Science is Beautiful Blog

RNAI – A Very “Mello” Subject

Posted by John Kouten, CEO

Apr 29, 2011 2:26:00 PM

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Topics: biotechnology and medical technology companies, personalized medicine, genomics, drug development, Medical device and diagnostics companies, RNAI

FY 2012 Budgets takes Aim at Patent Exclusivity for Biologics

Posted by John Kouten, CEO

Feb 23, 2011 5:48:00 PM

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Topics: US pharmaceutical market, biotechnology and medical technology companies, drug development, biosimilars, patent exclusivity

Healthcare Reform and Pharmaceutical Marketers – Sweethearts?

Posted by John Kouten, CEO

Feb 14, 2011 2:14:00 PM

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Topics: Healthcare communications, healthcare public relations, US pharmaceutical market, biotechnology and medical technology companies, personalized medicine, JFK Communications, healthcare reform

FDA Speak: Complex Molecules Are Not Biologics

Posted by John Kouten, CEO

Jul 26, 2010 2:47:00 PM

Could the recent FDA approval of a generic version of Lovenox (enoxaparin) be the beginning of approvals of other complex molecules?  We recall that the Biologics Price Competition and Innovation Act of 2009 found its way into the Health reform bill.  The Biologics Act provides a pathway for biosimilars, however, grants biologics innovator companies 12-years patent exclusivity (http://tiny.cc/ymnj1).   While biologics currently reside outside the current generics approval processes, it seems that “complex molecules” like enoxaparin do not.  The developers of the generic enoxaparin, Sandoz, division of Novartis, are hoping to win approval next for a generic version of the “complex mixture” Copaxone for the treatment of multiple sclerosis.  For more details on FDA’s position visit: http://tiny.cc/fvvve.  For more information regarding Sanofi’s position, read their July 23 statement here:  http://tiny.cc/zgib3.

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Topics: biotechnology and medical technology companies, FDA, JFK Communications, biosimilars

Will Media Report how Ted Kennedy’s Life was Extended through Improved Technology to Fight Brain Cancer? Probably Not

Posted by John Kouten, CEO

Aug 26, 2009 4:47:00 PM

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Topics: Healthcare communications, healthcare public relations, issues management, US pharmaceutical market, biotechnology and medical technology companies, media relations, healthcare reform, global oncology market

Biosimilars: High on Obama’s Agenda

Posted by John Kouten, CEO

Jun 19, 2009 4:39:00 PM

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Topics: US pharmaceutical market, biotechnology and medical technology companies, biosimilars

 

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