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What’s in a name? Quite a lot actually when it comes to substances used in cell and gene therapies

The World Health Organization (WHO), as part of its International Nonproprietary Names (INN) system, has recently made progress in developing and harmonizing the definition paragraphs that support the naming of cell-based substances.

Biogen on aducanumab: ‘We’re ready for an immediate launch’

Biogen expects to begin shipping Aduhelm (aducanumab-avwa) in two weeks: after the FDA granted the Alzheimer's drug accelerated approval on Monday.

Content provided by Thermo Fisher Scientific

Notes on compliance: USP 60 compliance doesn’t have to be complicated

When United States Pharmacopeia 60 (USP 60) came into effect little more than a year ago, it added a new dimension to testing for objectionable organisms in pharmaceutical products.
The regulation, which was triggered by a string of Burkholderia...

NPD Gallery: Technology Insider

What's new in the world of biopharmaceutical tech this month? We track developments in process innovation equipment.

Shoreline Biosciences and BeiGene collaborate on genetically modified natural killer cell therapies

Shoreline Biosciences and BeiGene have announced an exclusive worldwide strategic collaboration to develop and commercialize a portfolio of natural killer (NK) based cell therapeutics.

Content provided by Yourway

Eliminating Variables Is Central to Kitting Design

Flexibility has become a necessity in clinical trials. The trend of decentralization is a significant change for the industry and has grown increasingly common. While certain treatment or assessment visits still need to occur at the investigators’ clinics,...