MedWorm provides a medical RSS filtering service. Over 6000 RSS medical sources are combined and output via different filters. This feed contains the latest medical blog items that have been tagged with 'cervarix'. Sat, 03 Sep 2011 02:09:33 +0100 http://www.medworm.com/index.php?rid=5159832&cid=t_111382_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FMZZz09zPr9Q%2F Despite strong endorsements from public health officials, teenage vaccination rates for the HPV vaccine are trailing the other two vaccines recommended for teens and pre-teens, according to the Centers for Disease Control and Prevention. The two vaccines approved to combat the human papillomavirus are Gardasil, which is sold by Merck, and Cervarix, which is sold by GlaxoSmithKline. To be specific, coverage was 49 percent for one dose of HPV vaccine; 63 percent for MenACWY, which protects against meningococcal meningitis; and 69 percent for the TDP vaccine, which guards against tetanus, diptheria and pertussis. Meanwhile, coverage increases for Tdap and MenACWY vaccines grew 13.3 percent and 9.1 percent, respectively. For girls who received the recommended three doses of HPV vaccine, covera... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=5159832 Fri, 26 Aug 2011 12:25:02 +0100 5159832 http://www.medworm.com/index.php?rid=4992991&cid=t_111382_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FrcQNRvANhJM%2F Once again, the vaccines for thwarting HPV, notably Merck’s Gardasil, are causing a stir. In the latest dust up, the California Catholic Conference is urging state residents to contact their legislators to oppose a bill that would remove parental consent for vaccinating children 12 and older against sexually transmitted diseases. Although California law already allows children 12 and older to consent to treatment for sexually transmitted diseases without involvement from their parents, the proposed bill would expand that right to immunizations (read the bill here). In an action alert, the bishops’ group warns parents that “minors do not have adequate judgment to make a decision about a vaccine that as of January 15, 2011, had 21,171 adverse reactions and 91 deaths report... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4992991 Fri, 01 Jul 2011 15:10:17 +0100 4992991 http://www.medworm.com/index.php?rid=4762936&cid=t_111382_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FAEspvdtrmw4%2F Less than a month after the FDA refused to approve the Gardasil vaccine for preventing HPV in women ages 27 to 45, Health Canada has gone in the other direction and issued an endorsement. Although Canada is a smaller market than the US, the approval is a notable step for Merck, which has been counting on a larger demographic target to boost sorely needed vaccine revenue. In the US, Merck has been repeatedly frustrated in trying to widen the market for Gardasil. Last year, the FDA postponed a decision about approval for women ages 26 to 45 after Merck had submitted additional data. The submission was made after the agency three years ago refused to approve the vaccine for this same age bracket and, instead, sought data on a 48-month study (back story). In Canada, Gardasil is now approved to... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4762936 Thu, 28 Apr 2011 16:32:43 +0100 4762936 http://www.medworm.com/index.php?rid=4684762&cid=t_111382_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FxvsJhjRYHqc%2F In a setback to Merck, the FDA has refused to approve the use of the Gardasil vaccine for preventing HPV in women ages 27 to 45, a market the drugmaker has been counting on to boost sorely needed vaccine revenue. In a brief statement, Merck says prescribing info was updated to indicate Gardasil has not demonstrated to prevent HPV-related cervical cancer in women older than 26. The drugmaker has been repeatedly frustrated in its quest to widen the market for Gardasil. Last year, the FDA postponed a decision about approval for women ages 26 to 45 after Merck had submitted additional data. The submission was made after the agency three years ago refused to approve the vaccine for this same age bracket and, instead, sought data on a 48-month study (back story). The vaccine is already approved ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4684762 Wed, 06 Apr 2011 22:11:21 +0100 4684762 http://www.medworm.com/index.php?rid=4642052&cid=t_111382_139_f&fid=38879&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FVirologyBlog%2F%7E3%2FsCXkxV-UUWQ%2F Hosts: Vincent Racaniello, Dickson Despommier, Alan Dove, Rich Condit, and Michelle Ozbun On episode #126 of the podcast This Week in Virology, virologist Michelle Ozbun and the TWiV team review the biology of human papillomaviruses. Click the arrow above to play, or right-click to download TWiV #126 (69 MB .mp3, 96 minutes). Subscribe to TWiV (free) in iTunes , at the Zune Marketplace, by the RSS feed, by email, or listen on your mobile device with the Microbeworld app. Links for this episode: Human papillomavirus page at CDC Human papillomavirus vaccines page at CDC A better test for HPV (pdf) Human papillomaviruses and malignancy (review) Should smallpox stocks be destroyed? (poll at virology blog) TWiV on Facebook Letters read on TWiV 126 Weekly Science Picks Michelle –... virology blog blogs http://www.medworm.com/rss/comments.php?id=4642052 Sun, 27 Mar 2011 15:43:44 +0100 4642052 http://www.medworm.com/index.php?rid=4446036&cid=t_111382_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FjcEW-wZX9A8%2F Hello, everyone, and nice to see you again. We hope the weekend was refreshing and interesting. Now, of course, the routine returns as those meetings and deadlines beckon. To cope, we are brewing our usual cup to stimulation - our flavor today is Gingerbread - and invite you to join us. Or grab a bottle of water, if you prefer. Meanwhile, here are a few tidbits to help you get started. Hope your day goes well and do stay in touch… AstraZeneca And Wellpoint To Conduct CE Studies (Dow Jones) Glaxo To Pay $250M To Resolve Avandia Lawsuits (Bloomberg News) Canada Debates HPV Vaccines For Boys (CTV) Pfizer Will Buy Danish Consumer Health Business (Associated Press) Roche Says Turkish Price Cuts Hurt Investment (Bloomberg News) Glaxo Updates Avandia Labeling (Associated Press) AstraZeneca ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4446036 Mon, 07 Feb 2011 12:54:46 +0100 4446036 http://www.medworm.com/index.php?rid=4155401&cid=t_111382_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fain6fpEbfME%2F The reasons are likely numerous, but only 27.3 percent of eligible teenage girls and young women chose to begin the three-dose series of an HPV vaccine. And of these, 39.1 percent completed just one dose, 30.1 percent got two doses and 30.7 percent finished the series, according to research being presented this week at the American Association of Cancer Research annual meeting. The data comes from a review of medical records of 9,658 girls and women between the ages of 9 and 26 who were seen at the University of Maryland Medical Center between August 2006 and August 2010, HealthDay writes. The abstract also revealed that blacks were less likely than whites to get all three doses, and women aged 18 through 26 were less likely than younger girls to complete the series. Last summer, a US Cen... