ePT--the Electronic Newsletter of Pharmaceutical Technology, Dec 2, 2010 - Pharmaceutical Technology

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ePT--the Electronic Newsletter of Pharmaceutical Technology, Dec 2, 2010
News
Week of Nov. 29, 2010: Company and People Notes: Lonza Forms Agreements with Two Partners; Covance Makes Executive Appointments; and More.
Lonza Forms Agreements with Two Partners; Covance Makes Executive Appointments; and More.
Genzyme Meets Consent Decree Deadline
By Erik Greb
Genzyme (Cambridge, MA) officially ended fill?finish operations at its Allston Landing, Massachusetts, plant for products sold in the United States, thereby fulfilling a requirement of a US Food and Drug Administration consent decree.
GSK Plans UK-Based R&D and Manufacturing Investment
By Patricia Van Arnum
GlaxoSmithKline (GKS, London) outlined a plan to invest EUR 500 million ($649 million) in research and development (R&D) and related manufacturing in the United Kingdom conditioned on the successful implementation of a so-called "patent box" measure by the UK government.
Regulatory Roundup: EMA Publishes New Transparency Policy, Releases Guideline for Biosimilar mAbs.
EMA Publishes New Transparency Policy, Releases Guideline for Biosimilar mAbs.
FDA Issues New Guidance for Industry on ANDAs: Impurities in Drug Products
By Angie Drakulich
The US Food and Drug Administration issued late last week a new guidance for industry on impurities in drug products.
Survey Offers Mixed Results of FDA's Performance
By Patricia Van Arnum
PricewaterhouseCoopers (PwC) released the results of a survey that analyzed the relationship of life-science companies with the US Food and Drug Administration and their views of the agency.

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