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Source: news.google.com --- 51 days ago
ABC News Glaxo's CERVARIX vaccine faces further delay Reuters - Jun 30, 2008 LONDON (Reuters) - GlaxoSmithKline Plc does not expect to win US approval for its cervical cancer vaccine CERVARIX until late 2009, marking a further delay for the key product, the world's second largest drugmaker said on Monday. Avandia Debacle Prompts FDA to Consider New Rules for Approving ... Newsinferno.com FDA Has Questions About Gardasil Use in Older Women EmpowHer South Carolina Now - WorldNetDaily - Pharma Times (subscription) - Newsinferno.com all 249 news articles ... Source: news.google.com --- 51 days ago
Canada.com Glaxo's CERVARIX vaccine faces further US delay Reuters - 16 hours ago By Ben Hirschler LONDON (Reuters) - GlaxoSmithKline Plc (GSK.L: Quote, Profile, Research) does not expect to win US approval for its key cervical cancer vaccine CERVARIX until late 2009, marking a further delay for the product. US Approval Is Delayed For Glaxo's CERVARIX Vaccine Wall Street Journal FDA now emphasizes safety rather than speed The News Journal Forbes - CNNMoney.com - Food Consumer - Wall Street Journal Blogs all 206 news articles ... Source: www.moreover.com --- 34 days ago
LONDON -(Dow Jones)- The U.K. government may save up to GBP18.6 million a year by deciding to use the HPV vaccine CERVARIX, given that it is equally effective as the more expensive Gardasil in preventing cervical abnormalities, according to a study ... Source: www.moreover.com --- 39 days ago
GlaxoSmithKline (NYSE:GSK) today provided the following update regarding its application to the (FDA) for approval of CERVARIX(R), its to prevent . GSK has submitted its response to questions raised by the FDA in their Complete Response Letter, ... Source: uk.reuters.com --- 34 days ago
LONDON (Reuters) - The decision to choose GlaxoSmithKline's CERVARIX cervical cancer vaccine over Merck and Co's Gardasil could save the government 20 million pounds annually, researchers said on Friday. ... Source: www.medicalnewstoday.com --- 49 days ago
GlaxoSmithKline on Monday said it does not expect to receive FDA approval for its human papillomavirus vaccine CERVARIX until late 2009, Reuters reports. GSK said it has decided to wait until results from a Phase III trial of the vaccine are available before seeking U.S. approval. ... Source: www.healthcentral.com --- 50 days ago
GlaxoSmithKline Plc does not expect to win U.S. approval for its key cervical cancer vaccine CERVARIX until late 2009, marking a further delay for the product. ... Source: blog.vaccineethics.org --- 42 days ago
There's been a flurry of media coverage this week about possible safety issues related to Gardasil. It appears that the attention was initiated by this report released by Judicial Watch, the conservative watchdog group. Like its previous reports alleging numerous deaths and illnesses caused by vaccine, this Judicial Watch report is based on unconfirmed submissions to VAERS , the government's clearinghouse for reports of possible vaccine-related adverse events. Reports to VAERS -- widely described as a 'hypothesis-generating mechanism' -- are later examined by government officials to determine what, if any, role a vaccine may have had in the reported condition. Numerous other outlets have raised questions about Gardasil's safety in the past few days, most notably this CBS News story by Sharyl Attkinson, the media member who is increasingly at the forefront of reporting on alleged vaccine risks. Other media outlets examining the topic include CNN and WebMD . In the meantime, officials from CDC and FDA have assured the public that the vaccine remains safe and effective and that reports of possible adverse events will continue to be investigated. Merck responded similarly yesterday, noting the limitations of reports made to VAERS. Meanwhile, it appears that the U.S. head-to-head battle between Gardasil and GSK's CERVARIX will most likely be delayed until late 2009. Last week, the Wall Street Journal and Reuters , among others, reporte ... Source: www.vaccinerx.com --- 42 days ago
GlaxoSmithKlines (GSK) cervical cancer vaccine, CERVARIX TM, was today confirmed as the UK Department of Healths vaccine of choice for its national human papillomavirus (HPV) immunisation programme. The programme, which aims to protect against the... ...