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4155401 Thu, 11 Nov 2010 13:36:09 +0100 4155401 http://www.medworm.com/index.php?rid=4133716&cid=t_111382_87_f&fid=39261&url=http%3A%2F%2Fvactruth.com%2F2010%2F11%2F02%2Fglaxo-smith-kline-brainwash-doctors-hpv-vaccine%2F In June 2008 a promotional DVD was sent to every General Practitioner (G.P.) in the UK just hours before the launch of the Cervarix vaccine in the UK. The DVD was posted with the G.P. magazine and was a clever marketing strategy aimed at busy G.P.’s to ‘brainwash‘ them into believing that the Cervarix vaccine protected young women from the perils of cervical cancer. With phrases such as ‘Cervarix, the vaccination to prevent cervical cancer’ and convincing animation, the DVD certainly goes all out to convince the medical profession that the vaccine is safe, effective, and a must for all young women. One organisation that promotes vaccination safety S.A.N.E Vax Inc (http://sanevax.org/) (Safe, Affordable, Necessary and Effective Vaccines) were so shocked at what... vactruth.com blogs http://www.medworm.com/rss/comments.php?id=4133716 Tue, 02 Nov 2010 19:54:02 +0100 4133716 http://www.medworm.com/index.php?rid=4118939&cid=t_111382_87_f&fid=39261&url=http%3A%2F%2Fvactruth.com%2F2010%2F10%2F26%2Fmultiple-deaths-linked-to-childhood-vaccines%2F On 24th October 2010, the Sunday Times reported new evidence suggesting that forty children have died over the past seven years following a routine childhood vaccination. This was revealed after the Sunday Times sent a Freedom of Information (FOI) data request to the Medicines and Healthcare products Regulatory Authority (MHRA). The FOI data revealed that childhood vaccinations are suspected to have caused forty deaths, of leaving two young children with brain injuries and causing more than 1,500 other neurological reactions, including 11 cases of inflammation of the brain, 13 cases of epilepsy and a coma. In the article ’40 deaths linked to child vaccines over seven years’ by Sarah-Kate Templeton (http://www.thesundaytimes.co.uk/sto/news…), Templeton reported that when a... vactruth.com blogs http://www.medworm.com/rss/comments.php?id=4118939 Tue, 26 Oct 2010 16:19:22 +0100 4118939 http://www.medworm.com/index.php?rid=4106059&cid=t_111382_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FSQVMR3QVZ2E%2F Taking a direct approach with the FDA is all the rage these days. For instance, aggrieved investors recently created an online petition to implore the FDA to investigate staffers for their input into a recent panel meeting for the Arena Pharmaceutical diet pill (see this). And now several parents, who formed a non-profit to protest widespread use of Merck’s Gardasil vaccine for HPV, have written the agency to demand that approval be rescinded. In its letter, SANE Vax argues that the FDA permitted Merck to use “an inappropriate primary endpoint and unreliable HPV genotyping methods” evaluating efficacy. You can read the letter here to learn more, but basically the group maintains that less serious cervical lesions were permitted as an endpoint and they cite National Cancer... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4106059 Mon, 25 Oct 2010 16:05:35 +0100 4106059 http://www.medworm.com/index.php?rid=4106064&cid=t_111382_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FjEVliExIRuE%2F Hello, everyone. Nice to see you again. Hope your weekend was refreshing and relaxing. Now, of course, the routine returns as we gear up for those meetings and deadlines. To cope, we are brewing our favorite cup of stimulation. Please join us as we peruse the news of the world and continue our quest for interesting items. Tidbits are always welcome. Hope your day goes well and see you soon… Novartis Menveo Vaccine Protects Infants In Study (Bloomberg News) Glaxo Cuts Cervarix Price By 30 Percent In Canada (Reuters) Chinese SFDA Steps Up Fake Avastin Investigation (Shanghai Daily) Alcon Names Dan Vasella As Chairman (MarketWatch) FDA Finds High Levels Of Peroxide In Batch of Crospovidone (InPharma-Technologist) J&J Faces UK Class-Action Suit Over Hip Devices (The Daily Mail) Penn... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4106064 Mon, 25 Oct 2010 11:40:04 +0100 4106064 http://www.medworm.com/index.php?rid=3899637&cid=t_111382_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fk0EBwlUTXr4%2F There may still be controversy over human papillomavirus vaccines - notably, Merck’s Gardasil - but teenage vaccination rates are creeping up, according to a US Centers for Disease Control and Prevention survey of more than 20,000 teens between the ages of 13 and 17 (see here). The vaccines, which include GlaxoSmithKline’s Cervarix, were endorsed by public health officials to thwart cervical cancer. Specifically, the survey found increases in the percentage of teens who received vaccines routinely recommended for 11 and 12-year-olds. Among teenage girls who received at least one of three necessary doses of an HPV vaccine, coverage increased 7 percent to about 44 percent. But for girls who received all three doses, coverage was only 27 percent, which amounted to a 9 percent incr... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3899637 Tue, 24 Aug 2010 12:00:24 +0100 3899637 http://www.medworm.com/index.php?rid=3672038&cid=t_111382_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FODzQwVUybYI%2F Yet another setback for Merck, at least for now. The FDA has postponed a decision to broaden usage of its Gardasil HPV vaccine to women between the ages of 27 and 45. Earlier this year, the drugmaker submitted new data to the FDA and had hoped to hear by the end of June, but a Merck spokeswoman tells us the agency will now respond by the end of 2010. The drugmaker has been repeatedly frustrated in its quest to widen the market for Gardasil. The vaccine is already approved to protect against some strains of the human papillomavirus, which can lead to cervical cancer, in girls and women ages 9 to 26. Gardasil is also approved to prevent genital warts in males of the same age. Exactly two years ago, the FDA bounced its request to treat older women and early last year, the FDA again withheld a... