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BioCardia Collaborates with CART-Tech to Advance Heart3D Fusion Imaging for Interventional Cardiology
Shots: BioCardia has entered into an exclusive development & commercialization agreement with CART-Tech for Heart3D Fusion Imaging to improve 2D x-ray images used for cardiac biotherapeutic delivery & biopsy procedures As per the deal, BioCardia secured global exclusive rights to CART-Tech’s IP for biotherapeutic interventions, plus exclusive US distribution rights for cardiac biopsy & global…
August 14, 20250Comments
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Merck Receives Health Canada’s Approval for Perioperative Keytruda for Locally Advanced Head and Neck Squamous Cell Carcinoma (LA-HNSCC)
Shots: Health Canada has approved neoadj. Keytruda followed by adj. Keytruda + SoC radiotherapy (RT) ± cisplatin & then as a single agent to treat operable LA-HNSCC tumors expressing PD-L1 (CPS ≥1) Approval was based on P-III (KEYNOTE-689) trial assessing neoadj. Keytruda (200mg, IV, Q3W × 2 cycles), followed by adj. Keytruda (15 cycles) + SoC RT ±…
August 14, 20250Comments
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Pilatus Biosciences Collaborates with Roche to Evaluate PLT012 & Tecentriq Combination for Hepatocellular Carcinoma (HCC)
Shots: Pilatus Biosciences & Roche have entered into a clinical trial collaboration to evaluate PLT012 + atezolizumab for HCC pts Under the collaboration, Roche will supply atezolizumab (Tecentriq) for Pilatus' P-I study of PLT012 in combination therapy for HCC, with plans to expand to other cancers PLT012 is a humanized mAb that blocks CD36-driven lipid uptake, targeting…
August 14, 20250Comments
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Basilea Pharmaceutica Enters Into a Licensing Deal with Venatorx Pharmaceuticals
Shots: Basilea Pharmaceutica entered into an exclusive license deal with Venatorx Pharmaceuticals to acquire global rights to ceftibuten-ledaborbactam etzadroxil, a P-III oral beta-lactam/beta-lactamase inhibitor (BL/BLI) combination for complicated urinary tract infections (cUTI), incl. pyelonephritis Under the agreement, Venatorx will receive an upfront payment along with potential milestone payments in 2025 and will also be eligible…
August 14, 20250Comments
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Mabwell Reports First Patient Dosing in P-I Trial of Bulumtatug Fuvedotin for Triple-Negative Breast Cancer (TNBC) in the US
Shots: Mabwell has dosed its first patient with Bulumtatug Fuvedotin (BFv or 9MW2821) in P-I trial for the treatment of TNBC pts Trial will assess safety & efficacy of BFv in TNBC pts previously treated with a taxane & an ADC with a topoisomerase inhibitor payload, measuring ORR as the 1EP Bulumtatug Fuvedotin, a Nectin-4–targeting…
August 13, 20250Comments
Remegen
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Remegen Reports P-III Trial Data of Telitacicept for Sjögren’s Syndrome in China
Shots: Remegen has reported P-III trial data assessing telitacicept vs PBO in pts with primary Sjögren's syndrome Trial met its 1EP of reduced EULAR Sjögren’s syndrome disease activity index (ESSDAI), showing improved disease activity at Wk. 24; NMPA’s BLA submission is planned, along with presentation of detailed data at an upcoming conference Telitacicept is a…
August 13, 20250Comments
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Greywolf Therapeutics Reports First Patient Dosing in P-I/II (EAST-1) Trial of GRWD0715 for Axial Spondyloarthritis
Shots: Greywolf Therapeutics has dosed its first patient with GRWD0715 in P-I/II (EAST-1) trial (n=~141) for the treatment of axial spondyloarthritis (axSpA) The P-I study will assess safety & tolerability of GRWD0715 in ~24 healthy participants & ~36 axSpA pts to utilize the results with proof-of-mechanism data for selecting the active dose for P-II trial…
August 13, 20250Comments