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Top Stories
Legislators look to widen access to medications for addiction treatment and overdose emergencies.
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The pharma major intends to spinoff Alcon as a stand-alone eye-care devices 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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Fagron Sterile Services is voluntarily recalling two lots of Neostigmine Methylsulfate 5mL syringes due to mislabeling.
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Supplier News
The acquisition of Flex Concepts adds custom, single-use products to Entegris' single-use bag product line.
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Amazon will acquire PillPack, an online pharmacy that offers pre-sorted doses of medications and home delivery.
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Bio/Pharma News
Sanofi will sell Zentiva, its European generics business, to private equity investor Advent International.
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The companies will partner to develop T-cell therapies for cancer.
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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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Regulatory News
The agency is asking firms to discuss internal quality metrics efforts as part of the approval process for new medical products.
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The European Medicines Agency recommended Novartis' Kymriah (tisagenlecleucel) and Kite's Yescarta (axicabtagene ciloleucel), chimeric antigen receptor (CAR) T-cell therapies, for approval in the European Union.
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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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OUTSOURCING
Open communication channels between all the parties involved is key when outsourcing analytical methods, says Susan Schniepp, distinguished fellow at Regulatory Compliance Associates.
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MANUFACTURING
PDA reviews an industry survey of concerns and best practices regarding the EU GMP's required PUPSIT test for filters used in sterile filtration.
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PACKAGING
While cold-form, foil-foil (aluminumaluminum) blister packaging is considered the most moisture-protective packaging available, in fact, plastic containers such as bottles and tubes, when combined with desiccants, such as silica gel canisters and packets, will often provide lower internal relative humidity for long time periods.
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DRUG DELIVERY
Pulmonary drug delivery is becoming increasingly used. When developing pulmonary drugs, pharmaceutical chemists must consider drug absorption, control of particle size, suitable toxicology models, and patient compliance. The author reviews the issues specific to developing drugs designed for pulmonary delivery and considers how—with the right knowledge and expertise—these challenges can be overcome.
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Events
August 6–10, 2018
August 13–14, 2018
August 15–16, 2018
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eBOOKS
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This ebook covers 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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