Insmed (Nasdaq: INSM) provided a status update on their development program. After recently receiving approval form the UK Medicines and Healthcare Regulatory Agency to initiate a clinical trial for INS-19 [a follow-on biologic of Amgen’s (Nasdaq: AMGN) Neupogen®] patient screening has begun and the first dosing is expected next month with similarity data to be [...]

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An important milestone for Insmed (NASDAQ: INSM), developer of follow-on biologics and biopharmaceuticals, was achieved in the form of approval from the UK’s Medicines and Healthcare products Regulatory Agency to initiate their first clinical study for INS-19, a follow-on biologic product candidate. INS-19, is a recombinant form of human G-CSF, is a follow-on biologic of [...]

• 375http://clsdf.com/2008/04/insmed-gets-first-fob-clinical-study-greenlight/Insmed+Gets+First+FOB+Clinical+Study+Greenlight%212008-04-18+14%3A14%3A00admin

It is often a challenging path to be first to market. Insmed (NASDAQ: INSM) is blazing that trail via their aim to be the first US-based biotechnology company to develop a comprehensive portfolio of Follow-on Biologics (FOBs). From my understanding, one such challenge the company faces is that no regulatory pathway currently exists for FOBs, [...]

• 349http://clsdf.com/2008/03/insmed-a-going-concern%e2%80%a6/Insmed%3A+A+Going+Concern%E2%80%A62008-03-20+14%3A43%3A00admin

Another question for today…What do Amgen (NASDAQ: AMGN) and Roche (VTX: ROG.VX) have in common with Richmond, VA-based Insmed (NASDAQ: INSM) and Columbia, MD-based Martek Biosciences (NASDAQ: MATK)? Answer…they too have their state-of-the-art FDA-approved biologic commercial manufacturing facilities in Boulder. I find it interesting how Colorado is emerging as an unambiguous center of excellence in [...]

• 281http://clsdf.com/2007/12/insmed-and-colorado-manufacturing/Insmed+and+Colorado+Manufacturing2007-12-21+03%3A55%3A00admin