GlaxoSmithKline Drops the Price of Cervarix

Source: PharmaLive MISSISSAUGA, ON, Oct. 25 /CNW/ - Today, GlaxoSmithKline Inc. (Canada), announced its plan to reduce the cost of CERVARIX™ by 30%. The cost reduction is in response to recent research that demonstrates the relatively high price of cervical cancer vaccines, coupled with a low understanding of their protective benefits topped the list of reasons why the majority of young Canadian women have yet to be immunized. Last week, research supported by The Society of Gynecologic Oncology of Canada (GOC), The Society of Obstetricians and Gynaecologists of Canada (SOGC), the Federation of Medical Women of Canada (FMWC), and the Society of Canadian Colposcopists (SCC) revealed that 9 out of 10 Canadian women aged 18 to 25 have not been vaccinated against cervical cancer. Half of young women polled (who do not have a private drug plan) cited cost as a barrier to obtaining the vaccine and 61% of mothers of young women agreed that cost was a deterring factor. In fact, 50% of non-vaccinated women aged 18 to 25 without vaccine coverage through their drug plan and 61% of mothers with daughters in this age group cited cost as a deciding factor. This is particularly relevant as 60% of Canadians do not have vaccine coverage through private insurance.1 As a patient-focused company, GlaxoSmithKline Inc. was concerned to learn that the cost of cervical cancer vaccines is deterring women from protecting themselves from a largely preventable disease that kills one Canadian woman every day.2 Effective today, October 25, 2010, the [...]

2010-10-26T13:57:51-07:00October, 2010|Oral Cancer News|

ACOG Endorses Guidelines on HPV Vaccination

Source: MedPage Today Author: John Gever The American College of Obstetricians and Gynecologists is adding its weight to recommendations that 11- and 12-year-old girls be vaccinated against human papillomavirus (HPV) and that "catch-up" shots are a good idea for unvaccinated teens and young women up to age 26. In a new statement, ACOG's Committee on Adolescent Health Care also stressed that Pap smears are still necessary for women starting at 21, even if they've been vaccinated against HPV. Current vaccines do not protect against all viral strains, and vaccination does not clear preexisting infections. Two HPV vaccines are now available: a bivalent product (Cervarix) that protects against genotypes 16 and 18; and a quadrivalent product (Gardasil) that protects against the same two strains plus genotypes 6 and 11. The new statement, published online in Obstetrics & Gynecology, updates one issued in 2006 when the quadrivalent product was approved. The bivalent vaccine was approved last October. The federal Advisory Committee on Immunization Practices has recommended that girls first receive HPV immunization at age 11 or 12, before becoming sexually active, and the ACOG committee said that was appropriate in most cases. "Depending on the circumstances, the vaccine can be given to individuals as young as age 9 years," the committee indicated. Vaccination before the start of sexual activity ensures maximal effectiveness, but ACIP has recommended catch-up vaccination for sexually active young women who have not received either product. The ACOG committee endorsed the recommendation, noting that the vaccines may even be given [...]

2010-10-13T16:40:03-07:00October, 2010|Oral Cancer News|

GSK European Commission amends licence for Cervarix

By: GlaxoSmithKline Source: PharmPro GlaxoSmithKline (GSK) confirmed today that the European Commission has granted Marketing Authorisation to amend the licence for its cervical cancer vaccine, Cervarix®. The approval from the European Commission is important as it recognises the extent of cervical cancer protection demonstrated by Cervarix®, which was not highlighted by the previous indication. The licence amendment is supported by data from the largest efficacy trial of a cervical cancer vaccine conducted to date, the PATRICIA study, and acknowledges that Cervarix® has shown efficacy beyond HPV 16 and 18, the two virus types contained in the vaccine. The summary of product characteristics (SPC) for Cervarix® will be updated to include the prevention of precancerous lesions and cervical cancer causally related to certain strains of the human papillomavirus (HPV) and will reflect data showing efficacy against the two vaccine types contained in the vaccine (HPV 16 and 18) and the three next most common cancer-causing virus types (HPV 31, 33 and 45).* Together these five HPV types (16, 18, 31, 33 and 45) account for 80 percent of all cervical cancers. * Vaccine efficacy is different for each of the HPV types 16, 18, 31, 33 and 45, and varies in different cohorts and endpoints. GlaxoSmithKline Biologicals (GSK Biologicals), GlaxoSmithKline’s vaccines business, is one of the world’s leading vaccine companies and a leader in innovation. The company is active in vaccine research, development and production with over 30 vaccines approved for marketing and 20 more in development - both in the prophylactic and therapeutic fields [...]

