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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.
LOS ANGELES, Oct. 3 (Xinhua) -- An organizer of the World Stem Cell Summit says one of the key problems medical researchers face these days is how to apply their findings in the real world."How do you take the phenomenal scientific research going on in labs and translate it into medical treatments,?" said Bernie Siegel, the founder and co-chair of the summit and executive director of the Genetic Policy Institute, which organized the event."It's a big job to do this, and more than just the science," Siegel said, noting that in a growing field now moving beyond basic lab research, the aim is to connect the people who do the work with those who finance it.The three-day summit, which opened Monday in Pasadena, features more than 150 top international speakers and 50 hours of programming with leaders from science, pharmaceutics, business, policy, ethics, law and other fields.The cell therapy industry, a "nascent" field, has emerged to be a potentially multi-billion business with unlimited potential, Siegel said.Stephen Dalton, a University of Georgia professor, reported that one of the biggest developments in stem cell research in the past year was the realization that cells can be transdifferentiated from one state to another without returning to a pluripotent state.Dalton said the principle was previously supported by a few isolated examples but it was not until 2010 that the idea was widely accepted.Mark Sussman, a professor from San Diego State University, called the identification of lung stem cells from human tissue samples capable of regenerating the highly complex and specialized structures of mature lungs a breakthrough in lung biology and regenerative medicine.He said results presented by the Anversa group in the New England Journal of Medicine demonstrate that human lung stem cells can be expanded in vitro and also retain the capacity to integrate into adult tissue upon introduction into mice.The study, Sussman said, has opened up an entirely new field of possibilities for lung regeneration and potential therapeutic applications for many conditions where treatment options are either very limited or nonexistent.
SEOUL, Nov. 8 (Xinhua) -- Samsung Electronics, the world's largest flat screen TV vendor, said Tuesday that it has suspended its plan to develop active shutter three-dimensional (3D) TVs with RealD, the U.S.-based 3D technology supplier."Samsung has decided to focus on our own initiatives of 3D technology, and continues to research and develop next-generation 3D display technologies, including a glasses-free 3D solution for the home," the tech firm said in an e-mailed statement.The active shutter 3D technology drew public attention after Samsung reached a deal with RealD earlier this year to jointly develop such technology, aiming to unveil 3D TVs based on the technology early next year.The active shutter is a next generation 3D technology that incorporates merits from both shutter-glass (SG) technology, which Samsung adopted, and film patterned retarder (FPR) technology, which LG introduced in December last year.The SG technology has been touted as better picture quality and deeper 3D images, but the eyewear is heavier because it requires batteries and chips to work. The active shutter 3D technology moved its function of 3D image creation from eyewear to flat panel, making the eyewear lighter.Despite the upgraded technology and its convenience, Samsung decided to focus on its existing SG technology as the global TV market is grappling with weak demand. The penetration rate, which gauges the ratio of 3D sets against the total flat screen TVs, was expected to rise to 9.9 percent by year-end from the 3 percent a year earlier, according to Woori Investment & Securities, a local securities firm.
UNITED NATIONS, Jan. 19 (Xinhua) -- China's Permanent Representative to the UN Li Baodong said here Thursday that caution should be called for in metering out sanctions in international affairs.Li made the remarks when addressing a Security Council open debate on the question of justice and rule of law."We are in favor of improving the UN sanction regime on the basis of extensive consultations so as to improve its credibility, procedures and establishing effective monitoring mechanisms and to establish strict criteria, define timelines, " Li said."Sanctions should be only carried out on basis of facts and evidence. Double standards must be avoided. Impacts against civilian lives and social economic development must be minimized," the ambassador said.Stressing that the UN chart and the fundamental principles of international law as established in it should be upheld, Li said rule of law in international relations should be strengthened.The Charter as well as principles of international law established in it constitute the call of rule of law in international relations and represents the bedrock for developing rule of law in international relations, he said."In the conduct of international relations and international affairs, adherence to the Charter and other fundamental principles of international law, such as respect for national sovereignty, non-interference in internal affairs, fulfillment in international obligation in real earnest is the essence of promotion of international rule of law," said Li.According to the Charter, UN Security Council resolutions constitute the integral part of international rule of law. Promotion of international rule of law requires strict implementation of the Security Council resolutions by member states, he added.
SAN FRANCISCO, Dec. 9 (Xinhua) -- Apple on Friday suffered a major setback in its global patent war, as a German court ruled over its copyright infringement battle in favor of Motorola Mobility.The German court ruled that Apple's iPhone and iPad infringe a Motorola patent and issued an injunction banning the import of iPhones and 3G-capable iPads into Germany.The dispute, one of Apple's several patent lawsuits around the world, is over a Motorola patent essential to GPRS. Motorola has been negotiating with Apple over licensing terms and conditions since 2007, and it will continue its efforts to resolve its global patent dispute as soon as practicable, said Motorola Mobility in a statement on Friday."We're going to appeal the court's ruling right away. Holiday shoppers in Germany should have no problem finding the iPad or iPhone they want," an Apple spokesman told tech news site AllThingsD.Apple is not too concerned about losing out in the Christmas shopping season as it has plenty of iPhones and iPads in Germany already, AllThingsD cited unidentified sources as saying.The ruling is against Apple's European sales company and only impacts its products sold in Germany. The German court also ruled that Motorola is entitled to a damages award.Apple can appeal the ruling to a higher court and request a stay of the injunction, according to a blog post of Florian Mueller, a U.S. patent expert who has been closely following patent lawsuits in the mobile industry.Mueller said should Apple make the appeal but the court declines the stay, Motorola must post a 100 million euro (around 134 million U.S. dollars) bond before the court will enforce the injunction.In August, Apple also filed a suit in Germany over the design of Motorola's tablet Xoom, which runs Google's Android system. But Apple did not make it clear whether it will seek to block the sales of Xoom in Europe.Also on Friday, Samsung won an appeal from the Australian High Court overturning a previous Apple victory that effectively banned Samsung from selling its Galaxy Tab in Australia.Based on claims of infringing Apple's patents, the Cupertino, California-based tech giant has been seeking court order to block Samsung's Galaxy line of mobile devices around the world.A German court issued an injunction in August, blocking Samsung from selling its Galaxy Tab 10.1 tablets across all European Union members, except for the Netherlands.On Thursday, Apple said it will appeal a San Jose, California judge's refusal to ban sales of Samsung 4G smartphones and Galaxy Tab 10.1 tablets in the United States.