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3672038 Wed, 16 Jun 2010 20:17:54 +0100 3672038 http://www.medworm.com/index.php?rid=3618092&cid=t_111382_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FVcXlT15h6x4%2F Welcome back. We hope you had a nice weekend. It was a long one here in the states. Now, of course, the routine has returned and that means a to-do list complete with meetings and deadlines. So grab that cup of stimulation and get ready for another day. To help you along, here are a few items of interest. Have a good one and stay in touch… Glaxo Settles More Avandia Lawsuits (Reuters) AstraZeneca Gets Complete Response Letter For Axanum (Bloomberg News) EMA Urges Cooperation On Overseas Trials (Outsourcing Pharma) UK’s NICE Rejects Novartis’ Xolair For Children (Reuters) CSL Recalls Flu As Side Effects Rise (Bloomberg News) Singapore Considers Mandatory HPV Vaccination (AsiaOne) Elan Optimistic On Sale Of Drug Delivery Unit (InPharmaTechnologist) (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3618092 Tue, 01 Jun 2010 12:03:14 +0100 3618092 http://www.medworm.com/index.php?rid=3408632&cid=t_111382_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FLiUgnNH3qCw%2F Here’s the connection: the human papillomavirus, which can cause cervical cancer, is also linked to head and neck cancer, including one form called oropharyngeal squamous cell carcinoma, or OSCC, which is spread by oral sex, according to a piece in BMJ. And more cases, particularly in the developing world, are being reported, and so the BMJ researchers suggest wider use of HPV vaccines should be explored - for boys as well as girls. “We need to look at the evidence again to re-evaluate the cost-effectiveness of male children in light of this new and rapidly rising incidence,” Hisham Mehanna of the Institute of Head and Neck Studies at University Hospital Coventry, one of the BMJ researchers, told Reuters. Currently, however, the HPV vaccines - Merck’s Gardasil and G... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3408632 Fri, 26 Mar 2010 12:57:33 +0100 3408632 http://www.medworm.com/index.php?rid=3288018&cid=t_111382_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FGM7yGlc5NZ4%2F A New York State bill that would allow healthcare practitioners to vaccinate children (not just girls) under 18 against HPV without parental consent appears to be on hold for now. The language in a Senate bill is being clarified and no other legislative action is currently under way, according to an email from New York State Senator Eric Schneiderman to Diane Harper, who was a researcher for Merck’s Gardasil vaccine and has called for more complete warnings for parents (some background). The disclosure concerning the bill comes after some hoopla over the initiative, which would dovetail with an assembly bill requiring vaccinations before children would be allowed to attend school. The overall effort drew some protest in light of the ongoing debate, in some quarters, over the safety ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3288018 Fri, 19 Feb 2010 16:03:36 +0100 3288018 http://www.medworm.com/index.php?rid=3172200&cid=t_111382_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FdhxPlWdO1r8%2F The Gardasil grope continues. Merck gave the FDA new data to win approval to market its HPV vaccine to women between the ages of 27 and 45. Gardasil is already approved to protect against some strains of the human papillomavirus, which can lead to cervical cancer, in girls and women ages 9 to 26. The vaccine is also approved to prevent genital warts in males of the same age. Merck has been trying for some time to win FDA approval to market Gardasil to more women, but has so far been frustrated. In June 2008, the agency bounced its request to treat women between ages of 27 and 45, which contributed to a slowdown in sales (background here). Early last year, the FDA again withheld approval and asked Merck to submit data when a 48-month study on a test group has been completed. Approved in 200... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3172200 Thu, 14 Jan 2010 12:53:31 +0100 3172200 http://www.medworm.com/index.php?rid=3119061&cid=t_111382_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FHin9M-44yk4%2F The big drugmaker apparently caused a stir in India by running ads to create awareness about cervical cancer, but the campaign drew complaints that GlaxoSmithKline was running fomenting fear. Glaxo, you may recall, markets Cervarix, which is used to prevent certain strains of the human papillomavirus, or HPV, which can lead to cervical cancer. The drugmaker was accused of violating India’s Drugs & Cosmetic Act and the Magical Remedies Act (interesting name, yes?), according to PharmaBiz, which cites unnamed sources saying Glaxo has now told the Drug Controller General of India that the ads will be withdrawn. Medical experts discounted Glaxo’s claim that the ads were launched in public interest to create awareness. “Such advertisements to create public awareness are nor... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3119061 Thu, 24 Dec 2009 13:22:00 +0100 3119061 http://www.medworm.com/index.php?rid=2916433&cid=t_111382_150_f&fid=34768&url=http%3A%2F%2Fpharmagossip.blogspot.com%2F2009%2F10%2Fattention-neurologists-look-for.html Oct. 16, 2009 (Baltimore) -- Researchers believe that there may be a link between a vaccine against cervical cancer and a rapidly progressive, fatal disease in two young women.Both the timing of the symptoms and autopsy results “suggest a link between” the Merck Gardasil vaccine and the fatal cases of amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig's disease, says Catherine Lomen-Hoerth, MD, director of the ALS Center at University of California San Francisco Medical Center.With only two confirmed cases, “we don’t know for sure if it’s coincidence or if they’re connected [to the vaccine],” she tells WebMD. “We hope that by raising awareness, we will become aware of any other cases."More at WebMDPresumably GSK will be looking at Cervarix as well.Hat tip: Helen ... PharmaGossip blogs http://www.medworm.com/rss/comments.php?id=2916433 Thu, 22 Oct 2009 08:48:00 +0100 2916433 http://www.medworm.com/index.php?rid=2905111&cid=t_111382_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FKJA-jZTfpig%2F This study found that while vaccine coverage and efficacy are high in girls, including boys in an HPV vaccination program generally exceeds what the U.S. typically considers good value for money,” researcher Jane Kim, an assistant professor at the Harvard School of Public Health told HealthDay. And this was released just as the CDC’s Advisory Committee on Immunization Practices this week reviews the cost-effectiveness of male vaccination (see agenda). (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=2905111 Mon, 19 Oct 2009 12:17:39 +0100 