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Susan Haigney is lead editor of BioPharm International®.
July 29, 2024
The US Pharmacopeia’s Microbiology Expert Committee approved the inclusion of a chapter into the United States Pharmacopeia–National Formulary that allows the use of non-animal-derived reagents for endotoxin testing.
July 24, 2024
In the second episode of the Ask the Expert video series, Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, and Siegfried Schmitt, vice-president, Technical, at Parexel, discuss the quality requirements needed when incorporating AI in bio/pharmaceutical development and manufacturing.
July 17, 2024
The company has issued a voluntary recall of one lot of Clonazepam Orally Disintegrating Tablets, USP (C-IV), because of incorrect strength published on product carton.
July 15, 2024
The acquisition provides Lantheus with worldwide exclusive rights to ß amyloid PET imaging agent, NAV-4694, for its Alzheimer’s disease diagnostic and treatment portfolio.
PRAC is recommending that patients who use glucagon-like peptide-1 receptor agonists (GLP-1 RAs) consider the risk of delayed gastric emptying before undergoing surgery with general anesthesia or deep sedation.
July 04, 2024
The companies have restructured their existing collaboration into a licensing agreement that invests in mRNA development.