUFA: Q2’26)
sBLA for Hympavzi (SC, QW) in adults & adolescents was supported by data from the inhibitor…
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Innovent & Eli Lilly have entered into a strategic collaboration to advance novel medicines in oncology & immunology
As per the deal, Innovent will advance the programs from discovery through P-II PoC trial in China using its antibody platforms, while Lilly will receive exclusive rights to develop & commercialize the assets globally, excl. Greater…
Akeso’s Ivonescimab + CT Receives the NMPA Breakthrough Therapy Designation for Biliary Tract Cancer
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The Chinese NMPA has granted BTD to ivonescimab + CT for the 1L treatment of advanced biliary tract cancer (BTC)
Ivonescimab is being assessed in the fully-enrolled P-III (AK112-309/HARMONi-GI1) in combination with CT for the 1L treatment of advanced BTC
The P-Ib/II trial data presented at ASCO 2024 showed ivonescimab plus CT showed an…
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The Chinese NMPA has approved sacituzumab tirumotecan for the treatment of adults with unresectable or metastatic HR+/HER2- (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have received prior endocrine therapy & ≥1L of CT in an advanced setting
Approval was based on the P-III (OptiTROP-Breast02) trial assessing sac-TMT vs CT for the…
GSK Reports the EC Approval of Nucala (Mepolizumab) for Chronic Obstructive Pulmonary Disease (COPD)
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The EC has approved Nucala as an add-on maintenance treatment of adults with uncontrolled COPD characterised by raised blood eosinophils phenotype on a combination of an inhaled corticosteroid, a long-acting beta2-agonist (LABA), & a long-acting muscarinic antagonist
Approval was based on the P-III (MATINEE) trial assessing Nucala (100mg, SC, Q4W; n=403) vs PBO (n=401)…
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The P-III (OCEANIC-STROKE) trial assessed asundexian (50mg, QD, PO) vs PBO, both in combination with antiplatelet therapy, in pts (n=12,327) for prevention of ischemic stroke after a non-cardioembolic ischemic stroke or high-risk transient ischemic attack
Trial showed a 26% reduction in recurrent ischemic stroke without increased ISTH major bleeding across all subgroups, met key…
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Eisai & Henlius have entered into an exclusive commercialization & co-exclusive development & manufacturing license agreement for serplulimab (Hetronifly in the EU) in Japan
As per the deal, Eisai will obtain exclusive rights to commercialize serplulimab in Japan in exchange for $75M upfront, ~$80.01M in regulatory milestones, ~$233.3M in sales milestones, with double-digit royalties…

