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Top Stories
Industry investment and regulatory support combined to move many important new medicines to market.
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The company is set to expand biologics and fill/finish capacity at its biologics manufacturing sites in Madison, WI, and Bloomington, IN.
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Exclusive Interview from AAPS
Developing New Technologies in Controlled Release
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Industry News
Sun Pharmaceutical Industries, Inc. is recalling lots of Vecuronium Bromide for Injection because of glass particulates.
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The National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) revealed 22 new projects and funding aimed to advance US biopharmaceutical manufacturing.
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Supplier News
The company will invest $4 million to increase topical and transdermal formulation development and testing services at its Durham, NC, facility.
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Fujifilm increases capacity of its Bio-CDMO business with an expansion of production in North Carolina facilities.
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Bio/Pharma News
The companies will collaborate to improve the manufacturability for two of Sanofi’s biotherapeutics.
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Agenus will leverage Selexis’ SUREtechnology Platform to progress Agenus’ portfolio of next-generation antibody programs.
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Regulatory News
The plan details five goals to guide the development of Sentinel, a national electronic system for medical product safety surveillance established as part of the FDA Amendments Act of 2007, over the next five years.
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The revised guidance aims to strengthen the agency’s global approach to develop new antibacterial medicines.
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QUALITY SYSTEMS
Success depends on supplier communication and transparency, but it’s up to buyers to demand the right information and to look at the vendor’s overall business goals.
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MANUFACTURING
Drug and adhesive formulation are crucial to the development of microneedle patches for pharmaceutical transdermal delivery systems.
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EU REGULATORY WATCH
EMA’s relocation to Amsterdam and resulting staff losses could severely weaken the agency’s role as a leading medicines regulator.
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Events
March 3–6, 2019
March 11–13, 2019
March 17–21, 2019
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eBOOKS
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The editors explore new tools for bio/pharma lab studies—such as robotics, augmented reality, and advanced instrumentation—as well as best practices for method development, multiple attribute monitoring, lab mixers, and raw material testing. |
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