The Asia Corner - From the Editors of PharmAsia News April 21, 2009
In this BioPharma Today feature, the editors of PharmAsia News take a closer look each week at the most important biopharma developments from China, India, Japan, and the Pacific Rim. Read today's features...
MUMBAI – Emerging from its usually slow process of patent examinations, the Indian Patent office has swiftly started clearing the backlog of pending applications filed by multinational drug companies. Roche successfully defended its hepatitis drug Pegasys against post-grant oppositions filed by Indian drug maker Wockhardt and Sankalp Rehabilitation Trust, a non-government organization based in the city. But Pfizer, Novartis and Gilead faced disappointment in getting patent clearances on their drugs (PharmAsia News, April 17, 2009).
U.S. FDA’s scrutiny seems to have intensified on Indian drug makers. After closely investigating the manufacturing processes of Ranbaxy and Lupin last year, it is now Cipla that is undergoing a thorough investigation by the drug regulator. Cipla first confirmed to PharmAsia News that nine Inspectional Observations have been issued by FDA and the company’s clarifications will be submitted within 30 days (PharmAsia News, April 17, 2009).
In an exclusive interview with PharmAsia News’ Tokyo bureau, Merck Japanese subsidiary Banyu Pharmaceutical’s Senior Director of Public and Industry Policy Elizabeth Cobbs discusses the company's strategic outlook and regulatory challenges. She talks about PMDA’s trend toward accepting data from global trials for registration in Japan as well as changes in the agency to reduce the drug lag (PharmAsia News, April 20, 2009).
The PharmAsia News team welcomes your feedback on stories we have covered as well as story ideas you would like to see. Email the editors at pharmasia@elsevier.com Not a subscriber? Click here to start your 30-day, risk-free trial of PharmAsia News– Immediate business intelligence from China, India, Japan and the Pacific Rim, from the publishers of "The Pink Sheet."
Industry insiders Carol Wingard and Helen Chen, of Shanghai-based L.E.K. Consulting offer advice on who will benefit from China’s long-awaited healthcare reform – both in the long term and short term. Understanding the government’s plans and how they will be implemented can help drug and device makers prepare for healthcare transitions related to their interests in China. With the country’s ambitious goal to set up safe, effective and affordable healthcare covering all urban and rural residents by 2020, device makers stand to gain the most while expanding sectors such as CMOs, CROs and private insurance companies will make big gains as well (PharmAsia News, April 20, 2009).
- Vikas Dandekar
