Nov 13, 2009
By:
Haydia Haniff
The FDA and Genzyme have notified healthcare professionals about the potential for foreign particle contamination of several Genzyme products: Cerezyme, Fabrazyme, Myozyme, and Thyrogen, which are supplied as lyophilized powders requiring reconstitution before administration; and Aldurazyme, which is supplied as a liquid solution. The foreign particles include stainless steel fragments, non-latex rubber from the vial stopper, and fiber-like material from the manufacturing process, and could potentially cause serious adverse events in patients.
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Oct 15, 2009
By:
Haydia Haniff
In keeping with the growing trend of iPhone applications for every conceivable convenience, DASGIP AG (Juelich, Germany), a provider of parallel bioreactor systems at benchtop scale, has launched an iPhone application for accessing bioprocesses online.
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Oct 7, 2009
By:
Haydia Haniff
New heparin standards recently adopted by the United States Pharmacopeia (USP) include new tests to ensure the quality of the drug.
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Aug 20, 2009
By:
Haydia Haniff
A new vaccine for norovirus has been produced in tobacco plants, a scientist reported on August 18 at the national meeting of the American Chemical Society in Washington DC.
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Aug 12, 2009
By:
Haydia Haniff
FDA Acting Commissioner Margaret Hamburg outlined six steps to improve FDA enforcement in a speech given on August 6, eight weeks into her tenure.
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Aug 12, 2009
By:
Haydia Haniff
Millipore Corporation (Billerica, MA) has filed a lawsuit in the US District Court for the District of Massachusetts against W.L. Gore & Associates for infringement of Millipore's patent rights under US Patent No. 7,293,477, "Disposable, Pre-Sterilized Fluid Receptacle Sampling Device."
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Aug 4, 2009
By:
Haydia Haniff
The US FDA has approved Genentech's Avastin (bevacizumab) plus interferon-alfa for people with metastatic renal cell carcinoma, the most common type of kidney cancer.
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Nov 14, 2008
By:
Haydia Haniff
The US Food and Drug Administration (FDA) has awarded the National Institute for Pharmaceutical Technology and Education (NIPTE, West Lafayette, IN) a contract to develop the science behind Quality by Design (QbD) and design space specifications
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Nov 14, 2008
By:
Haydia Haniff
A major problem in personalized medicine has been scale-up.
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