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Top Stories
Bioprocessing and manufacturing events bioLIVE and BioProduction Congress will take place as one event adjacent to CPhI Worldwide in Frankfurt, Germany, on November 5–7, 2019.
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The company received FDA approval for Hyrimoz (adalimumab-adaz), its biosimilar referencing AbbVie's blockbuster Humira (adalimumab).
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Industry News
New data highlights ability of the SQZ cell therapy platform to preserve cellular functions.
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Researchers evaluated the chemical stability of two different naloxone products administered to prevent opioid overdose deaths and found the products to have a significantly extended shelf life than previously known.
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Supplier News
Thermo Fisher Scientific has entered into a collaboration with Symphogen to deliver validated, platform workflows for simplified characterisation and quality monitoring of complex therapeutic proteins.
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Pharmatech Associates International Contracting and Services is a new company headquartered in Doha, Qatar, that will provide product development, facility design, and construction for high quality pharmaceutical and biotech products at low cost.
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Bio/Pharma News
Mylan announced the launch of its biosimilar to AbbVie’s Humira across major European markets.
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The multi-year collaboration will incorporate NextCure's FIND-IO platform, a technology designed to identify novel cell-surface molecular interactions that drive functional immune responses in the tumor microenvironment and other disease sites.
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Regulatory News
A statement from FDA Commissioner Scott Gottlieb and Deputy Commissioner Anna Abram detailed FDA’s new plan to advance plant and animal biotechnology innovation.
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A London-based pharmaceutical company has been charged with offences relating to the nature and quality of medicinal product used for parenteral nutrition in babies.
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ANALYTICS
Efforts strive to harmonize bioanalytical method validation for non-clinical and clinical studies.
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VIEWPOINTS
Susan Schniepp, executive vice-president of Post-Approval Pharma and Distinguished Fellow, Regulatory Compliance Associates, takes a look at the regulations around data integrity and how they relate to the concept of quality culture.
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Events
November 28–29, 2018
December 3–5, 2018
December 10–12, 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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