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Top Stories
Norman (Ned) Sharpless, director of the National Cancer Institute at the National Institutes of Health, will become FDA acting commissioner.
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The acquisition of the site in Copenhagen, Denmark, will significantly expand Fujifilm's capacity and capabilities.
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INTERPHEX 2019 KEYNOTE SERIES
Continuous Manufacturing and 3D Printing
At INTERPHEX 2019, experts will share strategies for bringing continuous manufacturing to commercial scale. Plus, learn how 3D printing technology is being used in bio/pharma applications.
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Industry News
Hetero Labs recalls losartan potassium tablets due to presence of N-Nitroso-N-methyl-4-aminobutyric acid.
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FDA Commissioner Gottlieb released a statement on the agency's efforts to refine the naming convention for biosimilars to balance competition and to help ensure patient safety.
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Supplier News
The collaboration's enhanced data exchange combined with advanced analytics are expected to reduce raw material variability and improve biomanufacturing performance reliability.
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The companies will join forces to improve gene- and cell-therapy manufacturing using the cloud and machine learning.
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Bio/Pharma News
Biogen will acquire a clinical pipeline of gene-therapy candidates in ophthalmology.
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The new facility, located at the company's headquarters in Pittsburgh, PA, is expected to meet all clinical and commercial development needs of the company's lead gene therapy program.
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Webinar: Inhalation Performance Testing Webinar
Join Eurofins BioPharma Product Testing as we discuss requirements and common challenges in inhalation performance testing for drug/device combination products, such as pMDI and DPI. This webinar will include case studies; an overview of testing requirements, including extractables and leachables testing; guidelines for developing robust quality control testing methods; and more.
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Regulatory News
The agency sent a warning letter to ANDAPharm, LLC after inspectors found the company's cleaning and stability testing procedures were inadequate.
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The agency prioritized the review of the generic angiotensin II receptor blocker to help relieve the shortage of valsartan due to recent recalls.
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Exclusive Interview from AAPS 2018
Cutting Edge Formulations in Topic Drug Development
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ANALYTICS
Leveraging vast quantities of analytical data requires digitalization and platform integration.
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eBOOKS
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Laboratory Best Practices 2018 eBook
The editors explore new tools for bio/pharma lab studies—such as robotics, augmented reality, and advanced instrumentation—as well as best practices for method development, multiple attribute monitoring, lab mixers, and raw material testing. |
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