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 'bristol myers squibb'. Sat, 03 Sep 2011 02:11:07 +0100 http://www.medworm.com/index.php?rid=5182323&cid=t_132659_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FvMmVEzuXRy0%2F Top of the morning to you. And yet another shiny day is unfolding over the Pharmalot corporate campus, where the short people and the official mascots appear to be snoozing indefinitely. This rare treat gives us more time this morning to brew those mandatory cups of stimulation and poke around for interesting items. So here they are. Meanwhile, we will get back to conducting our own version of R&D. So keep us in mind if you hear something interesting. Have a great day… Sanofi Strikes Deal To Make Generic Lipitor (Reuters) FDA And Drugmakers Agree On 6 Percent PDUFA Fee Hike (Wall Street Journal) XOMA CEO Resigns (Reuters) Baxter Sues Teva To Enforce Propofol Liability (Bloomberg News) Death Rate Rises In Clinical Trials In India (The Tribune) Contract Pharmaceuticals To Lay Off ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=5182323 Thu, 01 Sep 2011 12:08:48 +0100 5182323 http://www.medworm.com/index.php?rid=5174864&cid=t_132659_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fb0mlnNwQLrQ%2F Over the weekend, Pfizer and Bristol-Myers Squibb released complete results of a Phase III trial for their forthcoming bloodthinner and, as expected, the findings clearly suggest the drugmakers have a treatment that will surpass rival meds. Why? Eliquis prevented more strokes with less major bleeding than warfain, the decades-old standard treatment in patients with atrial fibrillation, and also reduced the number of deaths. Consequently, the outcome underscores that one of the next, big marketing battles in the pharmaceutical industry will unfold after the drugmakers secure FDA approval, a step that is not expected until 2012. Already, Boehringer Ingelheim is marketing Pradaxa and Johnson & Johnson and Bayer expect to launch their Xarelto treatment later this year. Xarelto, by the way... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=5174864 Mon, 29 Aug 2011 13:47:47 +0100 5174864 http://www.medworm.com/index.php?rid=5118993&cid=t_132659_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fro-VnpB2yDg%2F If numbers tell a story, then Bayer and Johnson & Johnson may have some explaining to do. The complete results of a widely anticipated study known as Rocket were just published and show their Xarelto bloodthinner is not only just as safe as warfarin - the standard treatment - but 21 percent better at preventing stroke in patients with atrial fibrillation. But there was more, and it was sobering. An editorial in the same issue of The New England Journal of Medicine maintains the use of multiple statistical analyses to assess the medication “muddied the waters” when it comes to fully understanding efficacy and effectiveness compared with warfarin. The point raised by Gregory Zoppo of the University of Washington, and Misha Eliasziw of the University of Calgary may prompt cl... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=5118993 Thu, 11 Aug 2011 13:11:12 +0100 5118993 http://www.medworm.com/index.php?rid=5097081&cid=t_132659_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F6qpt6RDLE8I%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 Avalere Health hired Leigh Ann Bruhn as a director. Previously, she was a director of managed care marketing at Abbott Laboratories, where she led both managed care and brand marketing teams. Prior to Abbott, she held various marketing and fina... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=5097081 Fri, 05 Aug 2011 12:34:12 +0100 5097081 http://www.medworm.com/index.php?rid=5097087&cid=t_132659_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FULvTVJYk9rM%2F Bristol-Myers Squibb was sued by the family of a New Jersey man whose death earlier this year was blamed on a toxic metal that was allegedly given to him by his estranged wife - who worked at the drugmaker as a chemist, The Star-Ledger of New Jersey reports. Specifically, the lawsuit charges that Bristol-Myers knew that Tiane Li should not have been permitted access to thallium and had known she was volatile and previously threatened another employee who had obtained a temporary restraining order, the paper writes (back story here). The lawsuit also named attending doctors at the University Medical Center in Princeton, where Xiaoye Wang, 39, went on January 14 with virus-like symptoms. However, the suit argues the docs did not take him seriously when he told them he believed his wife had p... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=5097087 Thu, 04 Aug 2011 19:42:20 +0100 5097087 http://www.medworm.com/index.php?rid=5086560&cid=t_132659_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FfEJZC4F4xVU%2F Good morning, everyone. Hope you had a nice weekend. Now, of course, the routine resumes, although this is often a slow time of year. Nonetheless, there is much to be done here in the official Pharmalot c-suite, where we are catching up on interesting documents and conversations. And of course, we are brewing that mandatory cup of stimulation and invite you to join us. Meanwhile, here are a few tidbits from around the world. Hope your day goes well and you accomplish much… Teva’s Copaxone Successor Fails In Latest Clinical Trial (Bloomberg News) Pfizer Says FDA Delays Prevnar Review For Three Months (Bloomberg News) Cuba Sentences Pharma Execs For Corruption (Associated Press) Japan’s Shionogi Acquires C&O Pharmaceutical Tech (ChannelNewsAsia) New FDA Commish Asks Co... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=5086560 Mon, 01 Aug 2011 12:00:25 +0100 5086560 http://www.medworm.com/index.php?rid=5051238&cid=t_132659_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FbCFE16uqAmc%2F And so, another working week will soon draw to a close. As you know, this is our welcome signal to daydream about weekend plans. Our agenda is modest - a dip in the pool, an evening of soccer with one of the short people and catching up on some reading. What about you? Given the heat, a few indoor activities may be in order. How about an air-conditioned drive in the country or a movie marathon (if you avoid paying for more than one flick, you have a bargain). You could take a trip to the mall and spur the economy. Or you could stay home and turn on the telly for updates on the debt talks. Whatever you do, have a good time and stay cool. See you soon… Bristol-Myers Buys Amira Pharmaceuticals For Up To $475M (Xconomy) Merck And Simcere Pharmaceutical Form Joint Venture (China Daily) Ex... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=5051238 Fri, 22 Jul 2011 11:44:20 +0100 5051238 http://www.medworm.com/index.php?rid=4992989&cid=t_132659_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fl9r_qs2CrEo%2F Three years after they were fingered in a US Senate probe into the interplay between academics who receive grant money from both pharma and the National Institutes of Health, three prominent psychiatrists from Harvard Medical School and Massachusetts General Hospital have been sanctioned for violating conflict of interest rules and failing to report the extent of their payments. In a mea culpa addressed to their colleagues, Joseph Biederman, Thomas Spencer and Timothy Wilens wrote that “we want to offer our sincere apologies to HMS and MGH communities…We always believed we were complying in good faith with the institutional polices and our mistakes were honest ones. We now recognize that we should have devoted more time and attention to the detailed requirements of these polici... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4992989 Sat, 02 Jul 2011 14:04:29 +0100 4992989 http://www.medworm.com/index.php?rid=4968909&cid=t_132659_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FVPghfLkLLqc%2F Good morning, everyone. Another working week is about to draw to a close and already, we are daydreaming about weekend plans. Our modest agenda includes catching up on some reading, tending to the official Pharmalot grounds and spending time with our short people. And you? Now that summer is here, perhaps a drive to the beach is in order. Or curling up with a good e-book. Of course, one can always take that proverbial walk in the park. Whatever you fancy, have a great time and see you soon… Patent Overhaul Bill Clears US Senate (Reuters) America’s Vanishing Science Jobs (The New York Post) EMA Delays Decision On Actos To July (Reuters) FDA Inspects New Ranbaxy Plant In India (The Economic Times) Commonly Used Drugs Raise Risk Of Death In The Elderly (Reuters) Pfizer To Keep 350... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4968909 Fri, 24 Jun 2011 11:56:33 +0100 4968909 http://www.medworm.com/index.php?rid=4960328&cid=t_132659_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_132659_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=4902696&cid=t_132659_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FbKhZl7DkcDs%2F Hello, everyone, and nice to see you again. We apologize for the delay this morning, but we were having technical difficulties. To cope, we are having downing several cups of stimulation. Now, though, the time has come to tackle those meetings and deadlines. Meanwhile, here are some tidbits, including news from the ASCO meeting. Hope your day goes well and stay in touch… A Contraceptive Pill For Men With No Side Effects? (The Daily Mail) Merck And Ariad Drug Delays Sarcoma In Trial (Reuters) UK Pharma Industry In Crisis (Press TV) Roche Says Avastin And Chemo Cut Ovarian Cancer Growth (Bloomberg News) Bristol Melanoma Drug And Chemo Extended Life In Study (Reuters) Pfizer Divestiture May Hurt Its Credit Rating (Bloomberg News) Chinese Drugmaker Cited For Significant Pollution (East D... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4902696 Mon, 06 Jun 2011 12:47:10 +0100 4902696 http://www.medworm.com/index.php?rid=4893917&cid=t_132659_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FaIPonxw6_os%2F One year after an analysis of five studies involving some 60,000 patients found links between angiotensin receptor blockers and an increased risk of cancer, the FDA has now decided that these meds - which are used to control high blood pressure, do not pose such a risk. The study, which was published in The Lancet Oncology and prompted the FDA review, found that 7.2 percent of patients on an ARB were diagnosed with cancer compared with 6 percent on a placebo, which was deemed statistically significant. Put another way: one extra cancer case would occur for every 105 people taking the meds for about four years (back story). Most of the patients were taking Boehringer Ingelheim’s Micardis, a $1.5 billion seller, prompting an angry rebuttal from the drugmaker. Other ARBs that were studied i... