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Top Stories
Sandoz's new CEO will assume responsibilities no later than Aug. 1, 2019.
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The World Health Organization (WHO) has welcomed the launch of a malaria vaccine in a pilot program taking place in Malawi, Africa.
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Industry News
University of Southern California scientists have made an advancement in chimeric antigen receptor (CAR) T-cell therapy that seems to eliminate its severe side effects, making the treatment safer and potentially available in outpatient settings.
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CDER Director Janet Woodcock is finalizing this more streamlined approach process for evaluating new drugs to handle the surge in drug application submissions.
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Biopharma News
Novartis has announced that FDA has accepted its biologics license application (BLA) for brolucizumab (RTH258) for the treatment of wet age-related macular degeneration (AMD).
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Expansion at GSK's Hamilton, MT site is designed to boost vaccine production capacity.
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Supplier News
The company passed a seven-day FDA surveillance GMP inspection and announced two upcoming manufacturing partnerships.
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The expansion of the CDMO's Skokie, IL facility includes additional refrigeration and freezer space.
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Regulatory News
Sharpless will seek further solutions to the opioid crisis and work to reduce cigarette use in adults and kids.
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The agency provides recommendations for the development of bispecific antibody development programs that include regulatory, quality, nonclinical, and clinical considerations.
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MANUFACTURING
To achieve further cost reductions in biosimilar manufacturing, a move away from traditional models is necessary.
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QUALITY SYSTEMS
A robust customer complaint handling system is an integral part of a quality management system, says Susan Schniepp, executive vice-president of post-approval pharma and distinguished fellow, Regulatory Compliance Associates.
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ANALYTICAL METHODS
Close collaboration between academic and industrial groups is vital to ensuring glycosylation models are fit for deployment.
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April 30–May 2, 2019
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This eBook covers method development, analytical techniques, and profiles of new instruments, equipment, and supplies used in the testing and analysis of raw materials, drug substances, and drug products.
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