Top Stories
Despite some progress, pharmaceutical companies have a long way to go in making their products accessible and affordable, this year's study finds.
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Biopharma proponents argue for FDA resources, Cures legislation, and science-based drug regulation.
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Industry News
At ICH's November 2016 meeting, the council announced new members and new guidelines.
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CDER is asking manufacturers to participate in the Experiential Learning Site Visit Program to educate OPQ staff about pharmaceutical manufacturing processes.
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EXPERT INTERVIEW
Barry Holtz, president, iBio CMO sat down with Pharmaceutical Technology to discuss plant models in biopharmaceutical manufacturing.
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Supplier News
The company expanded its commercial packaging facility in response to a growing demand for pediatric drugs.
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Avecia is adding drug substance capacity at its Milford, MA manufacturing site.
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Bio/Pharma News
Neovacs acquired Amegabiotech's Interferon Alpha manufacturing license for the manufacture of its lead therapeutic candidate.
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The company plans to expand access to its Prevanar 13 vaccine in humanitarian emergency settings.
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Regulatory News
Research by agency scientists may help speed development of Zika virus vaccines.
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The agency published guidance to help pharma companies in the clinical development of treatments for bacillus Calmette-Guerin (BCG)-unresponsive nonmuscle invasive bladder cancer.
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SUPPLY CHAIN
Vendor selection and materials testing are complex enough, but in today's volatile environment, risk mapping and monitoring are also crucial.
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GMPs
Siegfried Schmitt, PhD, principal consultant, PAREXEL, discusses how to prepare for an inspection by a foreign regulatory agency.
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Events
December 7–8, 2016
January 9–13, 2017
May 16–18, 2017
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REFERENCE BOOKS |
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A compilation of informative, useful articles designed to help you meet the challenges of process analytical technology, be more efficient in testing, reduce over-processing, enhance consistency, and minimize rejects.
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eBOOKS
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Read feature articles on accelerated scale-up for vaccine production, standards for air cleanliness classification, aseptic filling advances, a flexible approach to cleanroom design, a science-driven approach for microbial control, removing genotoxic impurities, regulatory enforcement, drug shortages, and validation of single-use shipping systems. |
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