2905111 http://www.medworm.com/index.php?rid=2899196&cid=t_111382_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FAolc0oPvLag%2F Good morning, everyone. The weather is a bit gloomy here at the Pharmalot corporate campus, but our spirits are holding up. And why not? After all, every brand new day should be unwrapped like a precious gift. Meanwhile, here are a few items of interest. Hope your day goes well and your weekend is thoroughly enjoyable… Pfizer To Close Bridgewater, NJ, Facility (MyCentralNJ.com) Glaxo’s Cervarix Wins Approval In Japan (Bloomberg) AstraZeneca’s Symbicort Also Wins Approval In Japan (Reuters) (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=2899196 Fri, 16 Oct 2009 12:07:13 +0100 2899196 http://www.medworm.com/index.php?rid=2882766&cid=t_111382_139_f&fid=38879&url=http%3A%2F%2Fmedia.rawvoice.com%2Fpmn_twiv%2Fwww.twiv.tv%2FTWiV053.mp3 Hosts: Vincent Racaniello, Dick Despommier, and Alan Dove In episode #53 of the podcast “This Week in Virology”, Vincent, Dick, and Alan talk about Nobel prizes for telomere research, bacteriophages that protect aphids from wasps, salicylates and pandemic influenza mortality, and hand washing. Download TWiV #53 (45 MB .mp3, 62 minutes) Subscribe to TWiV in iTunes, by the RSS feed, or by email Links for this episode: Nobel Prizes for telomere research Bacteriophages encode toxins that protect aphids from wasps 14 year old dies after receiving HPV vaccine Salicylates and pandemic influenza mortality Canadian microbiologist says hand washing is not proven to prevent influenza Surgical mask vs N95 respirator for preventing influenza Americans unsure about receiving pandemic H1N1 ... virology blog blogs http://www.medworm.com/rss/comments.php?id=2882766 Mon, 12 Oct 2009 14:35:08 +0100 2882766 http://www.medworm.com/index.php?rid=2855666&cid=t_111382_111_f&fid=36048&url=http%3A%2F%2Ffeeds.b5media.com%2F%7Er%2Fb5media%2FAHeartyLife%2F%7E3%2FEGWTLO6RZJg%2F Whether you agree with the new HPV (human papillomavirus) vaccines or not, one has to be fair about the news that comes out about it. Last week, it was widely reported that a 14-year-old British girl died after receiving the Cervarix vaccine. This vaccine is being given to young women and adolescent girls to reduce the risk of contracting some types of HPV, which are known to cause a significant number of cervical cancer cases. Sadly, Natalie, the 14-year-old, became ill shortly after being vaccinated and she died not long after. Of course, it wasn’t hard not to blame the vaccine as it certainly appeared that the cause and effect was there. But after examining Natalie’s body, doctors confirmed that her death was not due to the vaccine, but rather that, Natalie had an undetected... A Hearty Life blogs http://www.medworm.com/rss/comments.php?id=2855666 Fri, 02 Oct 2009 14:33:02 +0100 2855666 http://www.medworm.com/index.php?rid=2842785&cid=t_111382_150_f&fid=34768&url=http%3A%2F%2Fpharmagossip.blogspot.com%2F2009%2F09%2Fgsk-crevarix-our-thoughts-today-are.html Story (Source: PharmaGossip) PharmaGossip blogs http://www.medworm.com/rss/comments.php?id=2842785 Tue, 29 Sep 2009 04:50:00 +0100 2842785 http://www.medworm.com/index.php?rid=2006394&cid=t_111382_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F471402611%2F Unlike many other European countries, Ireland has chosen not to launch a program to vaccine young girls and women, prompting Glaxo, which sells Cervarix, and Sanofi-Pasteur, which markets Merck’s Gardasil in Europe, to fly in experts to talk to consultants and public health care professionals about the benefits of their HPV vaccines, according to The Times of London. Ireland’s health department cited administrative costs as its reason for not proceeding. A spokeswoman for health minister Mary Harney tells the Times she is already convinced of the important role a vaccine program would play “as part of a cohesive response” to cervical cancer, but the “decision not to proceed at this point is not based on the scientific evidence, but is related to the need to prioritize... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=2006394 Mon, 01 Dec 2008 15:26:07 +0100 2006394 http://www.medworm.com/index.php?rid=1892145&cid=t_111382_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F425618832%2F There are reports from the Netherlands that the Health Inspectorate raided the drugmakers’ offices late last week as part of an investigation into the Health Council, an independent body that advises the Dutch government and parliament on public health issues, and recently recommended that girls should be vaccinated against HPV (look here). In Europe, Sanofi-Aventis markets Gardasil, as part of a joint venture with Merck, and Glaxo markets Cervarix, which is not yet approved in the US. Both vaccines are given to treat HPV, which can lead to cervical cancer. The reports say that Health Council members were receiving research funding from the drugmakers at the same time the organization issued its recommendation to Health Minister Ab Klink. The Socialist Party is demanding a parliament... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1892145 Sun, 19 Oct 2008 17:22:45 +0100 1892145 http://www.medworm.com/index.php?rid=1829480&cid=t_111382_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F402067398%2F A Roman Catholic school in the UK has banned its students from receiving the Cervarix vaccine on its premises, the BBC reports. Governors at St Monica’s High School in Prestwich, Greater Manchester, believe the school is “not the right place” to administer the injections. The Roman Catholic Church says there is nothing wrong with allowing vaccinations, according to the BBC, but governors at St Monica’s, which has 1,200 pupils, sent a letter to parents questioning effectiveness and pointed out possible side effects. The letter says a number students who took part in a pilot study subsequently suffered nausea, joint pain, headaches and high fevers. “We do not believe that school is the right place for the three injections to be administered,” the letter ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1829480 Wed, 24 Sep 2008 19:19:00 +0100 1829480 http://www.medworm.com/index.php?rid=1798532&cid=t_111382_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F393115508%2F Welcome to the working week. We hope your weekend was pleasant and there was time to catch up on the important things in life. Now, of course, the routine returns with all those meetings and deadlines and political intrigue. Should be enough to keep anyone busy. So, time to get started… Scotland’s Catholic Schools Approve Use Of Glaxo HPV Vaccine (Catholic Exchange) Walgreens Tops CVS Bid For Longs Drug Stores (Yahoo/Associated Press) Data Supports Glaxo’s Tykerb For Head & Neck Cancer (Reuters) Cholesterol