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4893917 Thu, 02 Jun 2011 19:21:10 +0100 4893917 http://www.medworm.com/index.php?rid=4921560&cid=t_132659_113_f&fid=34634&url=http%3A%2F%2Fwww.emrandhipaa.com%2Femr-and-hipaa%2F2011%2F06%2F01%2Fdrug-mailings-and-patient-privacy%2F Many of you have quickly realized that I find it a lot more interesting to write about EMR than I do about HIPAA. Seems like most people prefer to read about EMR than they do HIPAA as well (except for this popular HIPAA Lawsuits post I did eons ago). However, I’m sure that many of you will find this article I found about privacy of medical data quite interesting. Here’s a quote from the beginning of the article which prefaces the health privacy situation quite well. A pharmaceutical company, Bristol-Myers Squibb Co., sent him an eight-page brochure pitching another medicine, Abilify, used to treat patients “when an antidepressant alone isn’t enough.” Lexapro was plenty for Spencer, but the mailing stuck in his craw. He has followed the recent debate over the u... EMR and HIPAA blogs http://www.medworm.com/rss/comments.php?id=4921560 Wed, 01 Jun 2011 20:40:22 +0100 4921560 http://www.medworm.com/index.php?rid=4853218&cid=t_132659_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_132659_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=4829305&cid=t_132659_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F9d0neOmCpbU%2F Late last week, the FDA approved a much-anticipated hepatitis C treatment from Merck, which the drugmaker inherited as part of its acquisition of Schering-Plough (see here). The move, which is the first FDA endorsement of a new hepatitis C med in a decade, came just 10 days before Vertex Pharmaceuticals is expected to win approval of its own drug, setting off a new round of speculation about what is certain to be an expensive and highly interesting battle. The US market alone offers substantial potential with an estimated 3.2 million Americans suffering from the afflication, including an untold number who may not be aware they are infected. Both Merck and Vertex, of course, will work hard to raise awareness. And their meds would be used in combination with older treatments - peginterferon ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4829305 Mon, 16 May 2011 13:09:51 +0100 4829305 http://www.medworm.com/index.php?rid=4795058&cid=t_132659_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F7SCLQKXldE8%2F Good morning, everyone. Another working week is about to draw to a close, which is our signal to daydream about weekend plans. Our agenda includes watching one of the short people play lacrosse, taking a long walk or two with Mrs. Pharmalot and catching up on some reading. And you? Will you ever clean out the garage? Maybe this is a chance to enjoy the great outdoors? Or simply count your blessings? Whatever you do, have a swell time. And, of course, say hi to mom… CVS Discloses SEC Inquiry Into Caremark (Associated Press) Former Bristol-Myers Chemist Indicted For Killing Her Husband (Daily Record) CVS Will Keep Caremark (The Street) Pfizer Returns Ashtma Med To Rigel (Xconomy) Most New Drugs Marketed Without Comparative Data (Reuters) Novartis Wins Expanded Indication For Pancreatic... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4795058 Fri, 06 May 2011 12:10:08 +0100 4795058 http://www.medworm.com/index.php?rid=4789635&cid=t_132659_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fh0ku9JI07Eo%2F An investigation by India’s health ministry has found that drugmakers running clinical trials in the country have not compensated survivors of most volunteers who died during their studies. Of 671 deaths that were reported last year, there is evidence that compensation was given in just three cases, The Business Standard writes. And so, the health ministry has asked 44 drugmakers to explain why they have not provided compensation, which is mandatory under the current law. Among those queried were Eli Lilly, Novartis, Pfizer, Bayer, Merck, Johnson & Johnson and Sanofi-Aventis. For instance, data compiled by the ministry show there were 152 deaths reported during Sanofi trials and 138 took place in Bayer trials. A Novartis spokesperson tells the paper that its clinical trial inves... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4789635 Thu, 05 May 2011 12:27:52 +0100 4789635 http://www.medworm.com/index.php?rid=4789639&cid=t_132659_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F0g87fDI2KB0%2F Was the evidence used for prescribing Abilify to combat bipolar disorder skimply? That’s the contention in a new paper, which argues the justification for using the Bristol-Myers Squibb drug as maintenance treatment was based on one long-term, controlled trial that had numerous limitations. Moreover, the paper maintains these limitations were not identified in many of 104 subsequent review articles and treatment guidelines. For its part, Bristol-Myers disagrees (keep reading). The original trial was published in the American Journal of Psychiatry in 2003 and compared the safety and efficacy of Abilify with placebo for treating bipolar patients. The study concluded that the pill had “significantly greater efficacy than placebo for the treatment of bipolar disorder patients in ac... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4789639 Wed, 04 May 2011 15:04:41 +0100 4789639 http://www.medworm.com/index.php?rid=4789640&cid=t_132659_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fn0IGPxirKGw%2F Two months ago, Pfizer signaled interest in selling or spinning off some of its so-called ‘non-core’ businesses - those that are not involved in brand-name pharmaceuticals. These would include the nutritionals, consumer health and animal health units, and possibly a generics operation. A business that makes capsules has already been sold (back story here and here). The rationale for this notion, of course, would be to unlock the underlying value in each entity and reward shareholders. But one Wall Street credit analyst cautions that divesting non-pharma businesses comes with risks. “Unless companies use the proceeds from asset sales to repay debt, or unless the businesses being sold are underperforming expectations and are a distraction to management, the credit implicati... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4789640 Wed, 04 May 2011 13:56:35 +0100 4789640 http://www.medworm.com/index.php?rid=4780488&cid=t_132659_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FGuogHFPFGkk%2F Good morning, everyone, and nice to see you again. A sunny day is unfolding here on the Pharmalot corporate campus, where we hope we have solved our recent tech problems. We appreciate your patience. Meanwhile, we are brewing the usual cup of stimulation - our flavor today is Mocha Nut Fudge - and perusing the news of the world. Let us know if you hear something interesting. And, of course, have a productive and rewarding day… Pfizer Earnings Rise On Lower Costs (Associated Press) Novartis CEO Not Thrilled With Health Care Reform (Fortune) Shanghai Pharma Raises $2.2B, Investors Include Pfizer (Bloomberg News) Could Chemicals In Wine Improve Stent Performance? (Health Day) Teva To Buy Japanese Generic Drugmaker (Globes) FDA Approves Boehringer/Lilly Diabetes Drug (Pharma Times) Parex... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4780488 Tue, 03 May 2011 12:02:39 +0100 4780488 http://www.medworm.com/index.php?rid=4768250&cid=t_132659_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FEKnIm6NQuKw%2F Another working week is about to draw to a close. And not a moment too soon. This is, of course, the signal to daydream about weekend plans. Our modest agenda includes a family gathering, mowing the lawn (wish us luck) and promenading with the official Pharmalot mascots. What about you? Does spring cleaning beckon? How about finding recession-era bargains at a garage sale? Or maybe take a moment to think big thoughts? Whatever you do, have a great time. And see you soon… Merck Profits Top Estimates (Bloomberg News) Woman Severely Hurt By Abbott Labs Truck (Lake County News-Sun) Johnson & Johnson Prostate Cancer Drug Approved By FDA (Bloomberg News) Generic Lipitor Ruling Expected Next Week (Dow Jones) FDA Panel Recommends Vertex Hepatitis C Drug (Boston Globe) Wolter Kluwers Buy... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4768250 Fri, 29 Apr 2011 11:48:24 +0100 4768250 http://www.medworm.com/index.php?rid=4684760&cid=t_132659_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fd_j1yofCUbQ%2F Five of the world’s biggest drugmakers failed to comply with mandatory disclosure laws for their patented medicines in India, which means they are vulnerable not only to fines, but also competition in the form of compulsory licenses that could be issued to generic drugmakers, which would then have the right to sell lower-cost versions of the patented drugs. The breach was uncovered by Shamnad Basheer, a professor of intellectual property law at the National University of Juridicial Sciences in New Delhi, India, and a contributor to the Spicy IP patent blog. He led a group of lawyers who collected information on patent disclosures made by foreign drugmakers to regulators under what is known as a Right to Information, or RTI, request. At issue is a requirement that drugmakers share in... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4684760 Thu, 07 Apr 2011 12:54:41 +0100 4684760 http://www.medworm.com/index.php?rid=4664473&cid=t_132659_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FCFkCzxDEPE8%2F File this under praying for relief. Several religious groups - including an order of Catholic nuns and a chain of Catholic hospitals - are pressuring a few big drugmakers to exercise some price restraint and have placed proposals that will be voted on during upcoming annual shareholder meetings. Such efforts are not new, but the latest attempt comes after one Wall Street analyst reported that prices for 130 best-selling brand-name drugs rose 6.9 last year, which was the biggest increase in a decade. For instance, a shareholder proposal in the Pfizer proxy from The Sisters of Charity of Saint Elizabeth, which is based in New Jersey, states that the cost of medicines has “skyrocketed in this country in recent years” and the “failure to control costs could undermine the goal... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4664473 Fri, 01 Apr 2011 12:37:46 +0100 4664473 http://www.medworm.com/index.php?rid=4658627&cid=t_132659_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fz32nDiD2ons%2F Good morning, everyone. How are you today? A busy agenda awaits us here on the Pharmalot corporate campus, where we have a pile of meetings and deadlines to attack. We trust you can relate. To cope, yes, we are downing a cup or two of stimulation. As always, we invite you to join us. And to get you started, here are some tidbits from the world at large. Hope your day goes well and do stay in touch… Sonova Execs Resign After Insider Trading Probe (Bloomberg News) Gilead And Yale Former Cancer Research Deal (Reuters) Valeant Offers To Buy Cephalon For $5.7 Billion (Bloomberg News) Glaxo’s Lovaza Partner Pronova Settles Patent Row With Apotex (Reuters) UK’s NICE Rejects Bristol-Myers’ Orencia Drug (Dow Jones) Vertex CF Drug Shows Promising Results (Mass High Tech) Merc... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4658627 Wed, 30 Mar 2011 11:41:48 +0100 4658627 http://www.medworm.com/index.php?rid=4653603&cid=t_132659_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=4653607&cid=t_132659_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FVId4_w7jKkA%2F Yesterday, we wrote that California State Controller John Chiang sent a letter to Gilead Sciences to ask the drugmaker for a reduction in the price of Atripla, a key AIDS med. As it turns out, Chiang actually sent letters to a total of nine drugmakers, asking each of them to lower the prices on their AIDS meds and also extend supplemental agreements that were reached last year to relieve financial pressure on the AIDS Drug Assistance Programs around the country. The other drugmakers he wrote were Abbott Laboratories, Merck, Boehringer Ingelheim, Genentech, Bristol-Myers Squibb, Merck, Johnson & Johnson’s Tibotec unit and ViiV Healthcare, a joint venture between Pfizer and GlaxoSmithKline. In each case, Chiang wrote that California’s ADAP program has experienced a 257 percent ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4653607 Tue, 29 Mar 2011 11:51:03 +0100 4653607 http://www.medworm.com/index.php?rid=4642996&cid=t_132659_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FWCD_uX1CWRo%2F For the second time in recent months, California State Controller John Chiang has written a drugmaker asking for a reduction in the price of a key AIDS med. This time, Chiang wrote Gilead Sciences to lower the price of its Atripla drug, which costs about $21,900 a year per patient and accounts for about 20 percent of all expenditures made by the AIDS Drug Assistance Programs (ADAP) nationally. The move comes amid shrinking budgets for state ADAP programs (back story) and nearly a dozen states maintain growing waiting lists that, cumulatively, number more than 7,200 people, according to the National Alliance of State & Territorial AIDS Directors (see this). And Chiang maintains California can no longer keep up with rising demand and rising prices, according to his letter. Specifically... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4642996 Mon, 28 Mar 2011 13:03:59 +0100 4642996 http://www.medworm.com/index.php?rid=4636657&cid=t_132659_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fa7mVVxiHQso%2F In a widely anticipated move, the FDA has approved a Bristol-Myers Squibb medication called Yervoy for treating advanced melanoma, which is the deadliest form of skin cancer. The approval for the drug, which will cost $30,000 a dose, or $120,000 for a four-course treatment over three months, was heralded by doctors, patients and investors alike. Yervoy is “an exciting drug, especially given the dearth of effective therapies for this bad form of cancer,” Sanford Bernstein analyst Tim Anderson wrote in an investor note earlier this week, who forecast $1.7 billion in sales by 2015, or 10 percent of companywide revenue. However, that was based on a more modest price tag of about $100,000 for a full course of treatment. “This is really the first time in the melanoma field tha... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4636657 Fri, 25 Mar 2011 19:41:24 +0100 4636657 http://www.medworm.com/index.php?rid=4636660&cid=t_132659_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F_LncIHegHag%2F Normally, a high price for a medication prompts outrage and accusations from consumers, politicians, doctors and insurers. Now, though, there is the courtroom spectacle of an attorney for GlaxoSmithKline charging Abbott Labs with being greedy, stifling competition and creating an illegal monopoly after more than quadrupling the price of its Norvir med. The pill is used in AIDS cocktails. The background: Abbott sells a combo pill called Kaletra that includes Norvir and its own protease inhibitor. Glaxo claims Abbott raised Norvir’s price - but not the Kaletra price - in 2003 in order to boost Kaletra sales at the expense of other protease inhibitors that require Norvir as a booster. In other words, Abbott allegedly tried to use Norvir to create an illegal monopoly. A Glaxo lawyer told a ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4636660 Fri, 25 Mar 2011 13:27:32 +0100 4636660 http://www.medworm.com/index.php?rid=4631648&cid=t_132659_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FLb25IzA8q8M%2F Good morning, everyone, and how are you today? Gloomy skies are hovering over the Pharmalot corporate campus again. Nonetheless, our spirits remain sunny. You know the refrain: ‘Every brand new day should be unwrapped like a precious gift.’ In other words, those meetings and deadlines may loom, but you will persevere. Meanwhile, please join us for, yes, that mandatory cup of stimulation and get ready to conquer the world. Have a good one and stay in touch… Merck Returns Blood Clot Drug to Portola (Reuters) Bayer Launches Melt-In-The-Mouth Impotence Pill In UK (Pharma Times) Abbott Settles HIV Drug Price Lawsuit With Pharmacies (Reuters) No Fracture Warnings Needed On OTC Heartburn Meds (Reuters) Canadian Access To Medicines Bill Stalls In Senate (Bridges Weekly) Amgen Say... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4631648 Thu, 24 Mar 2011 11:59:01 +0100 4631648 http://www.medworm.com/index.php?rid=4610996&cid=t_132659_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FRIn2KcUFrXo%2F In an unusual move, the California Insurance Commissioner has intervened, or joined, a whistleblower lawsuit that was filed in 2007 by three former Bristol-Myers Squibb employees, who charged the drugmaker with bribing doctors to prescribe its meds - Abilify, Avapro, Glucophage, Plavix, BuSpar, Pravachol and others. In all, private insurers in the state paid more than $3.5 billion to cover the drugs. “This sort of fraud has long plagued our health insurance system, leading to billions of dollars annually in added health care costs nationally,” Insurance Commissioner Dave Jones says in a statement. “Besides the obvious and deplorable ethical violations in such cases, health care fraud also leads to higher premiums for consumers and an unnecessary and unjust increase in hea... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4610996 Fri, 18 Mar 2011 22:20:28 +0100 4610996 http://www.medworm.com/index.php?rid=4606052&cid=t_132659_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FFiK0SOKwv4Q%2F Where, oh where, did your health care budget go? A larger chunk apparently went to pay for brand-name* prescription meds which, on average, rose 6.9 percent last year. The increase nudged past the 6.8 percent average advance registered in 2008, which was the largest annual jump since Barclays Capital began tracking price hikes, The Wall Street Journal reports. Some of the biggest: the Benicar blood pressure pill sold by Daiichi Sankyo rose 29.3 percent; the Gleevec cancer treatment marketed by Novartis jumped 20.9 percent; Johnson & Johnson’s Concerta pill for ADD moved up 19.7 percent; Pfizer’s Lipitor cholesterol blockbuster popped 12.4 percent, and the Plavix bloodthinner sold by Bristol-Myers Squibb and Sanofi-Aventis rose 13.2 percent. Obviously, drugmakers are &#8220... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4606052 Thu, 17 Mar 2011 12:15:48 +0100 4606052 http://www.medworm.com/index.php?rid=4592688&cid=t_132659_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=4592694&cid=t_132659_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fw63z2G8UvTM%2F After spending more than a decade growing into a behemoth by single-mindedly pursuing big acquisitions - think Warner-Lambert, Pharmacia and Wyeth - Pfizer is now signaling a change of heart. To wit, the drugmaker is said to considering the spin off or sale of all four non-pharma units, including nutritionals, consumer health, animal health and a business that makes capsules. Moreover, Pfizer may even shed what it calls the Established Products division, a $10 billion operation that includes off-patent meds, the Greenstone generics unit and biosimilars, according to an investor note from Sanford Bernstein analyst Tim Anderson. He writes that such moves would trim Pfizer nearly in half - from about $67 billion in annual revenue to between $35 billion and $40 billion. “If we hadn&#8217... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4592694 Mon, 14 Mar 2011 14:39:05 +0100 4592694 http://www.medworm.com/index.php?rid=4549939&cid=t_132659_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FzIiicEuNJck%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 IBM Global Business Service hired Neil Patel as an associate partner in the Life Sciences R&D Practice. Prior to joining IBM, he was with PricewaterhouseCoopers in the Pharma Life Sciences Practice as a director and, before that, he worked... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4549939 Fri, 04 Mar 2011 13:10:43 +0100 4549939 http://www.medworm.com/index.php?rid=4532571&cid=t_132659_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F3ON0OinTH9Q%2F In what is being hailed as a victory for sales reps, the US Supreme Court has decided not to review lawsuits in which a lower court decided that Novartis and Schering-Plough should have paid overtime to its sales teams. The move means that still other lawsuits filed against several other drugmakers are likely to yield the same outcome, possibly prompting changes in the way sales reps are compensated (see the court denials here and here). Here’s the background: a federal appeals court last July ruled Novartis reps are not exempt from overtime provisions of the Fair Labor Standards Act and, therefore, should be paid overtime. The same court also upheld a similar decision reached two years ago against Schering-Plough by a federal court, which denied a motion to dismiss a case brought ag... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4532571 Mon, 28 Feb 2011 17:17:56 +0100 4532571 http://www.medworm.com/index.php?rid=4517351&cid=t_132659_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FeCteA-oUlxo%2F NaniRx Therapeutics, a venture-backed drugmaker that is using proprietary technology to develop treatments for breast cancer and autoimmune disorders, has filed a lawsuit against its former ceo, because he allegedly breached his employment agreement after taking important company research data and canceling a potential partnership meeting with Bristol-Myers Squibb, among other things. David I. Cohen, who was a former co-chair of the National Institutes of Health’s HIV vaccine development committee before joining NaniRx as ceo three years ago (bio here), allegedly undermined the start up’s research efforts in