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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…
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The US FDA has granted Emergency Use Authorization for the use of Ivomec (ivermectin) 1% Injection for the prevention of infestations caused by New World screwworm (NWS) in cattle
Under the EUA, Ivomec is authorized for NWS prevention when administered within 24hrs. of birth, at castration, or upon wound appearance, with specific exclusions for…
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Hims & Hers Health has launched access to the Multi-Cancer Test by Galleri, offering a simple blood test for early cancer screening
The Hims & Hers Multi-Cancer Test by Galleri detects a shared signal from 50+ cancers, incl. those without recommended screenings, & can be taken annually to help identify cancers early, often before…