Drug Scientist Receives ‘America’s Nobel’ (Scientific American) (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1798532 Mon, 15 Sep 2008 11:10:20 +0100 1798532 http://www.medworm.com/index.php?rid=1790482&cid=t_111382_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F391130279%2F Perhaps this will fan the controversy over the HPV vaccine still more. In any event, the agency expanded Gardasil’s approved uses to include cancer of the vagina and vulva, but at the same time added new info to the prescribing label about reports of deaths and illnesses. Overall, though, the move gives Merck a boost over Glaxo, whose Cervarix HPV vaccine was delayed last year by the FDA. Gardasil was approved to protect females ages 9 to 26 against four strains of HPV, which can cause up to 70 percent of cervical cancers and 90 percent of genital warts. Docs, however, have needed incentives and Wall Street is disappointed with Gardasil revenue. You may recall that a recent study found Gardasil makes economic sense for preteens because they are less likely to have the sexually transm... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1790482 Sat, 13 Sep 2008 01:14:10 +0100 1790482 http://www.medworm.com/index.php?rid=1750107&cid=t_111382_150_f&fid=34768&url=http%3A%2F%2Fpharmagossip.blogspot.com%2F2008%2F09%2Fcervix-wars-contd-score-one-for.html The pink leaflets are ready, the posters are poised to go up and the advertising slots have been booked both on kids and primetime TV and radio.Tomorrow marks the start of a new academic year. It is also the launch date of a campaign which heralds the introduction of the biggest mass vaccination programme for more than a decade.By the end of September, there will hardly be a Year Eight girl (aged 12-13) in the UK who doesn't know that, barring an opt-out, she is shortly to receive three injections of the drug Cervarix, which will offer her 70 per cent protection against cervical cancer.More (Source: PharmaGossip) PharmaGossip blogs http://www.medworm.com/rss/comments.php?id=1750107 Tue, 02 Sep 2008 07:46:00 +0100 1750107 http://www.medworm.com/index.php?rid=1660743&cid=t_111382_150_f&fid=34768&url=http%3A%2F%2Fpharmagossip.blogspot.com%2F2008%2F07%2Fcervix-wars-contd_28.html The UK Department of Health has announced (PDF) that the human papillomavirus vaccination programme is to be extended to include young women aged 17-18.The decision to use Cervarix® has been criticised but this announcement does start to explain why the programme is using an apparently inferior vaccine.Hat tip: http://www.prescriber.org.uk/ (Source: PharmaGossip) PharmaGossip blogs http://www.medworm.com/rss/comments.php?id=1660743 Mon, 28 Jul 2008 14:00:00 +0100 1660743 http://www.medworm.com/index.php?rid=1556385&cid=t_111382_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F323640511%2Fgsk_answers_fda_on_cervarix.html 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, andwe expect the final results will strengthen the U.S. label forCERVARIX(R)," said Barbara Howe, M.D., Vice President and Director, NorthAmerican Vaccine Development, GlaxoSmithKline. "We continue to havepositive and productive disc... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=1556385 Mon, 30 Jun 2008 19:00:46 +0100 1556385 http://www.medworm.com/index.php?rid=1556509&cid=t_111382_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F323346511%2F As a result, the Cervarix vaccine may not become available until mid or late 2009, at the earliest. You may recall that, last December, the FDA issued a so-called ‘complete response letter’ for Glaxo’s HPV vaccine, which would compete with Merck’s Gardasil, but it was unclear at the time whether additional clinical trials would be required. Today, the drugmaker says new clinical studies are not expected to be required for approval, but other data will submitted. Specifically, this would be final data from a Phase III pivotal efficacy study, which should be available later this year and submitted to the FDA in the first half of 2009, although exact timing is hard to predict. And with another six-month review period, Cervarix won’t be on the market until late 2009, at t... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1556509 Mon, 30 Jun 2008 13:27:25 +0100 1556509 http://www.medworm.com/index.php?rid=1556512&cid=t_111382_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F323189744%2F So what else is new? In yet another round-up that discusses the slow rate of approvals compared with the number of FDA warnings, rejections and delays, The Wall Street Journal gathers some recent developments to re-examine the issue once again. Last year, the FDA approved 19 new meds, the fewest in 24 years, and announced about 75 new or revised Black Box warnings, which was twice the number in 2004. The number of approvable letters, which postpone FDA decisions pending more data, increased by 40 percent last year, according to Sagient Research, the paper writes. Meanwhile, pharma grouses the European Medicines Agency has approved several drugs that haven’t passed muster with the FDA, including Galvus, Prexige and Acomplia. The FDA has delayed approval of Glaxo’s HPV vaccine, ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1556512 Mon, 30 Jun 2008 11:42:48 +0100 1556512 http://www.medworm.com/index.php?rid=1535948&cid=t_111382_136_f&fid=36051&url=http%3A%2F%2Ffeeds.b5media.com%2F%7Er%2Fb5media%2FCancerCommentary%2F%7E3%2F316685691%2F GlaxoSmithKline has won a contract with the UK’s NHS to supply its cervical cancer vaccine, Cervarix. The battle to supply a vaccine against cervical cancer for use across Britain has been won by GlaxoSmithKline (GSK). Cervarix, the GSK vaccine, will be given to girls aged between 12 and 13, starting in September this year, and should prevent about 70 per cent of cervical cancers — saving 400 lives a year when the effect is fully felt. Read more from The UK Times Online. Let’s wait and see what Merck (maker of the other cervical cancer vaccine Gardasil) has to say about this. Tags: CErvarix, cervical-cancer, cervical-cancer-vaccine, Gardasil, GlaxoSmithKline, Merck, UK NHSShare This (Source: Cancer Commentary) Cancer Commentary blogs http://www.medworm.com/rss/comments.php?id=1535948 Sat, 21 Jun 2008 04:48:23 +0100 1535948 http://www.medworm.com/index.php?rid=1531224&cid=t_111382_150_f&fid=34768&url=http%3A%2F%2Fpharmagossip.blogspot.com%2F2008%2F06%2Fcervix-wars-score-one-for-cervarix.html The Department of Health has announced that the national contract for human papillomavirus vaccine (HPV) has gone to Cervarix®. This announcement has also been reported in the general media (BBC, The Times).As previously noted, Gardasil® has a wider range of licensed indications based on the current Summaries of Product Characteristics (Cervarix and Gardasil). In