ePT--the Electronic Newsletter of Pharmaceutical Technology, Dec 27, 2012 - Pharmaceutical Technology

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ePT--the Electronic Newsletter of Pharmaceutical Technology, Dec 27, 2012
News
Amgen Settles False Claims Act Allegations
By Amy Ritter
Amgen has agreed to pay $762 million to resolve criminal liability and false claims act allegations.
FDA Issues Final Guidance on Limiting the Use of Certain Phthalates as Excipients
By Patricia Van Arnum
The agency recommends to avoid the use of to dibutyl phthalate and di(2-ethylhexyl) phthalate in CDER-regulated drug and biologic products, including prescription and nonprescription products.
FDA Approves First Anthrax Antitoxin
By Amy Ritter
Anthrax antitoxin is the first monoclonal antibody approved under FDA's Animal Efficacy Rule, and the first product from BARDA's Project Bioshield to receive FDA approval.
First Commercially-Available Mycoplasma Detection Test Accepted by FDA
By Adeline Siew, PhD
Roche's MycoTOOL, which offers rapid detection of mycoplasms based on a polymerase chain reaction (PCR) test, has received FDA acceptance.
University of Connecticut Studies Drug-Carrying Nanoparticles
By Jennifer Markarian
A University of Connecticut chemical engineering professor received a National Science Foundation grant to study how nanoparticles flow in the bloodstream, which is crucial for their use in drug delivery.
Week of December 24, 2012: AAIPharma Expands Parenteral Drug Capacity; Novartis Buys Dendreon Plant; and More
AAIPharma Expands Parenteral Drug Capacity; Novartis Buys Dendreon Plant; 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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