FDA approves using Relenza to prevent flu

first_imgMar 29, 2006 (CIDRAP News) – The US Food and Drug Administration (FDA) today approved the use of the antiviral drug zanamivir (Relenza) to prevent—not just treat—influenza in adults and children aged 5 and older.Zanamivir, one of the two flu drugs known as neuraminidase inhibitors, was approved in 1999 for treating flu in people aged 7 and older, but not for prophylactic use. The other neuraminidase inhibitor, oseltamivir (Tamiflu), was approved for both treatment and prevention in adults and children from the age of 1 year.”This approval is a welcome addition to the available defenses against the flu,” Dr. Steven Galson, director of the FDA’s center for Drug Evaluation and Research, said in an FDA news release. “This new use offers the medical community another option to prevent and control influenza A and B.”Many countries are stockpiling oseltamivir, made by Roche, in the hope that it will offer some help in the next flu pandemic. Stockpiling of zanamivir, made by GlaxoSmithKline, has been less prevalent, but the United States is stocking up on both.”We have purchased, as of today, 4 million treatment courses of Relenza and 22 million treatment courses of Tamiflu,” Bill Hall, a spokesman for the Department of Health and Human Services, told CIDRAP News today. “We expect all of them to be in the stockpile by the end of this calendar year.”Hall said HHS is aiming for a total of 81 million treatment courses of the two antivirals by 2008, with zanamivir making probably up about 20%.Zanamivir is a powder that is inhaled by mouth with a “Diskhaler” device. Oseltamivir comes in capsule form.Four large, placebo-controlled studies have shown the effectiveness of Relenza for preventing flu, the FDA reported. In two trials, the incidence of flu in households whose members received the drug was 4.1%, versus 19.0% in households where people received a placebo.In a third trial, involving only adults, 2.0% of people in the Relenza group experienced flu symptoms, versus 6.1% of those in the placebo group, the FDA reported. In the fourth study, which involved mostly older adults, flu symptoms occurred in 1.4% of placebo group members and 0.2% of the treatment group.The FDA said zanamivir has not been found effective for preventing flu in nursing homes. Also, it is not recommended as a substitute for flu vaccine, the primary tool for preventing flu.The drug is not recommended for people who have asthma or other chronic respiratory disease, the FDA noted. After zanamivir’s initial approval, bronchospasm, in some cases fatal, was reported in some patients, most of whom had asthma or chronic obstructive pulmonary disease, the agency said.See also:Mar 29 FDA news releasehttp://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2006/ucm108622.htmFDA background information on Relenzahttp://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm183783.htmGlaxoSmithKline’s detailed information on Relenzahttp://us.gsk.com/products/assets/us_relenza.pdfCIDRAP overview on use of antiviral agents for pandemic flulast_img read more

US probing tire imports from South Korea, Thailand, Taiwan, Vietnam

first_imgThe US Commerce Department said on Tuesday it had opened investigations into vehicle tire imports from South Korea, Taiwan, Thailand and Vietnam to determine whether the tires are being sold at less than fair value.The department said it was also investigating whether tire producers in Vietnam were receiving unfair subsidies for passenger vehicle and light truck (PVLT) tires.The investigations were in response to petitions filed in May by the United Steelworkers (USW) representing workers at US tire plants. “Even though demand for PVLT tires increased, domestic producers were still forced to grapple with reduced market share, falling profits and lost jobs,” USW International President Tom Conway said earlier.The union won orders on imported vehicle tires from China in 2015, and Chinese imports have since shrunk dramatically, allowing the domestic industry to invest in new capacity, the union said.The United States imported almost $4 billion in tires from the four nations, including nearly $2 billion from Thailand and $1.2 billion from Korea, in 2019. The USW said tire imports from the four countries have risen nearly 20% since 2017, reaching 85.3 million tires.The Commerce Department said the alleged dumping margins range from 43% to 195% for Korea, 21% to 116% for Taiwan, 106% to 217.5% for Thailand and 5% to 22% for Vietnam.The USW represents workers at Michelin, Goodyear , Cooper, Sumitomo and Yokohama tire plants in Ohio, Arkansas, North Carolina, Kansas, Indiana, Virginia New York and Alabama.This month, Hankook Tires urged the Commerce Department not to investigate, saying the US domestic tire industry “is in robust health and growing.” In a filing it said, domestic vehicle tire producers “as a whole have not been materially injured and are not threatened with material injury by reason of subject imports.”Vietnam’s Ministry of Industry and Trade told Commerce its economy is “heavily dependent on light vehicles and passenger cars for transportation, logistics and travel and the PVLT tire industry is crucial for our continued economic advancement.” Topics :last_img read more

USC receives $1.9 million for digital humanities study

first_imgOn Tuesday the Andrew W. Mellon Foundation awarded USC a $1.9 million grant that will support graduate and postdoctoral students in digital humanities. The funds will be implemented through digitization of research materials, workshops, fellowships and coursework that can be applied to a digital humanities certificate through the Institute for Multimedia Literacy in the School of Cinematic Arts.The grant, which is one in a series of grants from the Mellon Foundation, will allow students and researchers to utilize digital technology within subjects such as literature, philosophy and anthropology.“For people training in old and traditional disciplines, we can use new hardware and new software to think about research in new ways and take advantage of technology and see things that we maybe didn’t see before,” said Peter Mancall, vice dean of humanities at Dornsife College of Arts, Letters and Science.Mancall said the grant will give students opportunities to research undiscovered patterns. As an example, Mancall said students interested in Shakespeare can utilize software to see patterns in Shakespeare’s writing that people have not studied before.“They can utilize a digitized archive and link to other archives. That couldn’t happen before because it was too                                     time-consuming to look at big data like that,” Mancall said.Within the next decade, USC hopes to invest $1 billion toward the support of digital knowledge and informatics.“Our century is dominated by the quantity and influence of information and data. USC is already a world leader in digital media and informatics,” said Elizabeth Garrett, provost and senior vice president for academic affairs, in a press release. “This prestigious award will help to enhance our teaching and scholarship through new ways to explore and communicate.”The university’s dedication to digital technology is demonstrated particularly through the strength of the Media Arts + Practice program as well as the Digital Repository, which holds more than 52,000 testimonials from the Shoah Foundation.Currently, the programs funded by the Mellon Foundation grant will only be utilized at the graduate level. Mancall, however, said summer courses are expected to be available to select undergraduates starting in 2015.In order to promote the spread of digital scholarship, the Mellon Foundation and USC agreed that all researchers supported by the grant will make their digital sources available to the scholarly community through the Digital Repository.Mancall said he hopes that the possibilities stemming from the grant will reveal the importance of college-level humanities.“I want to establish USC as a central place for the international center for digital humanities,” Mancall said.  “People talk about humanities in crisis and declining because students are moving toward professional schools. I hope this grant will show the central importance of humanities and show how cool humanities can be.”last_img read more