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Strategy Editor Strategy Editor

GBI Appoints Industry Veteran Sven Lee to Board of Directors

Florida-based CDMO, GBI Biomanufacturing (GBI), has announced the appointment of Sven Lee to its board of directors. Mr. Lee brings decades of global experience in the biologics CDMO sector, having held executive and board positions at companies such as Abzena, Catalent, and Biocina, with expertise encompassing strategic growth, marketing, commercialization, licensing, and innovation in drug development.

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Expansion Editor Expansion Editor

Axplora Enhances ADC Manufacturing at Le Mans Facility

API small molecule and antibody-drug conjugate (ADC) manufacturing company, Axplora, has expanded its Le Mans, France, facility with a cutting-edge payload manufacturing workshop. This expansion is part of the France 2030 program to increase commercial revenue by supplying 40% of the world's marketed ADCs and 50-percent of FDA-approved ADCs.

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Strategy Editor Strategy Editor

Catalent Appoints Three Industry Leaders to Board

Catalent has appointed Susan Mahony (formerly of Eli Lilly), Marie-France Tschudin (ex-Novartis executive), and Tim Walbert (CEO of Horizon Therapeutics) to its Board of Directors as the company looks to strengthen its position as an independent CDMO under Novo Holdings' ownership.

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Regulatory Editor Regulatory Editor

J&J Sues Samsung Bioepis Over Biosimilar Breach

Johnson & Johnson (J&J) has filed a lawsuit against Samsung Bioepis, alleging a breach of their 2023 agreement concerning the launch of Pyzchiva, a biosimilar to J&J's Stelara. The dispute centers on Samsung's attempt to sublicense Pyzchiva to a private-label distributor, a move J&J contends violates their settlement terms.

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Regulatory Editor Regulatory Editor

Merck Faces Keytruda Price Cuts Under IRA by 2028

Merck expects its leading cancer drug, Keytruda, to be included in government price negotiations under the IRA starting in 2026 as its U.S. patent expires at the end of 2028. In 2024, Keytruda accounted for 46% of Merck’s total sales, and Merck’s CEO has expressed that price-setting via Medicare could limit the development of new therapies.

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Dealmaking Editor Dealmaking Editor

Tiziana Life Sciences Partners with Renaissance Lakewood to Advance Intranasal Foralumab

Immunomodulation therapy company, Tiziana Life Sciences, has entered into a product development services agreement with Renaissance Lakewood LLC, a leading CDMO focused on nasal drug delivery, to optimize the formulation and scale-up production of Tiziana's intranasal lead candidate, foralumab, which is under development for treating neurodegenerative and inflammatory diseases or conditions.

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Dealmaking Editor Dealmaking Editor

Granules India Buys its Way Into Peptide Market

Indian pharmaceutical manufacturing company, Granules India, has acquired Swiss CDMO Senn Chemicals AG for USD 22.3 mn to expand into the peptide therapeutics market. Senn Chemicals, which specializes in liquid- and solid-phase peptide synthesis, will strengthen Granules’ position in high-growth areas like GLP-1 receptor agonists used for diabetes and obesity treatments.

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Dealmaking Editor Dealmaking Editor

Thermo Fisher Acquires Solventum's Purification & Filtration Business in Cash Transaction

Thermo Fisher Scientific has agreed to acquire Solventum's purification & filtration business for USD 4.1 bn in cash. The purification & filtration unit - which generated around USD 1 bn in revenue in 2024 - specializes in purification filters and membranes used in biopharma, medical technology, microelectronics, food and beverage production, and water filtration.

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