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Top Stories
Fresenius Kabi claims that Akorn failed to fulfill several closing conditions.
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The company received a complete response letter from FDA in response to the biologics license application for a proposed trastuzumab biosimilar.
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Industry News
Public health authorities and the biomedical research community are seeking new strategies to address global health threats.
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After a review of public comments, USP will not move forward with nomenclature proposal without further FDA collaboration.
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Biopharma News
The companies plan to advance programs for dementia and other neurological conditions.
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As Astellas Pharma winds down its Agensys research operations, the company sells the Santa Monica, CA, facility to Gilead.
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Supplier News
The company has begun expansion efforts for its process-development capabilities and laboratory infrastructure.
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The company will invest EUR 325 million (US$389 million) in a new biomanufacturing facility in Ireland using single-use bioreactors.
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Regulatory News
The agency updated its list of recommended influenza virus strains that manufacturers should include in vaccines for the autumn 2018 season.
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FDA sent a warning letter to Lijiang Yinghua Biochemical and Pharmaceutical Co., Ltd. for failure to follow current good manufacturing practices.
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FEATURED TOPICS
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BUSINESS TRENDS
The Biomanufacturing Technology Roadmap is accelerating innovative manufacturing strategies for biopharmaceuticals.
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MANUFACTURING
A technology roadmap aims to drive and consolidate improvements in a process that has remained unchanged for more than 70 years.
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PEER-REVIEWED RESEARCH
This study is an attempt to produce a fusion protein by binding the fragment NT-gp96 in upstream of sequence of the N terminal fragment (NT300) of the NS5B gene in an expression vector.
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June 4–7, 2018
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eBook
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How are contract development and manufacturing contract service organizations meeting the development and manufacturing needs of innovator biopharmaceuticals and biosimilars companies? In this BioPharm International ebook, the editors examine trends, partnerships, manufacturing capacity, regulatory, supply chain, and technical expertise issues.
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