first_imgSep 28, 2007 (CIDRAP News) – The Food and Drug Administration (FDA) today announced the approval of an Australian-made influenza vaccine called Afluria for use in adults, raising the number of US-licensed flu vaccines to six.The vaccine, made by CSL Limited, based in Parkville, Australia, was approved for protecting people aged 18 and older from type A and B influenza viruses.Like most flu vaccines, Afluria contains inactivated (killed) flu viruses grown in chicken eggs. People who are allergic to eggs should not receive the vaccine, the FDA said in a news release.The vaccine is given as a single injection in the upper arm. It will be available in single dose, preservative-free syringes and in multiple-dose vials containing thimerosal, a mercury compound, as a preservative, the FDA said.CSL expects to supply up to 2 million doses of the vaccine in the United States this season, according to Paul Perreault, executive vice president of commercial operations for the company’s US division, CSL Biotherapies, based in King of Prussia, Pa. Plans call for delivering all the doses to the United States by the end of October, the company said in a news release today.The FDA said the Centers for Disease Control and Prevention (CDC) has estimated that the six vaccine makers will supply a record total of 132 million doses of flu vaccine in the United States this year. The CDC had cited the same figure at a news conference last week, without mentioning the CSL vaccine.”The licensure of this additional flu vaccine contributes to having an adequate supply of seasonal influenza vaccine for Americans, one of FDA’s highest priorities,” said Jesse L. Goodman, MD, MPH, director of the FDA’s Center for Biologics Evaluation and Research, in the agency news release.CSL Biotherapies announced its filing for FDA approval of Afluria in April. The application included the results of a phase 3, randomized, placebo-controlled clinical trial that involved 1,357 volunteers at nine US sites, the company news release said. Sponsored by the National Institutes of Health, the study evaluated the safety and immunogenicity of thimerosal-free and thimerosal-containing formulations of the vaccine.The FDA used its accelerated approval pathway in evaluating the vaccine. “The manufacturer demonstrated that the vaccine induced levels of antibodies in the blood likely to be effective in preventing seasonal influenza,” the agency said. “As part of the accelerated approval process, the manufacturer will conduct further studies to verify that the vaccine decreases seasonal influenza disease after vaccination.”CSL-branded flu vaccines are approved and sold in 16 countries, and the company provides bulk antigen for flu vaccines sold in 24 countries, according to the CSL news release. Officials said the company has been making flu vaccines for 40 years.Perreault told CIDRAP News that the bulk antigen for the vaccine is made in Australia, and this year the product will be finished and packaged in a facility in Germany. But in the future the finishing and packaging will be moved to a CSL plant in Kankakee, Ill., he said.In August, CSL announced plans to expand the Kankakee plant by adding a line to fill single-dose syringes. The company plans to start operating the line and packaging flu vaccine at the plant in 2010, according to the August announcement.Last year CSL announced it would spend $60 million to double the capacity of the company’s Melbourne, Australia, plant to 40 million doses per year, making it one of the largest flu vaccine production facilities in the world.Other injectable flu vaccines licensed in the United States, with their manufacturers, are FluLaval, ID Biomedical; Fluarix, GlaxoSmithKline; Fluzone, Sanofi Pasteur; and Fluvirin, Novartis. The other licensed product is FluMist, the nasal-spray vaccine made by MedImmune.See also: Sep 28 FDA news releasehttp://www.fda.gov/bbs/topics/NEWS/2007/NEW01714.htmlSep 28 CSL Biotherapies news releaseOct 5, 2006, CIDRAP News story “FDA approves 5th flu vaccine”last_img read more

first_imgThe start time for Syracuse’s second-round NCAA tournament matchup has been moved to noon from 2 p.m. due to impending weather forecasts.The eighth-seeded Orange (11-3-4, 3-2-3 Atlantic Coast) face Dartmouth (9-4-5, 5-1-1 Ivy) in a rematch of last year’s NCAA tournament second round game at SU Soccer Stadium. In that game, the Orange came from behind for a 2-1 victory thanks to goals from Ben Polk and Louis Cross.The Big Green is coming off a first-round win against St. Francis (Brooklyn), in which Dartmouth needed a goal in the second overtime period to advance by a score of 1-0.Dartmouth hasn’t allowed a goal in over four games, a period lasting almost 400 minutes. The last time a team scored on the Big Green was Harvard’s 80th-minute tally on Oct. 29. Comments AdvertisementThis is placeholder text Facebook Twitter Google+ Published on November 19, 2016 at 4:25 pm Contact Matt: mcschnei@syr.edu | @matt_schneidmanlast_img read more

