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Top Stories
The acquisition will expand Pfizer's rare disease portfolio with an early pipeline candidate for treating dwarfism.
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AbbVie grants Boehringer Ingelheim a non-exclusive license to its intellectual property for Humira (adalimumab) in the United States.
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Industry News
Harvard University researchers used single-cell sequencing to identify a protein expressed uniquely by insulin-producing beta cells created from stem cells in the laboratory.
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The National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health (NIH), awarded grants totaling $41.6 million to establish four cooperative research centers focused on developing vaccines to prevent sexually transmitted infections (STIs).
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Biopharma News
The acquisition provides Valby, Denmark-based Lundbeck with a discovery platform and a US-based research hub.
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The acquisition of GlaxoSmithKline's manufacturing site in Cork, Ireland, will expand Thermo Fisher Scientific's global footprint for complex API manufacturing.
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Supplier News
The company announced plans to construct a 1.3 million-ft2 integrated manufacturing center in Chengdu, China.
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The partnership will focus on the commercialization of inducible promoters to improve biomanufacturing.
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Regulatory News
TraceLink will participate in the agency's Pilot Project Program under the Drug Supply Chain Security Act.
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FEATURED TOPICS |
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MANUFACTURING
This article presents some key differences between the US and European regulation of biosimilars, including naming conventions and pharmacovigilance of biosimilars, and the impact of biosimilars on commercialization and affordability of biotherapeutics.
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REGULATORY
Delays in revisions to guidelines by the European Union are impeding the pharmaceutical industry.
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ANALYTICAL METHODS
This article takes a look at current practices for cleaning and sterilizing biomanufacturing equipment used in a multi-product versus single-product setting.
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June 3–6, 2019
June 18–20, 2019
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eBook
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Experts share insight and advice for conducting CMC due diligence with contract development organizations, using multiple attributes methods to monitor quality attributes, and strategies for using specialized services for biopharmaceutical development applications.
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