New IGF drug stirs competition in growth factor segment

Article Abstract:

The US Food and Drug Administration (FDA) in 2005 approved Tercica's Increlex recombinant human IGF-1 as a long-term treatment for children with severe primary IGF-1 deficiency (IGFD) as it is the principal mediator of both cartilage and bone growth in the body. A deficiency of IGF-1 results in impaired growth and is associated with metabolic abnormalities including insulin resistance, increased adiposity and delayed wound healing.

Care and treatment, Licensing, certification and accreditation, Insulin-like growth factor 1, Insulin-like growth factor I, Stature, Short, Short stature, Tercica Inc., Increlex (Medication)

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Nature biotechnology: Lost in validation

Article Abstract:

The pharmaceutical industry has seen an increase in molecular diagnostics and pharmacogenetic test disease-associated molecular markers, but only a handful of diagnostic tests have passed approval by regulatory agencies. The absence of established, standardized means for validating the association between a marker and clinical outcomes is cited as the cause for such situation.

Legal issues & crime, Government regulation (cont), Legal/Government Regulation, Laws, regulations and rules, Government regulation, Biological markers

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A family of phosphodiesterase inhibitors discovered by cocrystallography and scaffold-based drug design

Article Abstract:

A family of potent phophodiesterases (PDE) 4 inhibitors discovered using an efficient method for scaffold-based drug design is described. It involves an iteration approach starting with low-affinity screening of compounds followed by high-throughput cocrystallography to reveal the molecular basis underlying the activity of the newly identified compounds.

Science & research, Research, Usage, Crystallography, Phosphodiesterases

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