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Takeda Partners with Boltz to Advance AI-Driven Drug Discovery

Shots: Boltz has partnered with Takeda to deploy its biomolecular AI platform across Takeda’s research organization, providing discovery teams access to proprietary foundation models, incl. BoltzMol-1 & BoltzProt-1, to accelerate AI-driven drug discovery The platform is designed to support in-silico molecular design, enabling structure prediction, affinity estimation, and generative design to enhance AI-driven drug discovery…

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Voro Therapeutics and Alloy Therapeutics Partner on Next-Generation T-Cell Engagers

Shots: Voro Therapeutics & Alloy Therapeutics have entered into a strategic research collaboration to discover and develop next-generation masked T-cell engager (TCE) therapies Partnership will combine Voro’s PrimeBody platform with Alloy’s optimized CD3 antibodies & multispecific engineering capabilities to develop novel immunotherapies designed to selectively activate immune responses within tumors PrimeBody is designed to unlock difficult-to-target…

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Merck

The US FDA Expands Merck’s Capvaxive Use to Children and Adolescents Aged 2-17 at Increased Risk for Pneumococcal Disease

Shots: The US FDA has expanded the indication for Capvaxive to incl. pts aged 2–17yrs. with certain chronic medical conditions who have completed a primary pediatric pneumococcal vaccination series & remain at increased risk of pneumococcal disease Approval was supported by P-III (STRIDE-13) trial data, which compared Capvaxive with PPSV23 in the above-mentioned pts Capvaxive…

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Genentech Reports the US FDA’s sBLA Acceptance of Lunsumio VELO + Polivy for R/R Large B-Cell Lymphoma

Shots: The US FDA has accepted sBLA for Genentech's Lunsumio VELO (mosunetuzumab-axgb; SC) + Polivy (polatuzumab vedotin-piiq) for treating adults with r/r LBCL, incl. diffuse large B-cell lymphoma (DLBCL), after ≥1L of systemic therapy (PDUFA: Feb 9, 2027) sBLA was backed by the P-III (SUNMO) study assessing Lunsumio VELO + Polivy (IV) vs R-GemOx in the above…

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Samsung Bioepis and Organon

Samsung Bioepis & Organon Expand Deal to Commercialize Pyzchiva (Biosimilar, Stelara) in Canada

Shots: Samsung Bioepis & Organon have expanded their development & commercialization agreement for Pyzchiva, a biosimilar version of Stelara (ustekinumab), with launch expected in 2026 As per the deal, Organon will gain exclusive commercialization rights to Pyzchiva in Canada, while Samsung Bioepis retains responsibility for development, manufacturing, & regulatory activities. The addition of Pyzchiva expands the…

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LabGenius Therapeutics and LG Chem Collaborate to Develop an AI/ML-Designed Tumour-Targeting Antibody

Shots: LabGenius has entered into a multi-year research collaboration, option & licensing agreement with LG Chem to identify next-generation multispecific antibodies for difficult-to-treat cancers, leveraging LabGenius’ AI/ML-driven antibody discovery platform, EVA As per the licensing deal, LabGenius will lead preclinical research, incl. in vitro efficacy studies, after which LG Chem will conduct further preclinical development, incl.…

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GSK & Spero Therapeutics Report the US FDA Approval of Utebzi for Complicated Urinary Tract Infections (cUTIs)

Shots: The US FDA has approved Utebzi (tebipenem pivoxil; 600mg, PO, Q6H) for the treatment of cUTIs incl. pyelonephritis, in adults who have limited or no alternative oral treatment options, with launch expected by the end of 2026 Approval was supported by the P-III (PIVOT-PO) trial demonstrating that Utebzi was non-inferior to IV imipenem-cilastatin in…

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