2010-09-17T09:07:55-07:00September, 2010|Oral Cancer News|

Dermatologist discusses advantages of vaccines that prevent human papillomavirus and herpes zoster

Source: www.prnewswire.com Author: public release Vaccines have a long history of successfully preventing disease and, in effect, improving the lives of countless Americans. Now, two serious diseases – human papillomavirus (HPV) and herpes zoster – could become a thing of the past as people better understand the safety and efficacy of vaccines to prevent these serious viral infections in specific populations. At the American Academy of Dermatology's Summer Academy Meeting 2010 in Chicago, dermatologist Jeffrey M. Weinberg, MD, FAAD, associate clinical professor of dermatology at Columbia University College of Physicians and Surgeons in New York City, highlighted the significant benefits associated with these two new vaccines. HPV Vaccine Protects Girls and Boys HPV is a group of viruses commonly linked to the sexually transmitted diseases known as genital HPV infection, which have long been associated with the development of cervical cancer, a life-threatening cancer. According to the American Cancer Society's 2010 estimates, approximately 4,210 women will die from cervical cancer in the United States. In 2006, a breakthrough vaccine was approved by the FDA for the prevention of HPV types 6, 11, 16 and 18. HPV types 6 and 11 are responsible for more than 90 percent of all cases of genital warts, and HPV types 16 and 18 cause 70 percent of all cervical cancers. Although the vaccine is specifically approved for use in females 9 to 26 years of age, Dr. Weinberg acknowledged that many people are still reluctant to get the vaccination due to a lack of [...]

European Commission amends licence for Cervarix

Source: www.pharmpro.com Author: press release GlaxoSmithKline (GSK) confirmed today that the European Commission has granted Marketing Authorisation to amend the licence for its cervical cancer vaccine, Cervarix®. The approval from the European Commission is important as it recognises the extent of cervical cancer protection demonstrated by Cervarix®, which was not highlighted by the previous indication. The licence amendment is supported by data from the largest efficacy trial of a cervical cancer vaccine conducted to date, the PATRICIA study, and acknowledges that Cervarix® has shown efficacy beyond HPV 16 and 18, the two virus types contained in the vaccine. The summary of product characteristics (SPC) for Cervarix® will be updated to include the prevention of precancerous lesions and cervical cancer causally related to certain strains of the human papillomavirus (HPV) and will reflect data showing efficacy against the two vaccine types contained in the vaccine (HPV 16 and 18) and the three next most common cancer-causing virus types (HPV 31, 33 and 45).* Together these five HPV types (16, 18, 31, 33 and 45) account for 80 percent of all cervical cancers. Note: 1. Vaccine efficacy is different for each of the HPV types 16, 18, 31, 33 and 45, and varies in different cohorts and endpoints.

Should boys also get vaccinated for HPV?

Source: www.npr.org Author: Brenda Wilson Many adolescents are having back-to-school visits with their doctors. That usually means shots — including, for some, the HPV vaccine. It's mainly given to adolescent girls to protect against the human papillomavirus, which causes cervical cancer. But there's a debate among scientists about whether to immunize boys as well. 'Herd Immunity' If this were a high school debate, it would go something like this: Be it resolved that all adolescent girls and boys should be vaccinated against HPV before they are sexually active, since more than half of all sexually active men and women will get HPV at some point in their lives. In the affirmative, there's Dr. Doug Lowy, co-inventor of the HPV vaccine who works at the National Cancer Institute. He says that since just 11 percent of girls now get all three doses of the vaccine and less than half get even one dose, rates of HPV in the U.S. are unlikely to come down very much. So, he says, let's offer the vaccine to boys as well. "When the percentage of girls getting vaccinated are in the 30 to 40 percent range, vaccinating boys is suggested to have a substantial enhancing impact on trying to protect those girls who are not vaccinated," Lowy says. He says it would provide "herd immunity." Boys don't get cervical cancer, but they can transmit HPV. So vaccinating boys would reduce the amount of HPV circulating in the population. Practical Dilemmas Speaking for the opposing side, [...]

Human papilloma virus (HPV) and cancer

Source: ezinearticles.com Author: David Warmflash, MD Human papilloma virus (HPV), is a category of viruses of which more than seventy subtypes are known. Most people have heard of HPV, because the media have spent a good deal of time discussing the issue of mandatory vaccination against the virus. The discussion in the news is well-deserved. Each year, approximately 6.2 million people are infected with (HPV). Usually, the virus is cleared by the immune system, before any disease can develop. However, because of the high rate of infection, HPV-associated disease is all-too common around the world. Each year 11,000 new cases of invasive cervical cancer are diagnosed in the United States, leading to approximately 4,000 deaths. The rate would be much higher, were it not for the advent of the the Papanicolaou test (Pap smear), used to screen for precancerous conditions since the 1930s. Since Pap smears and HPV vaccinations are hot topics, even if you have no background in medicine, it is likely that you are aware of HPV as an agent that causes cervical cancer. What you may not know, however, is that HPV also is involved in cancers of the throat and the skin. Actually, not all of the subtypes of HPV are known to be involved in the pathological process leading to cancer and precancerous conditions of the cervix. Of the HPV subtypes linked to cervical cancer, four types are most important. These are HPV-6b, HPV-11, HPV-16, and HPV-18, the latter two being the most dangerous for [...]

