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Top Stories
More consistent and reliable production processes are critical for advancing innovative treatments.
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Denmark-headquartered pharmaceutical company LEO Pharma is set to acquire Bayer's prescription treatment portfolio.
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Industry News
AuroMedics Pharma issued a voluntary, nationwide recall of two lots of piperacillin and tazobactam for injection, USP 3.375 g due to the presence of particulates identified as glass and silicone material.
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Researchers at the University of Pennsylvania found that diabetes drugs called thiazolidinediones can promote the metabolism of glutamine to help control disease-causing inflammation.
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Supplier News
Leistritz's Twin Screw Extrusion Workshop, taking place Nov. 28–29, 2018 in Clifton and Somerville, NJ, will feature classroom sessions and extrusion demonstrations.
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The companies will collaborate to bring InnoCore Pharmaceuticals' proprietary SynBiosys biodegradable polymer platform to market.
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Make Compliance a Competitive Advantage:
Are you searching for a CDS software that simplifies meeting the latest demanding regulations? With Thermo Scientific™ Chromeleon™ CDS software, sequence-level data organization and audit trails tracking all actions in the software — including CDS-related external events – you can defend your data with utmost confidence allowing you to focus on the important work of your lab. Visit resource center. Learn More |
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Bio/Pharma News
Stem-cell developer TiGenix has been acquired by Takeda Pharmaceutical.
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Early Bird Registration Available: Full Day E&L Symposium:
Register for Eurofins Lancaster Laboratories' 2nd Annual Extractables & Leachables Symposium for Drugs and Devices on Thursday, September 20th in San Francisco, CA. Don't miss this opportunity to learn best practices, gain insight on regulations and hear case studies from Sanofi and Janssen. Learn More |
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Regulatory News
The European Commission (EC) approved Pfizer's Trazimera (trastuzumab), a biosimilar to Roche's Herceptin, to treat certain breast and gastric cancers.
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2018 PDA Universe of Pre-filled Syringes and Injection Devices:
October 8-9, 2018 | Loews Royal Pacific| Orlando, FL
At the 2018 PDA Universe of Pre-filled Syringes and Injection Devices, October 8-10 in Orlando, Florida, industry and regulatory experts will share experiences, new developments, regulatory considerations, challenges, and industry trends and best practices. This is a must-attend event for all industry professionals involved in the development, manufacturing, testing, or marketing of pre-filled syringes and injection devices. Learn More |
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REGULATORY WATCH
EMA, the leading driver behind GMP inspection collaboration schemes, will be cutting back its involvement because of the need to concentrate on its relocation to Amsterdam.
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OUTSOURCING
Joe DiMasi, director of economic analysis and research associate professor, Tufts Center for the Study of Drug Development (CSDD), discussed research into the impacts of working with single source contractors with Pharmaceutical Technology.
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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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QUALITY SYSTEMS
SOPs need to reflect a company's specific manufacturing or other operations, says Susan Schniepp, distinguished fellow at Regulatory Compliance Associates.
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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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PI18083 24th Annual Validation Week:
Don't miss out on three days spent learning from industry trailblazers and networking with peers at IVT's 24th Annual Validation Week. Create your own unique conference experience by choosing between four tracks - Process Validation, Quality, CSV/Data Integrity and Cleaning Validation – and attend the 2nd Annual Women in Validation Empowerment Summit. You are guaranteed to walk away with essential tools for the dynamic validation industry. Learn More |
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Events
August 13–14, 2018
August 15–16, 2018
August 21–23, 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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