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WASHINGTON, Dec. 21 (Xinhua) -- The U.S. Food and Drug Administration (FDA) on Wednesday approved Isentress for the treatment of HIV-1 infection for children and adolescents.The drug is part of a class of medications called HIV integrase strand transfer inhibitors that works by slowing the spread of HIV in the body. It was first approved for use in adult patients in October 2007, under FDA's accelerated approval program."Many young children and adolescents are living with HIV and this approval provides an important additional option for their treatment," said Edward Cox, director of the Office of Antimicrobial Products in the FDA's Center for Drug Evaluation and Research.Isentress is a pill that can be taken twice daily, with or without food. The pill is also available in a chewable form. As the two tablet formulations are not interchangeable, the chewable form is only approved for use in children ages 2 to 11.A single, multi-center clinical trial of 96 children and adolescents aged 2-18 years with HIV-1 infection evaluated the safety and effectiveness of Isentress. These patients previously received treatment for HIV-1 infection. After 24 weeks of treatment with Isentress, 53 percent of these patients had an undetectable amount of HIV in their blood.According to the FDA, the most commonly reported severe, treatment-related side effects in patients taking Isentress include trouble sleeping and headache. The frequency of these side effects is similar for children and adults. One pediatric patient reported severe treatment-related insomnia, while another pediatric patient experienced a drug-related skin rash.
SAN FRANCISCO, Oct. 10 (Xinhua) -- Apple announced on Monday that pre-orders of its iPhone 4S have topped 1 million in a single day, surpassing the previous single-day pre-order record of the company's smartphone.The iPhone 4S pre-orders surpassed 1 million in the first 24 hours and the previous single day pre-order record held by iPhone 4 is 600,000, according to Apple."We are blown away with the incredible customer response to iPhone 4S," Philip Schiller, Apple's senior vice president of worldwide product marketing, said in a statement."The first day pre-orders for iPhone 4S have been the most for any new product that Apple has ever launched and we are thrilled that customers love iPhone 4S as much as we do," he added.U.S., newly installed Chief Executive Officer Tim Cook takes stage to give a general introduction of Apple's products, Oct. 4, 2011. Apple Inc. last Tuesday unveils iPhone 4S, the much-anticipated latest generation of iPhone.The iPhone 4S, which looks the same as the iPhone 4 but has major hardware upgrade inside, is available for pre-order last Friday and set to first arrive in stores in the United States this Friday.So far, iPhone 4, which, according to Apple, has been sold more than the first three generations of iPhones combined, is Apple's best selling iPhone.The pre-order numbers are good news for Apple as the initial introduction of iPhone 4S last Tuesday has not lived up to the anticipation of some investors and analysts, and spurred a new wave of concerns about whether the company could keep its innovation momentum in the wake of the passing of its co-founder Steve Jobs last Wednesday.

WASHINGTON, Nov. 18 (Xinhua) -- The U.S. Food and Drug Administration (FDA) on Friday revoked its approval of Avastin for treating the breast cancer after concluding that the drug has not been shown to be safe and effective for that use.Avastin will still remain on the market as an approved treatment for certain types of colon, lung, kidney and brain cancer."After reviewing the available studies it is clear that women who take Avastin for metastatic breast cancer risk potentially life-threatening side effects without proof that the use of Avastin will provide a benefit, in terms of delay in tumor growth, that would justify those risks," FDA Commissioner Margaret Hamburg said in a statement. "Nor is there evidence that use of Avastin will either help them live longer or improve their quality of life. "Avastin's risks include severe high blood pressure; bleeding and hemorrhaging; heart attack or heart failure; and the development of perforations in different parts of the body such as the nose, stomach, and intestines.Avastin was approved for metastatic breast cancer in February 2008 under the FDA's accelerated approval program, which allows a drug to be approved based on data that are not sufficiently complete to permit full approval. After the approval, the drug's sponsor, Genentech, completed two additional clinical trials and submitted the data from those studies to the FDA. These data showed only a small effect on tumor growth without evidence that patients lived any longer or had a better quality of life compared to taking standard chemotherapy alone -- not enough to outweigh the risk of taking the drug.FDA's Center for Drug Evaluation and Research, which is responsible for the approval of this drug, ultimately concluded that the results of these additional studies did not justify continued approval and notified Genentech it was proposing to withdraw approval of the indication.Genentech did not agree with the Center's evaluation of the data and, following the procedures set out in FDA regulations, requested a hearing on the Center's withdrawal proposal, with a decision to be made by the Commissioner. That two-day hearing, which took place June 28-29, included recommendations from the FDA 's Oncologic Drugs Advisory Committee, voting 6-0 in favor of withdrawing approval of Avastin's breast cancer indication.
MOSCOW, Nov. 25 (Xinhua) -- Russia's Proton-M carrier rocket was launched on Friday from the Baikonur space center in Kazakhstan with a Chinese communications satellite "AsiaSat-7", according to Russia's Federal Space Agency Roscosmos.Roscosmos' live broadcast on its official website showed that the Proton-M rocket atop the Briz-M upper stage was launched at 23: 10 Moscow time (1910 GMT). The separation of the satellite from the rocket was scheduled for 08:23 Moscow time (0423 GMT) on Saturday.The AsiaSat-7 which belongs to the Asia Satellite Telecommunications Company Limited (AsiaSat) located in Hong Kong, China, is a new generation satellite designed to replace AsiaSat 3S at the orbital location of 105.5 degrees East.The new satellite was expected to support a broad range of applications for the Asia-Pacific region, including television broadcast and VSAT (Very Small Aperture Terminal) networks.
XI'AN, Nov. 20 (Xinhua) -- Fish in Hongjiannao Lake, China's largest desert freshwater lake, are teetering on the verge of extinction, according to local fishery authorities."The fish in Hongjiannao have nearly vanished," said Li Weiping, the head of a fish monitoring station in northwest China's Shaanxi province.As the lake continues to shrink, its water has become more salty and its pH reading has reached 9.6, while the maximum reading suitable for fish is 8.5, according to Li.The lake has gradually lost the water that it used to get from underground streams and rivers, Li said, adding that excessive coal mining around the lake has changed the way water flows underground. Two reservoirs have been built on two rivers near the upper reaches of the lake, preventing river water from flowing into the lake.The lake's water level has plunged by 20 to 30 centimeters every year. Its total surface area has been reduced to 41.8 square km, down from 67 km in 1996.
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