Analyze the Business Issues Related to Orphan Drugs in Asia.DUBLIN, Ireland -- Research and Markets (http://www.researchandmarkets.com/reports/c58292) has announced the addition of "Orphan Drugs in Asia: Guidelines and Regulatory Requirements to Help Orphan Drug Products Enter the Asian Market 2007" to their offering. Following the example of the US FDA's Orphan Drug Act established in 1983, some Asian nations have developed orphan drug legislation, such as Singapore's Orphan Drug Exemption to the Medicines Act and Japan's Orphan Drug Amendment to the Pharmaceutical Affairs Law. While orphan drug laws in Asia may provide benefits for companies registering new drugs, such as marketing exclusivity, an expedited registration process, and a reduction in the number of clinical trials required, each registration process is unique and can pose a variety of challenges. This report reviews the orphan drug regulations throughout Asia and discusses various business issues related to orphan drugs in Asia. Lists of approved orphan drugs in Asia and orphan drug associations are also included. Topics Covered I. Introduction II. Overview of Asia III. Orphan Drugs in Asia IV. Issues to Consider Prior to Orphan Drug Registration V. Japan VI. Taiwan VII. Korea VIII. Hong Kong IX. China X. Singapore XI. Southeast Asia Introduction XII. Philippines XIII. Malaysia XIV. Thailand XV. Vietnam XVI. Sales and Marketing of Orphan Drugs XVII. Conclusion Companies Mentioned - Actelion Pharmaceuticals - Amgen - Astellas Pharma Astellas Pharma Inc. (アステラス製薬株式会社 US - Axcan Scandipharm - Bausch & Lomb - Baxter - Bayer - Biogen IDEC Biogen Idec, Inc. (NASDAQ: BIIB) is a biotechnology company specializing in drugs for neurological disorders, autoimmune disorders and cancer. The company was formed in 2003 by the merger of Cambridge, Massachusetts-based Biogen and San Diego, California-based Idec - BioMarin - Boehringer Ingelheim - Bristol-Myers Squibb Bristol-Myers Squibb (NYSE: BMY), colloquially referred to as BMS, is a pharmaceutical corporation, formed by a 1989 merger between pharmaceutical companies Bristol-Myers Company, founded in 1887 by William McLaren Bristol and John Ripley Myers in Clinton, NY (both were - Celgene - Centocor - ChiRhoClin - CoTherix - Cumberland Pharmaceuticals - Dialysis Solutions - DynPort Vaccine - Eli Lilly Eli Lilly can refer to:
MGI Modular Gateway Interface MGI McKinsey Global Institute MGI Military Geographic Information MGI Marine Geological Institute MGI Policy on the Management of Government Information (Canada) CP - Millennium Pharmaceuticals Millennium Pharmaceuticals NASDAQ: MLNM is a biotechnology company based in the Cambridge, Massachusetts area of the United States of America. Founded in 1993, the company conducts research in various scientific areas, currently focusing on inflammation and oncology. - Mylan Bertek Pharmaceuticals - Novartis - Novo Nordisk - Nutritional Restart Pharmaceutical Hameln - Orphan Medical, Inc. - Pharmaceuticals - Pharmion - Presutti Laboratories - PTC (PTC, Needham, MA, www.ptc.com) Long a world leader in mechanical computer-aided design, manufacturing and engineering software, PTC, through acquisitions and reorganization, has transformed itself into a leading provider of Internet-based B2B solutions for discrete manufacturers. Therapeutics - Reckitt Benckiser Pharmaceuticals, Inc. - Romark Laboratories - Salix Pharmaceuticals - Sanofi-Synthelabo Research- Schering-Plough - Sensus - Serono Laboratories - Shire Human Genetic Therapies - Swedish Orphan AB - Tercica - United Therapeutics - Yamanouchi - Fujisawa - Tsumura - Fujisawa - Mitsubishi Pharmaceutical - Shionogi - Banyu Pharmaceutical Chugai For more information visit http://www.researchandmarkets.com/reports/c58292 |
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