ePT--the Electronic Newsletter of Pharmaceutical Technology, May 31, 2012 - Pharmaceutical Technology

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ePT--the Electronic Newsletter of Pharmaceutical Technology, May 31, 2012
News
Industry Comments on Senate Passage of PDUFA V
By Angie Drakulich
The Pharmaceutical Research and Manufacturers of America and Biotechnology Industry Organization released statements last week regarding the Senate's vote to pass the Food and Drug Administration Safety and Innovation Act, which reauthorizes PDUFA.
Osiris Therapeutics Announces the World's First Approval of a Stem Cell Therapy
By Amy Ritter
Osiris Therapeutics announced that it received marketing authorization from Health Canada to market its stem cell therapy, Prochymal, for the treatment of graft-versus-host disease in children.
USP Further Strengthens Heparin Standards
By Jo Watts
The US Pharmacopeia has issued a third round of improvements to its blood thinner standard.
US Marshalls Seize Unapproved Drug From Crescendo Therapeutics
By Amy Ritter
Federal marshals seized an unapproved topical corticosteroid medication from California-based Crescendo Therapeutics.
Week of May 28, 2012: Astra Zeneca, GlaxoSmithKline Enter into Antibiotics Pact; Takeda to Acquire Multilab; and More
Astra Zeneca, GlaxoSmithKline Enter into Antibiotics Pact; Takeda to Acquire Multilab; and More.

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FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
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Eric Langerr Outsourcing Outlook Eric LangerTargeting Different Off-Shore Destinations
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerAsymmetric Synthesis Continues to Advance
Jill Wechsler Regulatory Watch Jill Wechsler Data Integrity Key to GMP Compliance
Sean Milmo European Regulatory WatchSean MilmoExtending the Scope of Pharmacovigilance Comes at a Price
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