ePT--the Electronic Newsletter of Pharmaceutical Technology, May 17, 2012 - Pharmaceutical Technology

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ePT--the Electronic Newsletter of Pharmaceutical Technology, May 17, 2012
ICH Q11 Drug Substance Guideline Has Gained Global Approval
By Angie Drakulich
ICH Q11, the anticipated guideline from the International Conference on Harmonization, titled Development and Manufacture of Drug Substances, has achieved international consensus. Q11 has been one of the fastest guidelines to move through the ICH harmonization process.
GlaxoSmithKline Moves Forward with $2.6 Billion Offer for Human Genome Sciences
By Patricia Van Arnum
GlaxoSmithKline tenders offer of $13.00 per share in an unsolicited bid despite an earlier rejection by Human Genome Sciences.
US Senators Probe Links Between Opioid Manufacturers and Medical Groups
By Amy Ritter
Senators Max Baucus (D-MT) and Chuck Grassley (R-IA) send letters to opioid manufacturers and pain groups asking them to disclose financial ties.
CDER Ombudsman Releases Annual Report
By Susan Haigney
The Center for Drug Evaluation and Research Ombudsman's office released its annual report detailing the common questions and complaints received by the office in 2011. A total of 461 inquiries was received, an increase of 11% from 2010. The majority of inquiries, 60%, originated from industry, with consumers accounting for 23%, healthcare providers 7%, FDA employees 5%, and other 5%.
Big Pharma Bands with Academia in $23-Million Deal
By Stephanie Sutton
AstraZeneca, Boehringer Ingelheim, GlaxoSmithKline, Janssen Pharmaceutica NV, Merck Serono, and Pfizer have pledged support of more than £14 million ($23 million) to a translational drug development project being run by the UK's Medical Research Council and the University of Dundee.
Week of May 14, 2012: GSK Agrees to Acquire Cellzome; Patheon Restructures; and More
GSK Agrees to Acquire Cellzome; Patheon Restructures; and More.


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