CMC Biologics and Trellis Bioscience have entered into a manufacturing agreement for the process development and production of two of Trellis’ monoclonal antibodies (mAbs).
Dr Reddy's says efforts to fix plant problems flagged by US FDA impacted its active pharmaceutical ingredient (API) business in the first quarter of fiscal 2018.
Integration of the Mapi Group has been initiated, Icon CEO Steve Cutler says, as the company looks to support customers facing increased pressure to demonstrate product value and safety.
This month’s roundup includes two new CEOs and a VP at Quanterix who will lead the company’s biomarker research, custom assay development, and clinical sample testing lab.
Lupin says it has already resolved a problem flagged in a Form 483 issued by US FDA inspectors who visited its Aurangabad manufacturing facility in July.
