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 'crestor'. Sat, 03 Sep 2011 02:10:04 +0100 http://www.medworm.com/index.php?rid=5182317&cid=t_116651_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FXwsNQshuTes%2F And so, a calculated bet has not paid for the drugmaker. In a head-to-head trial called Saturn, imaging tests showed patients on Crestor had a lower percentage of artery-clogging plaque than those on Lipitor, but the difference was not statistically significant. Crestor did show a significant improvement over Lipitor in a secondary endpoint. The purpose was to convince doctors that Crestor had a significant advantage in hopes of maintaining prescriptions as lower-cost generic versions of Lipitor arrive later this year. The disappointing results, however, mean that “payers could push back even harder against usage of the drug downstream of Lipitor generics,” according to a recent investor note by Sanford Bernstein analyst Tim Anderson. He added that the imaging method used is a ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=5182317 Fri, 02 Sep 2011 11:57:13 +0100 5182317 http://www.medworm.com/index.php?rid=4512615&cid=t_116651_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FuxeJeGTt4U8%2F Less than a month after announcing plans to eliminate 1,900 jobs, Abbott Labs is reorganizing its pharmaceutical unit and the head of the operation, Donald Patton, will retire next week. The reorg combines domestic and international pharma businesses into a “proprietary” division focusing on patented brand meds, and will be run by Carlos Alban, a senior vp for international pharma. Patton, 59, has been senior vp of US pharma biz since January 2010, but the unit has run into difficulties, such as the recent failure to win FDA approval for the Certriad cholesterol pill, which would have combined its own TriLipix with AstraZeneca’s Crestor. Development was then discontinued. And last month, Abbott disclosed plans to delay seeking FDA approval for a psoriasis med after receiving ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4512615 Wed, 23 Feb 2011 14:06:27 +0100 4512615 http://www.medworm.com/index.php?rid=4399821&cid=t_116651_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FpNBNg2yf5XM%2F Yet another big drugmaker is contracting its workforce. This time, Abbott Laboratories is cutting about 1,900 positions - or 6 percent of its US workforce - following a series of pipeline setbacks and what the drugmaker called a “challenging regulatory environment,” a reference to its inability to win FDA approval for various meds. The move is expected to save $200 million over the next few years (see statement). Last week, for instance, Abbott disclosed plans to delay seeking FDA approval for a psoriasis med after receiving word from agency staffers about safety concerns. There was also a disappointment last month when the FDA issued a Complete Response Letter for the Certriad cholesterol pill, which would have combined its own TriLipix with AstraZeneca’s Crestor. Develo... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4399821 Wed, 26 Jan 2011 14:25:53 +0100 4399821 http://www.medworm.com/index.php?rid=4106061&cid=t_116651_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FvbJfq4gqoWM%2F Two years ago, AstraZeneca halted a trial called Jupiter because its Crestor cholesterol pill outperformed a placebo. The study was undertaken to determine whether Crestor would reduce heart attacks and other cardiovascular problems in patients with no signs of pre-existing cardiovascular disease and low to normal LDL, but elevated levels of CRP, a market linked to heart attack risk (back story). In doing so, however, the stoppage helped fuel a debate about the vagaries of halting trials before their time. In this video, Gordon Guyatt, an epidemiologist, biostatistician and professor of medicine at McMaster University discusses concerns that stopping trials early is done so to inflate efficacy and the implications of the Jupiter trial. This first appeared on Currrent Medicine TV. There is ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4106061 Mon, 25 Oct 2010 13:36:17 +0100 4106061 http://www.medworm.com/index.php?rid=4013549&cid=t_116651_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FkX2b8wnMUrA%2F Two years ago, a study called JUPITER looked at AstraZeneca’s Crestor cholesterol pill and measured levels of a protein called CRP that can indicate arteries are inflamed and point toward heart disease. But the results prompted debate over the extent to which CRP should be used as a guidepost for treating cholsterol and prescribing Crestor and other statins to people with low cholesterol (see here). In June, a “critical reappraisal” appeared in The Archives of Internal Medicine calling the trial “flawed,” because there were various methodological problems and a “strong commercial interest” may have resulted in biased outcomes. Nine of 14 authors had ties to AstraZeneca and the principal investigator, Paul Ridker of Brigham and Women’s Hospital (pictured), is a co-holder of ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4013549 Tue, 28 Sep 2010 15:15:12 +0100 4013549 http://www.medworm.com/index.php?rid=3965701&cid=t_116651_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FxdaK6hHo5xs%2F Several years ago, an alternate method for measuring coronary risk was adopted by the National Cholesterol Education Program’s adult treatment panel as an outgrowth of the famous Framingham Heart Study. The newer method, which was referred to as a point-based approach, attempted to make it easier to classify patients into risk groups in order to pursue the appropriate treatment. However, a new study, which is published in the Journal of General Internal Medicine, compares the two approaches and finds the point-based system “misclassifies millions of Americans” and places them in higher risk groups for which different treatments are recommended. In other words, the implication is that a higher risk classification may prompt greater use of such treatments as cholesterol med... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3965701 Mon, 13 Sep 2010 12:54:39 +0100 3965701 http://www.medworm.com/index.php?rid=3714444&cid=t_116651_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FJSU5gTPTZaE%2F Earlier this week, the Archives of Internal Medicine published a few articles and editorials about statins, although one, in particular, generated some heat - a review of the controversial Jupiter study from 2008. The study, which focused on AstraZeneca’s Crestor cholesterol pill, measured levels of a protein called CRP that can indicate arteries are inflamed and point toward heart disease. The results prompted debate over the extent to which CRP should be used as a guideline for treating cholsterol and the wisdom in prescribing Crestor and other statins to people with low cholesterol. This week’s revisitation (see here) stirred anew the controversy, but also focused on allegations of poor methodology, bias and conflicts of interest (see here). However, as was noted yesterday, two ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3714444 Wed, 30 Jun 2010 13:42:30 +0100 3714444 http://www.medworm.com/index.php?rid=3710790&cid=t_116651_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F-b8gjxRZsWE%2F A federal judge has struck down litigation brought by several generic drugmakers, which sought to prove that AstraZeneca’s key patent on its Crestrol cholesterol pill was invalid. The outcome had been expected, but nonetheless, removed a potentially huge problem for the drugmaker, which racked up $4.5 billion in global Crestor sales last year. In reaching his decision, US District Court Judge Joseph Farnan ruled that the generic drugmakers, a group that included Apotex, Aurobindo Pharma, Cobalt Laboratories, Mylan Laboratories, Par Pharmaceuticals, Sandoz, Sun Pharmaceuticals and Teva Pharmaceuticals, failed to prove the AstraZeneca patent was invalid because it was an obvious invention. He also decided Apotex may be held liable for infringing the patent (read the ruling). In an inve... