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WASHINGTON, March 4 (Xinhua) -- New data suggest that the epilepsy drug Topamax (topiramate) and its generic versions increase the risk for the birth defects cleft lip and cleft palate in babies born to women who use the medication during pregnancy, the U.S. Food and Drug Administration (FDA) said Friday in a statement.Before prescribing topiramate, approved to treat certain types of seizures in people who have epilepsy, health care professionals should warn patients of childbearing age about the potential hazard to the fetus if a woman becomes pregnant while using the drug, the FDA said.Topiramate also is approved to prevent migraine headaches, but not to relieve the pain of migraines."Health care professionals should carefully consider the benefits and risks of topiramate when prescribing it to women of childbearing age," said Russell Katz, director of the Division of Neurology Products in the FDA's Center for Drug Evaluation and Research. "Alternative medications that have a lower risk of birth defects should be considered."Cleft lip and cleft palate, collectively called oral clefts, are birth defects that occur when parts of the lip or palate do not completely fuse together early in the first trimester of pregnancy, a time when many women do not know they are pregnant.The defects range from a small notch in the lip to a groove that runs into the roof of the mouth and nose, possibly leading to problems with eating, talking, and to ear infections. Surgery often is performed to close the lip and palate and most children do well after treatment.Data from the North American Antiepileptic Drug (AED) Pregnancy Registry indicate an increased risk of oral clefts in infants exposed to topiramate during the first trimester of pregnancy. Infants exposed to topiramate as a single therapy experienced a 1.4 percent prevalence of oral clefts, compared with a prevalence of 0.38 percent - 0.55 percent in infants exposed to other antiepileptic drugs.Infants of mothers who did not have epilepsy and were not being treated with other antiepileptic drugs had a prevalence of 0.07 percent. Similar data from the United Kingdom Epilepsy and Pregnancy Register supported the North American AED Pregnancy Registry data.According to the FDA, before starting topiramate, pregnant women and women of childbearing potential should discuss other treatment options with their health care professional.
BEIJING, May 10 (Xinhuanet) -- Professional social networking site LinkedIn is aiming for a valuation of 3.3 billion U.S. dollars for its initial public offering, media reports said Tuesday.The Mountain View, California-based company is expected to begin trading on the New York Stock Exchange within the next month and will use the symbol "LNKD."It plans to offer 7.84 million shares priced at 32 dollars to 35 dollars each, according to the filing, which it submitted to the Securities and Exchange Commission.LinkedIn, which has more than 100 million members in over 200 countries and territories, is seeking to raise as much as 274.4 million dollars from the initial public offering (IPO) with 146.6 million dollars going to the company itself.In 2010, LinkedIn made 15 million dollars in profit on 243 million dollars in revenue, according to the filing.LinkedIn's biggest shareholder is its founder and chairman, Reid Hoffman, who owns more than 21 percent of the company.
SAN FRANCISCO, April 28 (Xinhua) -- Microsoft Corp. on Thursday posted quarterly revenue and earnings that both beat analysts' expectations.In its fiscal 2011 third quarter ended on March 31, the software giant reported revenue of 16.43 billion U.S. dollars, up 13 percent from the same period a year earlier.Net income and earnings per share were 5.23 billion dollars and 61 cents, representing increases of 31 percent and 36 percent respectively year-on-year.Analysts had expected earnings of 56 cents per share on revenue of 16.19 billion dollars, according to Thomson Reuters."We delivered strong financial results despite a mixed PC environment, which demonstrates the strength and breadth of our businesses," Peter Klein, chief financial officer at Microsoft, said in a statement."Consumers are purchasing Office 2010, Xbox and Kinect at tremendous rates, and businesses of all sizes are purchasing Microsoft platforms and applications," he added.Revenue at four of Microsoft's five major divisions posted double-digit growth in the quarter, indicating the increase of technology spending by enterprises as well as strong demand for the company's entertainment products.The entertainment and devices division saw the biggest revenue growth of 60 percent, which according to Microsoft, were driven by strong demand for its Kinect hands-free motion control system for Xbox 360 and continued strong sales of Xbox 360 console.However, revenue for the division of the company's flagship Windows operating system dropped 4 percent in the quarter, which Microsoft said was "in line with the PC trends."The performance of the Windows division may fuel new concerns that Microsoft's dominance in software for PCs is being threatened by Apple's iPad and tablet computers running other operating systems, some analysts noted.
CHENGDU, May 8 (Xinhua) -- As a brand-name herbal capsule for cardiovascular disease in China, Di'ao Xinxuekang only needs to wait for another 15 years before reaching the EU market."The Dutch medical supervisors have recognized it as a qualified drug, but we still lack the evidence of 15-year presence in the EU market," said Ji Jianxin, a research manager with the drug's developer Di'ao Group based in southwest China's Sichuan Province.Di'ao, one of the largest Traditional Chinese Medicine (TCM) manufacturers, has been quite depressed, as many other TCM enterprises in China, by a European Union directive on traditional herbal medicinal products fully implemented from the beginning of this month.The directive requires that all herbal medicinal products, must obtain a medical license from any EU member state before it can be allowed in the EU market.It introduced a so-called simplified registration procedure with a seven-year transition period for traditional herbal medicinal products to be licensed, including Chinese and Indian ones.However, not a single Chinese herbal medicinal product has been granted the license so far, mainly due to the prohibitive registration cost and lack of required evidence to prove the product had a 30-year history of safe use, including 15 years in the EU.With a history of more than 2,000 years, TCM did not enter into the EU market until mid-1990s, and it has been imported into the EU and sold to European customers as food supplements instead of drugs.Most Chinese producers and importers did not reserve the customs papers a decade ago, thus unable to prove the 15-year use of their products in European markets.While TCM's globalization won't be doomed by one single EU directive as TCM export value to EU only takes up 14 percent of the total in 2010, experts and industry insiders still have had serious concerns about its future."Most TCM even don't have standardized labels that can help consumers to find out its origin," said Xian Sheng, from the China Association of TCM Export Companies.
CARACAS, March 30 (Xinhua) -- The number of confirmed cases of the A/H1N1 influenza in Venezuela has risen to 482 this year, Health Minister Eugenia Sader said on Wednesday.According to the latest report, the state of Merida in southeastern Venezuela has 189 A/H1N1 influenza cases, the biggest number ever reported, which was followed by the Capital District of Caracas with 112 cases. The other 181 cases were confirmed in 17 of 24 Venezuelan states.The first case for this year was reported in Merida earlier this month.Sader said that the Venezuelan government was trying to prevent the spread of the disease. Some 3 million people have been vaccinated against the virus.Three patients infected with the A/H1N1 influenza virus have died in the country this year, according to Sader.The A/H1N1 influenza can cause deadly pneumonia if it is not treated early.