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Top Stories
The collaboration will evaluate the combination of BMS' Opdivo immunotherapy with an investigational antibody drug conjugate in development by AbbVie.
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FDA participated in a global operation to combat the sale and distribution of unapproved and illegal drugs.
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Industry News
Biopharmaceutical companies developing new competitive biotech therapies have pressed hard for clarity on the testing and data required by FDA to gain market approval of biosimilars that can be filled by a pharmacist without prescriber preapproval.
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Validation and batch testing failures were among the violations found by the FDA at the company's Jiangsu facility.
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Please take a moment to participate in the Quality Management Priorities and Goals Survey. First 50 respondents receive a $5 gift card – All respondents can enter to win one of two $150 gift cards.
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Supplier News
MilliporeSigma announced the opening of its first end-to-end biodevelopment center in the Asia Pacific (APAC) region.
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Eurofins Scientific has announced an agreement to acquire EAG Laboratories to expand its reach in North America.
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Bio/Pharma News
This latest FDA approval expands the blockbuster anti-cancer biologic's indications in oncology.
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Under this partnership, Johnson & Johnson and BARDA will focus on the advanced development of a small-molecule drug and vaccine for the pandemic flu.
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Regulatory News
The agency sent out 13 warning letters on Sept. 19, 2017 to companies selling drug products online.
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Manufacturing
Innovative new technologies released over the past several months seek to enhance bio/pharmaceutical development and manufacturing.
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Analytics
Forced degradation studies can identify stability problems for drug substance and drug products.
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New Products and Services
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Contec, Inc. is a leading manufacturer of contamination control products for mission-critical cleaning in manufacturing environments worldwide.
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Emergent provides contract manufacturing services for the aseptic fill/finish of vials and syringes: liquid and lyophilized products.
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Eppendorf is a leading life-science company that develops and sells instruments, consumables, and services for liquid-, sample-, and cell handling.
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The Parenteral Drug Association (PDA) is the leading global provider of science, technology, and regulatory information and education for the pharmaceutical and biopharmaceutical community.
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Ross Bow Tie Dispersers, or High Viscosity Dispersers, are heavy-duty mixers designed for heavy pastes and viscous liquids up to several hundred thousand centipoise, with stainless steel 304 wetted parts.
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VAI's manufacturing and testing operations mirror current GMP/GLP standards.
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Events
October 16–17, 2017
October 19–20, 2017
October 23–24, 2017
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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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