first_imgNaomh Ultan 1-12 Ardara 1-11Naomh Ultan are into the Junior B Championship final – and are one game away from being the only adult side in the county to go a whole season unbeaten.Another nail biting affair saw them pip Ardara to the post in a thriller semi-final replay. Ardara opened an early lead with a penalty from Stephen Gildea and took a 3 point advantage in at the break.Naomh Ultan clawed back into the game in admirable fashion, Sean Furey getting on the end of the majority of the scores through placed ball.Their break came on 57 mins when Aaron Byrne slotted home stylishly after carrying the ball 30 yards. Ardara did take the game back to a point but the team stood resilient and after 6 minutes of injury time the victory was theirs.A massive congratulations to all involved, a tremendous effort was put in not only today but over the past few months. Third final in four years and still the only unbeaten adult team in Donegal! Naomh Ultan: S McNern; E Kennedy, P Byrne, M McGlynn; D Shovlin (0-1), P Fisher, C Battles; M Shovlin, R McCallig; D Quigley, E Byrne (1-1), A Blaine (0-2); L Kennedy, S Furey (0-8,8f), A Nesbitt. Subs., M O’Donnell for Nesbitt 52; K O’Donnell for Blaine 55;.Ardara: P Gavigan; D Breslin, C Gallagher, R McBrearty; M McShane, D Diver, C Gallagher; S O’Donnell, P McGill; S McGuinness (0-1), M Doherty (0-1), M Shovlin (0-1); L O’Donnell (0-2), C Shovlin, S Gildea (1-6, 3f,pen). Subs., J Doherty for C Shovlin 32; D McNelis for M Shovlin 45; K McCabe for J Doherty 50; D Maguire for McGill 55; D Earley for McGuinness 61. GAA NEWS: NAOMH ULTAN WIN THRILLER TO LAND PLACE IN FINAL was last modified: September 1st, 2013 by John2Share this:Click to share on Facebook (Opens in new window)Click to share on Twitter (Opens in new window)Click to share on LinkedIn (Opens in new window)Click to share on Reddit (Opens in new window)Click to share on Pocket (Opens in new window)Click to share on Telegram (Opens in new window)Click to share on WhatsApp (Opens in new window)Click to share on Skype (Opens in new window)Click to print (Opens in new window) Tags:GAA NEWS: NAOMH ULTAN WIN THRILLER TO LAND PLACE IN FINALlast_img read more

first_imgMajella O’Donnell has revealed she has a cheeky side to her life too!Majella, who is married to singer Daniel O’Donnell, revealed she has had the her husband’s name tattooed on her bum.In fact, Majella has a stamp with the initials DSM on her backside. As well as Daniel, the other initials refer to her grown-up children Siobhan and Michael.Hopefully it’s the only bum note that is heard in the O’Donnell household! MAJELLA O’DONNELL REVEALS SHE HAS A CHEEKY SIDE! was last modified: November 6th, 2014 by StephenShare this:Click to share on Facebook (Opens in new window)Click to share on Twitter (Opens in new window)Click to share on LinkedIn (Opens in new window)Click to share on Reddit (Opens in new window)Click to share on Pocket (Opens in new window)Click to share on Telegram (Opens in new window)Click to share on WhatsApp (Opens in new window)Click to share on Skype (Opens in new window)Click to print (Opens in new window) Tags:daniel o’donnelldonegalMajella O’Donnelltattoolast_img read more

first_imgShare Facebook Twitter Google + LinkedIn Pinterest By Chris ClaytonDTN Ag Policy EditorOMAHA (DTN) — While trade talks with China remain off again, on again, the battle over intellectual property theft of agricultural technology continues with the indictment of a former scientist at Monsanto and The Climate Corporation.Haitao Xiang, 42, was formally indicted Thursday by a grand jury in the U.S. District Court for Eastern Missouri more than two years after he was arrested trying to leave the U.S. for China in June 2017. Xiang was caught boarding a plane with trade-secret technology copied onto a micro SD card.The grand jury indicted Xiang for three counts of economic espionage and conspiracy to commit economic espionage, three counts of trade secret theft and one count of conspiracy to steal trade secrets. The economic espionage charges can carry up to 15 years in prison for each count, and the trade secret charges can carry up to 10 years in prison.China’s unwillingness to stop intellectual property theft remains one of the biggest unresolved issues in trade talks with the Trump administration.The U.S. Senate Permanent Subcommittee on Investigations just this week released a report and held a hearing on China’s strategy of recruiting talent who would steal trade secrets for the country.The Senate report largely focused on Chinese theft from public U.S. institutions, noting billions of dollars in taxpayer-funded research “has contributed to China’s global rise over the last 20 years. During that time, China openly recruited U.S.