The Asia Corner - From the Editors of PharmAsia News April 28, 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.
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The Asia Corner - From the Editors of PharmAsia News April 28, 2009
BEIJING – While U.S. FDA Commissioner, Andrew von Eschenbach spoke publicly about the need to transform FDA to respond to a globalized marketplace. In January 2008, the agency announced a new program referred to as FDA Beyond Our Borders to establish permanent offices abroad. Von Eschenbach now outlines some of the successes of that program, for instance in setting up FDA offices in China, in an exclusive interview with Dan Poppy, assistant managing editor of PharmAsia News. Von Eschenbach reflects on his time at FDA and the remaining challenges for the agency. Read on
Meanwhile, in a move that could ultimately lead to civil or criminal prosecution, U.S. FDA recently issued warning letters to two Chinese producers of raw heparin that was discovered to be contaminated with a look-alike chemical. FDA's Center for Drug Evaluation and Research sent the formal warnings after initially discovering heparin adulterated with over-sulfated chondroitin sulfate, whose molecular structure closely resembles that of heparin, sold by the companies and imported into the U.S. FDA officials then conducted inspections of the two Chinese API suppliers last summer, and found serious violations of GMP standards. Read on
The Chinese Ministry of Commerce's wielding of a new Anti-Monopoly Law to block Coca-Cola's purchase of a local juice producer, and to impose severe restrictions on the combination of two other international businesses, could signal troubled times ahead for any global outfit operating in China that seeks to expand through a merger. That means Beijing's vaguely written antitrust law might be used to erect barriers to the merger of global healthcare companies that have entered the Chinese market, or to their acquisition of any Chinese concern, according to European and Chinese lawyers. One global megamerger, between Wyeth and Pfizer, stands a slight chance of being completely derailed by Beijing. Their $68-billion merger agreement states that approval by China's Ministry of Commerce, in line with the Anti-Monopoly Law, is a fundamental precondition to the conclusion of their worldwide union. Read on
Across Asia, a new strain of swine flu that surfaced in Mexico and has spread to parts of North America prompted authorities to heighten alert levels and to renew their calls for a new vaccine. Fears of a potential pandemic also caused stock prices to drop throughout Asia. The outbreak has led the World Health Organization to consider asking vaccine manufacturers to switch to production of swine flu vaccine. Read on
In India, signs of a deepening financial crisis became visible when drug maker Ranbaxy outlined its first quarter results, with a worst-ever recorded quarterly loss of $153 million on sales of $313 million. Ranbaxy posted losses of a similar magnitude in its previous two quarterly earnings. Commenting on the dismal results, Malvinder Mohan Singh, chairman, Ranbaxy, said, "This quarter has been challenging for the global economy and also the pharmaceutical industry with depreciation in several currencies and a downturn in demand and liquidity affecting performance, across sectors." Read on
- Kevin Holden
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