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Top Stories
President Donald Trump announced his strategy for making prescription medicines more affordable and accessible in the United States.
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Takeda expands its global and therapy base with announced acquisition of Shire.
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Johnson & Johnson's Janssen Biotech will acquire biotechnology company BeneVir Biopharm to strengthen Janssen's immunotherapy platform.
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Industry News
The data and analytics company reports on the anticipated uptake of Humira (adalimumab) biosimilars in the EU once they are launched in 2018.
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A skilled workforce is needed to deliver on technology's promising medical advances.
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Biopharma News
The companies expanded their partnership to develop and commercialize messenger RNA (mRNA) cancer vaccines to include shared-antigen mRNA cancer vaccines such as mRNA-5671.
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The company received a complete response letter from FDA in response to the biologics license application for a proposed rituximab biosimilar.
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Supplier News
The companies have extended a contract agreement for the commercial manufacture of the active pharmaceutical ingredient for vonapanitase, an investigational drug intended to improve hemodialysis vascular access outcomes.
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The companies will partner to develop smart connected monitoring and support solutions for injectable drugs.
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Regulatory News
Smaller review divisions will bring experts closer to decision processes and reduce bottlenecks, FDA leaders say.
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The agency is seeking permanent injunctions to stop two stem cell clinics from marketing stem cell products without FDA approval and for violating cGMP requirements.
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FEATURED TOPICS
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OUTSOURCING
CDMOs can claim credit for the robust growth of emerging bio/pharma financings.
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MANUFACTURING
More published data and initial regulatory approvals are needed to drive adoption of continuous bio-manufacturing.
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UPSTREAM PROCESSING
The need to improve and understand processes is moving PAT and more advanced control strategies beyond the lab into manufacturing and downstream applications.
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DOWNSTREAM PROCESSING
The National Institute of Standards and Technology (NIST) has developed Standard Reference Material (SRM) 2082 as a pathlength standard for UV absorbance measurements for use with the new generation of microvolume spectrophotometers and short-pathlength cuvettes.
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BIO International Exhibitor Preview
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Distek is proud to present the BIOne Bioprocess Control Station. Key features include: touchscreen interface, smart media filling, variable speed pumps, email and text alerts, and much more.
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Eurofins BioPharma Product Testing is the largest network of bio/pharmaceutical GMP product testing laboratories providing comprehensive laboratory services for the world's largest bio/pharmaceutical companies.
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WuXi Biologics provides global pharmaceutical and biotechnological companies a single-source solution to discover, develop, and manufacture biologics from concept to commercialization.
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Events
June 4–7, 2018
June 7–8, 2018
June 14–15, 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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