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Regulatory Editor Regulatory Editor

FDA Clears Immpact Bio’s CAR-T MS Therapy

Immpact Bio announced that the FDA has cleared its IND application for a CD19/CD20, a bispecific CAR-T cell therapy for treating multiple sclerosis (MS). The therapy is designed to target and eliminate the B cells implicated in MS and offers a potential new treatment option for patients with this autoimmune disease.

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Strategy Editor Strategy Editor

Bora Makes Strategic Investment in Tanvex to Combine Biomanufacturing

Bora’s Board of Directors has approved a deal whereby Bora Biologics will combine its biomanufacturing capabilities with those of Tanvex, a biopharma focused on biosimilars that also provides CDMO services. The deal, which is expected to close in the first quarter of 2025, will bring together Bora’s CDMO capabilities and expertise from Tanvex, as well as its FDA-approved commercial-scale facility in San Diego.

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Strategy Editor Strategy Editor

WuXi Secures New US Contracts Despite Biosecurity Concerns

WuXi Biologics has secured 61 new projects in the first half of 2024, with half originating from the U.S. The proposed BIOSECURE Act, which targets named Chinese biotech firms including WuXi Bio because of national security concerns. Although Wuxi has reiterated its commitment to regulatory compliance and denies it poses any security threats, it saw modest revenue growth and a significant decline in profits.

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Dealmaking Editor Dealmaking Editor

Bora Completes Emergent Fill-Finish Facility Deal

Bora Pharmaceuticals has successfully completed the acquisition of a sterile fill-finish manufacturing facility in Baltimore-Camden, Maryland, from Emergent BioSolutions. The acquisition allows Bora to expand its manufacturing capabilities in the U.S., particularly in the production of sterile injectables, and complements its existing drug substance capabilities.

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Dealmaking Editor Dealmaking Editor

NEC Bio Therapeutics & AGC Biologics Partner to Advance Personalized Oral Cancer Vaccine

NEC Bio Therapeutics and AGC Biologics have partnered to advance the production of NECVAX-NEO1, a personalized, orally delivered cancer vaccine targeting patient-specific tumor neoantigens. The partnership aims to enhance the development and delivery of personalized cancer treatments using AI and traditional biologics and will leverage AGC Biologic’s expertise in microbial fermentation.

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Strategy Editor Strategy Editor

Rentschler Expands Production Capacity Amid Growing CDMO Demand

German CDMO, Rentschler Biopharma, has opened a new production line in response to the surging demand for its CDMO services. The company is looking to increase its capacity to support the growing biopharmaceutical market, particularly in producing complex biologics, as the company seeks reliable partners for scaling up production.

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Strategy Editor Strategy Editor

Ajinomoto to Lay Off 71 Employees as It Streamlines CDMO Business

Japanese biotech, Ajinomoto, plans to lay off 71 employees at its California facility as part of a strategic move to streamline its CDMO business. This decision follows the company’s recent $620mn investment in Forge Biologics, as it looks to enhance its capabilities in the biologics manufacturing sector through the optimization of operations and focus resources on key growth areas.

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