Another Australian Biotech Set to Enhance Millions of Lives as FDA Fast-Tracks Bronchitol.Pharmaxis Joins Growing List of Successful Australian Biotechs With Real Products Making a Real Difference SAN FRANCISCO San Francisco (săn frănsĭs`kō), city (1990 pop. 723,959), coextensive with San Francisco co., W Calif., on the tip of a peninsula between the Pacific Ocean and San Francisco Bay, which are connected by the strait known as the Golden -- The Australian Government's investment attraction agency, Invest Australia, today congratulated Australian pharmaceutical company Pharmaxis after it was granted FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. fast-track status for its cystic fibrosis cystic fibrosis (sĭs`tĭk fībrō`sĭs), inherited disorder of the exocrine glands (see gland), affecting children and young people; median survival is 25 years in females and 30 years in males. product Bronchitol. Phase II studies showed Bronchitol significantly improves lung function and wellbeing in patients with cystic fibrosis which affects approximately 75,000 people in the developed world, including 33,000 US patients and 2,500 Australians -- a fifth of whom are children under five years old. The FDA fast-tracks the New Drug Application (NDA (Non Disclosure Agreement) An agreement signed between two parties that have to disclose confidential information to each other in order to do business. In general, the NDA states why the information is being divulged and stipulates that it cannot be used for any ) process if a therapy can potentially address an unmet medical need for a life-threatening disease. There have been no treatment advances in over a decade and no products have previously been approved to improve lung hydration hydration /hy·dra·tion/ (hi-dra´shun) the absorption of or combination with water. hy·dra·tion n. 1. The addition of water to a chemical molecule without hydrolysis. 2. . The FDA recognizes the positive clinical data for Bronchitol in treating the lethally inherited condition of cystic fibrosis. Phase II studies show Bronchitol significantly improves lung function and well being in cystic fibrosis patients and Pharmaxis welcomes the opportunity to bring the product to the US market as rapidly as possible. Invest Australia's Senior Investment Commissioner for North America North America, third largest continent (1990 est. pop. 365,000,000), c.9,400,000 sq mi (24,346,000 sq km), the northern of the two continents of the Western Hemisphere. , Fred Welz, based in San Francisco, said Australia is a high-science and innovation region that has consistently delivered real products that change lives around the world. The most recent example is Gardasil, the revolutionary cervical cancer Cervical Cancer Definition Cervical cancer is a disease in which the cells of the cervix become abnormal and start to grow uncontrollably, forming tumors. vaccine developed in Australia by the University of Queensland's Professor Ian Frazer Ian Hector Frazer (born January 6, 1953) is an Australian immunologist, best known for his work on the development of a cervical cancer vaccine, which works by protecting women from Human papillomavirus (HPV). Frazer was born in Glasgow, Scotland. , CSL (Computerese as a Second Language) Said of people who love to speak high-tech words even though they often use them erroneously. See TLA. 1. CSL - Computer Structure Language. A computer hardware description language, written in BCPL. and Merck. The announcement by Pharmaxis is another good example of Australia's increasing abilities to take products to market. The Pharmaxis FDA fast-track status was announced at Australia's national biotech conference AusBiotech 2006 in November which was attended by a record number of international delegates, supported by a strong contingent of big pharma and US investors. To assist US companies in tapping this lucrative Australian biotech sector, the Australian Government also announced at the conference the launch of BioRegs Online. This web-based tool is designed to help the global biotech sector navigate and utilize Australia's biotechnology regulations to take a specific biotech product from concept to market -- saving both time and money. www.bioregs.gov.au About Invest Australia (www.investaustralia.gov.au) Invest Australia, the Australian Government's inward investment agency that helps companies build their business in Australia and offers investors with a free, comprehensive and confidential service. Between July 2002 and July 2006, Invest Australia played a verified role in attracting or facilitating 289 projects worth approximately A$42 billion, creating more than 21,000 jobs and generating A$8.1 billion in export earnings. Talk to one of our investment directors today by calling Tel: (415) 243-2068 or email: northamerica@investaustralia.gov.au. |
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