Sandoz sues FDA over delay in first biogeneric approval

Article Abstract:

Sandoz, the generic branch of Novartis of Basel, filed a lawsuit with the US District Court in September 2005 over the US Food and Drug Administration's (FDA) delay in approving Omnitrope, its follow-on version of recombinant human growth hormone (hGH). The case and its broader underlying issues could prove pivotal for the way FDA regulates follow-on protein products, biogenerics, as prominent Congress leaders see the need for new legislation covering the policy gap on such products.

United States, Product development, Legal issues & crime, Switzerland, Government regulation, CHEMICALS AND ALLIED PRODUCTS, Legal/Government Regulation, Company legal issue, Cases, Chemical industry, Licensing, certification and accreditation, United States. Food and Drug Administration, Pesticides industry, Herbicides, Drug approval, Sulphur industry, Sandoz Ltd., Omnitrope (Medication)

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Beer giant blindsides Ventria's pharmacrop

Article Abstract:

Ventria Bioscience, a Sacramento, California based biotech company scuttled plans for growing two of its genetically modified (GM) rice varieties in Southern Missouri after being blindsided by beer maker Anheuser-Busch. Ventria officials describe the decision as a minor setback that will not deter them from growing GM rice there in 2006.

Production management, California, Drugs, Rice, Rice Farming, Biotechnology industry, Biotechnology industries, Genetically modified crops

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Antivirals become a broader enterprise

Article Abstract:

The monoclonal antibodies (mAbs), nucleic acid therapies and biologics, are currently being tested in viral disease and the emphasis is broadening from virus targets to encompass targets within the host involved in immune responses or other virus-cell interaction.

Science & research, Research, Monoclonal antibodies, Immune response

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