ePT--the Electronic Newsletter of Pharmaceutical Technology, May 12, 2011 - Pharmaceutical Technology

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ePT--the Electronic Newsletter of Pharmaceutical Technology, May 12, 2011
News
FTC Finds 60% Increase in Pay-to-Delay Deals
By Erik Greb
In fiscal year 2010, the number of patent settlements in which the manufacturers of branded products paid makers of generic drugs to postpone the introduction of their products reached its highest level ever, according to the Federal Trade Commission.
FDA Issues Guidance on Bioequivalence Studies
By Amy Ritter
FDA issued a new guidance for industry concerning the submission of summary bioequivalence data for abbreviated new drug applications.
Alkermes Snaps up Elan Drug Technologies
By Stephanie Sutton
Alkermes purchased Elan?s Elan Drug Technologies (EDT) unit in a cash and stock transaction worth approximately $960 million. The two companies will be merged into a new holding company in Ireland under the name Alkermes.
PhRMA Comments on USTR Report on Pharmaceutical Trade Practices
By Patricia Van Arnum
The Office of the United States Trade Representative issued a report as part of its annual review of the global state of intellectual-property rights protection and enforcement.
Week of May 12, 2011: Company and People Notes: INC Research agrees to acquire Kendle; CMC Biologics hires Claes Glassell as CEO; and More.
INC Research agrees to acquire Kendle; CMC Biologics hires Claes Glassell as CEO; and More.
Regulatory Roundup: FDA asking for input on the development of a user-fee program for biosimilar and interchangeable biological product applications
FDA is asking for input on the development of a user-fee program for biosimilar and interchangeable biological product applications.

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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
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