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Samsung Bioepis
Samsung Bioepis Begins P-I Trial of SB35 (Biosimilar, Taltz)
Shots:  Samsung Bioepis Initiates Phase 1 Trial of SB35 (ixekizumab), a Biosimilar version of Taltz   The P-I randomized, double-blind study will compare single-dose SB35 and Taltz in healthy participants for PK, safety, tolerability, and immunogenicity. Participants will be randomized 1:1, with 1EP including AUCinf, Cmax, and AUClast through Day 85  Ixekizumab is a humanized IgG4 mAb that selectively binds to IL-17A, blocking IL-17 receptor signaling and reducing…
August 28, 2026
The US FDA Accepts Nicox’s NDA for NCX 470 in Glaucoma 
Shots: The FDA has accepted NDA for NCX 470 (bimatoprost grenod) to lower intraocular pressure in patients with open-angle glaucoma or ocular hypertension (PDUFA: Apr 30, 2027) The NDA, submitted by US licensee Kowa, is supported by P-III (Mont Blanc & Denali) trial data showing IOP reductions of up to 10mmHg with a favorable safety…
August 28, 2026
Natera and Angiex Partner to Monitor AGX101 Response Using Signatera
Shots: Natera has entered into collaboration with Angiex to use longitudinal Signatera testingfor circulating tumor DNA (ctDNA) to assess treatment response monitoring during AGX101 treatment AGX101 is designed to target TM4SF1-expressing tumor cells & tumor-associated endothelial cells, delivering a cytotoxic payload to both the tumor & its vasculature Angiex is conducting a P-I trial of…
August 28, 2026
Osivax and GC Biopharma Partner on Next-Generation Influenza Vaccine
Shots: Osivax & GC Biopharma have entered a long-term collaboration to develop & commercialize a next-generation seasonal influenza vaccine combining OVX836, Osivax’s T-cell vaccine, with GC FLU, GC Biopharma’s WHO-prequalified seasonal flu vaccine The single-injection combination is designed to generate complementary immune responses, with T cells targeting the conserved NP antigen alongside antibodies against the…
August 27, 2026
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