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May 17, 2011
FDA Issues Guidance on Bioequivalence Studies
Amy Ritter
FDA issued a new guidance for industry concerning the submission of summary bioequivalence data for abbreviated new drug applications.

FTC Finds 60% Increase in Pay-to-Delay Deals
Erik Greb
In fiscal year 2010, the number of patent settlements in which the manufacturers of branded products paid makers of generic drugs to postpone the introduction of their products reached its highest level ever, according to the Federal Trade Commission.

PhRMA Comments on USTR Report on Pharmaceutical Trade Practices
Patricia Van Arnum
The Office of the United States Trade Representative issued a report as part of its annual review of the global state of intellectual-property rights protection and enforcement.


Discovery Pipeline
Patterns and Intensity of Medical Therapy in Patients Undergoing Percutaneous Coronary Intervention
Recommendations for treatment of patients receiving a heart stent based on a high-profile clinical trial did not translate into changes in real-world clinical practice. (Journal of the American Medical Association)

Multiple Recognition Assay Reveals Prostasomes as Promising Plasma Biomarkers for Prostate Cancer
A possible alternative to the prostate-specific antigen (PSA) test for prostate cancer is explored, by the detection of prostasomes, vesicular structures that are normally confined to the seminal fluid, but which leak into the general circulation under cancerous conditions. (Proceedings of the National Academy of Sciences)

A Novel Tumor-Suppressor Function for the Notch Pathway in Myeloid Leukemia
Inactivation of the notch signaling pathway underlies some cases of myeloid leukemia, a blood cancer affecting children and adults. (Nature)

In Vivo Liver Regeneration Potential of Human Induced Pluripotent Stem Cells from Diverse Origins
Human induced pluripotent stem cells from different lineages are induced to differentiate into hepatic-like cells, and used to repopulate the liver in mice with liver cirrhosis. (Science Translational Medicine)


Company/People Notes
Almac, a contract development and manufacturing organization, launched selectAZyme, an offering of biocatalysts, including reductases, transaminases, hydrolases, and nitrilases. The offering also includes metabolite synthesis for oxidative and glycosylated products.
Precis Engineering is providing mechanical, electrical, plumbing, process engineering, and commissioning services for Morphotek's new $80-million, 60,000-ft2 manufacturing pilot plant currently under construction in Exton, Pennsylvania. The Morphotek facility will house a biologics plant, laboratories, a cGMP cell-culture core area, warehouse storage, and offices to support the company's production of biologics for early-stage clinical trials. The facility is scheduled to be completed in the spring 2011, and operations are slated to begin in 2012. Morphotek a biopharmaceutical subsidiary of Eisai.
CMC Biologics, a contract biopharmaceutical manufacturer, hired Claes Glassell as its CEO.
Pfizer CentreSource appointed Cristin B. Grove as director of global contract manufacturing. She most recently served as business development manager for Pfizer Global Supply.
Pharmaceutical Research and Manufacturers of America has named Rod Hunter as senior vice-president of international advocacy, effective June 10, 2011. Hunter will report to Chip Davis, executive vice-president of advocacy.

2009, Advanstar Communications, Inc.
224 Phillip Morris Drive, Suite 402
Salisbury, MD 21804


Biopharm International
The Magazine
Bioengineered Protein A Polymer Beads for High-Affinity Antibody Purification: The authors discuss an alternative to traditional Protein A resins
Read More
Coming soon!
The June issue of BioPharm International features a look at the top 1000 biopharmaceutical manufacturing facilities. www.BiopharmInternational.com

May 16-18: AAPS National Biotechnology Conference
San Francisco, CA

Registration details
May 23-26, 2011: 2011 PDA/FDA Glass Quality Conference & TRI Courses
Arlington, VA

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May 24-25, 2011: Developing and Validating a Cleaning and Disinfection Program for Controlled Environments
Bethesda, MD

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May 29-31, 2011: INTERPHEX Asia & ISPE Singapore

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June 27-30, 2011: BIO International Convention
Washington, DC

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Regional Business Consultants
St. Paul, MN

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