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Top Stories
Takeda is considering approaching Shire with a possible offer.
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Congress passed a $1.3-trillion omnibus budget bill March 22, 2018 that increases federal support for biomedical research and health programs for fiscal year 2018.
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INTERPHEX 2018 Keynote Series
Data Integrity Educational Sessions
Experts at INTERPHEX 2018 will discuss regulatory requirements for data integrity and best practices for data integrity and process security.
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Industry News
Major countries will be ranked based on the potential for biopharma market growth, innovation, and competitiveness.
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The draft guidance addresses the agency’s policy on evaluating bulk drug substances in drug compounding.
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Biopharma News
The acquisition strengthens Celgene’s position in the global cellular immunotherapy space.
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Novartis’ Sandoz is seeking approval of its biosimilar referencing Johnson & Johnson’s Remicade (infliximab) for all of Remicade’s indications across gastroenterology, rheumatology, and dermatology.
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Supplier News
Hitachi will manufacture regenerative medicines developed by Daiichi Sankyo and SanBio Group.
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The agreement gives IncoCell Tianjin, a wholly-owned subsidiary of China-based Boyalife Group, access to Cesca’s celluar processing contract development and manufacturing services.
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Regulatory News
The agency’s Committee for Medicinal Products for Human Use recommended six drugs for approval at its March 2018 meeting.
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FEATURED TOPICS
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QUALITY
The author reviews operative options for the implementation of a quality oversight and how companies can benefit from this function from a regulatory perspective.
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OUTSOURCING
A review of the latest investments in facilities, equipment, and acquisitions by biopharma contract service providers.
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MANUFACTURING
A different perspective on controlling fixed costs of biomanufacturing, based on know-how from other industries, provides a competitive edge, says the CEO of Samsung BioLogics.
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ANALYTICAL METHODS
Contract testing organizations can provide bio/pharma companies with a cost-effective way to adapt to new technologies and regulations.
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Events
April 17–19, 2018
April 24–26, 2018
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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