ePT--the Electronic Newsletter of Pharmaceutical Technology, Jun 7, 2012 - Pharmaceutical Technology

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ePT--the Electronic Newsletter of Pharmaceutical Technology, Jun 7, 2012
News
Takeda Completes Acquisition of URL Pharma
By Amy Ritter
Takeda Pharmaceuticals announced that it has completed the acquisition of URL Pharma for an upfront payment of $800 million.
ISPE Issues Change-Management Guide
By Patricia Van Arnum
New guide outlines potential product life-cycle approaches to the change-management system of a pharmaceutical quality system.
USP Issues Change to Viscosity Reference in Monographs
By Susan Haigney
The United States Pharmacopeia has stated that references to General Chapter <911> "Viscosity" will be changed to General Chapter <911> "Viscosity—Capillary Viscometer Methods," <912> "Rotational Rheometer Methods," or <913> "Rolling Ball Viscometer Method."
Dr. Reddy's and Merck Serono Team Up on Biosimilars
By Stephanie Sutton
Dr. Reddy's Laboratories and Merck Serono, a division of Merck KGaA, have partnered to codevelop a portfolio of biosimilar compounds in oncology.
EMA Pharmacovigilance Legislation to Take Effect; New Q&A Document Offers Practical Guidance to Industry
By Jo Watts
In July 2012, new pharmacovigilance legislation will come into effect across the EU as a result of changes adopted in 2010, specifically EU Regulation No. 1235 and Directive 84.
Week of June 4, 2012: Catalent Expands Fill–Finish Capabilities; Siegfried Acquires Alliance Medical Products; and More
Catalent Expands Fill–Finish Capabilities; Siegfried Acquires Alliance Medical Products; and More.

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FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
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Jim Miller Outsourcing Outlook Jim Miller Health Systems Raise the Bar on Reimbursing New Drugs
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerThe Mainstreaming of Continuous Flow API Synthesis
Jill Wechsler Regulatory Watch Jill Wechsler Industry Seeks Clearer Standards for Track and Trace
Siegfried Schmitt Ask the Expert Siegfried SchmittData Integrity
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