addition to the wider range of indications, Gardasil is also licensed in a wider age group and for both genders.The official announcement notes that the decision was based on a wide range of criteria such as their scientific qualities and cost effectiveness but that the price remains commercially confidential.At a time when the NHS has a significant cash surplus it must be hoped that, for reasons of transparency, the rationale f... PharmaGossip blogs http://www.medworm.com/rss/comments.php?id=1531224 Thu, 19 Jun 2008 08:39:00 +0100 1531224 http://www.medworm.com/index.php?rid=1314432&cid=t_111382_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F254359690%2F The FDA will consider whether to expand the HPV vaccine for women between 27 and 45 years old, according to a statement from the drugmaker. You may recall that Gardasil is currently approved for use in girls and women between 9 and 26 years old to block four types of humanpapilloma virus, which can lead to cervical cancer and genital warts. A decision is expected this summer. This, of course, would greatly increase the market for Gardasil. The question then becomes what kind of marketing campaign will Merck employ to promote the vaccine. The news comes, by the way, a year after the controversy over its aggressive marketing push. At that time, Merck attempted to influence Women In Government, which actively promotes the vaccine. Several legislators around the country who belong to the non-p... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1314432 Wed, 19 Mar 2008 15:58:58 +0100 1314432 http://www.medworm.com/index.php?rid=1215494&cid=t_111382_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F231093313%2F The drugmaker is having a rough time. The earnings report released today shows a steeper decline in fourth-quarter profit than analysts estimated and, to top it off, Glaxo ceo JP Garnier says earnings will drop this year, mostly due to docs abandoning the Avandia diabetes pill over safety concerns. In response, Glaxo shares plunged as much as 9.5 percent earlier, the most in almost nine years, Bloomberg News points out. Net income fell 10 percent to $2.1 billion, missing analyst estimates. Revenue was little changed, with drug sales dropping 2 percent. Avandia sales, in particular, fell 55 percent, continuing a slide after a study last May linked the pill to an increased risk of heart attacks and strokes. Several other best-sellers, such as Coreg for high blood pressure and antidepressant... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1215494 Thu, 07 Feb 2008 16:08:32 +0100 1215494 http://www.medworm.com/index.php?rid=1215497&cid=t_111382_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F230982477%2F Sanofi-Pasteur is criticizing Glaxo’s new Cervarix in an attempt to bolster its lead in the burgeoning market for HPV vaccines, The Financial Times writes. The vaccine maker, which sells Merck’s Gardasil in Europe, has been wooing investors this week with presentations claiming greater proven health benefits from Gardasil in preventing human papilloma virus infections, which is the leading cause of cervical cancer. Didier Hoch, who heads a joint venture between Sanofi-Aventis and Merck for European vaccine marketing, says published Glaxo results on Cervarix were less conclusive and dismissed as “a marketing gimmick” a clinical study that directly compares the two products. He lambasted the head-to-head study of Cervarix and Gardasil for its small sample size, use of... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1215497 Thu, 07 Feb 2008 13:33:03 +0100 1215497 http://www.medworm.com/index.php?rid=1200760&cid=t_111382_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F228865026%2F Welcome to the working week. We hope you enjoyed yourselves and feel refreshed, especially those of you who spent last night on the edge of your seats watching the Super Bowl. Not a bad contest, eh? Now, though, it is time to catch up with events. So grab a cup of something hot or a bottle of water and try these… Nigeria’s Case Against Pfizer Set To Resume (Legalbrief.com) Doubts Over Glaxo’s Cervarix Vaccine Launch Persist (The Financial Times) Schering-Plough Says AIDS Drug Subdues Virus (Bloomberg News) Pfizer Gives $1M To Canadian Researchers (The Vancouver Sun) (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1200760 Mon, 04 Feb 2008 12:24:48 +0100 1200760 http://www.medworm.com/index.php?rid=1149830&cid=t_111382_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F216553797%2F Another busy Monday morning. We hope yours is going as well as ours. As we track various interesting developments, here are a few more items to help you prepare for the rest of the day… USPTO Rejects Pfizer’s Basic Lipitor Patent (Yahoo/Reuters) France Backs Use Of Merck’s Gardasil Over Glaxo HPV Vaccine (Yahoo/Reuters) Maryland Court Rejects Thimerosal-Autism Link In Wyeth Vaccine (Yahoo/Reuters) Avalon Pharma Signs Development Deal With Novartis (The Baltimore Sun) Share / E-mail (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1149830 Mon, 14 Jan 2008 17:48:36 +0100 1149830 http://www.medworm.com/index.php?rid=1100156&cid=t_111382_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F201732157%2Fglaxosmithkline_receives_fda_complete_response_letter_for_cervarix.html GlaxoSmithKline announced that it received a FDA complete response letter with regards to its application for new drug status for Cervarix, a cervical cancer vaccine. A complete response letter is issued when the FDA has completed review of the file but still has unanswered questions prior to final approval."We have already started addressing the questions and will be engaged in discussions with the FDA to finalize our responses," said Barbara Howe, M.D., Vice President and Director, North American Vaccine Development, GlaxoSmithKline. "Our discussions with the agency continue to be positive and constructive, and we are working diligently to resolve any outstanding questions to bring CERVARIX(R) to the U.S. market."Cervarix, one of the largest drug hopes in Gl... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=1100156 Mon, 17 Dec 2007 16:00:45 +0100 1100156 http://www.medworm.com/index.php?rid=1098893&cid=t_111382_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F201605490%2F This is another blow for the drugmaker, which is still reeling from the controversy over its Avandia diabetes pill and the subsequent lost revenue. Now, the FDA has issued a so-called ‘complete response letter’ for its Cervarix vaccine. Although it’s not clear, though, whether the agency wants additional trials, leaving open the possibility that the unexpected delay in approval can last anywhere from just six months to up to two years. “We have already started addressing the questions and will be engaged in discussions with the FDA to finalize our responses,” Barbara Howe, vp and director for Glaxo’s North American vaccine development, says in a statement. “Our discussions with the agency continue to be positive and constructive, and we are working dil... