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Top Stories
In launching FDA's Biosimilar Action Plan, Gottlieb takes innovator companies to task for delaying competitive biosimilar products.
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Novartis is set to partner with MorphoSys and Galapagos in a deal worth up to $1.1 billion to develop and commercialize their joint investigational, fully human, IgG1 monoclonal antibody (mAb) directed against the target IL-17C.
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Industry News
Annual awards program recognizes innovation in bio/pharma drug development and manufacturing.
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Report predicts PAT, NIRS, continuous bioprocessing, and a 'technological arms race' could improve biopharma manufacturing efficiencies.
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Biopharma News
Pfizer will invest nearly half a billion dollars to build a sterile injectable facility in Michigan.
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The company has run into a snag in producing Kymriah for the diffuse large B-cell lymphoma patient population, the second indication for which the therapy was recently approved by FDA.
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Supplier News
The API and drug product provider will invest £375,000 (US$493,000) in additional nuclear magnetic resonance (NMR) instrumentation at its headquarters in Craigavon, UK.
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The acquisition would combine Sangamo's ex vivo gene-editing capabilities with TxCell's regulatory T-cell (Treg) expertise to create chimeric antigen receptor (CAR)-Treg therapies.
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Regulatory News
Commissioner Gottlieb is reorganizing FDA in the hopes of streamlining policymaking.
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FDA Commissioner, Scott Gottlieb, announced formation of a new, drug shortages task force and efforts to advance long-term solutions to prevent shortages.
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FEATURE TOPICS |
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BUSINESS TRENDS
Biopharma companies can balance competing demands from patients, investors, and regulators by keeping a focus on science.
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QUALITY SYSTEMS
Quality experts share insights on what the future may hold regarding regulatory quality requirements for biopharmaceuticals.
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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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August 13–14, 2018
August 15–16, 2018
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A review of new technologies and processes that are helping to drive the adoption of single-use systems for the commercial production of biologic-based drugs.
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