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Top Stories
A new report released at the BIO International Convention shows that the US bioscience industry has had a $2-trillion economic impact and has accelerated venture capital investment and job growth.
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Regulatory authorities have published draft guidance on strategies to facilitate pharmaceutical lifecycle management.
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Industry News
The Future Vaccine Manufacturing Hub will work with CPI as well as other UK institutions to address challenges of vaccine production and distribution so that the spread of new diseases can be effectively tackled.
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The International Society of Pharmaceutical Engineering (ISPE) is field-testing the design principles of a comprehensive, industry-led program of self-evaluation of pharmaceutical quality that will align with the purpose of FDA's quality metrics.
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Biopharma News
The agency has approved Mylan's Fulphila (pegfilgrastim-jmdb) as the first US-approved biosimilar to Amgen's Neulasta (pegfilgrastim) to reduce infection risk during cancer treatment.
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The company will provide the first FlexFactory manufacturing platform for TCR T-cell therapy manufacturing.
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Supplier News
Lonza has added four liver cell types to its hepatocytes portfolio for testing of in vitro drug models.
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Agilent Technologies expects the acquisition to improve its current software portfolio.
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Regulatory News
The FDA commissioner announced proposed steps to modernize the organization and functions of CDER's Office of New Drugs.
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The agency is encouraging team-based reviews and streamlined processes that will make the oversight process more efficient and consistent.
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IVT's Stability Testing Europe allows attendees to review core FDA and ICH guidance to breaking down the latest regulatory policies, including a brand new updated WHO draft guidance for API and finished drug stability testing. Don't miss the chance to participate in hands-on training for small molecules, biologics and medical devices to harmonize global systems and enhance stability programmes.
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Analytical Procedures & Methods Validation Europe provides a comprehensive understanding of regulatory trends and requirements, "hands-on" training for executing procedures that survive the lifecycle and solutions to challenges within the laboratory.
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SUPPLY CHAIN/LOGISTICS
Internet of Things, advanced analytics, and blockchain solutions such as smart contracts promise to give manufacturers more control over products and supply chains.
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Events
June 14–15, 2018
June 20–21, 2018
June 26, 2018
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eBook
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How are contract development and manufacturing contract service organizations meeting the development and manufacturing needs of innovator biopharmaceuticals and biosimilars companies? In this BioPharm International ebook, the editors examine trends, partnerships, manufacturing capacity, regulatory, supply chain, and technical expertise issues.
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