Source: www.pharmatimes.com --- 50 days ago
The chances of GSK’s CERVARIX reaching the US market anytime soon have disappeared after the company said it will be the end of 2009 before the cervical cancer vaccine gets approved across the Atlantic ... Source: www.overthelimit.info --- 50 days ago
GlaxoSmithKline PLC has come out and stated that they have answered all questions posed to them by the FDA in regards to their cervical cancer vaccine, CERVARIX. They went on to state though that they are also adding a late-stage study’s data on top of the review by the FDA. The new data will be given to [...] ... Source: www.pharmaceuticalonline.com --- 51 days ago
GlaxoSmithKline recently provided the following update regarding its application to the U.S. Food and Drug Administration (FDA) for approval of CERVARIX, its vaccine to prevent cervical cancer. ... Source: www.pharmatimes.com --- 29 days ago
An analysis in the BMJ which claims that the government could save £18.6 million annually following its recent decision to pick GSK's cervical cancer vaccine CERVARIX for its HPV immunisation programme has led to renewed criticism from those who feel Merck & Co’s Gardasil should have been chosen ... Source: www.topix.com --- 40 days ago
Main Category: Cervical Cancer / HPV Vaccine Also Included In: Pharma Industry / Biotech Industry Clinical Trials / Drug Trials GlaxoSmithKline provided the following update regarding its application to the ... ... Source: forums.randi.org --- 33 days ago
There was a lot of discussion and some criticism recently when England and Wales government opted... ... Source: foodconsumer.org --- 51 days ago
GlaxoSmithKline Plc does not expect the U.S. Food and Drug Administration to approve the application for the marketing license in the U.S. for its key cervical cancer vaccine called CERVARIX until late 2009, Reuters reports. ... Source: www.pharmagazette.com --- 50 days ago
GlaxoSmithKline (NYSE: GSK ) announced that it has submitted its response to the U.S. Food and Drug Administration to questions the agency had in response to GSK's drug application for CERVARIX. CERVARIX, a vaccine for the prevention of cervical cancer , one of the largest drug hopes in Glaxo's pipeline has already been approved in 67 countries but the FDA issued a "Complete Response" letter in December 2008 requiring the company answer questions. "Study 008 is a key study that will be completing later this year, and we expect the final results will strengthen the U.S. label for CERVARIX(R)," said Barbara Howe, M.D., Vice President and Director, North American Vaccine Development, GlaxoSmithKline. "We continue to have positive and productive discussions with the FDA and remain confident in the vaccine's safety and efficacy profile. We look forward to bringing this important new cervical cancer vaccine to girls and women in the U.S." [Source: PRNewsWire ] ... Source: www.frost.com --- 39 days ago
The much awaited news about the winner of NHS UK's contract for the supply of cervical cancer vaccine was released in June 2008. Gardasil-marketed by Sanofi-Pasteur MSD and CERVARIX-marketed by GlaxoSmithKline, competed for the contract to vaccinate girls in the UK, aged between 12 and 13. It would be fair to say that the decision has equally surprised, disappointed and delighted the general public, Sanofi-Pasteur MSD and GSK in that order. The NHS is expected to begin the vaccination programme in September 2008, which will benefit nearly more than 700,000 12 and 13 year old girls in the UK. The decision has left Sanofi-Pasteur MSD perplexed as it clearly looked to be in the forefront to win the contract, given that Gardasil was introduced earlier than CERVARIX and has also raked up a greater market share worldwide. ... Source: www.fiercebioresearcher.com --- 42 days ago
GlaxoSmithKline now says it will wait for the completion of a late-stage trial of its cervical cancer vaccine CERVARIX before answering the FDA's questions about the therapy. That will push back any approval of CERVARIX until 2010, at the earliest. And it confirms some of the worst fears of market analysts, who see Merck's Gardasil gobbling up the market long before CERVARIX arrives on the scene. The long-term efficacy trial that GSK is waiting on tracks the real-world experiences of girls and young women who have been vaccinated. The cancer vaccine is on sale in 67 countries. - read the report in the Financial Times Related Articles: Glaxo's CERVARIX delayed until late 2009 GSK hit with CERVARIX application delay U.K. health officials in cancer vaccine fight France picks Gardasil over GSK upstart ... Find more results for CERVARIX on RSSMicro.com |
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GlaxoSmithKline Vaccine Unlikely To Receive US Approval For 2 Years London-The new cervical cancer vaccine that has been submitted by GlaxosmithKline for approval in the United States is not likely to receive the go ahead until 2010 at the earliest. The company has released a new timetable that sets its expectant date for approval of its new CERVARIX Cancer Vaccine at 2010 at the earliest. The Food and Drug Administration has asked for fresh information from the company in December, and then decided to wait upon the completion of a clinical trial in the United States that is considered pivotal. After the results of the trial are made public the GSK Company believes that its efforts to have CERVARIX approved will be made a lot easier. The company believes that the trial will show the efficacy and positive usage of its new vaccine. The timetable tends to confirm the longstanding fears in the marketplace that CERVARIX would be delayed. There is a rival vaccine already in the market, Gardasil, which is produced by Merck and it is already on sale in the United States. The CERVARIX vaccine was originally submitted for FDA approval in March 2007 but has since been withdrawn by the company. ...