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1098893 Mon, 17 Dec 2007 12:07:39 +0100 1098893 http://www.medworm.com/index.php?rid=1003708&cid=t_111382_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F180029611%2F That’s what Merck is touting as the result of its latest study of the HPV vaccine, which so far is approved for girls and women ranging in age from 9 to 26 years of age. In a study of 3,800 women aged 24 to 45, the vaccine prevented 91 percent of cases of persistent infection, minor cervical abnormalities, pre-cancers and genital warts caused by four different HPV strains. “This is the first efficacy study in this age population,” Eliav Barr, who heads the Merck HPV Vaccine program, tells Reuters. “The vaccine performed as we expected. It was highly effective.” The company-funded study, presented at the 24th International Papillomavirus Conference in Beijing, China, found that Gardasil prevented 83 percent of infections, cervical abnormalities and pre-cancers ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1003708 Mon, 05 Nov 2007 11:55:06 +0100 1003708 http://www.medworm.com/index.php?rid=989735&cid=t_111382_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F177174813%2Fuk_to_vaccine_school_girls_against_hpv_gks_and_merck_vie_for_contract.html In what can only be seen as a huge bonus for Merck & Co. (NYSE:MRK) and GlaxoSmithKline Plc's (NYSE:GSK) , the U.K government has announced that it will begin vaccinating all girls between the ages of 12 and 13 as of next September against human papilloma virus (HPV).Marketed as Gardasil by Merck and Cervarix by GlaxoKlineSmith, both companies are competing for the government contract to immunize all those British school girls.The vaccine is purported to be most effective on girls who have yet to begin their sexual lives but may also be beneficial to women aged 24 and older depending on their exposure to HPV and their level of sexual activity. The vaccine protects against 70 percent of HPV strains leaving 30% of the HPV strains unprevented and thus leaving a chance f... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=989735 Mon, 29 Oct 2007 21:15:10 +0100 989735 http://www.medworm.com/index.php?rid=982729&cid=t_111382_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F175388616%2F The UK’s Health Minister announced today that, starting in September, girls who are 12 and 13 years old can get vaccinated, although the shots won’t be mandatory. A catch-up campaign to vaccinate girls up to 18 years old will start in 2009. “This is an exciting step towards preventing cervical cancer in the UK,” says Harpal Kumar, Cancer Research UK’s ceo. “Prevention is always better than cure and this vaccine will prevent many women from catching the human papilloma virus in the first place, potentially saving around 400 hundred lives a year,” says health minister Alan Johnson in a statement. But which vaccine? That hasn’t been decided. Both Merck’s Gardasil and Glaxo’s Cervarix are approved in Europe and priced comparably, set... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=982729 Fri, 26 Oct 2007 14:30:52 +0100 982729 http://www.medworm.com/index.php?rid=919096&cid=t_111382_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F164152049%2F And so another day has begun. We hope yours is getting off to a good start. For us, it is a bright beginning - the dog has pooped, the heirs are off to school and the hot coffee is beckoning… Roche has promoted Juergen Schwiezer to head its diagnostics division, replacing Severin Schwan, who becomes ceo on March 4. Schwiezer, 62, who leads the unit in Europe and Latin America, starts on Jan. 1. Franz Humer, the currrent ceo, will remain chairman and Schwan, 40, who joined Roche as finance officer in 1993, will become the youngest ceo to ever run Roche. Glaxo will charge $490 for a full course of Cervarix, its new HPV vaccine, in the UK and Germany, which matches the price set by Merck for Gardasil. The Glaxo vaccine goes on sale in the two countries today, although the European Unio... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=919096 Tue, 02 Oct 2007 10:50:32 +0100 919096 http://www.medworm.com/index.php?rid=919097&cid=t_111382_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F163968368%2F We apologize for delay since our last post, and the late sign-off, as well. We were meeting with a few people from, well, we shouldn’t say. But we do try to get out and about now and then, if only to hear the latest about whomever and whatever. So we appreciate your patience. Now, we will attempt to recharge before resuming the routine in the morning. Sleep well, everyone. We look forward to seeing you again shortly… FDA To Review Affect Of Osteoporosis Drugs On The Heart (Bloomberg News) Increased Options Activity In Bristol-Myers Squibb (The Wall Street Journal - subscription required) Glaxo’s Cervarix Priced At Same Level As Gardasil In The UK (Yahoo/Reuters) Share / E-mail (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=919097 Tue, 02 Oct 2007 01:10:59 +0100 919097 http://www.medworm.com/index.php?rid=901030&cid=t_111382_136_f&fid=36051&url=http%3A%2F%2Ffeeds.b5media.com%2F%7Er%2Fb5media%2FCancerCommentary%2F%7E3%2F161036890%2F Speaking of cervical cancer vaccines, there are two notables: Gardasil by Merck which was approved by the FDA earlier this year and Cervarix by GlaxoSmithKline which is expected to be approved by the FDA later this year (but already approved in Australia). Regarding these HPV vaccines that will protect women against cervical cancer, the CDC recommends that the vaccine should be routinely given to girls at 11-12 years of age – the stage before young girls are more likely to become sexually active. Now there is a new project that will evaluate and monitor the effectiveness of these vaccines. The said project -funded by the national Centers for Disease Control and Prevention (CDC) - will be jointly conducted by the University of Rochester Medical Center (URMC) and the New York State Depart... Cancer Commentary blogs http://www.medworm.com/rss/comments.php?id=901030 Tue, 25 Sep 2007 11:58:23 +0100 901030 http://www.medworm.com/index.php?rid=894335&cid=t_111382_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F160564679%2F And so we all return from the weekend. Hope yours was enjoyable. Ours was splendid. We managed to mow the lawn yesterday, a rare event that met with the approval of the neighbors (not that we care all that much). And we took the shortest of the short people on a hayride to pick a few pumpkins. Now, though, we are again scouring the world for interesting insights. Here are a few of the latest… EU Delays Schering-Plough, Organon Review For Two Weeks (CNNMoney/Dow Jones) EU Approves Pfizer’s Selzentry AIDS Drug (Yahoo/Reuters) Glaxo Wins EU Approval To Sell Cervarix HPV Vaccine (Bloomberg News) Novartis’ Exelon Alzheimer’s Patch Approved By EU (CNN/Thomson Financial) Lilly Sues Sun Pharma To Block Generic Version Of Strattera (Bloomberg News) FDA Delays Approval Of Gla... