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Top Stories
New FDA guidance developed to identify lapses in data integrity and promote best practices.
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The $62-billion acquisition of Shire by Takeda Pharmaceutical was approved by both sets of shareholders.
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Industry News
FDA has withdrawn the proposed rule that would have allowed generic-drug makers to independently update and distribute new safety information in drug labels.
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According to research from staffing firm, Kelly Services, 14% of life science professionals based in the UK may move abroad if Brexit results in negative changes to economic conditions.
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Biopharma News
A new facility in California will expand Orchard Therapeutic's capacity to develop and deliver lentiviral vector and gene-corrected hematopoetic stem cells.
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GSK and TESARO have entered into a definitive agreement concerning GSK's acquisition of TESARO for an aggregate cash consideration worth approximately $5.1 billion.
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Supplier News
The company will use GE Healthcare's off-the-shelf KUBio biologics factory, which is expected to start operations in 2020, to provide development and manufacturing for early- to late-clinical and early-commercial manufacturing stages.
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The new company will provide histopathology services in the research and pre-clinical therapeutics markets.
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Regulatory News
FDA cites Zhejiang Huahai Pharmaceutical in valsartan impurity investigation.
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The UK Pharma Industry has emphasized the need for the government to avoid a 'no-deal' Brexit in response to the prime minister delaying the deal vote.
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FEATUREd TOPICS |
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MANUFACTURING
Advances in single-use technologies, sensors, and cell retention systems facilitate processes designed for the long run.
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QUALITY SYSTEMS
Success depends on supplier communication and transparency, but it's up to buyers to demand the right information and to look at the vendor's overall business.
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OUTSOURCING
CMOs and CDMOs made investments in new and expanded facilities and services in the last quarter of 2018.
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REGULATORY
Unprocessed bulk material harvested directly from the bioreactor should be tested for contamination prior to downstream processing.
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Events
January 21–23, 2019
February 6–7, 2019
March 3–6, 2019
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This eBook covers method development, analytical techniques, and profiles of new instruments, equipment, and supplies used in the testing and analysis of raw materials, drug substances, and drug products.
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