-based researchers, scientists and experts in the public and private sector to provide China with knowledge and intellectual capital in exchange for monetary gain and other benefits.” https://bit.ly/…Xiang’s case highlights how that recruitment works.Xiang, 42, worked for nearly a decade as an advanced imaging scientist at The Climate Corporation, focusing on remote sensing work to estimate soil properties using satellite imagery, the indictment states. A permanent U.S. resident with Chinese citizenship, Xiang worked on the “Nutrient Optimizer” product that was part of an online farming software platform.The indictment notes the Chinese government established a national policy — “talent programs” — to identify and recruit people outside of China who have “expert skills, abilities and knowledge that could aid in transforming China’s economy.”One of the highest levels of those programs was the “Hundred Talents Program” in top research fields. Recruits to these talent programs were sought out to work for the Chinese government in specific areas of research. That typically required replicating key areas of research and development on intellectual property.The Climate Corporation and Monsanto have worked for years on platforms to visualize important agronomic field data and collect and store that information. The precision-agriculture tools help farmers with various agronomic decisions such as customizing fertilizer plans and seeding rates. The foundation of the Nutrient Optimizer is a “point-based biogeochemical process model that simulated biological, chemical, hydrological, and thermal processes occurring within an agricultural field.”The Nutrient Optimizer is an essential part of those digital software services, and Monsanto considers the information about it as confidential, proprietary and a trade secret, the indictment points out. The digital tool is sold both in the U.S. and internationally.Monsanto and The Climate Corporation took several steps to protect the technology around the Nutrient Optimizer, which included restricted access to facilities, video security cameras on the premises, log-in passwords for computers, nondisclosure agreements with employees, identification badges and annual training with employees on the protection of trade secrets.At some point, Xiang began sending information about his work to people in China. From at least June 2015 until June 10, 2017, while working for The Climate Corporation, Xiang began communicating about his work with people within the Chinese government about potential jobs at the Chinese Academy of Sciences Nanjing Institute of Soil Science. Xiang was then recruited by the Hundred Talents Program, the indictment states.Xiang then allegedly traveled in both the U.S. and China, talking about his knowledge and skills. From March 2014 until June 2017, Xiang also “copied, duplicated, transmitted and downloaded the Nutrient Optimizer from Monsanto systems.”In February 2016, Xiang had several communications with recruiters from the Chinese talent program and officially submitted an application. In describing his talents and abilities, Xiang stated he could do things that could only happen by duplicating the Nutrient Optimizer and its digital platform, the indictment states.In what might have been Xiang’s undoing, the indictment also states Xiang conducted some Google searches on a Monsanto computer looking for information on ways to avoid intellectual property theft being used as “evidence.”Starting in April 2016 and running through at least November that year, Xiang traveled again to China to interview for a position at the Nanjing Institute of Soil Science and was considered a candidate for a job there. Through May of 2017, Xiang went back and forth with people located in China about his possible job, compensation, benefits and research he would conduct.Xiang told Monsanto and The Climate Corporation on May 24, 2017, he would resign from his job, and he left the position on June 9, 2017. In an exit interview, Xiang said he had shredded all physical documents related to his work and did not keep any electronic storage devices are hard drives containing Monsanto and The Climate Corporation property. He also stated he had not sent any such information to his private email address. Xiang certified to the companies he did not keep any confidential information or trade secrets related to Monsanto and Climate Corp.During his exit interview, the indictment states, Xiang was confronted about some of his Google searches. Yet, the indictment states, “After completing his interview … Xiang copied and downloaded the Nutrient Optimizer to a Micro SD Card, and drove from St. Louis, Missouri, to Chicago O’Hare airport.” Xiang bought a same-day, one-way ticket to China, but was arrested at the airport.