| Eli Lilly and NIBRT Enter Research Collaboration
| | May 8, 2008 | The National Institute for Bioprocessing Research and Training (NIBRT, Dublin, Ireland) has entered into a new research collaboration with US pharmaceutical company Eli Lilly (Indianapolis, IN). |
| | FDA Finalizes CMC Guidance for Gene Therapy INDs
| | May 8, 2008 | The FDA has issued its guidance for chemistry, manufacturing, and control information that is included in investigational new drug applications (INDs) for gene therapies, called “Content and Review of Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs).” |
| | | Leached Impurity Found in Cubicin Stored in Cardinal Health’s ReadyMED Pumps
| | May 8, 2008 | Cubist Pharmaceuticals, Inc. (Lexington, MA) informed healthcare professionals on April 4 that a potentially significant impurity, 2-mercaptobenzothiazole (MBT), has been isolated from reconstituted Cubicin stored in ReadyMED elastomeric infusion pumps manufactured by Cardinal Health, Inc. (Dublin, OH). |
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