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Biotech News International news Biotechnology news from around the world. |
- AstraZeneca invest with CAT for inflammatory diseases
- Nucleonics licence Apath technology for RNAi therapeutic
- Tissue banks get FDA regulations
- WHO approves first international standard for common genetic test
AstraZeneca invest with CAT for inflammatory diseases
November 22 – AstraZeneca has entered into a five-year research and development alliance with UK-based Cambridge Antibody Technology in inflammatory diseases. AstraZeneca has made a US$140 million equity investment for an issue of over 10.2 million shares in CAT, representing a 19.9 per cent shareholding. The companies will initiate a minimum of 25 jointly funded programs during the five-year period. CAT will be responsible for antibody discovery, manufacturing processes and the supply of materials for clinical trials. AstraZeneca will lead the associated clinical development programs, regulatory filing and commercialisation.
[Source: Company Announcement]
Nucleonics licence Apath technology for RNAi therapeutic
November 17 – Nucleonics has received a non-exclusive licence to Apath technology related to the 3' non-translated region of the Hepatitis C viral genome. Nucleonics is using this as a target in its development of an expressed RNAi therapeutic against Hepatitis C. Financial details of the licence agreement were not disclosed.
[Source: Company Announcement]
Tissue banks get FDA regulations
November 18 – The FDA will enforce regulations on tissue banks in the United States to meet federal safety standards for the collection and processing of donated skin, ligaments and bones for transplant. Some US States currently regulate tissue banks, however until now there have been no federal rules. The standards to take effect in May 2005 are the last of three stage implementation process to regulate the tissue bank industry. In January 2004, the FDA required tissue banks to register with the FDA for regular inspections and in May 2004 ordered compulsory screening for all tissue donors and samples to undergo screening for diseases such as HIV, hepatitis B and C, syphilis and Creutzfeldt-Jakob disease. The new regulations also prohibit pooling of tissues from multiple donors and regulate testing procedures to prohibit clean tissue recovery on tissue that has failed a primary test.
[Source: Associated Press]
WHO approves first international standard for common genetic test
November 17 – The first international standard for a human genetic test was approved by the World Health Organisation in order to improve the accuracy and quality of laboratory results worldwide. The frequently used genetic test identifies a genetic predisposition to venous thrombosis (blood clotting) by the presence of a genetic mutation known as Factor V Leiden. The mutation occurs in 20-40 per cent of all cases and has been shown to result in a seven-fold to 80-fold higher risk of thrombosis depending on whether the patient carries one or two copies of the defective gene. The standard was developed by the National Institute for Biological Standards and Control in the UK and approved for international use by the WHO Expert Committee on Biological Standardisation. The WHO ECBS will likely approve standards for other genetic tests to further improve DNA-based disease diagnosis and management.
[Source: WHO Media Release]
