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 'astrazeneca'. Sat, 03 Sep 2011 01:50:32 +0100 http://www.medworm.com/index.php?rid=5182317&cid=t_100585_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=5125966&cid=t_100585_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FZ_ype3VE7CE%2F Once again, a big drugmaker has made a payment to a state in order to settle charges of inflating the average wholesale prices of its medicine. This time, AstraZeneca agreed to pay $2.5 million to Idaho, which argued its citizens were harmed because the state Medicaid program unnecessarily paid too much for various drugs. “Where published prices are false or misleading, the taxpayers are significantly harmed by excessive Medicaid reimbursements,” Idaho Attorney General Lawrence Wasden says in a statement. “Investigation by my office has revealed that the reported average wholesale price often is not related to the actual wholesale price paid for the drug.” In one example cited. a unit of the Prilosec heartburn had a published average wholesale price of $4.134 in 2003, but in fact,... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=5125966 Fri, 12 Aug 2011 13:03:51 +0100 5125966 http://www.medworm.com/index.php?rid=5078034&cid=t_100585_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FpESdhESRxXI%2F And so, another working week is drawing to a close. This is, of course, our signal to daydream about weekend plans. We have not yet finalized our agenda, but we do hope to catch up on some reading and spend time with our short people. We may even tidy up the Pharmalot corporate campus. And you? Anything special in the offing? A day at the beach? A night at the movies? Maybe a dinner with someone special? Or if you have a high pain threshold, you could track the children in Washington DC as they jeopardize the economy. Whatever your pleasure, have a great time, but be safe. See you soon… Pfizer Wins Prempro Case In West Virginia (Bloomberg News) Nevada Wins Right To Continue Hormone Replacement Lawsuit (Las Vegas Sun) Sanofi Won’t Make Genzyme Milestone Payment (The Boston Globe... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=5078034 Fri, 29 Jul 2011 12:10:06 +0100 5078034 http://www.medworm.com/index.php?rid=5029186&cid=t_100585_150_f&fid=34768&url=http%3A%2F%2Fpharmagossip.blogspot.com%2F2011%2F07%2Fslumdog-clinical-trials-contd-fault.html US Pharmaceutical companies have moved their operations overseas over the course of the past decade. Instead of testing trial medicines on Americans, more and more of these tests are being carried out on poor people in faraway places. Russia, China, Brazil, Poland, Uganda, and Romania are all hot spots for what is called clinical research or clinical trials. Now employing CROs—or Clinical Research Organizations—the industry is big business, worth as much as $30 billion US dollars today.One country has experienced a boom like no other in this industry--India. Spoken English, an established medical infrastructure, welcome attitudes toward foreign industry and most importantly legions of poor, illiterate test subjects that are willing to try out new drugs have transformed the Indian lands... PharmaGossip blogs http://www.medworm.com/rss/comments.php?id=5029186 Wed, 13 Jul 2011 04:34:00 +0100 5029186 http://www.medworm.com/index.php?rid=4992993&cid=t_100585_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fe5AHzRsT-Fg%2F Pipelines are shriveling. Revenue is falling. Plants are closing. Employees are being shown the door. Signs of an industry in decline, to be sure. Not that pharma lacks the commitment to attempt a turnaround, but these developments reflect, in part, the ascendance of the finance team. In the view of industry veteran and consultant Daniel Hoffman, this emphasis on numbers crunching threatens to turn pharma into a version of the US auto industry. And since we like mixing things up, we asked him to write what amounts to a guest column. Why? We like the idea of livening up the usual menu of items with input from a loyal reader, but also one who has experience in the trenches and a refreshing point of view. We hope you enjoy this contribution. Here are his thoughts… Control of Pharma Oper... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4992993 Fri, 01 Jul 2011 13:20:38 +0100 4992993 http://www.medworm.com/index.php?rid=4960328&cid=t_100585_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FBKp9JbQ2S5I%2F Good morning, everyone. How are you today? Getting ready for those meetings and deadlines? We relate. There is much to do here on the Pharmalot corporate campus - reading, writing, chasing down interesting people. To prepare, we are brewing that reliable cup of stimulation - our flavor today is Rain Forest Nut. Feel free to join us. And to get things started, here are some tidbits. Have a good one and stay in touch… Bristol And Astra Diabetes Pill Faces Safety Hurdles (Bloomberg News) Biotechs Want Faster Drug Approvals (Boston Globe) Lilly CEO Blames Tax Laws And Immigration For Slower Innovation (Bloomberg News) Glaxo Ordered To Give Plaintiff Lists To United Health (Legal Intelligencer) Too Many UK Patients Are Prescribed Risky Drugs (Pharma Times) Abbott Labs Plant Closure Delaye... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4960328 Thu, 23 Jun 2011 11:54:26 +0100 4960328 http://www.medworm.com/index.php?rid=4945197&cid=t_100585_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F6lF6tGbTdbE%2F And so, another working week is about to draw to a close. This is, of course, our signal to daydream about weekend plans. For now, we intend to do some reading, catch up with our short people and promenade with the official Pharmalot mascots. And you? Anything special? Perhaps a drive in the country? A chance to meet with friends? Or maybe balance your checkbook and show the indebted nations how it’s done? Whatever your fancy, have a great time. Oh, and say ‘hi’ to Dad… FDA Reviewers Say Novartis Gout Drug Data Is Complicated (Reuters) Roche Faces Significant Hurdles For Avastin Breast Cancer Indication (Financial Times) UK Officials Say Pfizer Doing ‘Too Little’ As Plant Closes (BBC) FDA Approves Expanded Use Of Celgene Lymphoma Drug (Reuters) AstraZene... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4945197 Fri, 17 Jun 2011 12:15:14 +0100 4945197 http://www.medworm.com/index.php?rid=4921735&cid=t_100585_150_f&fid=34768&url=http%3A%2F%2Fpharmagossip.blogspot.com%2F2011%2F06%2Fmy-name-is-allen-jones-i-am.html AllenJonesTMAPJanuary20.pdf (application/pdf Object) (Source: PharmaGossip) PharmaGossip blogs http://www.medworm.com/rss/comments.php?id=4921735 Sat, 11 Jun 2011 04:29:00 +0100 4921735 http://www.medworm.com/index.php?rid=4902690&cid=t_100585_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FiilDc3sIUbE%2F AstraZeneca will pay $250,000 to 124 women who were subjected to pay discrimination while working at an office in Wayne, Pennsylvania, according to the US Department of Labor, which filed a lawsuit last year alleging the drugmaker discriminated against female sales reps by paying them salaries that were, on average, $1,700 less than their male counterparts. The department’s Office of Federal Contract Compliance Programs conducted a scheduled compliance review of the business center in 2002 and found that AstraZeneca had violated Executive Order 11246 by failing to meet its obligations as a federal contractor to ensure employees were paid fairly without regard to sex, race, color, religion and national origin (read the lawsuit). AstraZeneca holds a contract valued at more than $2 bil... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4902690 Mon, 06 Jun 2011 21:07:59 +0100 4902690 http://www.medworm.com/index.php?rid=4893916&cid=t_100585_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F_PKuBogHIcg%2F And so, another working week will soon draw to a close. This is, of course, our signal to daydream about the weekend. Our agenda includes some therapeutic swimming, catching up on our reading and taking in a soccer match with the short people. And you? How about enjoying the weather with a nice bike ride? Or spending time with someone special? Perhaps thinking big thoughts is in order. Whatever you do, have a wonderful time. And be safe. See you soon… Pfizer And Hisun Pharmaceuticals Plan Generic Venture (Bloomberg News) Tianjin Tasly Pharmaceutical To Build A Factory In Maryland (CapitalVue) Drugmakers Bolster US Corporate Philanthropy (Reuters) The New Pricing Game In Germany (Business Week) Endo Sales Reps Granted Class-Action Lawsuit For Overtime (Reuters) Teva Gives Big Golden P... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4893916 Fri, 03 Jun 2011 12:03:23 +0100 4893916 http://www.medworm.com/index.php?rid=4893907&cid=t_100585_150_f&fid=34768&url=http%3A%2F%2Fpharmagossip.blogspot.com%2F2011%2F06%2Fintroducing-seroquel-lawsuit-blog.html http://seroquellawsuitblog.blogspot.com/ (Source: PharmaGossip) PharmaGossip blogs http://www.medworm.com/rss/comments.php?id=4893907 Thu, 02 Jun 2011 04:02:00 +0100 4893907 http://www.medworm.com/index.php?rid=4872476&cid=t_100585_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fl6OCIRjRzwE%2F And so another working week is about to come to an end, which means we can daydream about weekend plans. Our modest agenda includes hanging out with the short people and catching up on some reading. What about you? Maybe a dip in the pool? A walk in the park? Perhaps gazing into the future? This side of the pond has a three-day break, of course, so there will be more time to indulge. Whatever you do, have a great time and see you soon… Novartis Found Not Liable For Jaw Disease (Reuters) Medco Loses Blue Cross Blue Shield Contract (Reuters) Trimeris Gets $5M In Roche Settlement (Triangle Business Journal) Pharma Protests UK Pricing Plan (Bloomberg News) AstraZeneca Confirms Endings Payments For Docs To Attend Meetings (Reuters) CMS Proposes Looser E-Prescribing Rules (Internal Medicin... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4872476 Fri, 27 May 2011 12:09:07 +0100 4872476 http://www.medworm.com/index.php?rid=4853218&cid=t_100585_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FYC8nXoQY5XE%2F In the latest example of who antipsychotics are being prescribed inappropriately, Florida’s state-run jails and residential homes are regularly giving large doses of the meds but not for uses that were approved by the FDA. And in some cases, the drugs are prescribed by contract doctors who have taken speaking fees and other gifts from drugmakers, according to The Palm Beach Post. As a result, the state’s Department of Juvenile Justice has ordered a review. “The questions recently brought to our attention are serious, and deserve answers based on a careful, thorough and independent review of the facts,” DJJ Secretary Wansley Walters tells the paper, which ran a two-part series about the problem (read here and here). The series raises familiar questions about the exte... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4853218 Mon, 23 May 2011 15:08:23 +0100 4853218 http://www.medworm.com/index.php?rid=4848154&cid=t_100585_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FkTurjNnKuyc%2F And so another working week will soon draw to a close. This is, of course, our signal to daydream about weekend plans. Our modest agenda includes yardwork, hanging with assorted short people and another installment in the ‘Let’s-see-them-before-they-die‘ concert series. And you? Anything special in the pipeline? How about curling up with a good e-book? Or a dinner with a favorite someone? Or maybe just a walk in the park? Whatever you do, have a great time and be safe. See you soon… FDA Approves J&J HIV Med For Combo Use (Reuters) EU OKs Bloodthinner From Pfizer And Bristol (Associated Press) EMA Approves Glaxo And Human Genome’s Benlysta For Lupus (Reuters) Pfizer Truck Robbed On Way To CVS (Securing Pharma) AstraZeneca To Eliminate 135 Jobs In Massachus... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4848154 Fri, 20 May 2011 11:39:57 +0100 4848154 http://www.medworm.com/index.php?rid=4841981&cid=t_100585_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fm8q5cglpFYs%2F For all the intriguing evidence that emerges from product-liability litigation about potential hazards of different medicines, still more documents are often kept under wraps. Why? Drugmakers often succeed in convincing judges to issue protective orders so that certain info - sometimes labeled as trade secrets - remains sealed. And attorneys for plaintiffs generally agree in order to advance the cases. However, the tactic has long riled critics who say select and crucial safety info may never reach the public. And so the US Senate Judiciary Committee today voted 12 to 6 to approve the “Sunshine in Litigation Act,” which would require judges to consider public health before granting a protective order or sealing court records and settlement agreements. You can read the text here... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4841981 Thu, 19 May 2011 16:35:48 +0100 4841981 http://www.medworm.com/index.php?rid=4821150&cid=t_100585_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FYw_11Z337sQ%2F And so another working week will soon draw to a close. Already, we are daydreaming about weekend plans. Our modest agenda includes mowing the lawn (again), catching up on some reading and taking one of the short people to watch a soccer match. And you? Anything special in the works? Maybe a drive in the country? A mysterious rendezvous? Or perhaps some spring cleaning is in order? Whatever you fancy, have a great time. But, of course, go safely. Meanwhile, here are some tidbits. See you… Shire Is A Takeover Target (Bloomberg News) Iperian Fires Top Execs (Xconomy) UK’s NICE Backs Merck And J&J’s Simponi For Rheumatoid Arthritis (InPharm) Prescription Drug Price Increases Cannot Go On Forever (Reuters) Ranbaxy Hopes To Supply Nexium To US By Year’s End (Economic... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4821150 Fri, 13 May 2011 12:01:46 +0100 4821150 http://www.medworm.com/index.php?rid=4821153&cid=t_100585_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FttGLcZVmqVw%2F Has a new UK law aimed at snuffing out bribes forced AstraZeneca to change some practices? Kai Richter, medical director for AstraZeneca Deutschland, told the Financial Times Deutschland that, as of this summer, the drugmaker will not cover the cost of hotels and travel or conference fees for doctors attending medical science events. Although he did not say specifically the decision was due to the new Bribery Act, he did indicate the policy change was an internal decision. Nonetheless, the German paper quoted an industry insider as saying the new law was a “catalyst moment” (read here). An AstraZeneca spokesperson, meanwhile, acknowledges to BMJ that changes are afoot in global sales and marketing practices. “To that end, we are discontinuing certain activities, even though the... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4821153 Thu, 12 May 2011 13:34:14 +0100 4821153 http://www.medworm.com/index.php?rid=4813667&cid=t_100585_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FU-E_cUnzOJg%2F Good morning, everyone, and nice to see you again. A busy day is planned here on the Pharmalot corporate campus as we hustle to meet some deadlines and undertake our own version of R&D. No doubt, you relate. So please join us for that mandatory cup of stimulation. Meanwhile, here are some tidbits we found floating about. Hope you conquer the world and see you later… Takeda In Talks To Buy Nycomed For $12 Billion (Bloomberg News) Carl Icahn And His Big Bet On Biotech (The Boston Globe) Glaxo & Astra Hook Up With Academia For Inflammation Research (Pharma Times) Experimental AIDS Vaccine Shows Promise In Monkeys (Reuters) Shire Eyes Big Sales For New Vyvanse Uses (Reuters) Procrit And Epogen May Worsen Heart Attacks (Health Day) Docs Busted For Supplying Oxycodone Network (Th... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4813667 Thu, 12 May 2011 12:15:38 +0100 4813667 http://www.medworm.com/index.php?rid=4780474&cid=t_100585_147_f&fid=39273&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FePharmaSummit%2F%7E3%2FB-3pjMYEf4o%2Fastra-zeneca-expanding-digital-customer.html AstraZeneca has now placed “Click To Chat” features on the “Contact Us” pages of Crestor and Nexium. The IMing feature is the first of its kind in the Pharmaceutical industry, and AZ believes this is just one more way they can connect digitally with their customers. Donna Holder, senior director, AstraZeneca Information Center, stated “AstraZeneca understands that our consumers want flexibility, especially when it comes to health information. This new resource enables consumers to have easier access to the information they seek through the convenience of a real-time, online channel.” (Source: Jack's Posterous) ePharma Summit West is the best event to help you understand how to use your digital toolbox to access customers. Sessions like “Measuring Digital Marketing Toward S... ePharma Summit blogs http://www.medworm.com/rss/comments.php?id=4780474 Tue, 03 May 2011 15:32:00 +0100 4780474 http://www.medworm.com/index.php?rid=4762937&cid=t_100585_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fhg7QGCQONN0%2F Hello, everyone. Another busy day is about to unfold here on the Pharmalot corporate campus, as we prepare for a round of meetings and deadlines. To cope, we are our brewing our mandatory cup of stimulation - we continue to favor Wild Mountain Blueberry this week. Meanwhile, here are some items to help you get started. Hope your day goes well and stay in touch… Par Pharma Pays $153M To Settle Pricing Lawsuits (Reuters) Sanofi-Aventis Profit Falls Due To Generics (Bloomberg News) More US Women Are Using The Morning After Pill (Reuters) Roche Wins FDA Approval For HPV Diagnostics Test (Bloomberg News) AstraZeneca Profits Get A Lift From Tax Breaks (Pharma Times) Merck Hepatitis C Drug Wins FDA Panel Backing (Boston Globe) Australia Delays Subsidies For Some Medicines (Australian Broadc... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4762937 Thu, 28 Apr 2011 11:49:06 +0100 4762937 http://www.medworm.com/index.php?rid=4759025&cid=t_100585_150_f&fid=34768&url=http%3A%2F%2Fpharmagossip.blogspot.com%2F2011%2F04%2Fas-of-31-march-2011-legal-defence-costs.html Source (Source: PharmaGossip) PharmaGossip blogs http://www.medworm.com/rss/comments.php?id=4759025 Thu, 28 Apr 2011 08:01:00 +0100 4759025 http://www.medworm.com/index.php?rid=4759031&cid=t_100585_150_f&fid=34768&url=http%3A%2F%2Fpharmagossip.blogspot.com%2F2011%2F04%2Fastrazeneca-seroquel-click-to-chat-to.html Click here! (Source: PharmaGossip) PharmaGossip blogs http://www.medworm.com/rss/comments.php?id=4759031 Wed, 27 Apr 2011 15:23:00 +0100 4759031 http://www.medworm.com/index.php?rid=4759039&cid=t_100585_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FlVjvoT8rNwo%2F The sad case of Dan Markingson appears to have no end. The latest twist is playing out as an issue of academic freedom at the University of Minnesota where, seven years ago, researchers ran a clinical trial in which the 26-year-old participated. But the circumstances surrounding his participation and subsequent death led to widely publicized allegations the university put its own interests first. One university researcher also consulted for AstraZeneca, which sells the drug and sponsored the study. And researchers were allegedly under pressure to bolster enrollment. These details emerged following a lawsuit filed by Markingson’s mother, who objected to her son’s participation because he was already mentally ill and possibly incompetent, but was enrolled anyway. Her lawsuit went nowher... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4759039 Wed, 27 Apr 2011 15:16:18 +0100 4759039 http://www.medworm.com/index.php?rid=4724256&cid=t_100585_150_f&fid=34768&url=http%3A%2F%2Fpharmagossip.blogspot.com%2F2011%2F04%2Fseroquel-take-three.html (Source: PharmaGossip) PharmaGossip blogs http://www.medworm.com/rss/comments.php?id=4724256 Sun, 17 Apr 2011 23:00:00 +0100 4724256 http://www.medworm.com/index.php?rid=4724257&cid=t_100585_150_f&fid=34768&url=http%3A%2F%2Fpharmagossip.blogspot.com%2F2011%2F04%2Fseroquel-take-two.html Seroquel Voice Over Auditions - Watch more Funny Videos (Source: PharmaGossip) PharmaGossip blogs http://www.medworm.com/rss/comments.php?id=4724257 Sun, 17 Apr 2011 22:52:00 +0100 4724257 http://www.medworm.com/index.php?rid=4684761&cid=t_100585_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F7VtbjQj12Pw%2F Good morning, everyone. Another brand new day is on the way. Of course, this calls for a hearty cup of stimluation - our flavor today is Cinnamon Cream Swirl. Feel free to grab one yourself, or a bottle of water if you prefer, and join us as we peruse the news of the world. As always, we appreciate tips and hints and allegations. So send them our way. Meanwhile, have a great day and see you soon… J&J May Do $10B Deals To Bolster Growth (Bloomberg News) Synthetic Drugs Send Thousands To Emergency Rooms (Associated Press) Merck’s Dutch R&D Unit To Keep Some Jobs After All (Reuters) The Valent Pharma CEO And His Acquisition Binge (Bloomberg News) Where Are The ImClone Alumni? (Xconomy) FDA Approves Restless Legs Syndrome Med (Reuters) AstraZeneca Wins FDA Approval Of Thy... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4684761 Thu, 07 Apr 2011 12:03:32 +0100 4684761 http://www.medworm.com/index.php?rid=4653603&cid=t_100585_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FSGckQ4pqQfc%2F The US Supreme Court ruled today that Santa Clara County cannot proceed with a lawsuit alleging its hospitals and clinics were overcharged for prescription meds by various drugmakers, which failed to offer discounts as part of what is known as the 340B program. This offers access to discounted drugs to healthcare entities certified by the US Department of Health and Human Services. The 8-to-0 decision overturned a federal appeals court ruling of a lawsuit filed in 2005 against Pfizer, AstraZeneca, Bayer, GlaxoSmithKline, Bristol-Myers Squibb, Merck and Sanofi-Aventis, among others. The county had filed suit after the HHS Office of Inspector General found the drugmakers had violated pricing ceilings between 2001 and 2005. The dispute centered on the rights of 14,500 health providers that sp... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4653603 Tue, 29 Mar 2011 15:52:55 +0100 4653603 http://www.medworm.com/index.php?rid=4642998&cid=t_100585_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Ff-2Dp6cVgAU%2F Hello, everyone, and welcome to another working week. We hope the weekend was relaxing and enjoyable. Now, though, the time has come to resume that routine of meetings and deadlines. To cope, we are quaffing our mandatory cup of stimulation. Please feel free to join us. Meanwhile, here are a few items from around the world. Hope your day goes well and stay in touch… AstraZeneca Raises Forecast After Settling Tax Dispute (Bloomberg News) Novartis Invests In Chinese Vaccine Maker (InPharma Technologist) Pfizer Employee Arrested For Carrying Knife On Plane (New York Post) Speculation Rises That Roche Is A Takeover Target (Pharma Times) Pfizer Recalls Two Drugs Over Mislabeling (MoneyControl) Non-Profit Proposal Would Save 25 Pfizer Research Jobs (The Day) Actelion Board Seeks Rejection ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4642998 Mon, 28 Mar 2011 12:00:50 +0100 4642998 http://www.medworm.com/index.php?rid=4627017&cid=t_100585_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FmN81QTJn9qc%2F Just three months after the FDA rejected the new Brilinta bloodthinner from AstraZeneca, France is now reportedly giving the drugmaker a hard time as well. Even though the European Medicines Agency already endorsed the treatment, the HAS health technology assessment agency in France has decided the med has an unfavorable risk/benefit profile, which puts a halt to final pricing talks and a product launch, according to an investor note from Sanford Bernstein analyst Tim Anderson. AstraZeneca, he writes, has confirmed that its application was withdrawn in France, where the drug was to be called Brilique. This is an issue for the drugmaker. Even though the EMA decision applies to 27 countries, France is “one of the largest markets in developed Europe for these types of drugs, accounting ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4627017 Wed, 23 Mar 2011 16:10:32 +0100 4627017 http://www.medworm.com/index.php?rid=4606049&cid=t_100585_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FCjndVwqn8V0%2F Last week, AstraZeneca agreed to pay $68.5 million to 36 states and the District of Columbia to resolve litigation charging the drugmaker with illegally marketing its Seroquel antipsychotic, failing to sufficiently disclose potential side effects and withholding negative safety and effectivness info (back story). But seven states were not among them, including South Carolina, which has a pending lawsuit against the drugmaker. Now, though, AstraZeneca has filed a counterclaim. The drugmaker alleges Attorney General Alan Wilson is violating its constitutional due process rights by prosecuting a “law enforcement action akin to a criminal proceeding” dressed up as a civil suit, The National Law Journal writes. And AstraZeneca accuses him of reaching an “unlawful” agreem... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4606049 Thu, 17 Mar 2011 17:32:07 +0100 4606049 http://www.medworm.com/index.php?rid=4600792&cid=t_100585_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FNv54Gsv6Djw%2F Joining its rivals, Novartis is the latest global drugmaker to shed jobs in the UK. To be specific, 550 positions from a facility in West Sussex, which employs a total of 950 people, will be eliminated over the next two years as manufacturing is discontinued at the site. Gastrointestinal research will be shifted elsewhere, although a respiratory research group that employs about 330 will remain. “With significant changes in health-care systems aimed to contain or cut cost, this critical assessment and the subsequent potential changes to the Novartis UK organization are key to maintain significant investment in innovative drugs and our research efforts in the UK,” Sue Webb, Novartis general manager for the UK and Ireland, says in a statement, according to the BBC. This is the l... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4600792 Wed, 16 Mar 2011 20:52:28 +0100 4600792 http://www.medworm.com/index.php?rid=4592688&cid=t_100585_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FE7DPjM4TBcw%2F Given the enormity of the unfolding crisis in Japan and the potential for long-lasting disruption, one securities analyst has drawn up a list of the big global drugmakers with the largest exposure to this beleaguered nation. On a percentage basis, Novartis is at the top of the list with 10.9 percent of its 2010 revenue, or $3.3 billion, coming from Japan. Next up is Merck with 8.2 percent of more than $45 billion, or nearly $3.8 billion. Behind Merck is AstraZeneca with 7.9 percent of 2010 revenue of $33 billion, or $2.6 billion generated in Japan. Bristol-Myers Squibb, by contrast, has the lowest exposure, with 3 percent of $19.5 billion in revenue, or $585 million generated in Japan last year, according to Leerink Swann analyst Seamus Fernandez. “The majority of large pharma opera... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4592688 Tue, 15 Mar 2011 17:30:51 +0100 4592688 http://www.medworm.com/index.php?rid=4570757&cid=t_100585_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FPmtKJqwRTaY%2F AstraZeneca agreed to pay $68.5 million to 36 states and the District of Columbia to resolve a lawsuit charging the drugmaker with illegal marketing of its Seroquel antipsychotic, failing to sufficiently disclose potential side effects to health care providers and withholding negative info in studies about safety and effectiveness. The drugmaker allegedly marketed Seroquel, which was approved only for schizophrenia and bipolar disorder, for several off-label uses to treat both children and the elderly, specifically in nursing homes. Among the unapproved uses: Alzheimer’s Disease, dementia, anxiety, depression, sleep disorders and post traumatic stress disorder, according to the lawsuit (read here). “This case sends a message that we take seriously the duty pharmaceutical companies have... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4570757 Thu, 10 Mar 2011 19:37:14 +0100 4570757 http://www.medworm.com/index.php?rid=4570753&cid=t_100585_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2011%2F03%2Fastrazenecas-twitter-survey-will-they.html @astrazeneca is currently asking its Twitter followers (of which it has over 5,000) to fill out an online survey hosted on SurveyMonkey. AZ tweeted this a few minutes ago: "Last chance 2 complete our Twitter survey, closing fri...we’d like your ideas: http://ow.ly/4bzf0" In case the survey is closed by the time you read this, you can find a PDF version I created for archival purposes here: http://bit.ly/AZTsurveyI also use SurveyMonkey to survey my Twitter followers and have received over 1,600 responses to date. You can take my survey (here) and/or see the de-identified results (here). What is AZ interested in learning from its followers? There's the standard demographic-type questions, including "How would you best describe yourself?" The choices listed tell us something about who AZ e... Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=4570753 Thu, 10 Mar 2011 14:08:00 +0100 4570753 http://www.medworm.com/index.php?rid=4545255&cid=t_100585_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fj7-yb8Q-oVg%2F Rise and shine, everyone, another shiny day is on the way. What lies in store? Meetings and deadlines, no doubt, and we relate. To cope, we are brewing our mandatory cup of stimulation and invite you to join us. Meanwhile, we will pause to hustle one of the short people off to the local schoolhouse. So here are a few tidbits. Also, please note that we posted some items last night, but placed them above our morning greeting in the event some people did not see them. Have a great day and stay in touch… Traditional Drug Discovery Model Is Ripe For Reform (Nature) McKesson Fights $212M Pricing Fine Levied By Arizona (Courthouse News) Lilly To Outsource Bioanalytical Work (Pharma Times) Eisai To Cut 900 Jobs Over Five Years (Bloomberg News) Panel Told No Guarantees Against Unethical Resea... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4545255 Thu, 03 Mar 2011 12:00:30 +0100 4545255 http://www.medworm.com/index.php?rid=4532567&cid=t_100585_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FsAQS7vachLg%2F Japan’s Osaka District Court late last week ordered AstraZeneca to pay 60.5 million yen - or about $733,000 - to nine of 11 plaintiffs for failing to include proper warnings about serious side effects on the labeling for its Iressa lung cancer med when it was approved in the country in July 2002. However, the three-judge panel ruled the Japanese government was not liable for any damages. At issue was interstitial lung disease, or ILD, which was cited in 810 deaths through March 2010, according to Medwatcher Japan, a non-profit watchdog, and attorneys who represent the plaintiffs. They argued AstraZeneca downplayed safety issues by failing to prominently note on the labeling the potential for ILD at the time of approval and then advertised Iressa as “anti-cancer drug with little... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4532567 Tue, 01 Mar 2011 13:53:37 +0100 4532567 http://www.medworm.com/index.php?rid=4532569&cid=t_100585_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FyUS59WunmL4%2F About 6,000 ‘blue chip’ jobs are leaving the UK as Pfizer, Glaxo and AstraZeneca gradually shutter operations. The development hit home when Pfizer recently decided to close its Sandwich facility, eliminating 2,400 positions, a move that came just after weeks the government claimed pharma is a big part of the future (see here and here). But many jobs will eventually find their way to other shores which are more competitive, according to Thom Thorp of Eli Lilly. “I’m concerned about the future of pharma in the UK ….” Confederation British Industry director general John Cridland tells the UK’s Channel 4. “I think government has taken the sector a little bit for granted. I’ll say it on behalf of the sector. They need to feel loved and wanted. The UK is n... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4532569 Tue, 01 Mar 2011 13:03:55 +0100 4532569 http://www.medworm.com/index.php?rid=4522275&cid=t_100585_150_f&fid=34768&url=http%3A%2F%2Fpharmagossip.blogspot.com%2F2011%2F02%2Fone-for-spitzstrategy-astrazeneca-still.html (Source: PharmaGossip) PharmaGossip blogs http://www.medworm.com/rss/comments.php?id=4522275 Fri, 25 Feb 2011 23:00:00 +0100 4522275 http://www.medworm.com/index.php?rid=4517353&cid=t_100585_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FI5f-Cre6Hz4%2F Four months after we heard the FDA was concerned with a facility run by Aurobindo, a major supplier of active pharmaceutical ingredients that is based in India, the agency has now restricted imports from one of its plants, according to reports. The plant, by the way, also makes various generic meds that are sold by for Pfizer, which struck a supply deal with Aurobindo two years ago. The facility, which is known as Unit-VI, makes antibiotic pills and injectable products, and contributes about $30 million, or 3.8 percent, to annual sales, Aurobindo told Bloomberg News. All shipments destined for the US have been halted, although the supplier hopes to be able to resolve the problems within three months, the news service adds. Aurobindo supplies 75 pills and 12 injectables for Pfizer, specifi... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4517353 Thu, 24 Feb 2011 13:10:00 +0100 4517353 http://www.medworm.com/index.php?rid=4512613&cid=t_100585_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fc--MjGyqugU%2F Earlier this month, a Medicaid managed care provider in Ohio agreed to pay $26 million to settle a whistleblower lawsuit brought by former employees, who alleged that assessments of adults and children with special needs were never conducted, but data was submitted anyway to the state Medicaid program for reimbursement. What has this episode to do with drugmakers? Well, the state of Ohio collected $10 million of the total $26 million paid by CareSource, the managed care provider. And Ohio attorney general Mike DeWine then bemoaned publicly that the state would have received more money if there was a False Claims Act statute on its books (look here). In general, such a law would allow Ohio to collect a bigger payday each time it participates in a whistleblower settlement. And in an era of i... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4512613 Wed, 23 Feb 2011 16:28:43 +0100 4512613 http://www.medworm.com/index.php?rid=4512615&cid=t_100585_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=4498392&cid=t_100585_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2011%2F02%2Fastrazeneca-hosts-take-on-depression.html DISCUSSIONS tab to post about what you’re going through in order to help others."There were no responses, so I decided to post a reply asking for a definition of bipolar depression and MDD. The following notice popped up (click on image for an enlarged, readable view):This is pretty typical stuff; ie, absolutely no mention of product names will be tolerated. There's one small problem, however.Seroquel Lurks Behind the ScenesI noticed that it took a long time to display the discussion page and posts. During the minute or so the application was loading, I also noticed the following URL being accessed: http://www.seroquelfbdiscapp.com/, which contains a product brand name; ie, Seroquel!In fact, you can type that URL in your browser and you will see the "naked" app without the surrounding Fa... Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=4498392 Sat, 19 Feb 2011 18:20:00 +0100 4498392 http://www.medworm.com/index.php?rid=4489970&cid=t_100585_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2011%2F02%2Fomg-astrazeneca-hosts-twitter-chat.html Despite dire predictions of "PR failure," the #rxsave Twitter chat (see "AstraZeneca to Host First-Ever Pharma-Sponsored Twitter Chat!") hosted by @AstraZenecaUS last night was, IMHO, a great success and proof that a pharmaceutical company can indeed host meaningful Twitter chats. Read the transcript of the entire chat here.There were a few attempts by two or three "malcontents" to "hijack" the conversation as I warned about in a previous blog post (here). But despite their attempts to ask "the tough questions" about off-label promotion of drugs and Seroquel side effects, everyone completely ignored the hijackers and the conversation continued as if these people were not even there. [Perhaps there should be Twitter chats on these other topics. Pharma companies will not host these, but pati... Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=4489970 Thu, 17 Feb 2011 13:15:00 +0100 4489970 http://www.medworm.com/index.php?rid=4482966&cid=t_100585_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2011%2F02%2Fquestions-i-hope-az-can-answer-during.html By now everyone should know that AstrazenecaUS is hosting the first-ever one hour pharma-sponsored Twitter chat tonight starting at 8 PM Eastern Time (for details, see here). Many of my Twitter colleagues -- not all of them friendly to me or to AZ -- are already engaging in the chat using the #rxsave hashtag (follow the Twitter #Rxsave tweet stream here).I raised a few hackles when I suggested that the chat may be "hijacked" by "anti-Seroquel folks & pharma critics". Pharma has some experience with "disgruntled" patients who have "hijacked" their social media efforts (see, for example, "Disgruntled Patient Shuts Down sanofi-aventis Facebook Page").As with any social media conversation, this one will be controlled by the vocal minority -- those people who actually post something. We kno... Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=4482966 Wed, 16 Feb 2011 15:05:00 +0100 4482966 http://www.medworm.com/index.php?rid=4482967&cid=t_100585_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2011%2F02%2Fastrazeneca-to-host-first-ever-pharma.html Back in November, 2010, I asked "Will a Pharma Company Ever 'Host' a Chat on Twitter?" (see here). I just learned that AstraZeneca (US) will be the first pharma company (that I know of) to do so according to this @AstraZeneca Twitter post:AstraZeneca to host Twitter chat on Rx savings. 8p EDT Wednesday. Details here http://ow.ly/3W3G7 #rxsave #socpharmHere are the relevant details:AstraZeneca (@AstraZenecaUS) will host a one-hour chat on Twitter at 8 p.m. EDT on Wednesday, February 16 to raise awareness about helping patients save money through prescription savings programs.The chat will be led by Jennifer McGovern, the director of the AZ&Me prescription savings programs. She will answer questions while offering ideas about how patient assistance needs are evolving and how social media... Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=4482967 Tue, 15 Feb 2011 20:12:00 +0100 4482967 http://www.medworm.com/index.php?rid=4478139&cid=t_100585_150_f&fid=34768&url=http%3A%2F%2Fpharmagossip.blogspot.com%2F2011%2F02%2Fmore-dave-brennan-he-likes-word-trust.html (Source: PharmaGossip) PharmaGossip blogs http://www.medworm.com/rss/comments.php?id=4478139 Tue, 15 Feb 2011 15:14:00 +0100 4478139 http://www.medworm.com/index.php?rid=4464694&cid=t_100585_150_f&fid=34768&url=http%3A%2F%2Fpharmagossip.blogspot.com%2F2011%2F02%2Fwhat-were-astrazenecas-senior.html Looks like full marks fromDr John Patterson back in 2001But wait! There's more:Martin Nicklasson 2002Nigel Doran 2004Geoff Birkett 2004 (Source: PharmaGossip) PharmaGossip blogs http://www.medworm.com/rss/comments.php?id=4464694 Fri, 11 Feb 2011 23:01:00 +0100 4464694 http://www.medworm.com/index.php?rid=4464705&cid=t_100585_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FUzPmlJi0yIs%2F Hired someone new and exciting? Promoted a rising star? Finally solved that hard-to-fill spot? Share the news with us and we’ll share with it others. That’s right. Send us your announcements and we’ll find a home for them. Don’t be shy. Everyone wants to know who is coming and going, especially with all the layoffs. Despite the downsizing, there is movement. Here are some of the latest changes. Recognize anyone? And here is our regular feature. Send us a photo and we will spotlight a different person each week. This time around, we note that AstraZeneca hired John Yee as vp and US head medical officer. Previously, he was vp and global head, evidence-based medicine and health outcomes research at Genzyme, where he spent eight years. And before that, Yee was a faculty member at Harva... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4464705 Fri, 11 Feb 2011 13:13:18 +0100 4464705 http://www.medworm.com/index.php?rid=4455482&cid=t_100585_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FuEu4Ajq_SyY%2F In 2005, AstraZeneca ran into a problem with its Iressa cancer drug, which had been approved two years earlier to treat non-small cell lung cancer as part of the FDA accelerated approval program. This meant the drugmaker was required to conduct so-called confirmatory studies, but the follow-up failed to show a survival benefit and Iressa was withdrawn, except for patients already being treated. In fact, this turned out to be the first of five instances in which such follow-up trials flopped and a drug was subsequently yanked or new restrictions were imposed. This was a distinction that, no doubt, AstraZeneca would like to forget. Of course, the drugmaker was not helped after receiving reports of serious illness and deaths due to a lung disease associated with the med in Japan. However, con... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4455482 Wed, 09 Feb 2011 22:11:48 +0100 4455482 http://www.medworm.com/index.php?rid=4455486&cid=t_100585_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FuT2spYvGiGQ%2F Pfizer has agreed to pay about $330 million to settle more than 2,200 lawsuits charging its Prempro hormone replacement therapy caused women to develop breast cancer, embracing a strategy used by several other drugmakers to cap the cost of growing product-liability litigation that can worry investors. The cases settled for an average of about $150,000, according to Bloomberg News, which first reported the settlement, although a Pfizer spokesman disputed the figures. The move came after a Pennsylvania appeals court reinstated $1.7 million in compensatory damages and $8.6 million in punitive damages against Pfizer in a lawsuit filed by an Arkansas woman, who alleged its Wyeth unit failed to warn that Prempro could cause her to develop breast cancer. The settlement comes just weeks after Ian ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4455486 Wed, 09 Feb 2011 13:09:42 +0100 4455486 http://www.medworm.com/index.php?rid=4450518&cid=t_100585_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FSxHKLul2w-s%2F Nearly seven years ago, 26-year-old Dan Markingson killed himself while participating in a clinical trial at the University of Minnesota, where researchers were studying the Seroquel antipsychotic. And the circumstances surrounding his participation and subsequent death led to widely publicized allegations that the university put its own interests ahead of the patient. How so? One reason - an academic researcher also consulted for AstraZeneca, which markets the pill and sponsored the study. And the researchers were allegedly under pressure to bolster enrollment. These details emerged following a lawsuit filed by Markingson’s mother, who objected to her son’s participation because he was already mentally ill and possibly incompetent, but was enrolled anyway (background here). H... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4450518 Tue, 08 Feb 2011 21:21:42 +0100 4450518 http://www.medworm.com/index.php?rid=4450523&cid=t_100585_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FujKHiAQXNLE%2F Hello, everyone, and welcome to a brand new day. Here on the Pharmalot corporate campus we are getting our start by hustling our short people off to the local school houses. And you? No doubt, you are readying for another round of meetings and deadlines. To help you along, we have gathered some tidbits. Meanwhile, please join us for a cup of stimulation. Hope your day goes well and stay in touch… Merck-Serono Opens R&D Site, Adding 100 Jobs (Boston Business Journal) Roche’s Avastin Works In Late-Stage Trial For Ovarian Cancer (Reuters) Teva Earnings Miss Analyst Estimates (Bloomberg News) Has RNAi Fever Cooled? (The New York Times) Black Box Warnings Are Applied Inconsistently (Health Day) Glaxo To Move Philadelphia Offices, Denies Job Cuts (Philadelphia Inquirer) Schizoph... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4450523 Tue, 08 Feb 2011 13:06:18 +0100 4450523 http://www.medworm.com/index.php?rid=4424446&cid=t_100585_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F9T5uMwVXXjQ%2F The list of product web sites that manage to get consumers to actually do something contains some very familiar names, such as Viagra, Nexium, Yaz and Lunesta. Of course, these are used to treat rather common concerns and all have, at one time or another, been widely advertised. Yet they also share something else in common - often, coupons are available, according to a recent survey that found, on average, 74 percent of consumers took some type of action after visiting a product web site. In other words, coupons appear to act as a motivator for following up in some fashion. “One thing we see when looking at satisfaction in years past is that there seems to be a high correlation beween satisfaction and a coupon,” says Meredith Ressi, president of Manhattan Research, which canvas... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4424446 Tue, 01 Feb 2011 14:04:32 +0100 4424446 http://www.medworm.com/index.php?rid=4406036&cid=t_100585_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FQi1kO4OIQZc%2F Hello, everyone. And how are you today? Yet another pile of snow has descended on the Pharmalot corporate campus, where we have a shovel in one hand and a cup of stimulation in the other. Nonetheless, we will not be deterred from foraging for interesting news and assorted developments. And so here are a few tidbits to get us all started. Enjoy, and we hope your day goes well… AstraZeneca To Double Stock Buybacks Amid Drug Setbacks (Bloomberg News) Lilly Profit And Sales Beat Wall Street Forecasts (Reuters) Off-Label Prescribing To Children Is Widespread In Europe (PharmaTimes) FDA Denies Additional Indication For Glaxo’s Avodart (Reuters) Data Exclusivity Remains Hurdle To EU-India Free Trade Deal (Business Standard) Novartis Profit Falls And Vaccine Sales Slide (Bloomberg News... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4406036 Thu, 27 Jan 2011 12:56:53 +0100 4406036 http://www.medworm.com/index.php?rid=4399821&cid=t_100585_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=4399822&cid=t_100585_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FYUnyDo-9nKo%2F For the past year, several big drugmakers have been embracing Russia as one of the next emerging markets in which to invest. Sanofi-Aventis, AstraZeneca, GlaxoSmithKline, Novartis, Novo Nordisk, Nycomed, Pfizer and Servier, among others, have previously announced intentions or are possible plans to establish or expand manufacturing facilities there (back story). But apparently few are moving fast enough for Prime Minister Vladimir Putin, who issued what amounts to a warning on the Russian government website to drugmakers that do not help expand the domestic market: “There will be restrictions for (global drugmakers) in the Russian market if they do not launch production and transfer technology,” according to In-Pharma Technologist. Then, sounding a little bit like a watchdog from a... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4399822 Wed, 26 Jan 2011 14:10:22 +0100 4399822 http://www.medworm.com/index.php?rid=4382951&cid=t_100585_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F8XrunC8mJJE%2F And so, another work week will soon draw to a close. Although once again, we are dusting off the snow on the Pharmalot corporate campus. Please excuse any delays this morning, but due to the economy, we no longer have a maintenance crew. This does give us the opportunity, though, to daydream about weekend plans - hanging out with the short people and catching up on some reading. What about you? Anything fun on the agenda? How about a good flick or spending time with someone special? Whatever you do, enjoy. Meanwhile, here are some tidbits. Catch you soon… EMA To Review Safety Of Sanofi’s Multaq (Wall Street Journal) AstraZeneca Responds To FDA About Brilinta (Bloomberg News) Biogen Boosts Prices Of MS Drug (Wall Street Journal) EU Panel Does Not Recommend Biogen MS Pill (Reuter... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4382951 Fri, 21 Jan 2011 12:55:15 +0100 4382951 http://www.medworm.com/index.php?rid=4377787&cid=t_100585_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FcjCmn3mBJKE%2F Two years ago, the US Federal Trade Commission filed a highly publicized lawsuit against Cephalon over pay-to-delay deals worth an estimated $200 million with some generic drugmakers - Ranbaxy Labs, Mylan Labs and Teva Pharmaceuticals - to keep a copycat version of its Provigil sleep-disorder pill off the market until 2012 (read this). Now, though, more than three dozen other drugmakers have raced to court to try to keep details of their own deals from being disclosed as a result of this battle. In a motion filed in federal court in Philadelphia this week, no fewer than 37 drugmakers - including Abbott Laboratories, Merck, Novartis, Bristol-Myers Squibb, Sanofi-Aventis, GlaxoSmithKline, Pfizer, Bayer, AstraZeneca, Johnson & Johnson, Actavis, Waston Pharmaceuticals, Dr. Reddy’s, ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4377787 Thu, 20 Jan 2011 20:48:02 +0100 4377787 http://www.medworm.com/index.php?rid=4360928&cid=t_100585_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2011%2F01%2Fim-not-here-to-sell-drugs-then-why-use.html In October, 2010, we discussed a series of reports by Pro Publica and multiple other respected news organizations about payments by seven pharmaceutical companies to thousands of doctors.  Industry often claims that they only pay the best and the brightest physicians and academics to provide education relevant to their products.  However, the ProPublica et al report suggested that they mainly recruited physicians who already showed their favor to their products by prescribing them often, but soothed their consciences by dubbing them "thought leaders" or "key opinion leaders."  While some of the physicians were well-known academics, others had notably blemished records.  Since then, news media around the US have looked into interactions among local physici... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=4360928 Tue, 18 Jan 2011 17:59:00 +0100 4360928 http://www.medworm.com/index.php?rid=4343334&cid=t_100585_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FCgLvWskDCNk%2F Hello, everyone, and top of the morning to you. A steely, wintry sky hovers over the Pharmalot corporate campus this morning, where we are enduring the usual routine of hustling short people to this or that school house. As we cope - where is that cup of stimulation? - please join us in perusing the news of the world. Meanwhile, feel free to pass along interesting tidbits. Have a good one… AstraZeneca And Cancer Charity Strike Drug Testing Deal (Bloomberg News) FDA Warns Of Acetaminophen Risks Of Liver Toxicity (Drug Store News) Drug Shortages Persist With No End In Sight (Daily Finance) Biotechs And Generics Spar Over Biologic Exclusivity (The Wall Street Journal) FDA Says Sanofi-Aventis’ Lantus Link To Cancer Is Unclear (Reuters) US Cancer Costs Are Expected To Soar (Los Ange... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4343334 Thu, 13 Jan 2011 13:02:18 +0100 4343334 http://www.medworm.com/index.php?rid=4331239&cid=t_100585_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F25BnSsPy6VY%2F Next week, the US Supreme Court will hear arguments about a highly contentious issue in which hospitals and clinics want the right to file lawsuits against drugmakers, which they believe have overcharged by not offering discounts or reimbursements as part of what is known as the 340B program. This provides access to discounted prescription meds to healthcare entities certified by the US Department of Health and Human Services. However, the White House recently filed an amicus brief siding with the pharmaceutical industry over concerns that its administration will get mired in an unending number of lawsuits, even though this position is at odds with the notion that the 340B program is designed to ensure underprivileged patients get access to needed meds (read the brief here). “You can par... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4331239 Mon, 10 Jan 2011 15:50:36 +0100 4331239 http://www.medworm.com/index.php?rid=4309851&cid=t_100585_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FOeVXELaM3qA%2F Yet another big drugmaker faces a job action in Europe. This time, nine unions that represent Sanofi-Aventis workers in France plan to strike tomorrow over plans to eliminate more than 900 jobs. “The reality is that these job cuts are part of a vast 2 billion-euro savings plan that group management wants to achieve by 2013. All the group’s business are affected,” the unions said in a statement. A Sanofi spokesman tells Reuters the drugmaker had not announced any new job cuts since unveiling a reorganisation of its French commercial division last month, which would lead to 575 out of 2,800 jobs that will be cut by the end of this year. The unions say they tallied 916 jobs by adding 575 plus 260 unoccupied posts and 81 staffers who are expected to change roles. The unions a... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4309851 Tue, 04 Jan 2011 13:35:36 +0100 4309851 http://www.medworm.com/index.php?rid=4305105&cid=t_100585_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F---sJ6wFY7c%2F This is hardly surprising. Given the ongoing talk at the FDA about placing greater emphasis on safety, no one should be shocked that the pace of drug approvals remains modest. Last year, 21 new drugs were approved, down from 25 in 2009 and 24 in 2008. However, the latest tally is actually higher than the 18 approvals issued in 2007. As The Wall Street Journal notes, the latest approvals included a few biologics that are expected to become sizeable sellers: Amgen won approval for Prolia, which is used to treat osteoporosis in postmenopausal women; Roche’s Genentech scored with Actemra for rheumatoid arthritis; Boehringer Ingelheim received approval for Pradaxa, a new type of bloodthinner and Novartis garnered FDA endorsement for its Gilenya multiple sclerosis pill. And how can anyone ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4305105 Mon, 03 Jan 2011 13:02:45 +0100 4305105 http://www.medworm.com/index.php?rid=4305106&cid=t_100585_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FIFTJm_-1GXw%2F Hello, everyone. Nice to see you again. We hope you had a pleasant respite and feel refreshed after the holiday break. Now, of course, the time has come to resume the routine, which means gearing up for those meetings and deadlines. As always, we have gathered a few items to help you along. Meanwhile, please join us for a much-needed cup of stimulation. Hope your day goes well… Inspire Pharma’s Cystic Fibrosis Drug Fails (Reuters) Elder Pharma Gets Japanese Approval For API Facility (Business Standard) J&J And MassGen Strike Deal For Testing Cancer Cells (Boston Globe) UK’s NICE May Back Avastin For Macular Degeneration (The Guardian) Roche Buys Marcadia And Its Obesity Compounds (BioWorld Today) Indian Pharmas Had Most ANDA Approvals (Business Standard) AstraZeneca&... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4305106 Mon, 03 Jan 2011 13:02:30 +0100 4305106 http://www.medworm.com/index.php?rid=4277957&cid=t_100585_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FcvdSbe-ci1k%2F At a time when tens of thousands of industry jobs are being eliminated, union membership can offer a different perspective. And so more than 200 workers at GlaxoSmithKline’s consumer healthcare division in Gloucester will vote tomorrow on whether they should begin a strike. What’s the beef? A 0 - that is a zero - percent pay hike offered by the drugmaker. The Unite union, which represents engineers, administrators, analysts and warehouse workers, say the employees were given a “measly” 1.2 per cent pay increase last year. Although talks have been under way since June, Unite says GSK refuses to budge. We have asked Glaxo for comment, but a spokeswoman says there will be no comment and will update you accordingly. Balloting closes next month, by the way. “It is ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4277957 Tue, 21 Dec 2010 16:09:56 +0100 4277957 http://www.medworm.com/index.php?rid=4275593&cid=t_100585_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fqgj83FqbBu0%2F Rise and shine. Another day is on the way. Here on the chilly Pharmalot corporate campus, we are doing our best to scurry the short people off to their school houses. As always, this ritual calls for a cup or two of stimulation. Please join us - or grab a bottle of water, whatever you fancy - as we indulge and scan the news of the world. Hope your day goes well… Novartis Moves Infectious Disease Unit From Massachusetts (SF Business Times) Pfizer Recalls More Bottles Of 40 mg Lipitor (Associated Press) Novartis Pill For Advanced MS May Be A $5B Blockbuster (Bloomberg News) Greece Sets Generic Pricing (Pharma Times) Pfizer Settles Two Prempro Cases (Reno Gazette-Journal) AstraZeneca Takes $445M Charge On Failure Of RSV Drug (Bloomberg News) (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4275593 Tue, 21 Dec 2010 13:09:42 +0100 4275593 http://www.medworm.com/index.php?rid=4272591&cid=t_100585_150_f&fid=34768&url=http%3A%2F%2Fpharmagossip.blogspot.com%2F2010%2F12%2Fazs-brennan-speaks-pass-me-bucket-of.html Bucket storyThe Seroquel storyQuestion 1. How much did Dave Brennan know about "The Seroquel Issue" at the time?http://pharmagossip.blogspot.com/2009/10/astrazeneca-to-pay-520-million-to.htmlThe pharmaceutical company AstraZeneca said Thursday (29/Oct/09) that it had reached a $520 million agreement to settle two federal investigations and two whistle-blower lawsuits over the sale and marketing of its blockbuster psychiatric drug Seroquel.One of the investigations related to “selected physicians who participated in clinical trials involving Seroquel,” AstraZeneca disclosed in a government filing. The other case related to off-label promotion of the drug.H. Waxman's letter:http://oversight.house.gov/Documents/20070305175741-03469.pdfThe Zoladex issue:http://www.justice.gov/opa/pr/2003/J... PharmaGossip blogs http://www.medworm.com/rss/comments.php?id=4272591 Sun, 19 Dec 2010 21:14:00 +0100 4272591 http://www.medworm.com/index.php?rid=4266262&cid=t_100585_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FsDzjB1vBQ8I%2F Now that the FDA has refused to approve its new Brilinta bloodthinner, the AstraZeneca team may regret choosing that name. In any event, the agency issued a so-called complete response letter and wants more analysis of a key clinical study, although there was no request for addtional trials as a prerequisite for possible approval (see the statement). The move - which hits AstraZeneca just as patents are due to expire on such best sellers as the Nexium heartburn pill and Seroquel schizphrenia treatment - is a bit of a shocker to Wall Street, given that Brilinta was already approved in Europe and, moreover, an FDA advisory panel last summer voted 7-to-1 to recommend marketing approval (back story). In fact, FDA approval had already been delayed since last September, suggesting a favorable r... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4266262 Fri, 17 Dec 2010 13:52:51 +0100 4266262 http://www.medworm.com/index.php?rid=4266264&cid=t_100585_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FSZ-Te091wg0%2F And so another working week draws to a close, which means the time has come to daydream, just a little, about our weekend plans - a brisk walk with the official Pharmalot mascots, spending time with our short people and taking a nap or two. What about you? Will you brave the shopping crowds? Curl up with your favorite e-book reader? Connect with a special person? Whatever you do, we hope you have a pleasant time. Meanwhile, here are some tidbits to jumpstart the day. Stay in touch…. Merck Extends Deadline For Closing Organon Dutch Facilities (Reuters) Your Pharmaceutical Cargo Theft Update (Securing Pharma) Celgene Raises Revlimid Price To $85K A Year (Dow Jones) FDA Considers Generic User Fees (Pittsburgh Post-Gazette) Sanofi-Aventis And Merck KGgA Sign Cancer Drug Deal (Bloomberg N... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4266264 Fri, 17 Dec 2010 12:44:28 +0100 4266264 http://www.medworm.com/index.php?rid=4266239&cid=t_100585_150_f&fid=34768&url=http%3A%2F%2Fpharmagossip.blogspot.com%2F2010%2F12%2Flolpharma-contd-i-vant-to-thin-your.html Story (Source: PharmaGossip) PharmaGossip blogs http://www.medworm.com/rss/comments.php?id=4266239 Fri, 17 Dec 2010 09:29:00 +0100 4266239 http://www.medworm.com/index.php?rid=4245594&cid=t_100585_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2010%2F12%2Fad-execs-not-viewed-as-innovative-by.html Sorry to break this to you, but Americans don't think advertising executives are very innovative. This is according to the AstraZeneca Innovation Survey (find it here). "By carrying out this survey we sought to shed some light on what innovation means to people around the world and whether they believe it is valuable to society as a whole," said David Brennan, AZ CEO.The survey shows that Americans think advertising executives are only as innovative as teachers, but much less innovative than doctors, artists, engineers, or scientists (see chart below; click on image for a larger view).But in the "emerging" nations of India and China -- where pharma pins its hopes for the future of sales -- advertising executives are seen as much more innovative than doctors and somewhat more innovative tha... Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=4245594 Thu, 09 Dec 2010 20:14:00 +0100 4245594 http://www.medworm.com/index.php?rid=4238147&cid=t_100585_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FJub8q6MBpJY%2F There may not be many physicians running big drugmakers (lawyers seem to be more popular choices), but the pharmaceutical industry does employ oodles of people with medical degrees. But what makes some more likely to become high-ranking managers? An ability to work efficiently in the lab? Publish lots of studies? A keen knowledge of office politics? How about bedside manner? To find out, Amrop Battalia Winston, an executive search firm, assessed 39 docs and gauged 23 personality traits and motivational factors that may have helped some rise to the top. Among those queried were docs in clinical research and medical affairs and work as senior director; executive director; assistant vp; associate vp; therapeutic head or chief medical officer. And they worked for Boehringer-Ingelheim; Bristol-... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4238147 Tue, 07 Dec 2010 15:44:38 +0100 4238147 http://www.medworm.com/index.php?rid=4233424&cid=t_100585_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F69Q-JUDmm-A%2F Welcome to the working week. We hope the weekend was refreshing and restful, although now, of course, the routine resumes. To prepare, we are brewing the mandatory cup of stimulation. Meanwhile, we would like to note that we are hosting a webinar on Thurs., Dec. 9 about the FDA’s Accelerated Approval process (please look here). Please join us. And now, the news of the world. Have a great day and if you run into Jeff Kindler, please send our regards… Celgene Stock Hurt By Revlimid Cancer Data (TheStreet) Elan Replaces Martin With Former Glaxo CEO Ingram (Bloomberg News) AstraZeneca Bloodthinner Gets EU Approval (Reuters) FDA Delays Decision On Benlysta Lupus Med (Associated Press) China To Lead Innovation By 2020: AstraZeneca Survey (PharmaTimes) (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4233424 Mon, 06 Dec 2010 12:45:55 +0100 4233424 http://www.medworm.com/index.php?rid=4225657&cid=t_100585_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FdczYYLlP0h4%2F Once again, European Commission antitrust regulators have raided the offices of several drugmakers seeking evidence that they struck anticompetitive deals or used their dominant market positions to squeeze rivals. So far, though, only AstraZeneca has confirmed that it received a visit. “The Commission has reason to believe that the companies concerned may have acted individually or jointly, notably to delay generic entry for a particular medicine,” the commission says in a statement. This could be a potential violation of EU antitrust rules.” The focus of the raid on AstraZeneca was its Nexium heartburn med, which is a $5 billion global seller but faces generic competition across Europe. “Earlier this week, competition authorities commenced inspections at a small numbe... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4225657 Fri, 03 Dec 2010 13:18:40 +0100 4225657 http://www.medworm.com/index.php?rid=4225659&cid=t_100585_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FaUJt6QgUc6g%2F Once again, another work week is about to draw to a close. Although meetings and deadlines loom today, already we are looking ahead to spending time with the short people, a night at the movies, catching up on some reading and promenading with the official Pharmalot mascots. What about you? Anything special planned? Maybe an afternoon nap or a fancy dinner? Well, you could always pay some bills. In any event, here are a few tidbits to peruse while you consider the possibilities. Whatever you do, have a great time and stay safe. See you soon… Pharma Mergers Scrutinized In Insider Trading Probe (Reuters) Merck Pays $500 For SmartCell Diabetes Drugmaker (Bloomberg News) FDA Panel Backs AstraZeneca Thyroid Drug (MedPage Today) Licensing Deal Threatends Cheap AIDS Meds For Poor (The Indep... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4225659 Fri, 03 Dec 2010 12:36:07 +0100 4225659 http://www.medworm.com/index.php?rid=4220458&cid=t_100585_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F7L5bE1wLCDc%2F Maybe GlaxoSmithKline sales reps deserve a bonus. A new survey of more than 1,800 primary care physicians ranked the drugmaker’s field force as the best, even as sales calls to these docs - which include general practitioners, family med physicians and doctors of osteopathy - fell 12 percent in the 12 months ending September 2010, compared with the previous 12-month period. On a score of 1 to 7, Glaxo’s average quality score was 5.71, up from 5.54 in 2009, according to SDI Health, a market research firm that conducted the survey. The showing catapulted Glaxo from third place last year, when the drugmaker followed Pfizer and Merck, both of which moved down a notch from the No. 1 and No. 2 slots, respectively. On a related note, in both years, 97 percent of the docs indicated they w... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4220458 Wed, 01 Dec 2010 13:01:57 +0100 4220458 http://www.medworm.com/index.php?rid=4190521&cid=t_100585_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fqa0NwEy2H04%2F As the US Department of Justice steps up its pursuit of health care fraud, one official stopped today to offer a progress report. To wit, the DOJ secured $3 billion in civil settlements and judgments in cases involving overall fraud against the federal government in the fiscal year that ended Sept. 30. However, this included $2.5 billion in health care fraud recoveries. In a briefing with the media, Tony West, assistant Attorney General for the Civil Division, noted this was the largest in history and represents 83 percent of the year’s total civil fraud recoveries. And not surprisingly, most of the cases resulting in recoveries were brought to the government by whistleblowers under the False Claims Act. And of the $3 billion in settlements and judgments obtained in fiscal year 2010, ove... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4190521 Mon, 22 Nov 2010 17:07:14 +0100 4190521 http://www.medworm.com/index.php?rid=4183543&cid=t_100585_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F9LyvHMKYP70%2F Good morning, everyone. And welcome to another busy day, although already we are daydreaming about the weekend. And why not? For our part, we envision getting exercise in the form of raking still more leaves; frolicking with the short people and catching up on sundry chores. What about you? Time for a movie or a good book? Tossing a football? Maybe stopping to appreciate a special someone? Whatever you fancy, have a great time. Meanwhile, here are some tidbits. See you soon… EMA Adopts New Guidelines On Biosimilar Antibodies (Reuters) Pfizer And Bristol-Myers Halt Study Of Bloodthinner (Bloomberg News) FDA Approves Amgen Bone Med For Some Cancers (Reuters) Merck Wins Reversal On ‘Unenforceable’ Patent Ruling (The American Lawyer) Court Says Baxter’s Heparin Was &#82... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4183543 Fri, 19 Nov 2010 12:54:35 +0100 4183543 http://www.medworm.com/index.php?rid=4179521&cid=t_100585_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FkeyFm8US98k%2F Now that some drugmakers are starting to disclose just how much they pay doctors for speaking engagements, a new wrinkle is emerging - some of these docs have rather questionable qualifications. Such as? Some were sanctions for prescribing unjustified or excessive meds; having inappropriate sexual relations with patients and making serious medical errors. And the disclosures are making some drugmakers uncomfortable. Consequently, at least three pharma companies - Eli Lilly, AstraZeneca and Pfizer - now say they will take steps to monitor docs who are retained as speakers, according to ProPublica, which recently compiled several databases of info based on web site postings by drugmakers, and followed up by searching for docs who have transgressed. This is no small matter, by the way. ProPub... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4179521 Thu, 18 Nov 2010 14:37:56 +0100 4179521 http://www.medworm.com/index.php?rid=4179522&cid=t_100585_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FAFtgFxHbZMM%2F Given the big patent expirations and thin pipelines, it is hardly surprising that Moody’s Investor Services has issued a report finding that the credit outlook for brand-name drugmakers remains negative for the next 12 to 18 months. More specifically, the ratings agency notes that hurdles for drug approvals remain high, given the ongoing emphasis on safety concerns; various governments are instituting austerity measures to deal with budget deficits and taking a tougher stance on drug price; mergers and acquisitions will continue to be financed with debt; and huge litigation settlements over illegal marketing underscore legal risks. And of course, these negative pressures are expected to remain through 2012, when the biggest patent expirations have largely passed. But as of June, the ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4179522 Thu, 18 Nov 2010 14:11:28 +0100 4179522 http://www.medworm.com/index.php?rid=4179523&cid=t_100585_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FggN0pc0DhfA%2F Less than a year after the FDA issued a warning about the long-term use of long-acting beta agonists, Saudi Arabian regulatory authorities have revoked marketing authorization for four such products - including GlaxoSmithKline’s Serevent and Foradil, which is sold by Novartis - over increased risks of worsening asthma symptoms, hospitalizations of children and adults, and deaths. In a statement, the SFDA says recent evidence found that LABAs were associated with increased risk of asthma-related deaths, intubation (the placement of a tube into the windpipe) and hospitalization of 2.8 percent for every 1,000 patients using a long-acting beta agonist compared to those who did not use such a medication. In analyzing data, the agency noted there were 16 deaths among LABA patients versus ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4179523 Thu, 18 Nov 2010 13:28:42 +0100 4179523 http://www.medworm.com/index.php?rid=4179468&cid=t_100585_136_f&fid=37846&url=http%3A%2F%2Fhealthinfoispower.wordpress.com%2F2010%2F11%2F17%2Fparp-inhibitor-mk-4827-shows-anti-tumor-activity-in-first-human-clinical-study%2F MK-4827, a new drug that targets proteins responsible for helping cancer cells repair their damaged DNA, has shown promising anti-tumor activity in its first human clinical trial. MK-4827, a new drug that targets proteins responsible for helping cancer cells repair their damaged DNA, has shown promising anti-tumour activity in its first human clinical trial. Some patients with [...] (Source: Libby's H*O*P*E*) Libby's H*O*P*E* blogs http://www.medworm.com/rss/comments.php?id=4179468 Thu, 18 Nov 2010 06:34:33 +0100 4179468 http://www.medworm.com/index.php?rid=4175972&cid=t_100585_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FFvPTSac3G7I%2F Drugmakers may be squeamish about social media and their web sites may not be choice destinations for most consumers (see this), but the pharmaceutical industry is not shying away from using the Internet to promote meds to docs. A new analysis shows more than 150 drugs were marketed for the first time using online details and events during the first nine months of 2010, which marks a new record. Leading the pack was Merck’s Singulair asthma med, with more than 110,400 different so-called e-promotional activities that cost more than $15.5 million to generate, a 2.9 percent increase. The runner-up was Pfizer’s Pristiq, which is sold to treat depression - e-promotions rose nearly 74 percent to more than 103,700 activities that cost $13.6 million, an 86 percent rise. (In case you w... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4175972 Wed, 17 Nov 2010 15:08:16 +0100 4175972 http://www.medworm.com/index.php?rid=4159506&cid=t_100585_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FUn-ROdfR8Lc%2F Good morning, everyone. Once again, the time has come to daydream, just a little, about the upcoming weekend. We envision long walks with the official Pharmalot mascots, entertaining our short people and, in the name of getting exercise, raking countless leaves shed by our towering pin oaks. What about you? How about a drive in the country? Some time with that special someone? Maybe a good book is in order. Whatever you do, have a great time and be safe. Meanwhile, here is the news of the world. See you soon… The AHA Meeting And Some Big Heart Drugs (Reuters) UK’s NICE Rejects Roche’s Avastin For Colorectal Cancer (Bloomberg News) J&J To Release Bloodthinner Results (The Wall Street Journal) Japan’s Otuska To Raise $2.8 Billion In Record IPO (Reuters) AstraZene... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4159506 Fri, 12 Nov 2010 12:54:49 +0100 4159506 http://www.medworm.com/index.php?rid=4159498&cid=t_100585_150_f&fid=34768&url=http%3A%2F%2Fpharmagossip.blogspot.com%2F2010%2F11%2Fwhen-health-provider-betrays-trust-it.html StoryChristiane Truelove writes: So I decided to ask Earl how a pharma company can win back the trust of patients and consumers with such seemingly damning evidence of corporate perfidy constantly circulating around the Internet, just a Google search away.His answer was, “By the overall actions of the company,” the good stuff that they do, their transparency, etc.Guess what: That’s not working. Think about it, folks – when someone betrays you in some way (whether they meant to or not) and then showers you with attention and love but never acknowledges the betrayal in the first place, are you won over?If the burn is minor, you might forgive them in time, but the bigger the hurt, the more impossible it becomes to forgive. So when someone posts on Facebook or Twitter that a drug hurt ... PharmaGossip blogs http://www.medworm.com/rss/comments.php?id=4159498 Thu, 11 Nov 2010 19:32:00 +0100 4159498 http://www.medworm.com/index.php?rid=4152270&cid=t_100585_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FI8ne3iTzhik%2F A brief respite in the job action undertaken by AstraZeneca workers at two UK sites has come to an end after talks about a proposed pension freeze went nowhere this week, The Manchester Evening News writes. Just two weeks ago, the GMB union agreed to suspend its series of one-day strikes and a ban on overtime in hopes of reach an accord (back story). But Allan Black, GMB’s national officer, says the drugmaker offered nothing new during three meetings. “It’s a great shame, but we have made the decision to reinstate the strikes,” he tells the paper. “The company has said nothing new over the series of meetings. There has been no compromise over the pensions. “They said they were trying to get a mandate from the board in America to resolve the dispute, but ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4152270 Wed, 10 Nov 2010 13:29:41 +0100 4152270 http://www.medworm.com/index.php?rid=4152272&cid=t_100585_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FyEol_ZBMUqs%2F Good morning, folks. How are you today? We are just fine, thank you. After all, the sun is shining here on the Pharmalot corporate campus, where the official mascots are chasing squirrels and two cups of stimulation are brewing. What will today bring? Hmm… One never knows, but to help you prepare, we have gathered a few interesting tidbits of information. So dig in. And we hope your day goes well… PhRMA CEO John Castellani On Elections And Health Care Reform (Politico) Merck Results For Cholesterol Pill Are Due Next Week (Bloomberg News) FDA Commish Defends Handling Of Heparin Crisis (Reuters) Glaxo Sees More Industry Consolidation (The Business Standard) Pharma Needs Lessons On Winning Trust (MedAd News) Court Is Urged To Narrow Patent-Misconduct Standard (Bloomberg News) FDA ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4152272 Wed, 10 Nov 2010 12:39:39 +0100 4152272 http://www.medworm.com/index.php?rid=4139471&cid=t_100585_150_f&fid=34768&url=http%3A%2F%2Fpharmagossip.blogspot.com%2F2010%2F11%2Fdr-melissa-delbello-speaks-but-this.html Sen. Charles Grassley's hall of shame: The chairman of the Senate Finance Committee raised the case of Dr. Melissa DelBello, a psychiatrist who got hundreds of thousands of dollars in travel expenses, consulting fees, and lecture payments from AstraZeneca. DelBello also happened to be lead author of a study that concluded kids did well on AstraZeneca's antipsychotic med Seroquel.Here's the timeline: DelBello authored the study, published in 2002. In 2003, she got $100,000 from the drugmaker, or so she told the University of Cincinnati. In 2004, she reported $80,000. AstraZeneca's figures total $238,000.Grassley was pretty peeved not only about the apparent conflict of interest--which AstraZeneca denied; DelBello wasn't available for comment--but also by the fact that DelBello also got NIH ... PharmaGossip blogs http://www.medworm.com/rss/comments.php?id=4139471 Sat, 06 Nov 2010 04:53:00 +0100 4139471 http://www.medworm.com/index.php?rid=4119716&cid=t_100585_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F_uKvTFMX99I%2F Rise and shine, everyone. Another day beckons. And this is a special one here on the Pharmalot corporate campus as the shortest of short people celebrates a birthday. An especially large cup of stimulation is in order…among other things. While we fuss, please enjoy these items and, of course, we hope your weekend is wonderful. Whether you pick a pumpkin, rake some leaves, read a book or enjoy a walk, do enjoy yourselves. See you soon… Glaxo Licenses Amicus Therapeutics’ Fabry Drug (Reuters) Sanofi-Aventis Buys A Chinese OTC Maker (Associated Press) Glaxo Cuts Prices In Indonesia By Up To 50 Percent (Reuters) Hepatitis C Is Fertile Field For Blockbusters (The Wall Street Journal) Supreme Court To Review Roche And Stanford Dispute Today (The Tech) AstraZeneca And Daiichi Sign $... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4119716 Fri, 29 Oct 2010 11:35:14 +0100 4119716 http://www.medworm.com/index.php?rid=4119626&cid=t_100585_140_f&fid=35439&url=http%3A%2F%2Fbipolarsoupkitchen-stephany.blogspot.com%2F2010%2F10%2Fastrazeneca-spends-732-million-in-legal.html (Source: soulful sepulcher) soulful sepulcher blogs http://www.medworm.com/rss/comments.php?id=4119626 Thu, 28 Oct 2010 15:27:00 +0100 4119626 http://www.medworm.com/index.php?rid=4106061&cid=t_100585_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=4106063&cid=t_100585_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FKtFErbiCVU8%2F There have been numerous headlines lately about healthcare fraud and whistleblowers whose lawsuits eventually prompted huge settlements with the federal government. The latest tally, however, shows that the US Department of Justice recovered over $3.1 billion in fraudulent claims in the 2010 fiscal year that can be traced to lawsuits filed under the federal False Claims Act. Specifically, there were 145 FCA cases settled in the 2010 fiscal year and the 10 largest settlements involved health care fraud, with eight involving drugmakers, according to Taxpayers Against Fraud, a non-profit that supports whistleblower lawsuits. The 10 largest cases accounted for $2.7 billion recovered. Although fiscal year 2009 actually recovered a larger pot of money - $5.6 billion. It also worth that health ca... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4106063 Mon, 25 Oct 2010 12:32:03 +0100 4106063 http://www.medworm.com/index.php?rid=4106051&cid=t_100585_150_f&fid=34768&url=http%3A%2F%2Fpharmagossip.blogspot.com%2F2010%2F10%2Fquick-stop-clinical-trial-weve-go-p.html Gordon Guyatt, MD, epidemiologist, internist, and biostatistician at McMaster University updates us on the progress being made against the problem of clinical trials being stopped early to inflate efficacy of drugs. Since our first coverage of the topic two years ago, the FDA, the Cochrane group, and other agencies have implemented changes in policy.  Dr. Guyatt discusses the Crestor JUPITER trial as an example of a trial that was stopped early and inflated efficacy.Click here for the video interview (Source: PharmaGossip) PharmaGossip blogs http://www.medworm.com/rss/comments.php?id=4106051 Sun, 24 Oct 2010 17:27:00 +0100 4106051 http://www.medworm.com/index.php?rid=4098054&cid=t_100585_109_f&fid=34750&url=http%3A%2F%2Fpsychcentral.com%2Fblog%2Farchives%2F2010%2F10%2F23%2Ftop-50-psychiatrists-paid-by-pharmaceutical-companies%2F Who were the top 50 psychiatrists in the U.S. paid by the top seven pharmaceutical companies? This past week, ProPublica, an independent, non-profit newsroom that produces investigative journalism in the public interest, recently decided to answer that question by compiling a list of 384 physicians and health care providers who earned more than $100,000 total from one or more of the seven companies that have disclosed payments in 2009 and early 2010. Click here for the full list of 384 physicians. We combed that list and found the top 50 psychiatry earners for the past two years (2009-2010). You can click on any name below to learn more about the physician. According to an accompanying article to this data, ProPublic notes that “[p]ayments to doctors for promotional work are not ill... World of Psychology blogs http://www.medworm.com/rss/comments.php?id=4098054 Sat, 23 Oct 2010 19:00:37 +0100 4098054 http://www.medworm.com/index.php?rid=4098463&cid=t_100585_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FNHui_6K0h3g%2F Hired someone new and exciting? Promoted a rising star? Finally solved that hard-to-fill spot? Share the news with us and we’ll share with it others. That’s right. Send us your announcements and we’ll find a home for them. Don’t be shy. Everyone wants to know who is coming and going, especially with all the layoffs. Despite the downsizing, there is movement. Here are some of the latest changes. Recognize anyone? And here is something that’s become a regular feature. Send us a photo and we will spotlight a different person each week. This time around, we note that the Biomedical Research Alliance of New York hired Carmela Houston-Henry as business development director. Prior to joining BRANY, she was a senior manager for corporate clinical research at Bracco Diagnostics, and also ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4098463 Fri, 22 Oct 2010 12:26:00 +0100 4098463 http://www.medworm.com/index.php?rid=4082329&cid=t_100585_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FU8e0B1NqNTw%2F An in-depth analysis of the money paid by drugmakers to doctors has been undertaken by ProPublica, which has just published a detailed look that is sorted by company, doctor, state and activities for which docs were compensated. The database includes payments made by seven drugmakers in 2009 and early 2010 - $257 million went to about 17,700 docs. Although as ProPublica notes, more than 70 companies have yet to publicly disclose their payments but will be required to by 2013 under the federal health care reform law. And existing disclosure are not done so on a uniform basis - travel fees and research payments rarely show up. To give you a taste of the dollars shelled out, Pfizer paid out nearly $10 million, on average, during the third and fourth quarters of 2009 (see here), and a doctor i... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4082329 Tue, 19 Oct 2010 17:21:31 +0100 4082329 http://www.medworm.com/index.php?rid=4074421&cid=t_100585_150_f&fid=34768&url=http%3A%2F%2Fpharmagossip.blogspot.com%2F2010%2F10%2Ftrust-its-two-way-thing.html I'll let Stephany explain about FaceDepression! (Source: PharmaGossip) PharmaGossip blogs http://www.medworm.com/rss/comments.php?id=4074421 Sat, 16 Oct 2010 14:57:00 +0100 4074421 http://www.medworm.com/index.php?rid=4055959&cid=t_100585_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FByPBOCJFGeY%2F Welcome back, everyone. We hope the weekend was pleasant and relaxing. Now, of course, the routine has returned, although there is a holiday for some here in the states. With that in mind, we will brew our mandatory cup of stimulation and help you get caught up as the day unfolds, whatever your plans may be. Have a good one and stay in touch… Lilly Drops Alimta For Head And Neck Cancer After Study Fails (Reuters) Novartis Kidney Drug Failed To Slow Form Of Pancreatic Cancer (Bloomberg News) Merck KGgA To Ask EU To Reconsider MS Pill (Reuters) AstraZeneca’s Osteoarthritis Drug Wins EU Backing (Associated Press) Erbitux Fails In Colon Cancer Study (Indianapolis Business Journal) FDA Bounces Jazz Pharma Fibromyalgia Drug (Reuters) Gelesis Obesity Drugs Helps Rats Eat Less (Xconomy... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4055959 Mon, 11 Oct 2010 11:40:52 +0100 4055959 http://www.medworm.com/index.php?rid=4040788&cid=t_100585_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FHJJo5laMi_I%2F About three dozen drugmakers have agreed to pay $82 million to settle charges they overcharged the state of Hawaii between 1993 and 2006 based on published average wholesale prices, which actually exceeded the prices paid by pharmacies. For instance, the cost of prescription drugs in Hawaii’s Medicaid program soared from $45 million in 1999 to $117 million in 2004. This may get your stomach churning: an ulcer med that was available for $27.70 cost the state $1,480. But he methods used to inflate prices went undetected until a Florida pharmacy filed a whistleblower lawsuit, which has reverberated in numerous states (see here, here and here). “The feds didn’t see it. We didn’t see it,” Hawaii Attorney General Mark Bennett tells the Associated Press. “Ever... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4040788 Thu, 07 Oct 2010 15:19:13 +0100 4040788 http://www.medworm.com/index.php?rid=4031501&cid=t_100585_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2010%2F10%2Flilly-vs-astrazeneca-on-covering.html Two pharma companies have responded very differently to recent stories in the press about pharma's "deal" with democrats to help cover the gap ("doughnut hole") in Medicare drug coverage. Whereas Lilly hemmed and hawed and skirted the issue and mainly defended high drug prices (see "Why Price Controls Are Not The Right Answer" and my comments here: "LillyPad Launches Specious Rocket Attack Against Drug Price Control Straw Man" and ), AstaZeneca seized the moment to support the coverage and explain how else it is helping senior citizens pay for their prescription drugs (see "Our Fair Share: Closing the Coverage Gap").[For background, see "Medicare "Doughnut Hole" to Cost Pharma Less Than 1% of US Sales."]Just on the basis of the two blog post titles, I have to give AZ kudos for its positive... Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=4031501 Mon, 04 Oct 2010 17:37:00 +0100 4031501 http://www.medworm.com/index.php?rid=4018441&cid=t_100585_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FaK3IEXLaIa8%2F Another week, another drugmaker agrees to settle off-label marketing charges brought by the federal government. This time, Novartis will pay $422.5 million for illegally promoting its Trileptal epilepsy med for unapproved uses, such as bipolar disorder and neuropathic pain, along with five other drugs - Diovan, Zelnorm, Sandostatin, Exforge and Tekturna. The fine includes roughly $237 million to settle four lawsuits brought by whistleblowers, while $185 million goes toward criminal penalties. One of the lawsuits was filed by Jeremy Garrity, a former cardiovascular sales rep, who worked for Novartis between 2002 and 2008 before being fired (you can read it here, and you can read the settlement here. Oh, and this is the guilty plea). This is the latest in a stream of settlements involving bi... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4018441 Thu, 30 Sep 2010 17:26:16 +0100 4018441 http://www.medworm.com/index.php?rid=4013546&cid=t_100585_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FZbkIW8inHAo%2F The US Supreme Court agreed to hear an appeal by drugmakers seeking to block thousands of public hospitals and community health clinics from suing for violations of a federal program that lets them buy medicines at a discount, according to reports (here and here). The justices agreed to review to an appeal by Pfizer, AstraZeneca, Bayer, GlaxoSmithKline, Bristol-Myers Squibb, Merck and Sanofi-Aventis, among others, which are challenging a lower court ruling permitting a suit against the drugmakers filed by the California county of Santa Clara. That suit was filed the lawsuit in 2005 for alleged overcharges at its medical facilities from 2001 to 2005. The dispute centers on the rights of 14,500 health providers that spend about $4 billion a year on outpatient drugs. A 2006 government report ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4013546 Tue, 28 Sep 2010 22:27:57 +0100 4013546 http://www.medworm.com/index.php?rid=4013549&cid=t_100585_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=4003434&cid=t_100585_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FpYWhwlZl3PU%2F Earlier this year, a former Pfizer exec amended his whistleblower lawsuit accusing the drugmaker of illegally scheming to boost Lipitor sales by misrepresenting product labeling and federal cholesterol guidelines; using misleading educational programs for doctors, and unlawful sampling kickback schemes that resulted in off-label marketing that allegedly defrauded Medicaid and Medicare. Jesse Polansky, who was director of outcomes management from April 2001 until July 2003, claims “thousands of physicians have prescribed Lipitor to millions of patients for whom drug therapy is not recommended, and for whom the medication could be dangerous. Millions of those improper prescriptions were ultimately paid for by various government healthcare plans, the suit charges. And in a newly filed brie... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4003434 Mon, 27 Sep 2010 15:28:45 +0100 4003434 http://www.medworm.com/index.php?rid=4003438&cid=t_100585_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FVIyzP8yQEzA%2F Welcome back, everyone. We hope your weekend was restful and rejuvenating. Now, of course, the routine has returned. Meetings and deadlines, as usual, beckon. What better way to prepare than with a cup of stimulation? So please join us as we indulge. Meanwhile, here are a few items to help you get started. Hope your day goes well and stay in touch… AstraZeneca Prostate Cancer Drug Fails Phase III (TheStreet) Pfizer Plans More Partnerships In Asia (OutsourcingPharma) Sanofi Keeps Genzyme Bid Steady, For Now (Reuters) Merck To Hire 300 At No. Carolina Vaccine Plant (The Herald Sun) Wyeth’s Genetically Modified Baby Formula Causes Protest (Sydney Morning Herald) European Rx Sales To Slow Due To Cost-Cutting (PharmaTimes) Actelion Drug For Brain Hemorrhage Fails In Study (Bloomberg... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4003438 Mon, 27 Sep 2010 11:51:00 +0100 4003438 http://www.medworm.com/index.php?rid=3994346&cid=t_100585_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fbt1ErEE14EA%2F Another day, another drugmaker refocuses. Today, Lundbeck disclosed plans to cut 50 people from its R&D operations in the US and Europe as part of a plan to greater emphasize collaborations with universities and other companies. Although the Danish drugmaker will continue to devote resources to developing compounds for brain diseases, such as depression, Parkinson’s and Alzheimer’s (see the statement). “A lot of new knowledge in this field of disease biology is being developed right now, at universities and biotech companies, and we need access to it,” Lundbeck research chief Peter Hongaard Andersen tells Reuters. “Up until now, the starting point for our work was more existing mechanisms…so we were less dependent on new research than we will be wit... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3994346 Wed, 22 Sep 2010 17:01:36 +0100 3994346 http://www.medworm.com/index.php?rid=3981018&cid=t_100585_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FFhfKaF5_N6U%2F And so another week will soon draw to a close. And not a moment too soon, yes? After all, this has been a busy stretch. What will you do this weekend? A drive in the country to pick apples? Take in a new movie? Spend time with someone special? For our part, we will reflect on the year past and the year ahead. And then take the official Pharmalot mascots for a brisk stroll. Meanwhile, the news of the world awaits. Whatever you do, we hope all goes well. See you soon… New Russian Law Eases Red Tape For Drugmakers (The Economist Intelligence) J&J Wants To Buy The Rest Of Crucell Vaccine Maker (Reuters) FDA Panel OKs Wider Use For Alkermes Drug (Reuters) Bayer Sees Huge Market For Its Bloodthinner (Bloomberg News) Childhood Vaccination Rates Remain High (The Los Angeles Times) Settl... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3981018 Fri, 17 Sep 2010 11:55:07 +0100 3981018 http://www.medworm.com/index.php?rid=3973110&cid=t_100585_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F0cOi5gqhOWU%2F How is this for poor timing? Just as walkouts get under way at the AstraZeneca site in Macclesfield, UK, over plans to end contributions to a defined benefit pension plan (back story), there is the revelation that the pension for AstraZeneca ceo David Brennan has grown by 50 percent in the past two years and will now provide him approximately $1.4 million annually, according to The Manchester Evening News. “It is particularly shocking that, at the very time when this hugely profitable company is attacking GMB members’ pensions, its chief executive, David Brennan, has reached third in the UK league of the top bosses’ pension entitlements,” Paul Kenny, general secretary of the GMB union, tells the paper. “When he retires based on today’s figures, Mr. Brennan will ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3973110 Wed, 15 Sep 2010 16:51:25 +0100 3973110 http://www.medworm.com/index.php?rid=3965701&cid=t_100585_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=3958061&cid=t_100585_150_f&fid=38374&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FePharmaSummit%2F%7E3%2FeTiSl1C8pdI%2Ftop-10-reasons-you-should-join-us-for.html This October in Princeton, New Jersey, we hope you’ll join us for the Multi Channel Pharma Marketing Event. Why? Here are the Top 10 reasons:1. Get updates and insight into FDA promotional guidance from AstraZeneca, Sanofi-Aventis, and Bristol-Myers Squibb2. Identify the next big idea and follow it from concept to execution3. Debate the optimal channel mix for your market segment4. Bring the customer to you with live physician and patient focused break out groups5. Participate in facilitated roundtable discussion groups based on your interest in consumer, HCP or managed care marketing6. Learn how to spot new insights and opportunities by collaborating across functional teams7. Gather predictive consumer insight to optimize your cross-channel media plan8. Maximize your experience with spe... ePharma Summit blogs http://www.medworm.com/rss/comments.php?id=3958061 Fri, 10 Sep 2010 13:00:00 +0100 3958061 http://www.medworm.com/index.php?rid=3943021&cid=t_100585_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2010%2F09%2Fazhelps-is-this-good-model-for-pharma.html Recently, @jilliantate (Jullian Tate), Director, digital strategy, for Integrated Media Solutions in Los Angeles, and someone I follow on Twitter, tweeted this:"Wow. Great article on how @astrazeneca is using Twitter to monitor mentions of products, and respond. #socpharm #fdasm http://bit.ly/crk3K8"Naturally, I had to have a look and see what all the fuss was about. In the blog post that @jillintate referred to, Bruce Grant was said to have pointed to AstraZeneca as "one company with a solid grasp of the social-media realm. The company has used its Twitter account to monitor any tweets about its products, so that it can respond to consumers directly."The Twitter account Grant was undoubtedly referring to is @AZHelps and NOT @Astrazenca (AZ has several Twitter accounts). Practically every ... Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=3943021 Tue, 07 Sep 2010 18:42:00 +0100 3943021 http://www.medworm.com/index.php?rid=3943030&cid=t_100585_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F3hInnF9Llts%2F Welcome back, everyone. We hope your weekend was splendid and you had a chance to recharge. The weather, after all, was magnificent. Now, of course, the time has come to return to the routine. So as you brace for those meetings and deadlines, please join us as we reach for our treasured cup of stimulation and dig in for another day. Hope yours goes well. And do stay in touch… Glaxo Will Not Bid For Genzyme (Reuters) The Problem With Gardasil (Fortune) Abbott Signs R&D Deal With Israeli Science Office (Globes) A Painful Summer For J&J CEO Bill Weldon (Fortune) Actus And Sequoia To Sell Stake In Paras (Bloomberg News) Genzyme Job Cuts To Follow Takeover (The Boston Globe) Roche Strikes Deal For Alzheimer’s And Parkinson’s Drugs (Reuters) AstraZeneca Signs Emerging... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3943030 Tue, 07 Sep 2010 11:52:27 +0100 3943030 http://www.medworm.com/index.php?rid=3925085&cid=t_100585_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FXW-OHW3ZCaI%2F In a lawsuit filed in federal court in Philadelphia, the US Securities and Exchange Commission has charged Jim Self, a pharmaceutical executive, and Stephen Goldfield, a hedge fund manager, with insider trading in connection with the 2007 acquisiton of MedImmune by AstraZeneca. Ultimately, Goldfield made nearly $14 million on his trades, according to the lawsuit. The men allegedly met while attending the Executive MBA program at the Wharton School of Business in the mid-1990’s and, in March 2007, Self exec passed along confidential info about MedImmune. At the time, investment bankers were shopping the biotech to 22 drugmakers and Self had been assigned to evaluate a potential acquisition, according to the lawsuit. In fact, Self was “involved in practically all of the meetings&... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3925085 Wed, 01 Sep 2010 17:38:23 +0100 3925085 http://www.medworm.com/index.php?rid=3921073&cid=t_100585_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F2qiuzJpIj5Q%2F The widely used Seroquel antipsychotic was never approved to treat post-traumatic stress disorder or the insomnia sometimes related to the afflication, but that hasn’t stopped the drug from being prescribed for that purpose by the US Department of Veteran Affairs and, in the process, becoming one of the VA’s biggest expenditures. Since 2001, VA spending on Seroquel jumped more than 770 percent, while the number of patients covered by the VA increased just 34 percent, the Associated Press writes. Seroquel is now the VA’s second-biggest prescription drug expenditure since 2007, behind the Plavix bloodthinner. The agency spent $125.4 million last fiscal year on Seroquel, up from $14.4 million in 2001, and the growth in spending outpaces the growth in personnel who have gone ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3921073 Tue, 31 Aug 2010 14:33:09 +0100 3921073 http://www.medworm.com/index.php?rid=3921077&cid=t_100585_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FIdVyE8QL1Fg%2F Hello, everyone. Nice to see you again. A chipper morning here on the Pharmalot corporate campus, where our sponsor - me - would like to remind you about an upcoming webinar with former US Attorney Michael Loucks, who will chat about avoiding litigation over promoting medicines (please click here). Meanwhile, the time has come again to reach for that cup of stimulation and draw back the curtains to let the sunshine in. Hope your day goes well… AstraZeneca Fails To Win FDA OK For Respiratory Drug (Associated Press) Robo-Tripping May Lead To New Controls On Cough Meds (Bloomberg News) Glaxo And Valent Face Delay For Their Epilepsy Drug (Bloomberg News) Meet The Gardasil Girls (The Irish Examiner) Drugmakers Seek Alternatives To Steroids (The New York Times) European Regulators OK Shire... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3921077 Tue, 31 Aug 2010 12:05:01 +0100 3921077 http://www.medworm.com/index.php?rid=3911868&cid=t_100585_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F7ibCIiCGLnc%2F In response to changes made to their pensions, AstraZeneca employees at the Macclesfield site will stage walkouts in various stages over three different days next month - Sept. 8, 15 and 22, according to the GMB, which is the largest union at the facility. The union blames “draconian proposals” to end a defined benefit pension plan that covers about 2,500 employees, most of whom work at the Macclesfield facility, and last week, more than 70 percent of GMB members voted to strike after three months of negotiation failed to close the divide. The pension, reportedly has run up a deficit of about $2 billion. “The last thing our members want to do is to take strike action at Astra Zeneca but the attack by the company on the pension entitlement of our members leaves them with ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3911868 Fri, 27 Aug 2010 13:04:53 +0100 3911868 http://www.medworm.com/index.php?rid=3903130&cid=t_100585_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Ftv9Dj06babs%2F The retail prices for the 217 most widely used brand-name drugs rose an average of 8.3 percent last year, despite a drop in inflation, according to a new survey by AARP. And for the most popular meds, prices rose 41.5 percent, outpacing a 13.3 percent rise in the Consumer Price Index. The results were first reported in The New York Times and here is the complete survey. However, the findings may not match reality for many Americans who take lower-cost generics, according to John Vernon, an assistant professor of health policy at the University of North Carolina who consults for drugmakers. “It can easily be shown that branded prices are higher here than they are in other countries, but we have the lowest and the most competitively priced generic drugs in the world, and the generic share ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3903130 Wed, 25 Aug 2010 13:16:57 +0100 3903130 http://www.medworm.com/index.php?rid=3899634&cid=t_100585_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FQV82PczRStE%2F What happens when a university is bound up in the outcome of an industry clinical trial? What does it say when university researchers are actively recruiting patients for a trial while also accepting consulting or speaking fees from the same drugmaker sponsoring the study? Is the research furthering commercial needs more so than scientific needs? And how are patients protected in such situations? These are among the questions explored in a sobering piece in Mother Jones magazine by University of Minnesota bioethicist Carl Elliott. He focuses on the sorry plight of Mary Weiss, who lost her 26-year-old son, Dan, while he was enrolled - over her strenuous objections - in a trial at the University of Minnesota (yes, the same school) to compare AstraZeneca’s Seroquel antipsychotic with ri... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3899634 Tue, 24 Aug 2010 13:58:26 +0100 3899634 http://www.medworm.com/index.php?rid=3889297&cid=t_100585_150_f&fid=34768&url=http%3A%2F%2Fpharmagossip.blogspot.com%2F2010%2F08%2Fmaking-killing-by-carl-elliott.html A great read! (Source: PharmaGossip) PharmaGossip blogs http://www.medworm.com/rss/comments.php?id=3889297 Sat, 21 Aug 2010 09:16:00 +0100 3889297 http://www.medworm.com/index.php?rid=3862188&cid=t_100585_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FQm8J2nm4xXA%2F A new study claims a new superbug that is resistant to even the most powerful antibiotics has entered UK hospitals, and the researchers trace what they say is a potentially global health problem back to the prevalence of NDM-1, which is becoming more common in Bangladesh, India, and Pakistan. And most of the UK patients had recently traveled to…India. So what does the Indian government think of this finding? Government officials are outraged for a few reasons. They resent that the bug - New Delhi metallo-beta-lactamase 1 - is named after their city. They complain that the study is dripping with conflicts of interest. And they worry about the impact on tourism. For instance, the study in The Lancet was funded by the European Union, as well as Wyeth and the Wellcome Trust charity, both... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3862188 Thu, 12 Aug 2010 14:38:22 +0100 3862188 http://www.medworm.com/index.php?rid=3858094&cid=t_100585_83_f&fid=34856&url=http%3A%2F%2Finsidesurgery.com%2F2010%2F08%2Fmedical-tourists-risk-spreading-superbug-bacteria-resistant-antibiotics%2F Medical tourists to India and Pakistan are being blamed for the international spread of bacteria that carry the NDM-1 gene that is easily passed between bacteria and that allow them to become resistant to almost all antibiotics. Dr. Anders Ekblom of AstraZeneca comments. (Source: Inside Surgery) Inside Surgery blogs http://www.medworm.com/rss/comments.php?id=3858094 Thu, 12 Aug 2010 02:39:36 +0100 3858094 http://www.medworm.com/index.php?rid=3845282&cid=t_100585_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F4xi4_YanGhk%2F As promised, the US Justice Department - along with the US Securities and Exchange Commission - is paying closer attention to interactions between the pharmaceutical industry and foreign governments (background). In recent months, at least five big drugmakers have received letters as the federal government seeks to uncover any violations of the Foreign Corrupt Practices Act, which forbids US companies from bribing foreign government officials. Among those that have been contacted in recent months concerning their activities are AstraZeneca, Bristol-Myers Squibb, Baxter, Eli Lilly and Merck (see page 26 here). An AstraZeneca spokesman says the drugmaker is cooperating. A Lilly spokesman notes the drugmaker, which was the subject of a 2003 probe of its Polish subsidiaries, is also cooperatin... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3845282 Mon, 09 Aug 2010 13:12:04 +0100 3845282 http://www.medworm.com/index.php?rid=3845285&cid=t_100585_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FFOrZaTvjZxY%2F AstraZeneca is moving closer to resolving the large number of lawsuits filed in the US over claims that the risks of its Seroquel antipsychotic were not properly disclosed. In the latest disclosure, AstraZeneca has agreed to pay about $198 million to settle 17,500, or roughly two-thirds of the outstanding lawsuits, according to a statement. Over the past few weeks, there were piecemeal reports that AstraZeneca agreed to settle large numbers of lawsuits, such as one that the drugmaker agreed to pay $55 million to resolve some 5,500 lawsuits alleging the company knew Seroquel could cause diabetes, but failed to provide adequate warnings. Those settlements, however, are part of the 17,000 lawsuits that are now being resolved. In all, the average payments work out to about $10,000 to $12,000, ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3845285 Mon, 09 Aug 2010 11:43:34 +0100 3845285 http://www.medworm.com/index.php?rid=3827340&cid=t_100585_150_f&fid=34768&url=http%3A%2F%2Fpharmagossip.blogspot.com%2F2010%2F08%2Flolpharma-contd-wanna-see-seroquel.html Ed has the story (Source: PharmaGossip) PharmaGossip blogs http://www.medworm.com/rss/comments.php?id=3827340 Thu, 05 Aug 2010 13:42:00 +0100 3827340 http://www.medworm.com/index.php?rid=3827348&cid=t_100585_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FPJSB-Co_w5E%2F Here is an interesting dichotomy: At the same time that AstraZeneca is forking out tens of millions of dollars to settle thousands of product-liability lawsuits claiming the risks of its Seroquel antipsychotic were not properly disclosed (see this), the drugmaker is tagged by the FDA for distributing promotional material that, among other things, fails to mention the risk that promped the lawsuits - a link to diabetes. A July 29 letter sent by the Division of Drug Marketing and Advertising Communications notes that the efficacy of Seroquel XR was overstated and risk info was omitted in so-called leave-behind sheets. For instance, various studies were cited, but overstated remission rates, the FDA scolded. “These claims misleadingly suggest that patients will achieve ‘remission... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3827348 Thu, 05 Aug 2010 12:19:23 +0100 3827348 http://www.medworm.com/index.php?rid=3827349&cid=t_100585_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FxlR5KWqXo1w%2F Hello, everyone. How are you today? Hope your week is going well. We have had a rather busy time, but that is to be expected. And so you know what this means - time for two cups of stimulation. Feel free to join us as we gear up for another cycle of meetings and deadlines. Meanwhile, here are some snippets of activity that may interest you. Have a good one and please do stay in touch… Epilepsy Drugs Don’t Increase Suicide Risk (Bloomberg News) Merck Proteomics Research Matches Drugs To Activated Pathways (BioIt World) Gilead’s Ace Drug Developer Resigns (Xconomy) Bayer, J&J’s Xarelto Meets Study Goal (Reuters) Glaxo Find New Way To Fight Drug-Resistant Bacteria (Dow Jones) WHO Withdraws Pre-Qualification Of Sanofi Vaccine (Vaccine News Daily) Glaxo Signs Cancer... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3827349 Thu, 05 Aug 2010 11:47:17 +0100 3827349 http://www.medworm.com/index.php?rid=3807523&cid=t_100585_150_f&fid=34768&url=http%3A%2F%2Fpharmagossip.blogspot.com%2F2010%2F07%2Fastrazeneca-remains-committed-to-strong.html (Source: PharmaGossip) PharmaGossip blogs http://www.medworm.com/rss/comments.php?id=3807523 Sat, 31 Jul 2010 21:47:00 +0100 3807523 http://www.medworm.com/index.php?rid=3806021&cid=t_100585_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FPKdqKzAJy3w%2F There was news last week that AstraZeneca was settling at least 200 lawsuits that charged the drugmaker with hiding the risks of its Seroquel antipsychotic and links to diabetes (back story). As it turns out, AstraZeneca has agreed in principle to settle nearly 4,000 such claims (see page 34). Terms were not disclosed. AstraZeneca is only the latest big drugmaker to strike settlments with a large number of plaintiffs in ongoing product-liability litigation. Recently, GlaxoSmithKline has done the same concerning lawsuits filed over its Avandia diabetes med and Paxil antidepressant (see here and here). The goal, of course, is to dispense with the litigation before associated costs spiral upwards and further distract managers, all of which combines to unhinge investors if court battles are lo... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3806021 Sat, 31 Jul 2010 02:29:47 +0100 3806021 http://www.medworm.com/index.php?rid=3798819&cid=t_100585_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FM-x7b-V2W30%2F After an intriguing debate over the mysterious outcome of a clinical trial, an FDA advisory committee has voted 7-to-1 to recommend that the agency approve AstraZeneca’s Brilinta blood thinner. The outcome increases the likelihood the FDA will, in fact, endorse the medication, even though a clinical trial found an unexpected - and adverse - result only in patients from the US. The key clinical trial compared Brilinta to Plavix in 18,624 patients in 43 countries who were being treated for a blocked artery or heart attack. The results showed the med reduced heart attacks, strokes and cardiovascular death 16 percent compared with Plavix after a year’s treatment. And all of the patients were given aspirin. But about 9 percent - who were from the US - saw no benefit. The FDA had exp... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3798819 Wed, 28 Jul 2010 21:55:50 +0100 3798819 http://www.medworm.com/index.php?rid=3798825&cid=t_100585_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FwfqWwZwCEWM%2F Rise and shine, everyone. Another beautiful day is unfolding here on the Pharmalot corporate campus, where we are brewing two cups of stimulation simultaneously. We are two-fisted drinkers, you know. Please join us and grab one or more yourself, or a bottle of water, if you prefer. Meanwhile, here are a few interesting tidbits to help you along. Hope your days goes well and stay in touch… FDA Panel Reviews AstraZeneca’s Brilinta Today (Reuters) Merck KGgA Multiple Sclerosis Pill Gets Priority Review (Bloomberg News) Viagra May Be Used For Lung Disorder In Children (Bloomberg News) UK’s NICE Recommends Roche’s MabThera For Leukemia (Dow Jones) Merck Paid 3,468 Death Claims To Resolve US Vioxx Suits (Bloomberg News) Pfizer Trovan Suit Transferred To Nigerian State Cou... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3798825 Wed, 28 Jul 2010 11:46:21 +0100 3798825 http://www.medworm.com/index.php?rid=3780564&cid=t_100585_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FWZygSBtdHvo%2F Another day, another large settlement. Rather than ring up tabs for expensive lawyers and confront the possibility of bad publicity indefinitely, drugmakers are choosing to settle gobs of product-liability lawsuits with big settlements. Such moves, of course, appease anxious investors and allow senior execs to focus on the important stuff, such as their compensation packages developing new meds. Over the past few weeks, GlaxoSmithKline has been practically racing to resolve Avandia and Paxil lawsuits (see here and here). And Eli Lilly has done the same with its Zyprexa antipsychotic. Now, AstraZeneca has agreed to pay $2 million to settle more than 200 lawsuits charging its Seroquel antipsychotic causes diabetes, marking the first time the drugmaker agreed to settle such claims. There are ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3780564 Thu, 22 Jul 2010 15:06:32 +0100 3780564 http://www.medworm.com/index.php?rid=3780565&cid=t_100585_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FhUrAUHm71Bo%2F With all those patent expirations under way, brand-name drugmakers, of course, are desperate to wring as much money as possible out of their products. So how do they counter the generic onslaught? There are several tricks and every company employs multiple strategies, although patent challenges were the most popular choice over the past three years, according to a new survey. Patent litigation, in fact, was pursued by 60 percent of those queried by Cutting Edge Information, followed closely by defensive pricing, which was popular among 57 percent of the respondents. Half of those surveyed also like to concoct new formulations or a next-generation drug, with new indications clocking in at 45 percent. Only 29 percent pointed to an authorized generic or generics subsidiary. Over the next thre... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3780565 Thu, 22 Jul 2010 14:42:20 +0100 3780565 http://www.medworm.com/index.php?rid=3750255&cid=t_100585_140_f&fid=35439&url=http%3A%2F%2Fbipolarsoupkitchen-stephany.blogspot.com%2F2010%2F07%2Fastrazenecas-seroquel-wonder-drug-its.html (Source: soulful sepulcher) soulful sepulcher blogs http://www.medworm.com/rss/comments.php?id=3750255 Tue, 13 Jul 2010 13:16:00 +0100 3750255 http://www.medworm.com/index.php?rid=3750275&cid=t_100585_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FQ3eBZlyjWkI%2F The California Supreme Court has overturned a lower court decision that dismissed a price-fixing lawsuit brought by a group of pharmacies. They had charged the largest drugmakers agreed to set artificially high prices, and acted in concert to restrain reimportation of their lower-priced foreign drugs into the US and restrict price competition from generics. As a result, the drugmakers were able to maintain prices 50 to 400 percent higher than for the same drugs sold outside the US. The drugmakers - which included Abbott Labs; AstraZeneca; Novartis; Allergan; Boehringer Ingelheim; Eli Lilly; Johnson & Johnson; Janssen Pharmaceutica; Ortho McNeil; Ortho Biotech; GlaxoSmithKline; Pfizer; Hoffman-LaRoche; Aventis Pharmaceuticals; Amgen; Purdue Pharma; Merck; Bristol-Myers-Squibb, and Wyeth - a... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3750275 Tue, 13 Jul 2010 12:03:55 +0100 3750275 http://www.medworm.com/index.php?rid=3730099&cid=t_100585_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FsAJ1_8Kfznw%2F Welcome back. We hope the long weekend was relaxing and refreshing. Some folks may still be on holiday, but for the rest of the us, the routine has returned. And so, we are preparing ourselves with a cup of stimulation. Please join us as we confront the usual deadlines and scan the news of the world. Meanwhile, have a great day, everyone… Contract Manufacturing To Grow At 12 Percent (OutsourcingPharma) Sex Diseases Are Higher In Men Over 40 Taking ED Pills (Reuters) Australia Reviews Genetic Testing For Cancer Drug (Sydney Herald) Aspen To Lower Its Bid For Sigma Pharma (Bloomberg News) AstraZeneca Strikes Deal With Academia (Financial Times) Astellas Breaches ABPI Code Of Practice (PharmaTimes) Atripla Co-Pay Program To Cover More People (POZ) US Companies Eye British Takeover Targe... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3730099 Tue, 06 Jul 2010 11:58:34 +0100 3730099 http://www.medworm.com/index.php?rid=3724567&cid=t_100585_140_f&fid=35439&url=http%3A%2F%2Fbipolarsoupkitchen-stephany.blogspot.com%2F2010%2F07%2Fwhen-big-pharma-courts-academia-2002.html (Source: soulful sepulcher) soulful sepulcher blogs http://www.medworm.com/rss/comments.php?id=3724567 Mon, 05 Jul 2010 01:21:00 +0100 3724567 http://www.medworm.com/index.php?rid=3718695&cid=t_100585_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FRnVigrnX3FU%2F Since the passage of the False Claims Act in 1986, the federal government has recovered about $22 billion through qui tam, or whistleblower lawsuits and a fair number of these have emanated from the pharmaceutical industry. An untold number of such lawsuits are always in the wings, as people who work with or for drugmakers attempt to expose alleged wrongdoing. There have been accusations that some whistleblowers are only in it for the money (see this), but life as a whistleblower has its challenges (see here). And so concerned that the pharmaceutical industry may not be doing enough to educate employees about whistleblowing protection, US Senator Chuck Grassley has written 16 big drugmakers to provide information about their programs. The letters went to Abbott Labs, Amgen, AstraZeneca, Br... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3718695 Thu, 01 Jul 2010 14:34:30 +0100 3718695 http://www.medworm.com/index.php?rid=3714444&cid=t_100585_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_100585_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