Vaccines might help fight throat cancer, but hurdles are high

Source: www.npr.org Author: Chao Deng There's been a big and controversial push to protect girls from cervical cancer by vaccinating them against the human papillomavirus. Turns out, the same vaccine might also protect boys from developing throat cancer later in life. Researchers estimate HPV causes more than 11,000 cases of throat cancers in the U.S. each year. Many are cropping up in younger people, especially in white men. Changes in sexual behavior have led to an increase in that could mean more than 20,000 cases annually by 2015, Forbes reports. So wouldn't you think that a growing market like that would be attractive to makers of HPV vaccines? Not so much, it turns out. Merck's Gardasil vaccine is approved for use in boys, but only to protect against genital warts. And a company spokeswoman told us in an email that Merck isn't looking to pursue approval of a throat-cancer indication anytime soon because of "competing research and business priorities." Same goes for Glaxo, according to Forbes. A big hurdle is that doctors can't screen for throat cancer the way they can for cervical cancer with a Pap smear. Without a simple test, it's harder to show the HPV vaccine reduces the risk of throat cancer. And that, in turn, makes it harder for vaccine makers to run a study that will pass muster with the Food and Drug Administration. But the outlook isn't completely bleak. Ohio State researcher Maura Gillison, who got funding for a pilot vaccine study [...]

Nicotine vaccine shows effectiveness in early tests

Source: CNN Author: Val Willingham (CNN) -- A vaccine that could help people stop smoking is showing promise in early clinical trials, researchers announced this week at a national meeting of addiction specialists. The vaccine is designed to stimulate the immune system to generate antibodies that would latch on to nicotine in a smoker's body and prevent it from ever entering the brain. The vaccine maker, Nabi Biopharmaceuticals, reported that those who responded best to NicVAX in earlier testing had been able to quit smoking for three times longer than those in the placebo group, with data from 19 to 26 weeks, and then for 12 months. These are considered statistically significant results and superior to the testing results of Zyban and Chantix, prescription medications already approved to help smokers over the age of 18 quit, Nabi officials told the National Institute on Drug Abuse conference in Albuquerque, New Mexico. In addition, those whose bodies responded most effectively to NicVAX cut the number of cigarettes smoked, from a baseline of 20 cigarettes per day to 10 cigarettes per day. Those who took the vaccine experienced few side effects, said Dr. Raafat Fahim, president and CEO of Nabi Biopharmaceuticals. In 2009, Zyban and Chantix were ordered by the Food and Drug Administration to carry "black box" warnings of the risk of depression and suicidal thoughts. Nabi began the first phase III trials for NicVAX last November, enrolling 1,000 people. In March, a second phase III trial began with another 1,000 participants. [...]

2010-04-23T07:03:24-07:00April, 2010|Oral Cancer News|

Another call to extend HPV vaccine to boys. Is anyone listening?

Source: www.abc.net.au Author: Lindy Kerin Australian researchers say the human papillomavirus (HPV), which can cause cervical cancer in women, is now a leading cause of oral cancer in men in the Western world. The news has reignited debate over whether the HPV vaccine, which is free for young women, should also be offered to men. A University of Sydney study shows that 60 per cent of throat and tonsil cancers are caused by the virus. "We've tested just over 300 cancers of the oropharynx, and the oropharynx includes the tonsil and the base of tongue and part of the pharangyl wall," said Barbara Rose, an Associate Professor in research at the University of Sydney. "We've tested those for the human papillomavirus type-16 and type-18, which are the major cause of cervical cancer in women. "And we found a sizeable proportion are associated with those types. In fact, probably in excess of 50 per cent now." Those figures from 2001 to 2005 increased to almost 60 per cent in 2006 and 2007. Associate Professor Rose says head and neck cancers have traditionally been associated with older men and related to alcohol and smoking. She says these findings show that has now changed and most are due to the increasing practise of oral sex. "We now know that there's another subset, which is quite distinct biologically, which tends to affect younger people who don't smoke and don't drink, caused by human papillomavirus probably by sexual transmission," she said. "And the types of [...]

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