ePT--the Electronic Newsletter of Pharmaceutical Technology, Feb 16, 2012 - Pharmaceutical Technology

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ePT--the Electronic Newsletter of Pharmaceutical Technology, Feb 16, 2012
News
White House's 2013 Budget Includes FDA Increases
By Susan Haigney
President Barack Obama released his budget proposal for fiscal year 2013. Included in the proposed budget is a $654-million increase in FDA funding, for a total FDA budget request of $4.49 billion.
FDA Releases Draft Guidance on Monitoring Crude Heparin for Quality
By Amy Ritter
FDA has released a draft guidance for API manufacturers in response to a 2008 incident in which heparin sourced from China was adulterated with oversulfated chondroitin sulfate, causing serious adverse reactions in patients.
South Africa Plans Joint Venture for New API Plant
By Stephanie Sutton
The South African government is involved in talks with the Swiss biopharmaceutical company Lonza regarding a joint venture to construct the country's first plant to manufacture APIs for antiretroviral medicines.
Week of Feb. 13, 2012: Alexion Completes Acquisition of Enobia Pharma; BMS Completes Acquisition of Inhibitex; and More
Alexion Completes Acquisition of Enobia Pharma; BMS Completes Acquisition of Inhibitex; and More.
Regulatory Roundup: EMA Releases Genetic Variability Guideline
EMA Releases Genetic Variability Guideline.

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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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