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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…
NEWS
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…
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Biomica (Evogene’s subsidiary) & Shanghai Lishan Biopharmaceuticals have entered into an exclusive worldwide licensing agreement for BMC128, currently in P-I trial
As per the deal, Lishan Biotech will receive exclusive rights to develop, manufacture, & commercialize BMC128, with Biomica receiving development milestone payments & royalties on future commercial sales
Lishan Biotech is planning to…
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Alvotech reported positive top-line data from the AVT80-GL-P01 PK study comparing AVT80 with Entyvio in healthy adults
The study met all 1EP, demonstrating PK similarity between AVT80 & Entyvio following a single 108mg/0.68mL SC dose, supporting AVT80’s biosimilar profile
Alvotech is developing AVT16 (IV) & AVT80 (SC) as Entyvio’s biosimilars, with the AVT80-GL-P01 study…
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PrimeGen US has entered into a definitive business combination agreement with DT Cloud Star at an implied equity value of ~$1.5B, with closing expected in H2’26
After closing, the combined entity is expected to operate as PrimeGen US or a successor company & will be listed on Nasdaq under a new ticker symbol
PrimeGen…
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Daiichi Sankyo has dosed the first patient with DS3790 in the P-I/II trial for pts with r/r B-cell non-Hodgkin lymphoma
The trial will assess DS3790 in ~420 pts with r/r B-cell NHL, evaluating safety endpoints as well as efficacy endpoints incl. overall response, DCR, DoR, time to response, PFS, & OS
DS3790 is a…