“Xiang promoted himself to the Chinese government based on his experience at Monsanto. Within a year of being selected as a Talent Plan recruit, he quit his job, bought a one-way ticket to China, and was caught at the airport with a copy of the company’s proprietary algorithm before he could spirit it away,” Assistant Attorney General for National Security John C. Demers, said in a news release.John Brown, assistant director of the FBI’s Counterintelligence Division, said Monsanto/The Climate Corporation’s technology at the core of the case “represents both the best of American ingenuity and why the Chinese government is so desperate to steal it for themselves.”Monsanto and its subsidiaries became part of Bayer AG in 2018. A spokesperson for Bayer in St. Louis released a statement to DTN but declined further comment.“We take the protection of trade secrets very seriously for the sustainability of the company and for the importance that plays in providing excellence for the U.S. farmer. We work closely with law enforcement agencies when we face insider threat or cyberattacks. That said, this a personnel issue and we do not comment on personnel matters,” Bayer stated.Agriculture has been the victim of a few similar cases in the past several years. A biotech rice research company in Kansas, Ventria Bioscience, had rice stolen from it and sent to China by a rice breeder who worked for the company in 2012. U.S. Customs officials later found the company’s rice seeds in the baggage of members of a Chinese delegation that had come to the U.S. Monsanto and DuPont Pioneer also were targeted by a Chinese businessman who shipped biotech corn seed to China.A federal magistrate on Friday granted a request by prosecutors to keep Xiang in detention until the trial because he is considered a significant risk to leave the country.Chris Clayton can be reached at Chris.Clayton@dtn.comFollow him on Twitter @ChrisClaytonDTN(AG/CZ )© Copyright 2019 DTN/The Progressive Farmer. All rights reserved.last_img read more

first_imgLater this month, iPhone and iPod application developers can expect to see sales drastically increase by as much as 300 or 400 percent over the course of a couple days.They’ll also be unable to change their applications, change marketing materials or download sales reports during much of this time. iTunes Connect, the interface that allows developers to manage all their applications in the App Store, will be unavailable from December 23 – December 28, 2009.The same downtime occurred last year and caused some consternation within the developer community.“I guess iTunes Connect [team members] want a break too,” wrote one developer, “but come on, closed for the holidays when people have a lot of time on their hands to buy apps ?”Another dev shop, Bottle Rocket, wrote, “Apple is taking the next 4 days off. Good for them. So, should we take the hint and lower the shades on Bottle Rocket for at least a few days? The answer is, well, no comment.”Here’s a graph showing the kind of traffic and sales pattern app developers can expect to see right around Christmas Eve, Christmas Day and the ensuing week or so. This is a visualization of data from iPod Touch devices last December: Tags:#Apple#web jolie odell Why Tech Companies Need Simpler Terms of Servic… A Web Developer’s New Best Friend is the AI Wai… Top Reasons to Go With Managed WordPress Hosting Related Posts 8 Best WordPress Hosting Solutions on the Market So, once again, during what may be some app developers’ biggest sales spike of the entire year, they will not have access to information on sales performance or other metrics, and they won’t be able to tweak their marketing materials or create new incentives as the year’s biggest gift-giving holiday approaches.In the interest of maintaining our holiday spirit, we will refrain from comment on whether or not this is a lame move and instead caution our application developer friends to get their ducks in a row before iTunes Connect is out of commission.last_img read more