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Merck
NEWS

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…
June 19, 2026

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NEWS

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…
June 18, 2026

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Samsung Bioepis and Organon
NEWS

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…
June 18, 2026

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NEWS

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.…
June 18, 2026

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NEWS

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…
June 18, 2026

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NEWS

Biogen to Acquire RayThera for ~$1B

Shots: Biogen has entered into a definitive agreement to acquire RayThera, expanding its immunology pipeline As per the deal, Biogen will acquire RayThera for ~$1B, incl. an upfront payment & clinical and regulatory milestone payments; closing is expected in Q3’26 Following closing, Biogen will lead development, manufacturing & global commercialization of RayThera’s assets, incl. the…
June 18, 2026

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NEWS

Jazz Pharmaceuticals and AbCellera Collaborate to Discover T-cell Engaging Multispecific Antibodies

Shots: Jazz has entered into a preclinical research collaboration, option & license agreement with AbCellera to discover & develop next-generation T-cell engaging (TCE) multispecific antibodies for GI cancer & other solid tumors, leveraging AbCellera’s antibody discovery engine  AbCellera will lead discovery & early-stage research for 2 initial programs, with a third to start within…
June 17, 2026

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