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Top Stories
Leaders of the two parties are open to challenging the status quo on drug costs and spending.
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The decision follows an FDA request for additional information to complement the company’s submission for biosimilar rituximab.
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Did you know you can streamline your workflows with a faster, more in-depth view of your biologic with Multiple Attribute Methodology (MAM).
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Industry News
Formulation issues cause significant drug project delays and project failures, according to a 2018 survey conducted by Informa Pharma Intelligence, Rentschler Biopharma, and LEUKOCARE.
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The new program will provide cell and gene therapy companies a more efficient way to ensure quality compliance across collection center networks and to minimize quality system audit burden on these centers.
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Biopharma News
The multi-year collaboration will incorporate NextCure's proprietary 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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AbbVie will grant Momenta license to launch a biosimilar to AbbVie’s Humira.
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Biopharma News
The multi-year collaboration will incorporate NextCure's proprietary 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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AbbVie will grant Momenta license to launch a biosimilar to AbbVie’s Humira.
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Supplier News
The company has rolled out the first batch of TRACON Pharmaceutical’s lead product candidate from its Singapore-based single-use bioreactor.
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The expanded Frederick, MD, site will help meet global demand for diagnostic instruments and cell and gene therapies for clinical trials.
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IVT's 6th Annual Laboratory Week
IVT's 6th Lab Week conference series draws over 100 laboratory professionals and provides the value of three conferences in one, giving your team the ability to select sessions that best meet your business objectives. Hear from FDA and choose from over 25 workshops, think tanks, interactive presentations, case studies and educational courses surrounding analytical procedures and methods validation, stability testing and lab data integrity.
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Regulatory News
Permission from the United Kingdom's Supreme Court has been granted to the UK BioIndustry Association, allowing it to intervene in a dosage regimen patent case.
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The agency is developing a new way to assess, record, and report data from surveillance and preapproval inspections of sterile drugs.
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FEATURE TOPICS |
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DRUG DEVELOPMENT
Providing analytical data on the comparison between a biosimilar and the reference product is a primary consideration in biosimilar development.
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ANALYTICAL INSTRUMENTATION
By adapting techniques from other sciences—and exploring better tools for biologics drug development—researchers are addressing challenges of protein characterization.
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QUALITY SYSTEMS
The testing of raw materials is essential as raw material quality determines the outcome of biologic product quality.
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Events
December 3–5, 2018
December 10–12, 2018
January 21–23, 2019
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eBook
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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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