ePT--the Electronic Newsletter of Pharmaceutical Technology, Mar 8, 2012 - Pharmaceutical Technology

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ePT--the Electronic Newsletter of Pharmaceutical Technology, Mar 8, 2012
News
FDA Issues Guidance Agenda for 2012
By Angie Drakulich
FDA has issued a list of planned draft and final guidance documents for release throughout 2012. There are approximately 50 such guidances planned.
GSK and Daiichi Sankyo Launch Vaccine Venture in Japan
By Stephanie Sutton
GlaxoSmithKline and Daiichi Sankyo have formed a joint venture that they claim will create the biggest vaccines company in Japan. The joint venture will seek to improve access to vaccinations in the Asian nation as well as introduce new vaccines.
BI Expands Biomanufacturing Capacity in Europe
By Amy Ritter
Boehringer Ingelheim (BI) has announced the expansion of its biopharmaceutical manufacturing capabilities at its plants in Biberach, Germany and in Vienna, Austria. The expansion will include cell-culture and microbial-fermentation capacity, and support cell-line and process-development services for BI's contract manufacturing business.
SOCMA Issues Support for Generic-Drug User Fees
By Patricia Van Arnum
The Bulk Pharmaceuticals Task Force, an affiliate of the Society of Chemical Manufacturers and Affiliates (SOCMA), issued its support for the introduction of a House bill, the Generic Drug and Biosimilar User Fee Act (HR 3988), which SOCMA says will help to achieve parity between foreign and domestic firms.
Week of Mar. 5, 2012: BASi Restructures; Celerion, Ricerca Biosciences Form Biosimilars Alliance; and More
BASi Restructures; Celerion, Ricerca Biosciences Form Biosimilars Alliance; and More.

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Jim Miller Outsourcing Outlook Jim MillerCMO Industry Thins Out
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerFluorination Remains Key Challenge in API Synthesis
Marilyn E. Morris Guest EditorialMarilyn E. MorrisBolstering Graduate Education and Research Programs
Jill Wechsler Regulatory Watch Jill Wechsler Biopharma Manufacturers Respond to Ebola Crisis
Sean Milmo European Regulatory WatchSean MilmoHarmonizing Marketing Approval of Generic Drugs in Europe
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