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3710790 Tue, 29 Jun 2010 21:31:33 +0100 3710790 http://www.medworm.com/index.php?rid=3710792&cid=t_116651_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FHnUEoke6eyQ%2F When the Jupiter study was released in November 2008, the results caused a hoopla. The study looked at AstraZeneca’s Crestor cholesterol pill and measured levels of a protein called CRP that can indicate arteries are inflamed and point toward heart disease. But the results prompted debate over the extent to which CRP should be used as a guidepost for treating cholsterol and the wisdom in prescribing Crestor and other statins to people with low cholesterol (background). Now, a “critical reappraisal” has appeared in The Archives of Internal Medicine that calls the trial “flawed,” because there were all sorts of methodological problems and that a “strong commercial interest” may have resulted in biased outcomes. Why? Nine of 14 Jupiter authors have fi... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3710792 Tue, 29 Jun 2010 17:00:24 +0100 3710792 http://www.medworm.com/index.php?rid=3683869&cid=t_116651_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FWwG08X6tEdA%2F Over the past few months, Lilly ceo John Lechleiter has made speeches in which he criticized various government policies for hindering research and development efforts (see this). And central to his theme has been the importance of innovation. “Innovation is not a panacea for the challenges facing our health care systems, but it is hard to see any way out of the current crisis – and I don’t think that’s too strong a word – without innovation,” he told the American Chamber of Commerce in Germany which, earlier this year, was preparing to cut brand-name drug prices (look here). Today, however, the drugmaker has begun marketing yet another statin for controlling cholesterol, which it calls Livalo. This is a big market, of course, with statins ringing up some $13 b... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3683869 Mon, 21 Jun 2010 14:23:08 +0100 3683869 http://www.medworm.com/index.php?rid=3617949&cid=t_116651_117_f&fid=37824&url=http%3A%2F%2Fwww.doctorkalitenko.com%2Fblog%2Fproblem-solution%2Ffda-now-pushing-cholesterol-medication-with-significant-side-effects Crestor, a brand name medication, a statin to be exact, is now being touted by the Food and Drug Administration as a wonder-drug and the government agency has deemed it is safe even for healthy people to keep cholesterol down. Do you see something wrong with this? Let us take a look. Statins have two major side effects: 1. Rhabdomyolysis, which is the breakdown of muscle fibers and release of those fibers into the bloodstream. This can cause aches and pain all over the body. Rhabdomyolysis can also cause dark colored urine. If the kidneys get loaded up with these fibers, it can even cause kidney failure and death. 2. Increased Liver Enzymes: statins in the body can cause an increased production of liver enzymes, which can be linked to liver damage. Last year when a CNBC host asked why we ... Doctor Kalitenko antiaging blog blogs http://www.medworm.com/rss/comments.php?id=3617949 Mon, 31 May 2010 18:49:10 +0100 3617949 http://www.medworm.com/index.php?rid=3581841&cid=t_116651_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FHBVEEExbnfk%2F For the second year in a row, the growth in the use of prescription drugs by youngsters exceeded all other age groups. In fact, the increase was nearly four times higher than in the overall population, partly because there were a slew of new indications for existing meds that traditionally treat “adult diseases, according to the latest annual report from Medco Health Solutions. Which drugs and indications? WelChol and Crestor for children aged 10 to 17 with heterozygous familial hypercholesterolemia; Protonix for erosive esophagitis in patients aged 5 and up; Abilify for irritability associated with autistic disorder in children aged 6 to 17; Atacand for hypertension in children aged 1 to 17; Zyprexa for schizophrenia and acute mania (bipolar I) in children ages 13 to 17; Axert for acute... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3581841 Wed, 19 May 2010 18:59:01 +0100 3581841 http://www.medworm.com/index.php?rid=3526947&cid=t_116651_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FGcH7rZ8YJbU%2F Another month, another list. Once again, there is speculation about which medications will generate the most revenue over the next few years. Interestingly, the latest conclusion mirrors another recent list that suggests conventional pills will easily be eclipsed. Only two small molecules make this newest ranking, which was compiled by EvaluatePharma. Not surprisingly, one of them is AstraZeneca’s Crestor cholesterol fighter, although the newest list differs slightly from this list. And so once again, there are myriad implications raised, including the strategic direction pursued by the biggest drugmakers and the costs for patients. The percentage figure refers to sales growth from 2009 to 2016… 1. Humira (arthritis) Abbott Labs/Eisai - $10.1b; 9 percent 2. Avastin (cancer) Roc... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3526947 Mon, 03 May 2010 12:47:00 +0100 3526947 http://www.medworm.com/index.php?rid=3508448&cid=t_116651_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fnf6jcSWzpi8%2F Rise and shine. Another day lies ahead. And no doubt, it will be a busy one. As always, there is much to do - meetings and deadlines beckon. While we attempt to hustle one of the short people off to the local schoolhouse, here are a few items to jumpstart your day. We hope it is a good one. And once again, do stay in touch… AstraZeneca Wins Wider EU Crestor Labeling (Reuters) Novo Nordisk Raises Forecasts (Bloomberg News) Irish Reference Pricing Could Cause Shortages (PharmaTimes) Abbott Court Loss Prompts Review Of Patent Standards (Daily Herald) ACRO To Fund CRO Academic Research (OutsourcingPharma) J&J Unit Denied Appeal Of Patent Decision (MarketWatch) (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3508448 Tue, 27 Apr 2010 11:31:24 +0100 3508448 http://www.medworm.com/index.php?rid=3468018&cid=t_116651_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FZbwVlkKVymw%2F And the winner is…. Roche’s Avastin, which is used to treat various cancers. Everyone loves a list, of course, so Reuters compiled this ranking and the most interesting finding is there seems to be just one pill that will be among the biggest sellers in 2014. In other words, injectables will dominate. Assuming this is reasonably accurate, what might it say about big drugmakers? Will they spend more in the lab or strike still more deals with smaller prey developing the next big thing? Will pills become passe? And what will it mean for patient costs? Consensus sales forecasts for world’s top 10 drugs in 2014: 1. Avastin (cancer) Roche - $8.9b 2. Humira (arthritis) Abbott - $8.5b 3. Enbrel (arthritis) Pfizer - $8b 4. Crestor (cholestero... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3468018 Wed, 14 Apr 2010 15:58:25 +0100 3468018 http://www.medworm.com/index.php?rid=3425124&cid=t_116651_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FczDsL7jmB-U%2F AstraZeneca recently received FDA approval to market its Crestor cholesterol fighter as a preventive pill for millions of folks who don’t have high cholesterol - and that prompts some to wonder whether this is a good idea, The New York Times writes. The skeptics point to concern that cholesterol meds may not be as safe as a preventive drug as previously believed for people who are at low risk of heart attacks or strokes. Others suggest the benefits may not outweigh side effects. One risk - a recent paper indicated that statins could raise the risk of developing Type 2 diabetes by 9 percent, the paper continues. “It’s a good thing to be skeptical about whether there may be long-term harm from healthy people taking a drug like this,” Mark Hlatky, a professor of health research an... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3425124 Wed, 31 Mar 2010 12:36:23 +0100 3425124 http://www.medworm.com/index.php?rid=3298599&cid=t_116651_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F5xxdypuLBUM%2F A rainy day here on the Pharmalot corporate campus. But our spirits remain sunny. And why not? Once again, we are reminded of one of our favorite sayings: ‘Every brand new day should be unwrapped like a precious gift.’ So untie the proverbial ribbon and forge ahead. And grab that cup of stimulation as you proceed. Have a great day, everyone… AstraZeneca Resolves UK Tax Dispute (The Wall Street Journal) Avastin Fails To Extend Lives Of Stomach Cancer Patients (Associated Press) Gilead Inhaled Antibiotic For CF Wins FDA OK (Bloomberg News) Dendreon Posts Wider Fourth-Quarter Loss (Reuters) Opening Arguments Begin In Crestor Patent Trial (Reuters) Pfizer Lays Off 72 Pearl River Workers (Times Herald-Record) Novartis Unit Pays $3.5M Fine For Medicaid Fraud (US Dept of Justice... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3298599 Tue, 23 Feb 2010 12:27:45 +0100 3298599 http://www.medworm.com/index.php?rid=3254715&cid=t_116651_150_f&fid=34768&url=http%3A%2F%2Fpharmagossip.blogspot.com%2F2010%2F02%2Fhcc-interviewed-dr-gordon-guyatt-to.html Source (Source: PharmaGossip) PharmaGossip blogs http://www.medworm.com/rss/comments.php?id=3254715 Tue, 09 Feb 2010 15:44:00 +0100 3254715 http://www.medworm.com/index.php?rid=3254723&cid=t_116651_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FCKQE3vGwPJU%2F Hello, everyone. Nice to see you again. Another busy day awaits, yes? Many of you are dashing about the BIO gathering in New York. Meanwhile, there are forecasts of still more snow in some parts of our readership area. Business cards in one hand. A shovel in the other. Meanwhile, we are about to wake the short people for another day at the schoolhouse. So while we brace for our various activities, here are a few items to see you through. All best… Amgen’s D-mab Helps Fractures In Prostate Cancer Patient (Bloomberg) Lilly’s CEO Got $20.9M In ‘09 Compensation (Indianapolis Star) FDA Clears Wider Use Of Crestor (Reuters) Most Glaxo Job Cuts To Come From The UK (The Harlow Herald) Pfizer Gives Trovan Documents To Nigerian Authorities (ThisDay) Merck Sorono’s Lawye... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3254723 Tue, 09 Feb 2010 12:33:43 +0100 3254723 http://www.medworm.com/index.php?rid=3084982&cid=t_116651_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FE6aXSJb2tfM%2F The big drugmaker failed to win a summary judgment as it races toward a February 2010 trial over the patent for its blockbuster cholesterol pill. The US District Court for the District of Delaware rejected its motion to dismiss claims of inequitable conduct, which were made by several generic drugmakers seeking to invalidate Crestor’s ‘314 patent. The main US patent runs until 2016 (see ruling here). The generic drugmakers - Apotex, Aurobindo, Cobalt, Mylan, Par, Sandoz and Sun - contend material info was omitted when the original Crestor patent was filed by AstraZeneca’s partner Shionogi and this was inequitable conduct. AstraZeneca denies the charge. In an investor note, Leerink Swan analyst Seamus Fernandez wrote that, in redcated documents, a patent attorney who worke... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3084982 Mon, 14 Dec 2009 13:13:02 +0100 3084982 http://www.medworm.com/index.php?rid=2944095&cid=t_116651_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fp3XeceGN3s0%2F That’s what some researchers are suggesting. “Statins may have a role in reducing mortality from influenza, but our findings do not justify broader use of statins without confirming these findings in the setting of randomized controlled trials,” study author Dr. Ann Thomas, from the Emerging Infections Program at the Oregon Department of Human Services Public Health Division in Portland. “Statins may have a benefit, in conjunction with vaccine and antivirals, in reducing morbidity and mortality associated with influenza, likely due to their effect of reducing the body’s inflammatory response to influenza infection,” she tells HealthDay News in advance of her presentation today at the Infectious Diseases Society of America annual meeting in Philadelphia. Her team examined ou... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=2944095 Fri, 30 Oct 2009 11:22:18 +0100 2944095 http://www.medworm.com/index.php?rid=2442758&cid=t_116651_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2009%2F05%2Fuh-oh-will-fda-cite-this-one-click-rule.html Remember the 14 Notice of Violation (NOV) letters that FDA sent to 14 drug companies citing their Adwords -- paid search engine ads -- for violating FDA regulations? At issue was (and still is) the so-called "One-Click Rule," which states that an online Rx drug ad can mention the brand name and the benefits (indications) without including all or any of the major side effect effects (fair balance) as long as the fair balance is just one click away (ie, on the landing page). See "The 'One-Click Rule': Rant or No Rant?" and "Death of the One-Click 'Rule' or 'Received Precedent' or Whatever!" for my long-standing criticism of the "One-Click Rule."The FDA letters only focused on paid search engine ads where there is a limit of about 70 characters. You can feel some empathy for pharma marketers ... Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=2442758 Thu, 28 May 2009 12:35:00 +0100 2442758 http://www.medworm.com/index.php?rid=2077285&cid=t_116651_117_f&fid=38158&url=http%3A%2F%2Famericanacupuncture.blogspot.com%2F2008%2F12%2Fis-crestor-for-everyone.html This study was to be for 5 years but was stopped with less than 2 years.  Stopping the trial early limited getting more meaningful details on  the long-term safety of taking this drug.  The number of patients that were saved by going on the statins had much more details in their studies.   Other reports in 2007 showed that taking the statins to lower LDL had no effect on whether you lived longer or died sooner. The Crestor study showed that if 120 people take the drug, one would be helped. Twenty-five people would need to take the drug, and only one heart attack in 5 years would be prevented.  Your chances of dying would be the same. So, who should take the C reactive protein, CRP, blood test?  At what high level of the protein should one start statins? The role of the protein, CR... Dr. Needles Medical Blogs blogs http://www.medworm.com/rss/comments.php?id=2077285 Thu, 01 Jan 2009 02:03:00 +0100 2077285 http://www.medworm.com/index.php?rid=2008507&cid=t_116651_117_f&fid=38158&url=http%3A%2F%2Famericanacupuncture.blogspot.com%2F2008%2F12%2Fdoes-high-crp-cause-heart-disease.html DOES HIGH CRP LEVELS CAUSE HEART DISEASE? The Jupiter study on statins has carved out a new class of people that could be helped by cholesterol drugs.  They don’t get them because their cholesterol levels are normal.  The study can’t say why the anti-  cholesterol drug Crestor helped those in the study who had elevated CRP levels. The 9000 people in the study who took Crestor had their CRP lowered by 32% and the bad LDL lowered by 50%.  Heart attacks and strokes were 50% lower than in the placebo group.  At least some of the benefit was due to the lowering of CRP levels.  The manufacturer can’t explain why. Is CRP a heart risk indicator?  CRP is a nonspecific, and it is up in several diseases.  It is a marker for not being healthy.  By focusing on this inflammation, they thi... Dr. Needles Medical Blogs blogs http://www.medworm.com/rss/comments.php?id=2008507 Mon, 01 Dec 2008 19:36:00 +0100 2008507 http://www.medworm.com/index.php?rid=1991567&cid=t_116651_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F464959599%2F A bit dreary here in the nation’s medicine chest as we awake to gray skies and a slight drizzle. Still, our spirits are high. And despite the looming holiday here in the US, there is much to do. So time to get started. Here are a few items to help you along. Hope your day is meaningful… AstraZeneca, Abraxis To End Cancer Drug Trial (Reuters) Lilly Outsources Clinical-Data Management (PharmaTimes) Roche Agrees To Pay $50M For Memory Pharma (The Star-Ledger) Crestor Scrips Rise After Jupiter Study (Reuters) Schering-Plough Sees 5 NDAs In 2009 (Dow Jones) FDA Panel OKs New Gout Drug (WebMD) Avandia Riskier Than Actos For Older Diabetics (Philly.com) (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1991567 Tue, 25 Nov 2008 11:48:34 +0100 1991567 http://www.medworm.com/index.php?rid=1980641&cid=t_116651_150_f&fid=34768&url=http%3A%2F%2Fpharmagossip.blogspot.com%2F2008%2F11%2Fjupiter-study-meh.html The British Medical Journal has published an editorial discussing the results of the recently completed JUPITER Study.This editorial aims to put the results of the study in context with the existing evidence based and understand what the results mean in terms of current practice.The authors of this study conclude that no change is required.In addition the Rapid Responses are heavily critical of the decision to stop the study early and make for interesting reading.Hat tip: Matt (Source: PharmaGossip) PharmaGossip blogs http://www.medworm.com/rss/comments.php?id=1980641 Fri, 21 Nov 2008 16:01:00 +0100 1980641 http://www.medworm.com/index.php?rid=1970979&cid=t_116651_117_f&fid=38158&url=http%3A%2F%2Famericanacupuncture.blogspot.com%2F2008%2F11%2Fshould-everyone-take-statins.html This study implies millions of people with even low cholesterol would be helped with Crestor, since it lowers heart attacks and strokes by almost 50%.   The clinical trial  was to be for 5 years but was stopped with less than 2 years.  Stopping the trial early limited getting more meaningful detail and the long term safety of taking this drug. as the number of patients that were saved by going on the statins.  Other reports in 2007 showed taking the statins to lower LDL had no effect on whether you lived longer or died sooner. Visit my Nov 3 blog on this subject. The study showed that if 120 people take the drug, one would be helped. Twenty five people would need to take the drug, and only one heart attack in 5 years would be prevented.  Your chances of dying would be the same. So,... Dr. Needles Medical Blogs blogs http://www.medworm.com/rss/comments.php?id=1970979 Tue, 18 Nov 2008 23:06:00 +0100 1970979 http://www.medworm.com/index.php?rid=1964331&cid=t_116651_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F454055116%2F In case you missed the latest sardonic insights from Dr. Stephen T. Colbert, DFA, the other night he offered some important medicinal tips on women’s health and cholesterol that were sponsored by Prescott Pharmaceuticals. (Doctor of Fine Arts sounds like a legitimate qualification to be discussing your health, does it not?) Colbert, who crushes statins on his bacon-chili-cheese corn dogs, tells us the Jupiter trial for AstraZeneca’s Crestor “is a great breakthrough in the battle to find things to prescribe to people who don’t need them…True, the drug costs $100 a month, but that is a small price to pay to not have the heart attack that there’s no way of knowing that you would have had.” Still worried? Take VaxaCrest, which eliminates your concerns about taki... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1964331 Sat, 15 Nov 2008 15:59:11 +0100 1964331 http://www.medworm.com/index.php?rid=1960665&cid=t_116651_150_f&fid=34768&url=http%3A%2F%2Fpharmagossip.blogspot.com%2F2008%2F11%2Fpharma-giles-on-jupiter.html “So me an’ Paul were ‘aving a couple of pints dahn the pub, as yer do, like, when ‘e sez t’me, “’Ere, Dave, ‘ow’s the ol’ Crestor sales doin’ then?”“Leave it aht,” I sez. “We keep runnin’ trial after bleedin’ trial based on tryin’ to show some sort of worthwhile clinical benefit, an’ all we keep comin’ up wiv is bugger all, know wotta mean, like? Best fing we can do is t’ let it slide off patent in a coupla year’s time, like, an’ jus’ cut our losses.”