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=894335 Mon, 24 Sep 2007 11:10:00 +0100 894335 http://www.medworm.com/index.php?rid=743321&cid=t_111382_87_f&fid=34865&url=http%3A%2F%2Fwww.thecancerblog.com%2F2007%2F07%2F19%2Fgskc-cervarix-drug-gets-support-from-europe%2F Filed under: Drug, Cervical CancerGlaxoSmithKline's Cervarix cervical cancer drug is closer to approval in Europe after an influential medical panel there Wednesday afternoon suggested the drug be approved.GSK expects EU approval in the coming months, with a European Cervarix launch possibly in 2007 sometime. Cervarix assists in the prevention of pre-cancerous lesions in the cervix caused by the human papillomavirus (HPV), which has been a center of contention as certain states in the U.S. have suggested mandatory vaccinations for teenage girls against the HPV.Cervical cancer is the second-most common form of cancer in women after breast cancer worldwide. So far, Cervarix has not received approval by the FDA in the U.S.Read | Permalink | Email this | Linking&n... The Cancer Blog blogs http://www.medworm.com/rss/comments.php?id=743321 Thu, 19 Jul 2007 04:00:00 +0100 743321 http://www.medworm.com/index.php?rid=696852&cid=t_111382_87_f&fid=34865&url=http%3A%2F%2Fwww.thecancerblog.com%2F2007%2F06%2F26%2Fglaxosmithkline-to-launch-five-new-cancer-drugs%2F Filed under: Drug, Daily newsFive new cancer treatments are in the works and could be available for use as early as 2010, thanks to GlaxoSmithKline, PLC, the world's second largest drug company.The drugs will treat a range of different cancers -- one will be cervical cancer -- and are known as cervarix, pazopanib, promacta, rezonic, and ofatumumab."Over the next three years, GSK will make a difference to millions of patients facing cancer," said Glaxo's head of research and development, Moncef Slaoui.Glaxo's most recent cancer drug is Tykerb, an oral breast cancer treatment launched in March.Read | Permalink | Email this | Linking Blogs | Comments (Source: The Cancer Blog) The Cancer Blog blogs http://www.medworm.com/rss/comments.php?id=696852 Tue, 26 Jun 2007 04:00:00 +0100 696852 http://www.medworm.com/index.php?rid=650899&cid=t_111382_87_f&fid=34865&url=http%3A%2F%2Fwww.thecancerblog.com%2F2007%2F05%2F31%2Fcervical-cancer-vaccine-cervarix-slowed-by-fda%2F Filed under: Drug, Prevention, Cervical CancerThe Food an Drug Administration is not going to grant a priority review to GlaxoSmithKline's experimental cancer vaccine Cervarix. Adding pressure is recent controversy surrounding its diabetes drug Avandia. Cervarix will now have to go through a standard 10-month review, instead of going the fast-track route. GlaxoSmithKline is defending its diabetes drug after a study published in the New England Journal of Medicine said that those taking the drug are at greater risks of heart attacks. GlaxoSmithKline expects to market the drug Cervarix in the United States sometime in 2008. Read | Permalink | Email this | Linking Blogs | Comments (Source: The Cancer Blog) The Cancer Blog blogs http://www.medworm.com/rss/comments.php?id=650899 Thu, 31 May 2007 04:00:00 +0100 650899 http://www.medworm.com/index.php?rid=539138&cid=t_111382_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2007%2F04%2Fpharma-still-stinks-but-not-as-much-as.html According to yet another poll (the second edition of I-Rep, Ipsos’ biannual survey on perceptions of large companies), most US consumers think oil and tobacco (industries) stink. They also think pharmaceuticals stink, but only slightly less than oil and gas (see chart and "Survey Says: Pharma Still Stinks But Not as Much as Oil or Tobacco!"). The good news is that slightly more consumers view pharma favorably than unfavorably (35% vs. 32%, respectively).Nevertheless, I don't smell any victory and I see no light at the end of the tunnel in pharma's PR war for consumer approval.GSK's Missed Opportunity to Wipe Off Some StinkAn example of how pharma misses opportunities to win a PR battle for consumers' minds is how and when GSK decided to pull it's ads from the Imus in the morning MSNBC sh... Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=539138 Thu, 12 Apr 2007 15:00:00 +0100 539138 http://www.medworm.com/index.php?rid=538376&cid=t_111382_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2007%2F04%2Fgsk-pulls-imus-adsbut-only-until-media.html Within hours of my call for Glaxo to pull its Imus ads (see "Glaxo, Pull Your Imus Ads"), which I posted at around 6 AM this morning, I learn that GSK has heeded my advice (see "GlaxoSmithKline Pulls Imus Ads").Unfortunately, the action was not accompanied by any press release or statement by GSK other than this bland corporate-speak:“The bottom line is that we have suspended our advertising with MSNBC until we can determine that we can have a level of confidence that our media standards are being adhered to,” GlaxoSmithKline spokeswoman Nancy Pekarek told MM&M.GSK missed an opportunity to explain what it's "media standards" are. Imus is well-known to have engaged in racial parodies before:"He’s ALWAYS said racist remarks. His show often makes fun of African-Americans and Latinos... Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=538376 Wed, 11 Apr 2007 22:13:00 +0100 538376 http://www.medworm.com/index.php?rid=536638&cid=t_111382_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2007%2F04%2Fglaxo-pull-your-imus-ads.html The Wall Street Journal reports that several advertisers, including Pocter & Gamble, announced that are pulling their ad support of the Imus radio show. GlaxoSmithKline is another pharmaceutical company whose ads run on the Imus show.Glaxo should pull its support and make a strong public statement about it. Not only is this the right thing to do, but it is good marketing considering that the company just applied for U.S. approval of its Cervarix vaccine to prevent cervical cancer. You want to reach out to young women, don't you Glaxo? If nothing else, women's basketball is about respect for young women and their ability to compete and live in a man's world.Imus, you recall, exhibited his racism on his FCC-regulated talk show by referring to the Rutgers women basketball team as "nappy-heade... Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=536638 Wed, 11 Apr 2007 11:03:00 +0100 536638