Feliza Mirasol is the science editor for 

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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.

Nexcella Begins Production of CAR-T Cell Therapy Engineering Batches at US Manufacturing Site

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.

Olon Makes Headway into ADCs Market with New Manufacturing Facility in Italy

Sandoz’s marketing authorization applications for a proposed biosimilar to denosumab are supported by a comprehensive analytical and clinical data package.

EMA Accepts MAAs from Sandoz for Proposed Denosumab Biosimilar

Under the new MTA and Option License Agreement, Adcendo can nominate ADCs against two novel ADC targets, according to the press release.

Adcendo and Duality Biologics in License Agreement to Expand ADC Pipeline

The project is being coordinated by the recently formed not-for-profit CCRM Nordic AB and gathers engaged stakeholders to move the initiative forward.

Vinnova Supports the Formation of Nordic CCRM Hub

Aragen and FAR Biotech will collaborate to advance a small-molecule neurodegeneration program.

Aragen Life Sciences and FAR Biotech Enter Neurodegeneration Collaboration

The $87.5 million purchase grants Novartis rights to an investigational gene therapy program intended for treatment of cystinosis.

Novartis Purchases Cystinosis Gene Therapy from AVROBIO

The guidance describes FDA’s current recommendations regarding adjusting for covariates in statistical analysis of randomized clinical trials.

FDA Releases Final Guidance on Adjusting for Covariates in Randomized Clinical Trials 

The next Cannabis Science Conference Fall meeting is soliciting a call for abstracts.

Cannabis Science Conference Fall Meeting Issues Call for Abstracts

Jill Wechsler is Pharmaceutical Technology's Washington Editor, jillwechsler7@gmail.com.

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.

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