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Top Stories
Pharma majors AstraZeneca and Merck & Co. form $8.5-billion partnership to develop cancer therapies revolving around AstraZeneca’s PARP inhibitor, Lynparza.
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Pharma major aims to focus majority of R&D capital into priority therapy areas and plans to cut approximately 30 R&D programs.
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Industry News
Stainless-steel particulates were found in one lot of 0.9% Sodium Chloride Injection, USP 1000 mL, prompting the recall to the hospital/user level.
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Apace Packaging LLC labeling error initiates national recall of cyclobenzaprine HCL and amantadine HCL (Lot 16710).
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Supplier News
New patent for automated cell processing technology provides commercially viable automated CMC solution for developing CAR-T cell therapies.
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Corning and Gerresheimer have been working together to accelerate innovations for pharmaceutical glass packaging.
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IVT’s Validation Week celebrates its 23nd anniversary this year in Philadelphia! The industry’s gold-standard for validation training is back to provide the most comprehensive information on new global regulations, technology advances and industry case models for developing, implementing and deploying validation procedures enterprise-wide. This year’s program features customizable content for beginner and advanced professionals from bio/pharma and medical device fields.
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Bio/Pharma News
Partnership aims to develop new vaccine regimens against hep B and HIV by combining respective proprietary vaccine technologies.
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Takeda Pharmaceutical partners with US biopharmaceutical company, TESARO, in deal worth up to $340 million to develop and commercialize PARP inhibitor.
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Regulatory News
The agency has developed a business continuity plan to ensure that the public’s health is protected during the agency’s relocation.
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The agency is asking for public consultation on the concept paper.
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OUTSOURCING
How has the bio/pharmaceutical contract manufacturing industry evolved over the years and what does the future hold?
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Events
August 15–16, 2017
August 16–17, 2017
August 21–25, 2017
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REFERENCE BOOKS |
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Pharmaceutical Technology Outsourcing Guide provides details behind recent partnerships, strategies for selecting an appropriate CDMO/CMO, and quality by design factors for outsourced operations.
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eBOOKS
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New technologies, including single-use systems, are leading the push for faster production and higher titers. At the same time, ensuring quality in raw materials and water systems, and controlling contamination are paramount. In this Biologics and Sterile Manufacturing eBook, the editors explore key technology, process, and operational topics. |
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