Nov 17, 2009
By:Laura Bush
Following a five-week inspection of Genzyme's plant in Allston Landing, MA, the US Food and Drug Administration is still not satisfied with the company?s large-scale manufacturing of Lumizyme.
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Oct 12, 2009
By:Laura Bush
The Korean CMO Celltrion and Hospira, a small-molecule injectable generics and drug delivery company based in Lake Forest, IL, agree to co-market biosimilars developed by Celltrion.
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Oct 7, 2009
By:Laura Bush
Diminutive bacteria with the right geometry (i.e. very thin) may be useful for research and development work on sterilizing-grade and other 0.2 uM filters, said Kurt Brorson, PhD, a staff scientist for the FDA/CDER's Division of Monoclonal Antibodies.
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It seems clear that insuring the roughly 46 million Americans who are now uninsured will increase drug sales.
Oct 1, 2009
By:Laura Bush
It seems clear that insuring the roughly 46 million Americans who are now uninsured will increase drug sales.
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Sep 16, 2009
By:Laura Bush
The US Food and Drug Administration announced yesterday that it has approved four vaccines against the 2009(A)H1N1 (?swine?) influenza virus.
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Sep 11, 2009
By:Laura Bush
Lonza (Basel, Switzerland), broke ground earlier this week on a new cell therapy manufacturing facility in Tuas Biomedical Park, Singapore, adjacent to Lonza?s large-scale mammalian manufacturing facility.
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Sep 2, 2009
By:Laura Bush
Novavax (Rockville, MD) recently achieved positive Phase 2a results for its trivalent virus-like particle (VLP) vaccine against seasonal influenza, and positive preclinical results for a VLP vaccine against H1NI (swine) flu.
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If risk assessments only identify "the usual suspects," the process will not add much value.
Sep 1, 2009
By:Laura Bush
If risk assessments only identify "the usual suspects," the process will not add much value.
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ICH Q9 encourages companies to apply the concept of quality risk management. Easier said than done.
Sep 1, 2009
By:Laura Bush
ICH Q9 encourages companies to apply the concept of quality risk management. Easier said than done.
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