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Top Stories
Legislators look to widen access to medications for addiction treatment and overdose emergencies.
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Strategic restructuring is designed to position GE Healthcare as a pure-play healthcare company.
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Industry News
FDA sent a warning letter to Henan Lihua Pharmaceutical Co. Ltd. after inspectors found the company failed to ensure the accuracy of its data.
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A new oral delivery method developed by the Harvard John A. Paulson School of Engineering and Applied Sciences could change the way diabetics regulate blood sugar levels.
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Biopharma News
The companies will partner to develop T-cell therapies for cancer.
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Sanofi will sell Zentiva, its European generics business, to private equity investor Advent International.
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bioLIVE
9-11 October 2018, IFEMA, Madrid, Spain
bioLIVE is a new focused event, with an exhibition and a live content stage, that establishes premium class, global leadership in bioprocessing and manufacturing. The event aims to bring the small and large molecule worlds together, creating a unique platform where both industries can learn from each other. Running adjacent to CPhI Worldwide, bioLIVE is a truly global hub for the biopharma community to do business, network, and learn.
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Supplier News
Minakem's facility in Belgium enhances capacity to scale production of highly potent ingredients for small to full GMP batches.
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Regulatory News
FDA, EMA, and senior officials from the European Commission met to discuss the EU-US mutual recognition agreement for inspections, the development of advanced therapies, the requirements for approving generic drugs, and Real-World Evidence used for post-authorization monitoring.
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GW Research's Epidiolex, which treats two forms of epilepsy, receives FDA's approval; spurs FDA reminders about unapproved products.
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Cleaning Validation:
As the industry's leading hands-on cleaning validation training, IVT's Cleaning Validation conference goes beyond best practices and solution oriented approaches; from bring your own challenge workshops and brainstorming think-tank discussions to solutions showcases and faculty "office hours" attendees are guaranteed to walk away with key actionable items for tackling the top challenges faced throughout critical cleaning process and validation lifecycles specific to their own environment.
 www.cbinet.com/cleaning
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FEATURED TOPICS |
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MANUFACTURING
Silicone is one of the polymeric materials that can be used for single-use components and assemblies in biopharmaceutical manufacturing.
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UPSTREAM PROCESSING
Understanding differences in bioreactor lifecycle, design space, and product platforms is important for selecting a bioreactor type.
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Data Integrity:
With FDA attention pinpointed on data integrity in recent 483s and warning letters, it is critical to arm yourself with the tools and resources to ensure data integrity in manufacturing processes. IVT's 4th Annual Data Integrity Validation provides a variety of industry perspectives in an unmatched training environment, diving deep into the nuances of building and maintaining a compliant data governance program across company-wide systems.  www.cbinet.com/dataintegrity
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SUPPLY CHAIN/LOGISTICS
Robust materials management, supplier quality management, quality control, and business continuity planning are essential to ensure continuous supply of single-use bags.
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Events
July 9–10, 2018
August 13–14, 2018
August 15–16, 2018
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eBook
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A review of new technologies and processes that are helping to drive the adoption of single-use systems for the commercial production of biologic-based drugs.
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