Top Stories
Paragon Bioservices entered into a contract with the International Aids Vaccine Initiative for the process and analytical development and cGMP manufacturing of an HIV vaccine candidate.
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Catalent has entered into an exclusive long-term supply agreement to produce Pfizer's OTC proton-pump inhibitor for heartburn treatment, Nexium 24HR (esomeprazole), which is also marketed as Nexium Control outside the US.
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Industry News
Scientists at Rice University have developed a method to control the infectivity of viruses and gene delivery to the nuclei of target cells.
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Biogen, Genentech, Johnson & Johnson, Novartis, and Patheon publicize their support for action on climate change.
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Supplier News
The plant will manufacture Clariant’s moisture-control products to support the growing pharmaceutical packaging market in India.
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Vetter receives AEO-F certificate from the European Union for global movement of goods.
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Bio/Pharma News
Seqirus, CSL Limited’s influenza vaccine business, announced the opening of their corporate headquarters in the United Kingdom.
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Adaptimmune Therapeutics and Universal Cells enter into collaboration and license agreement to develop universal allogeneic T-cell therapies.
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The Life Sciences Guidebook
In a market where high-demand causes organizations to seek software systems that will fit into their complex business infrastructure, the pressure to find the right system often causes angst to many. Learn some key elements to spotting a good FDA Compliance solution, techniques for achieving GMP Compliance, and how to ensure that Quality and Compliance are met in the Life Science industry.
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Regulatory News |
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FDA sets a July 2016 deadline for the final version of the rule on labeling changes for approved drugs and biologics.
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GMPs
Susan Schniepp, distinguished fellow, and Andrew Harrison, chief regulatory affairs officer and general counsel, both of Regulatory Compliance Associates, discuss how to write standard operating procedures that hold up to audits.
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REGULATIONS
FDA confirmed quality focus while Congress moved to bolster biomedical innovation.
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REFERENCE BOOKS |
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This three-volume set of comprehensive pharmacology reference guides cover solid-dosage form principles such as oral solid-dosage forms, powders, mixing and blending, excipients, tableting, and coating. Stay current with compressed tablet manufacturing processes, solid dosage processing equipment, tablet-pressing processes, and pharmaceutical industry trends in oral solid dosage manufacturing and solid dosage form development.
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Pharmaceutical Technology's Drug Development Application Handbook is a compilation of technical articles from the magazine's archives and application notes, technical information, and educational materials from the handbook's sponsors.
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