“Sounds t’ me like you ain’t designin’ the trials right,” sez Paul, neckin’ ‘is Stella. “Wot you need is a way of testing all the old geezers you sign up, such that when you put ‘em on your drug, some of ‘em give the answers you want rather than poppin’ their clogs or gett... PharmaGossip blogs http://www.medworm.com/rss/comments.php?id=1960665 Fri, 14 Nov 2008 04:50:00 +0100 1960665 http://www.medworm.com/index.php?rid=1955502&cid=t_116651_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F449644613%2F And what is the drugmaker’s ceo cautious about? The eye-popping assumptions that Crestor sales will skyrocket, pun intended, now that the widely hyped Jupiter study found that cholesterol pill reduced the risk of cardiovascular death and heart attacks by 44 percent in people with low LDL cholesterol levels compared with patients on a placebo. “We’ve seen a flurry of estimates from analysts about the commercial impact of Jupiter, some of them pretty bullish, reflecting a view that there will be a near term, dramatic shift in medical practice,” he told journalists on a conference call. “I would urge caution when forecasting the speed of such changes in medical practice.” Why so sobering? Well, the Jupiter study measured a protein called CRP, which is used ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1955502 Tue, 11 Nov 2008 15:39:15 +0100 1955502 http://www.medworm.com/index.php?rid=1951848&cid=t_116651_150_f&fid=34768&url=http%3A%2F%2Fpharmagossip.blogspot.com%2F2008%2F11%2Fastrazeneca-crestor-pharmagossip-starts.html As the pharma world continues to digest data from the JUPITER study on AstraZeneca’s Crestor, the firm’s chief executive is taking a cautious line on what effect it will have on sales of the cholesterol blockbuster.In a teleconference with reporters, David Brennan said it is too early to predict how the data from the landmark study, which demonstrated a dramatic risk reduction of cardiovascular death in people with low to normal cholesterol levels, will affect sales of Crestor (rosuvastatin). He noted that there has been “a flurry of estimates” from analysts about the commercial impact of JUPITER, “some of them pretty bullish” but “I would urge caution when forecasting the speed of such changes".The initial response to the study has been that it will transform the way statins... PharmaGossip blogs http://www.medworm.com/rss/comments.php?id=1951848 Tue, 11 Nov 2008 11:21:00 +0100 1951848 http://www.medworm.com/index.php?rid=1962895&cid=t_116651_117_f&fid=38158&url=http%3A%2F%2Famericanacupuncture.blogspot.com%2F2008%2F11%2Ffewer-heart-attacks-with-new-statin.html CONCLUSION A study performed by authors who have ties to the blood test monitoring system and who have received grants to make the study, who has 25% more diabetics in this study, who tests 50 year old men, who relies on an inflammatory marker CRK, as the only criteria for taking Crestor, who has reported a study only of two years duration, is a premature study.The big question is, after 5 years are there fewer deaths in patients taking Crestor? Your comments are always appreciated. Sources:   NEJM Nov 10,2008                   Medical blog Nov 1, 2008, drneedles.com Visit www.drneedles.com for more blogging on these medical controversial subjects. (Source: Dr. Needles Medical Blogs) Dr. Needles Medical Blogs blogs http://www.medworm.com/rss/comments.php?id=1962895 Tue, 11 Nov 2008 00:37:00 +0100 1962895 http://www.medworm.com/index.php?rid=1947485&cid=t_116651_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F448643380%2F A shiny day here in the nation’s medicine cabinet. We are spending a great deal of time chatting with interesting people and reading up on various things. Meanwhile, we thought to share with you some of the interesting tidbits that have floated by… AstraZeneca CEO Can’t Predict Jupiter Impact (Dow Jones) Bayer Clot Drug Misses Midstage Study Goal (Yahoo/Reuters) Pfizer’s Indiana Plant Is For Sale (The Indianapolis Star) Exelixis Lays Off 10 Percent Of Staff (San Francisco Business Times) (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1947485 Mon, 10 Nov 2008 17:55:34 +0100 1947485 http://www.medworm.com/index.php?rid=1947490&cid=t_116651_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F448376933%2F Welcome back. We hope your weekend was pleasant. Big news, of course, emerged from the American Heart Association about AstraZeneca’s Crestor, which you can see below. Meanwhile, meetings, deadlines and projects beckon. So here are a few items to help you get acclimated. Enjoy the day, everyone… Roche Sticks By Its Genentech Bid (Yahoo/Reuters) High-Dose Zocor Study Has Mixed Results (Yahoo/Reuters) Roche Says Tarceva Data Is Promising (The Wall Street Journal) Shionogi Stock Soars On Crestor Study (Bloomberg News) (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1947490 Mon, 10 Nov 2008 13:00:08 +0100 1947490 http://www.medworm.com/index.php?rid=1947159&cid=t_116651_150_f&fid=34768&url=http%3A%2F%2Fpharmagossip.blogspot.com%2F2008%2F11%2Fastrazeneca-crestor-pr-alert.html Story (Source: PharmaGossip) PharmaGossip blogs http://www.medworm.com/rss/comments.php?id=1947159 Mon, 10 Nov 2008 10:58:00 +0100 1947159 http://www.medworm.com/index.php?rid=1947203&cid=t_116651_87_f&fid=34935&url=http%3A%2F%2Fmedicine.com.my%2Fwp%2F%3Fp%3D5229 Rosuvastin (Crestor) has hit the medical headlines lately. The BBC News reported Statin use ‘may benefit healthy’ Guidelines on who is eligible for statins may need to be rewritten after an international trial found benefits in “healthy” adults, experts say. The study of 17,800 men and women with normal cholesterol levels found rosuvastatin cut deaths from heart attacks and strokes. Currently statins are offered to people with a moderate to high risk of a cardiovascular “event”. The patients in the trial, funded by AstraZeneca, had cholesterol levels below those usually indicating a need for treatment and had no other signs of heart disease. But they did have increased levels of a C-reactive protein, which indicates inflammation in the body and is beli... Malaysian Medical Resources blogs http://www.medworm.com/rss/comments.php?id=1947203 Mon, 10 Nov 2008 05:00:00 +0100 1947203 http://www.medworm.com/index.php?rid=1947491&cid=t_116651_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F447441711%2F The results of AstraZeneca’s hotly anticipated Jupiter study - which measured levels of a protein called CRP that can indicate arteries are inflamed and point toward heart disease - were just released at the American Heart Association meeting and they are likely to stir as much debate as promised. The cholesterol pill reduced the risk of cardiovascular death and heart attacks by 44 percent compared with patients on a placebo. The 17,802 participants were men over 50 years old and women over 60 years old - ripe ages for heart attacks, but who were healthy. They did not display signs of heart disease and had cholesterol levels not requiring meds under current guidelines. The study is available in The New England Journal of Medicine. Other findings: the combined risk of heart attack, st... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1947491 Sun, 09 Nov 2008 14:47:57 +0100 1947491 http://www.medworm.com/index.php?rid=1939688&cid=t_116651_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F444390166%2F A widely anticipated study will be released Sunday morning at the American Heart Association meeting that will show whether AstraZeneca’s cholesterol pill can reduce inflamed arteries. Positive results could double sales to more than $6 billion, according to some Wall Street estimates. Although, a little debate about the need for a $25 blood test may still have to be settled. The test would measure levels of a protein linked to inflammation called CRP, which can indicate arteries are inflamed and point toward heart disease. This was the measurement used in the Crestor study. But the CRP test isn’t widely used now because doctors disagree about who should get it and whether the results are consistent enough to guide care, Bloomberg News writes. “There will continue to be... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1939688 Thu, 06 Nov 2008 13:59:17 +0100 1939688 http://www.medworm.com/index.php?rid=1933427&cid=t_116651_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F442039071%2F As pipelines thin and regulatory approvals become more difficult, big drugmakers are increasingly shifting R&D around. The lastest change has John Patterson, 61, retiring from AstraZeneca this coming March, and he will be replaced by Anders Ekblom, 54, who actually assume full responsibilities at the end of January. Patterson was appointed executive director responsible for development in December 2004 and has been in charge of the new drug pipeline during a not-so-great stretch (look here). An industry veteran, who started out with ICI Pharmaceuticals, he was initially brought in as development head in a bid to restore confidence in the pipeline after two big setbacks - FDA rejection of the Exanta anticoagulant Exanta and the failure of the Iressa lung drug in a key trial. During hi... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1933427 Tue, 04 Nov 2008 12:22:09 +0100 1933427 http://www.medworm.com/index.php?rid=1924709&cid=t_116651_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F437306919%2F A forthcoming AstraZeneca study could dramatically increase the market for cholesterol-lowering drugs, otherwise known as statins, which are already pharma’s biggest success story, Forbes writes. Known as Jupiter, the study tested the theory that Crestor combats lower artery inflammation, which can cause cholesterol plaque to burst into heart-attack-causing clots. Some 18,000 people were tested with low levels of LDL, but high levels of C-reactive protein (CRP), which could indicate that the arteries are inflamed, the mag writes. In March, the study was stopped early because of “unequivocal” benefit, and now, some scientists hope for blowout results when the full data are presented on November 9 at the American Heart Association meeting, Forbes says. And by the way, sinc... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1924709 Thu, 30 Oct 2008 20:31:21 +0100 1924709 http://www.medworm.com/index.php?rid=1750395&cid=t_116651_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F379694361%2F This may be the Labor Day weekend in the US, but in Munich, leading cardiologists and pharmaceutical mavens are gathering for the annual European Society of Cardiology meeting, which began today and runs through Wednesday. Beyond the usual stream of clinical trials, the most sensational story is likely to be the final results of the Vytorin SEAS study. Preliminary data showed an unexpected linked to cancer. The full picture will be presented Tuesday morning. Meanwhile… A prescription fish-oil pill offered moderate benefits in patients with heart failure, such as lessened risk of death and hospital admissions, unlike widely prescribed cholesterol-lowering drugs called statins. In a large trial involving almost 7,000 patients in Italy, researchers found that people taking the pill - so... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1750395 Sun, 31 Aug 2008 19:17:25 +0100 1750395 http://www.medworm.com/index.php?rid=1709093&cid=t_116651_150_f&fid=34768&url=http%3A%2F%2Fpharmagossip.blogspot.com%2F2008%2F08%2Fastrazeneca-crestor-making-hay.html The British drugmaker is going to jointly promote Crestor with Abbott Labs in the US, a noteworthy reversal of AstraZeneca’s solo strategy up until now.More (Source: PharmaGossip) PharmaGossip blogs http://www.medworm.com/rss/comments.php?id=1709093 Thu, 14 Aug 2008 18:30:00 +0100 1709093 http://www.medworm.com/index.php?rid=1492077&cid=t_116651_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2008%2F06%2Fbad-news-about-good-cholesterol-adds-to.html "'Good' cholesterol that scientists have thought helped unclog arteries had no effect on heart disease in a study, casting doubt on a theory drugmakers have spent more than $1 billion pursuing," says an article on Bloomberg.com (see "Why Pfizer Flopped: Good Cholesterol, not so good, says study").Add this to results from the Vytorin/Zetia study that failed to prove that lowering 'bad' cholesterol does not seem to lessen buildup of plaque on arteries and you seem to have a "perfect storm" that may eventually sink the whole anti-cholesterol drug market!Maybe I am not a good focus group of one, but in response to all this bad news about the failings of statins and other cholesterol-lowering drugs, I have done the following:Stopped taking my cholesterol drugs (Pravachol and Zetia) and focused ... Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=1492077 Wed, 04 Jun 2008 12:10:00 +0100 1492077 http://www.medworm.com/index.php?rid=1393904&cid=t_116651_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F276105192%2F Wondering just what managed care and pharmacy benefit managers may be thinking about Vytorin and Zetia? A survey of 71 execs taken during the week immediately following the American College of Cardiology meeting finds that 67 percent felt there would be “no immediate change” to their coverage plans, according to Cognet-X, a healthcare research firm. The reason? The marketplace will make changes for them. About 84 percent expected prescribing to shift dramatically from Vytorin to generic versions of Zocor, or simvastatin. And roughly 53 percent expect more Crestor scrips to be written, while 38 percent foresee greater Lipitor utilization. But 81 percent said any changes would be made within six months. Here are some of the findings… – 18 percent expect a possible tier c... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1393904 Wed, 23 Apr 2008 11:45:19 +0100 1393904 http://www.medworm.com/index.php?rid=1391024&cid=t_116651_150_f&fid=34768&url=http%3A%2F%2Fpharmagossip.blogspot.com%2F2008%2F04%2Fastrazeneca-crestor-no-crown-for-heart.html This study aimed to assess the cardiovascular benefits of rosuvastatin (Crestor®) in older patients with heart failure.The study recruits 5,011 patients who were at least 60 years of age and had a diagnosis of heart failure (New York Heart Association class II, III or IV). Participants were randomly assigned to rosuvastatin 10mg or placebo and followed up for a median of 32.8 months. The primary outcome of the study was a composite of cardiovascular death, non-fatal myocardial infarction or non-fatal stroke.The study found no statistical difference in the primary outcome or in the rate of all cause mortality.Source (Source: PharmaGossip) PharmaGossip blogs http://www.medworm.com/rss/comments.php?id=1391024 Tue, 22 Apr 2008 12:59:00 +0100 1391024 http://www.medworm.com/index.php?rid=1361153&cid=t_116651_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F266952930%2F Not us. A survey of 101 primary care docs conducted by Deutsche Bank analyst Barbara Ryan has predictably bad news for Schering-Plough and Merck - the results suggest “both additional abrupt and sustained declines for Vytorin and Zetia, and increased utilization of other statins, especially Crestor,” she writes in an investor note this morning. The findings, by the way, are supplemented with data from ImpactRx. Approximately 85 percent of the respondents in this survey were aware of the recent Enhance results, and about 75 percent expect that usage of Vytorin and Zetia will decline in their practices. (Our thought - where were the other 15 percent? Out of the country on a jaunt paid for by a drugmaker? How could they not be aware of the medical controversy of the moment?) Anywa... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1361153 Wed, 09 Apr 2008 11:11:31 +0100 1361153 http://www.medworm.com/index.php?rid=1344256&cid=t_116651_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2008%2F04%2Fexciting-news-fda-approves-new-use-for.html I just received this e-mail from AstraZeneca, which indicates how it is currently using eMarketing to reach out to me and untold millions of other people about CRESTOR. I believe it is an innovative way to use eMarketing to beat the competition!Dear John,We're writing you because you've asked us for more information about CRESTOR® (rosuvastatin calcium) in the past. Well, today there's even more reason why CRESTOR, along with a gullible mind, is a smart choice for adults with high cholesterol. Now CRESTOR is approved to slow the progression of Vytorin and Zetia, as part of a treatment plan to lower cholesterol to goal and to further depress the stock price of Merck and Schering-Plough.Vytorin, or "bad cholesterol drug" as we call it, represented the progressive buildup of bullshit via TV ... Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=1344256 Tue, 01 Apr 2008 21:10:00 +0100 1344256 http://www.medworm.com/index.php?rid=1338213&cid=t_116651_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F261223749%2F A bit of good news, actually, at least for the drugmaker. The trial was halted because the cholesterol pill outperformed a placebo in a study to determine whether Crestor would reduce heart attacks and other cardiovascular problems in patients with no signs of pre-existing cardiovascular disease and low to normal LDL, but elevated levels of CRP, a market linked to heart attack risk. In a statement, AstraZeneca says the independent monitoring board for its Jupiter study met over the weekend and decided there was “unequivocal evidence” of a reduction in cardiovascular morbidity and mortality among patients on Crestor in the study. This is, of course, a boost for the drugmaker, because Crestor its one of its biggest sellers, and the news contrasts sharply with the growing doubts o... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1338213 Mon, 31 Mar 2008 11:22:22 +0100 1338213 http://www.medworm.com/index.php?rid=1316662&cid=t_116651_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2008%2F03%2Fmake-way-for-150-second-vytorin-tv-ad.html Schering-Plough CEO Fred Hassan told listeners at a recent Lehman Brothers healthcare conference that Vytorin-Zetia TV ads will soon be back on the air. This time, however, do NOT expect to see the cute food-people comparison ads, which I thought were getting old a long time ago (see "Vytorin Ads Are Getting Old -- and Disturbing!").As I said before:Personally, I don't think there's a snowball's chance in hell that the people-food comparison ads will come back. They are as dead as dodos. SP-Merck will have to come up with new ads like Pfizer did for Celebrex after Vioxx (a similar NSAID) was pulled from the market (see "New Vytorin TV Ads Are in the Works - IMHO").As a matter of fact, my sources (neurons) tell me that the new Vytorin ads will be very similar to the Celebrex 150-second comm... Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=1316662 Thu, 20 Mar 2008 13:22:00 +0100 1316662 http://www.medworm.com/index.php?rid=1239264&cid=t_116651_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2008%2F02%2Fpharma-r-succumbs-to-dark-side.html I once said "God bless the dedicated researchers and scientists of the pharmaceutical industry! They are truly the unsung heroes of the pharmaceutical industry! Too bad they are sequestered in their labs!" and "If God blesses the folks in pharma R&D, the devil may take pharmaceutical marketers -- unless they reform!"(see "God Bless R&D, but Marketers May Go to Hell!").I even came up with a nice visual image of this sentiment:Of course, I held little hope that Pharma Marketing would reform, but I didn't think that R&D would make a pact with the devil! The more I learn about about Merck's and Schering-Plough's failed ENHANCE study (see, for example, "How high hopes ultimately hurt Vytorin study"), the more I think a deal indeed was made.Perhaps the following image is better suite... Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=1239264 Mon, 18 Feb 2008 16:11:00 +0100 1239264 http://www.medworm.com/index.php?rid=1191572&cid=t_116651_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F226509147%2F Another day, another earnings report, or two. And who knows what else? As we assemble another interesting tale, we are also hunting and gathering all sorts of items. Here are a few for you. So grab your coffee or tea, or bottle of water, and catch up with the rest of us… AstraZeneca reported fourth-quarter profit declined as cutbacks and acquisition costs swelled while demand for its biggest meds slowed. Net income fell 12 percent to $1.3 billion, or 86 cents a share, from $1.43 billion, or 93 cents, a year earlier, while sales increased to $8.2 billion. The drugmaker is eliminating 7,600 jobs, or 11 percent of its workforce. Meanwhile, the Nexium heartburn med and the Crestor cholesterol pill slowed because of competition from cheaper generics, a trend that will be exacerbated by Wy... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1191572 Thu, 31 Jan 2008 12:13:34 +0100 1191572 http://www.medworm.com/index.php?rid=1188603&cid=t_116651_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2008%2F01%2Fcaucuses-coffee-shop-focus-groups-and.html Discussion of CholesterolBack to politics, where everything is tested in focus groups, even if just gabbing with a few people in a coffee shop.Not only is politics the topic of discussion in coffee shops around America these days, but so is high cholesterol and drugs that treat it. If a cholesterol drug were running in the Rx drug primaries, it would be the Giuliani of candidates! Vytorin and Zetia have dropped out of the race (see "Vytorin and Zetia Are Dead in the Water") and Crestor has re-emerged, phoenix-like, as a contender (see "Crestor Print Ad Touts Plaque Buildup Advantage").In this month's Pharma Marketing News, I published the following article by Jim Avery, professor of advertising at the University of Oklahoma. He recounts his conversation with college-educated friends at a l... Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=1188603 Wed, 30 Jan 2008 11:51:00 +0100 1188603 http://www.medworm.com/index.php?rid=1185746&cid=t_116651_150_f&fid=34768&url=http%3A%2F%2Fpharmagossip.blogspot.com%2F2008%2F01%2Fcrestor-vs-vytorin-john-mack-spots.html Who says Americans can't "do irony"!John Mack has a great post about AZ trying to replace Vytorin with Crestor! The irony:The ENHANCE and METEOR studies are similar in one respect: each studied only a few hundred people over a limited time period. Merck and Schering-Plough are trying to say we shouldn't place too much emphasis on a clinical trial involving only a few hundred people. Yet, a clinical trial involving only a few hundred people was good enough for the FDA to approve a new Crestor indication worth hundred of millions of dollars to AstraZeneca!Hmm!Maybe the FDA should rethink that Crestor indication! (Source: PharmaGossip) PharmaGossip blogs http://www.medworm.com/rss/comments.php?id=1185746 Tue, 29 Jan 2008 14:32:00 +0100 1185746 http://www.medworm.com/index.php?rid=1185765&cid=t_116651_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2008%2F01%2Fcrestor-print-ad-touts-plaque-buildup.html Click image to enlarge.Have you seen this new Crestor print ad from AstraZeneca? Crestor is one of the newer anti-cholesterol drugs that recently gained the right from FDA to claim it slows the progression of atherosclerosis (plaque buildup in arteries). That new indication is clearly the focus of these ads, a sample of which -- taken from the February 4, 2008, issue of Time Magazine -- is shown above.Recall that with all the hullabaloo over Vytorin/Zetia and the failure of the ENHANCE clinical trial (see "Should I Stop Taking Zetia?"), Merck and Schering-Plough have pulled direct-to-consumer (DTC) ads for these products from TV. I haven't seen any Crestor ads on TV lately either.As I suggested previously, I believe these ads will be back on TV after Merck/Schering figure out how to spin t... Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=1185765 Tue, 29 Jan 2008 12:15:00 +0100 1185765 http://www.medworm.com/index.php?rid=1088843&cid=t_116651_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F199157887%2F Rise and shine. Another day means another opportunity to grab a cup of coffee and take in the world. And so here are a few items to help you get started… China And US Sign Deal To Regulate Drugs (The New York Times) AstraZeneca Sues 7 Generic Drugmakers Over Crestor Patents (Yahoo/Reuters) AstraZeneca Appeals $12.9M Penalty In AWP Case (HealthLaw 360) Share / E-mail (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1088843 Wed, 12 Dec 2007 12:01:34 +0100 1088843 http://www.medworm.com/index.php?rid=1021310&cid=t_116651_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F183625480%2Fclogged_arteries_take_crestor.html AstraZeneca plc (NYSE:AZN) has received U.S. Food and Drug Administration approval to sell its cholesterol drug, Crestor, to also treat clogged arteries. Crestor will now be available to treat atherosclerosis in addition to being used as to lower cholesterol. It is the first widely used statin to receive this new approval.AstraZeneca has been conducting a large number of clinical trials to prove that it is superior to other statins. "This new indication gives Crestor an important differentiator from competitors in the cholesterol-lowering marketplace," AstraZeneca said in a statement.The new FDA approval is expected to give Crestor a leg up over competitors in the cholesterol lowering market like Lipitor from Pfizer Inc."FDA today approved Crestor as adjunctive therapy to di... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=1021310 Mon, 12 Nov 2007 15:30:06 +0100 1021310 http://www.medworm.com/index.php?rid=1017858&cid=t_116651_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F182279526%2F Such a busy day. But that can happen on a Friday. And so amid the spate of Vioxx news, we thought we would offer you a few items about other matters. Just in case… Lilly Plans More Drug Development In China (Reuters) Brain Boosting Drugs Spark Ethical Debate In The UK (Yahoo/Reuters) Alpharma Drug Is Designed To Fail A Test (nj.com) Bristol-Myers’ Sprycel Gets New Labeling (Yahoo/AP) AstraZeneca’s Crestor Gets FDA OK To Fight Artery Disease (Yahoo/AP) Share / E-mail (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1017858 Fri, 09 Nov 2007 17:24:47 +0100 1017858 http://www.medworm.com/index.php?rid=1003704&cid=t_116651_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F180061230%2F More bad news for the drugmaker. The latest development is from a study that found its Crestor cholesterol pill didn’t reduce deaths in older people with heart failure, which means AstraZeneca will have a hard time generating new scrips for such patients. The research, reported today at the American Heart Association meeting in Orlando, Florida, found that 11.4 percent of those on Crestor died, or had a heart attack or stroke, compared with 12.3 percent given a placebo. A successful result could have added $1 billion to U.S. revenues alone, according to industry analysts, although Reuters reports many had thought proving the drug’s benefits would be tough. Crestor sold $2 billion worldwide in the first nine months of 2007. “Our findings suggest the major cause of death in... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1003704 Mon, 05 Nov 2007 14:38:55 +0100 1003704 http://www.medworm.com/index.php?rid=968377&cid=t_116651_122_f&fid=35055&url=http%3A%2F%2Fsarasotaneurology.com%2F2007%2F10%2F22%2Fstroke-prevention-a-better-way-of-stroke-treatment%2F The objective is to have a total cholesterol less than 180, good cholesterol (HDL) of greater than 50 and bad cholesterol (LDL) less than 100. A recent study published in the journal Stroke reported that discontinuing statin therapy in the year after a stroke is associated with a significant increase in the risk for death, even in the absence of heart disease. Medications are not the only treatment for stroke prevention. Smoking is associated with a 2-3 times greater risk of stroke and bleeding in the brain. Smoking also contributes to the accelerated development of heart disease, emphysema and peripheral artery disease. Chantix is a new medication that received FDA approval to help stop smoking. Exercise is important in maintaining overall body conditioning and weight control. This in tur... Sarasota Neurology blogs http://www.medworm.com/rss/comments.php?id=968377 Mon, 22 Oct 2007 11:15:34 +0100 968377 http://www.medworm.com/index.php?rid=867460&cid=t_116651_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F155588891%2F The drugmaker accomplished this feat by engineering a special supplement that was published along with an issue last January of The Pharmaceutical Journal, which is read by UK pharmacists. The supplement was purportedly about guidelines for statin use but was later tagged as a mere disguise for Crestor, AstraZeneca’s cholesterol fighter. Following publication, complaints were lodged with the Medicines and Health Regulatory Agency, which decided there was no foul. But the Prescription Medicines Code of Practice Authority, which enforces the Association of the British Pharmaceutical Industry’s code, determined otherwise - AstraZeneca brought the industry into disrepute, according to a new essay in the same journal. Why? The case yielded 27 complaints, one of the highest number ever ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=867460 Wed, 12 Sep 2007 17:24:19 +0100 867460