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Bioanalytical Focus Group
The AAPS Annual meeting for 2011 will be held in Washington DC from 23-27 October. Efforts towards developing the program have been initiated. The Bioanalytical Focus Group leadership is seeking ideas and suggestions for developing an informative and relevant program. Members of this group have always actively contributed to the BFG programming efforts and we are looking to you again for excellent program suggestions for the 2011 meeting that fit as Symposium, Roundtable or Open Forum sessions.
Please send vie e-mail (mark.arnold@bms.com) your programming suggestions no later than 30-June-2010 so that they may be compiled and reviewed by the BFG Steering Committee.
Bioanalytical Focus Group Homepage
http://www.aapspharmaceutica.com/inside/focus_groups/Bioanaly/index.asp |
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EMA Draft Guidance - Validation of Bioanalytical Methods
The European Medical Agency (EMA), Committee for Medicinal Products for Human Use (CHMP), has iissued a draft guideline on validation of bioanalytical methods - http://www.ema.europa.eu/pdfs/human/ewp/19221709en.pdf |
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Agilent Technologies Completes $1.5 Billion Acquisition Of Varian Inc.
The AP (5/15) reported that on May 14, Agilent Technologies Inc. announced that "it had completed its $1.5 billion all-cash acquisition of Varian Inc.," a deal in the works since July 2009. At the start of this year, "Agilent won approval from European Union regulators for the deal, on the condition that it must sell off units from both companies to eliminate antitrust worries." In March, Bruker Corp. announced that it would purchase "Varian's Australia-based inductively coupled plasma mass spectrometry instruments business, its Netherlands-based laboratory gas chromatography instruments business, and its California-based gas chromatography triple-quadrupole mass spectrometry instruments business." |
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Biosimilar Development Said To Be More Difficult Than Generic Endeavors.
The Wall Street Journal (5/17, Gryta) reports that Merck & Co.'s decision to end its effort to copy Amgen Inc.'s Aranesp (darbepoetin alfa) anemia drug may highlight the difficulties drugmakers face when developing biosimilars. The FDA is asking some companies to conduct extensive clinical trials, which increases the risk and may limit the industry to only the largest drug companies, the Journal notes. In addition, biosimilars will likely have their own brands and not be automatically substitutable for biotechnology therapies, as opposed to traditional generics, which can earn the majority of market share in months. |
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