18
Apr
2008
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 [...]
11
Apr
2008
Amgen: Denosumab, Part III
Posted in CO Pub Rel: Amgen
CLSDF has been paying particular attention to the clinical development of Amgen’s (NASDAQ: AMGN) Denosumab, a monoclonal antibody that targets RANK Ligand, the essential mediator of osteoclasts – the cells that break down bone (Read Part I HERE and Part II HERE). Now, pivotal Phase III data shows Denosumab increased bone density at multiple skeletal [...]
20
Mar
2008
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, [...]
12
Mar
2008
Most recently Amgen (NASDAQ: AMGN) announced the second successful Phase III trial for Denosumab (manufactured in Longmont, CO) osteoporosis study, which met all of its primary and secondary bone mineral density (BMD) endpoints in a head-to-head comparison with Merck’s (NYSE: MRK) Fosamax® in post menopausal women. Back in December of ‘07 CLSDF set the Amgen-Denosumab [...]
07
Jan
2008
Source MDx: And the Band Played On…
Posted in CO Private: Source MDx, CO Pub Rel: Amgen, CO Pub Rel: Celgene, CO Pub Rel: Pfizer
CLSDF previously highlighted Source MDx, read the post (here)…there is nothing hotter than incorporating validated biomarkers under the umbrella of personalized medicine and that is what continues to transpire at the Source MDx Boulder headquarters. An impressive list of partners and clients of Source MDx include Abbott Labs (NYSE: ABT), Amgen (NASDAQ: AMGN), Celgene (NASDAQ: [...]
17
Dec
2007
From my understanding Amgen (NASDAQ:AMGN) is manufacturing denosumab (AMG162) at the Longmont, CO facility and announced results from the first Phase III pivotal study of the monoclonal antibodies effect on bone density across the skeleton in women with non-metastatic breast cancer who were receiving adjuvant Aromatase Inhibitor therapy (AI’s lower the amount of estrogen in [...]
16
Oct
2007
Amgen (NASDAQ: AMGN) announced that the company has decided to postpone indefinitely its planned design and build-out of a bulk manufacturing facility in Cork, Ireland. Amgen has two manufacturing facilities in Boulder and Longmont, Colorado. Longmont is responsible for bulk manufacture of Epogen and Aranesp. Boulder manufactures Kineret, Kepivance and a number of product candidates [...]
08
Sep
2007
3 Commercialized Products & Counting!
Posted in CO Pub Rel: Amgen, CO Pub Rel: Merck, CO Pub Rel: OSI Pharma
QUESTION: What do ZostaVax®, Kineret® and Macugen® have in common… ANSWER: They are all FDA approved first-in-class commercialized products originating from University of Colorado intellectual property. Want to learn more about these products and the rich product pipeline portfolio at the University of Colorado? Then take a listen to this podcast featuring David Allen, Ph.D., [...]
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