Articles by Amy Ritter, PhD - BioPharm International

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Articles by Amy Ritter, PhD

Takeda Completes Acquisition of URL Pharma

Jun 6, 2012

Takeda Pharmaceuticals announced that it has completed the acquisition of URL Pharma for an upfront payment of $800 million.

25 Years of Protein Expression

Charles H. Squires of Pfenex discusses advances in expression platform solutions.
Jun 1, 2012

Charles H. Squires of Pfenex discusses advances in expression platform solutions.

25 Years of Nanoparticles: A Look Forward

Panayiotis P. Constantinides of Biopharmaceutical & Drug Delivery Consulting on growth of nanoparticle delivery systems.
Jun 1, 2012

Panayiotis P. Constantinides of Biopharmaceutical & Drug Delivery Consulting on growth of nanoparticle delivery systems.

US Marshals Seize Unapproved Drug From Crescendo Therapeutics

May 30, 2012

Federal marshals seized an unapproved topical corticosteroid medication from California-based Crescendo Therapeutics.

Osiris Therapeutics Announces the World's First Approval of a Stem Cell Therapy

May 30, 2012

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.

US Senators Probe Links Between Opiod Manufacturers and Medical Groups

May 16, 2012

Senators Max Baucus (D-Mont.) and Chuck Grassley (R-Iowa) send letters to opoid manufacturers and pain groups asking them to disclose financial ties.

Institute of Medicine Releases Report on Studying the Safety of Approved Drugs

May 2, 2012

At the request of FDA, the IOM prepared a report containing recommendations for how FDA might better monitor the safety of drugs after they have been approved.

Choosing an Expression System

A Q&A with Alan Shaw of Vaxinnate. This article is part of a special section on expression systems.
May 1, 2012

A Q&A with Alan Shaw of Vaxinnate. This article is part of a special section on expression systems.

FDA Issues Final Guidance for Media Fills for Validation of Aseptic Preparations for PET Drugs

Apr 17, 2012

FDA has released a final guidance describing cGMP for preparing media fills for validation of aseptic preparations for positron emission tomography (PET) drugs. Most PET drugs, which are used for imaging, are given parenterally, and produced by aseptic processing. PET drugs came under the auspices of FDA relatively recently, with the passage of the 1997 Food and Drug Administration Modernization Act, and minimum cGMP standards for this class of drugs were established in 2009. A guidance for preparing new drug applications and abbreviated new drug applications for PET drugs was issued in March 2011, and in comments to the March 2011 guidance and in questions raised at the public meeting, stakeholders requested that FDA provide guidance on media fills for validation of aseptic preparation for PET drugs. This most recent guidance is designed to help manufacturers of PET drugs comply with FDA regulations.

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