ePT--the Electronic Newsletter of Pharmaceutical Technology, Mar 29, 2012 - Pharmaceutical Technology

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ePT--the Electronic Newsletter of Pharmaceutical Technology, Mar 29, 2012
News
Court Dismisses AstraZeneca's FDA Lawsuit
By Stephanie Sutton
A US court has denied AstraZeneca's request for a preliminary injunction against the FDA.
GlaxoSmithKline Plans Biopharmaceutical Manufacturing Investment in the UK
By Patricia Van Arnum
GlaxoSmithKline plans to invest more than £500 million ($798 million) in the United Kingdom across its manufacturing sites to increase production of key active ingredients for its pharmaceutical products and vaccines. The company announced selection of Ulverston in Cumbria as the location for the first new GSK manufacturing facility to be built in the UK for almost 40 years.
Waters, NIBRT Partner to Grow Knowledge of Large-Molecule Characterization
By Angie Drakulich
The National Institute for Bioprocessing Research and Training in Ireland and Waters are partnering on training and research to increase large-molecule characterization capacity and knowledge.
FDA Issues Warning Letter to IntelliCell Biosciences
By Amy Ritter
On Mar. 13, 2012, FDA issued a Warning Letter to Steven Victor, CEO of IntelliCell Biosciences for a violation of the Food, Drug, and Cosmetic Act, and for violations of cGMP and Good Tissue Practice in the manufacture of its adipose tissue-derived stem-cell product.
Europe Adopts Transparency Guideline
By Stephanie Sutton
The European Medicines Agency has released guidance that outlines a European-wide approach for dealing with transparency and access to information included in marketing authorization applications.
Week of Mar. 26, 2012: Catalent Completes UK Expansion; Novasep Opens New Facility in China; and More
Catalent Completes UK Expansion; Novasep Opens New Facility in China; and More.

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Eric Langerr Outsourcing Outlook Eric LangerTargeting Different Off-Shore Destinations
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerAsymmetric Synthesis Continues to Advance
Jill Wechsler Regulatory Watch Jill Wechsler Data Integrity Key to GMP Compliance
Sean Milmo European Regulatory WatchSean MilmoExtending the Scope of Pharmacovigilance Comes at a Price
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