Tag Archives: insulin

“When Genetic Engineering Came Of Age”

insulin

October 29 was the 30th anniversary of the approval by the Food and Drug Administration (FDA) of human insulin synthesized in genetically engineered bacteria. In an article for Forbes, Henry Miller, the founding director of the FDA’s Office of Biotechnology, marked the anniversary and commented on today’s regulatory environment: “Regulators have adopted a highly risk-averse and even adversarial mindset, few new drugs are approved without convening extramural advisory committees, and decisions are sometimes hijacked by Read More >

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BIO submits comments on Australian Senate Patent Amendment

The Australian Senate has proposed the Patent Amendment (Human Genes and Biological Materials) Bill 2010 that aims to ban ‘gene patents’.  From the BIO Submission to Australian Senate Legal Committee on Patent Amendment: This amendment would exclude from patent protection “any” biological material, whether a human gene or otherwise, that is substantially identical to a naturally-occuring biological material.  Specifically, the amendment states that the following materials would be catergorically declared unpatentable:             “biological materials including their components Read More >

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