“One cool judgment is worth a thousand hasty councils.”  W.Wilson

Monthly Archives: January 2013

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Approval of Kynamro

The January 2013 approval of Kynamro (mipomirsen) marks the first systemically administered antisense oligonucleotide to reach the market: http://www.fiercebiotech.com/story/fda-hands-sanofi-isis-approval-hofh-drug-kynamro/2013-01-29

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New FDA guidance documents issued

Two useful guidance documents were recently issued by FDA: 1) a final ICH guidance on Development and Manufacture of Drug Substances: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM261078.pdf and 2) a draft FDA guidance on Immunogencity Assessment for Therapeutic Protein Products: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM338856.pdf

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RNA therapeutics

RNA therapeutics are coming of age with the approval of mipomersen and multiple classes of RNAs in the clinic. Here is a nice overview: http://www.xconomy.com/san-diego/2013/02/08/rna-therapeutics-are-coming-of-age/2/