News in brief

Published: 1-Apr-2003


•NuGenesis Technologies and Foss NIRSystems, the market leader in pharmaceutical NIR analysis, have integrated some of their technology features. This provides customers using the NuGenesis Scientific Data Management System (SDMS) and Foss NIR Analysers with enhanced automated software tools for secure data archival, retrieval and reuse.

•EU guidelines on checking the effectiveness of NIR spectroscopy methods used to identify pharmaceutical substances have been drawn up by EMEA's Committee for Proprietary Medicinal Products and Committee for Veterinary Medicinal Products. The guidelines include notes on the validation of the data produced through these methods.

•Indian pharma company Lupin is to set up a new plant for manufacturing lovastatin, the cholesterol-lowering API. The plant is being built to meet US FDA standards and will have an initial capacity of more than 12 t/yr. It will be built near the company's existing facilities in Tarapur, Maharashtra state, and the company is expected to invest Rupees 100m (US$2.09m) in the plant.

•An EC advisory group has criticised biotechnology companies that advertise genetic tests on the Internet, offering web-surfers the chance to check paternity of children and their predisposition to some diseases. The European Group on Ethics in Science and New Technologies has released a statement saying that the 'mass marketing of genetic tests raises several serious problems in ethical, social and legal terms.'

It added: 'The information currently being offered is likely to be misleading and incomplete, particularly in view of the limited level of predictability of diseases linked to test results.'

•The Committee for Proprietary Medicinal Products (CPMP), the scientific advisory body of the European Medicines Evaluation Agency (EMEA), has requested more clinical information relating to Biogen's application for Amevive (alefacept) for psoriasis. The US-based biotechnology company has withdrawn its application and plans to develop the additional clinical information necessary to obtain approval of Amevive for psoriasis patients in Europe. Developing the data and refiling the application could take several years.

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