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May 31, 2023
The start of production of US engineering batches of NXC-201, a CAR-T cell therapy candidate in early clinical development, is the first step in transferring Nexcella’s existing manufacturing process to the United States.
API supplier Olon has started construction of a new manufacturing facility in Milan, Italy, which will be dedicated to production of cytotoxic payloads and linkers for ADCs.
Sandoz’s marketing authorization applications for a proposed biosimilar to denosumab are supported by a comprehensive analytical and clinical data package.
Under the new MTA and Option License Agreement, Adcendo can nominate ADCs against two novel ADC targets, according to the press release.
The project is being coordinated by the recently formed not-for-profit CCRM Nordic AB and gathers engaged stakeholders to move the initiative forward.
May 30, 2023
Aragen and FAR Biotech will collaborate to advance a small-molecule neurodegeneration program.
The $87.5 million purchase grants Novartis rights to an investigational gene therapy program intended for treatment of cystinosis.
The guidance describes FDA’s current recommendations regarding adjusting for covariates in statistical analysis of randomized clinical trials.
The next Cannabis Science Conference Fall meeting is soliciting a call for abstracts.
May 26, 2023
Challenges to approval decisions have prompted FDA officials to reexamine of the role and composition of the agency’s many advisory committees and to explore options for change.