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Top Stories
Three months following his departure from FDA, former commissioner Scott Gottlieb joins Pfizer's board of directors.
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More than 30 lots of losartan drug products have been recalled due to contaminated API manufactured by Hetero Labs.
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Industry News
ABPI and BIA have issued responses to the recently published governmental guidance on European Union exit preparedness.
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Research from the Institute for Research in Biomedicine offers insight into the source of asymmetry between nucleic acid hybrids.
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Supplier News
Lonza Pharma & Biotech announced a binding contractual commitment for the purchase of a sterile drug product fill and finish facility.
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Novavax will sell two Maryland-based vaccine development and manufacturing facilities for Catalent's expanding gene therapy footprint.
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Bio/Pharma News
The companies will join forces to develop new immuno-oncology therapies in a deal worth up to $470 million.
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The companies will work to develop a liver tissue model for screening the toxicity of drugs.
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Regulatory News
FDA is collecting public comments on a draft guidance for bioanalytical method validation developed by ICH.
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FDA proposes rule to help ensure availability of hormones and enzymes formerly classified as drugs, and to stimulate biosimilars competition.
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ANALYTICS
Quality and compliance depend on the right approaches to training, standard operating procedures, and validation. More tools are available to help ensure success.
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SUPPLY CHAIN
Proactive approaches that consider long-term supply chain security compliance are recommended to ensure companies stay on the right track.
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OUTSOURCING
With an increased focus on the supply chain security of non-cGMP intermediates, companies need to re-emphasize upstream manufacturing.
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Events
September 10–11, 2019
September 16–18, 2019
September 18–20, 2019
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eBOOKS
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The editors explore novel technologies for the formulation, manufacture,
purification, and delivery of sterile small- and large-molecule drugs including single-use systems, facilities and equipment, contamination issues, and process analytics.
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