various ways that NaniRx charges is causing irreparable harm, according to the lawsuit filed in New York Superior Court (read here). For instance, the lawsuit claims that ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4517351 Thu, 24 Feb 2011 14:57:52 +0100 4517351 http://www.medworm.com/index.php?rid=4489971&cid=t_132659_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fk0F7O8CVBQE%2F A former Bristol Myers Squibb employee who admitted that he stole secret formulas so he could start a company in his native India was sentenced today to a year that he has already served in jail in upstate New York, The Syracuse Post-Standard reports. Shalin Jhaveri, 30, had pleaded guilty to stealing trade secrets and sending them in three attachments to an e-mail to a man he thought was an investor in a pharmaceutical company that Jhaveri wanted to start in India with his father. Jhaveri, who has a doctorate in chemistry from Cornell University, came to the US eight years ago from India and was a technical operations associate at Bristol-Myers, where he was in a management training program when he decided to steal the secrets. The program allowed him access to sensitive company info. Al... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4489971 Fri, 18 Feb 2011 01:16:22 +0100 4489971 http://www.medworm.com/index.php?rid=4464706&cid=t_132659_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fl26BfErWhfw%2F And so, once again, another working week draws to a close. Already, we are penciling in our weekend plans - a stroll with the official Pharmalot mascots, spending time with our short people and maybe a nap or two. What about you? Will there be a chance to read a book or watch a movie? How about spending time with a special someone? Or maybe take a nap? Whatever you do, enjoy. Meanwhile, here are a few tidbits. Catch you soon… Cephalon Receives Subpoena From US Postal Service Over Provigil (Reuters) FDA To Outsource More Overseas Plant Inspections (Bloomberg News) J&J Cordis Unit Cuts Sales Jobs (Reuters) Gilead Files Again For HIV Drug Approval (Silicon Valley Business Journal) Bristol-Myers And Pfizer Clotbuster Beats Aspiring In Study (HealthDay) Pfizer And EPA To Clean Up Con... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4464706 Fri, 11 Feb 2011 13:00:21 +0100 4464706 http://www.medworm.com/index.php?rid=4450517&cid=t_132659_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F7OQ0ZQz11zw%2F After nearly two years of squabbling with her husband, Tianle Li decided to put her decade-long experience as a chemist at Bristol-Myers Squibb to good use - she allegedly fed him a toxic metal known as thallium. Now, the 40-year-old New Jersey woman is in jail because her hubbie, Xiaoye Wang, 39, died late last month of poisoning, according to reports citing Middlesex County prosecutors. Apparently, Li gave him thallium on a regular basis starting some time in December. After becoming ill with what were described as flu-like symptoms, Wang checked himself into University Medical Center in Princeton on January 14, and subsequent testing determined that he had been poisoned. And his death prompted investigations by the FBI and New Jersey state police. Inititally, Li allegedly provided some... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4450517 Wed, 09 Feb 2011 02:07:42 +0100 4450517 http://www.medworm.com/index.php?rid=4429228&cid=t_132659_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fl411FQvaYHI%2F Good morning, everyone. How are you today? Here on the Pharmalot corporate campus, the Iceman Cometh, but we are keeping warm with our traditional cup of stimulation. Please join us as we dig in, so to speak, for the usual routine of deadlines and the like. And as always, feel free to share interesting stories. By the way, we would like to note that we are co-sponsoring an upcoming conference on patient adherence. We hope you will join us. Meanwhile, here are a few tidbits to help you along. Have a great day… Lilly & Bristol End Enrollment For Lung Cancer Trial Over Safety (Reuters) Sanofi Fails To Block Generic Taxotere In Australia (Bloomberg News) Glaxo Sells Quest Stake For $1.7 Billion (Reuters) Anti-Counterfeit Rules Will Limit Access To Meds: Oxfam (The Guardian) S&P... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4429228 Wed, 02 Feb 2011 13:05:31 +0100 4429228 http://www.medworm.com/index.php?rid=4377787&cid=t_132659_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=4349700&cid=t_132659_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F5NrfDeio_0c%2F And so another working week will soon draw to a close. In this case, a long weekend is about to begin, at least on this side of the pond. Have any special plans? We expect to tidy up around the Pharmalot corporate campus, spend time with our short and not-so-short people, and take a long walk or two. What about you? Take in a movie or read a good book? Maybe get rid of some flab? Whatever you do, have a great time and come back energized. Meanwhile, here are a few tidbits to help you along. See you next week… Abbott Labs Withdraws Psoriasis Drug (Wall Street Journal) Sanofi Tells Docs About Liver Transplants In Multaq Patients (CardioBrief) Glaxo Malaria Vaccine Works For 15 Months: Study (Bloomberg News) Ambien Makes Older People Too Sleepy (Reuters) Allos Therapeutics Lays Off 13 P... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4349700 Fri, 14 Jan 2011 13:00:43 +0100 4349700 http://www.medworm.com/index.php?rid=4322693&cid=t_132659_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FTPqRZ55bYTQ%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 Huron Consulting promoted Manny Tzavlakis to managing director in the Life Sciences Advisory Services practice, where he focuses on disclosure reporting, aggregate spend, transparency, sales and marketing compliance, commercial operations and b... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4322693 Fri, 07 Jan 2011 13:26:38 +0100 4322693 http://www.medworm.com/index.php?rid=4285353&cid=t_132659_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fj_8GX6iXEFk%2F The holiday weekend may be in the offing, but the Pharmalot corporate campus is still humming. And why not? The world has not stopped spinning, after all, and there is always something interesting going on. So while you prepare for a celebration or simply slow down the usual pace, here are a few items to help you along. Meanwhile, we pass along holiday greetings and hope everyone has a chance to catch up on some fun things and enjoy life. See you soon… Cephalon Names Kevin Buchi As CEO (statement) Lundbeck Alcoholism Pill May Be A Goldmine (Bloomberg News) Novartis To Build Vaccine Plant In North Carolina (Raleigh News & Observer) FDA Reviews Safety Of Human Growth Hormone Drugs (Reuters) Pfizer And Bristol Bloodthiners Beats Sanofi Drug In Study (Bloomberg News) Massachusetts Award... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4285353 Thu, 23 Dec 2010 12:54:53 +0100 4285353 http://www.medworm.com/index.php?rid=4266262&cid=t_132659_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=4220457&cid=t_132659_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FkzYJfcRyBTw%2F The AIDS Healthcare Foundation, which runs free AIDS clinics in the US and other countries, has filed a lawsuit against Bristol-Myers Squibb for overcharging the organization for drugs purchased under the federal 340B Drug Pricing Program. The 340B program provides access to discounted prescription drugs to various healthcare entities certified by the US Department of Health and Human Services. The dispute centers on rebates that AHF contends the drugmaker should have offered after the Patient Protection and Affordable Care Act increased the minimum discount. In its lawsuit, AHF maintains rebates should have been offered on a retroactive basis dating back to Jan. 1, but that Bristol-Myers did not adjust its rebates until July and, as a result, the organization overpaid about $124,000. &#82... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4220457 Wed, 01 Dec 2010 13:03:59 +0100 4220457 http://www.medworm.com/index.php?rid=4220459&cid=t_132659_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FenKjAWY1Koc%2F Good morning, everyone. Nice to see you again, despite the rain falling in buckets on the Pharmalot corporate campus. Nonetheless, our spirits are sunny and we thank the Morning Mayor for teaching us this lesson: ‘Every brand new day should be unwrapped like a precious gift.’ So while you consider the possibilities, please join us for a cup of stimulation and the news of the world. Have a great day… Pfizer Outsources Warehouse And Lays Off 186 Workers (Knoxville News-Sentinel) J&J May Renegotiate Crucell Deal (Bloomberg News) UK’s NICE Backs Bristol-Myers Abilify (Dow Jones) A Longer Index Finger Means Lower Prostate Cancer Risk (Bloomberg News) The Latest US Pharmacopeia Agenda (InPharma-Technologist) Simcere Pharma Is Fined Over Rabies Vaccine (Bloomberg News... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4220459 Wed, 01 Dec 2010 13:00:24 +0100 4220459 http://www.medworm.com/index.php?rid=4183539&cid=t_132659_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FpEZQOSs-dT8%2F There is a virtual parade of lawsuits working their way through the court system over charges that drugmakers have successfully schemed to avoid paying their sales reps overtime. The latest was filed by Jeff Bethune, who worked as a territory manager in Washington and Oregon for Bristol-Myers Squibb between 2006 and 2008. The lawsuit, by the way, seeks class-action status. Typically, sales reps argue they are not exempt from the overtime provisions of the Fair Labor Standards Act and, therefore, should be paid overtime. The FLSA’s overtime compensation requirement doesn’t apply to employees who work as outside salespeople, but the law does require employers to pay overtime for hours worked beyond 40 hours a week, unless a FLSA exemption applies. What are those exemptions? If an employe... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4183539 Fri, 19 Nov 2010 13:15:15 +0100 4183539 http://www.medworm.com/index.php?rid=4183543&cid=t_132659_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=4179522&cid=t_132659_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=4172329&cid=t_132659_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FFbCJyugESOg%2F Rise and shine. Another day is on the way. Although, clouds are hovering over the Pharmalot corporate campus. Nonetheless, we are reminded, once again, of what the Morning Mayor would say: ‘Every brand new day should be unwrapped like a precious gift.’ We urge you to tug on the ribbon. And, of course, please join us for a cup of stimulation and the news of the world. Have a great day, everyone… Docs Say Bloodthinner Race Is Too Close To Call (Reuters) Patent Upheld On Bristol-Myers Abilify Schizophrenia Med (Bloomberg News) Value-Based Pricing Is No Magic Bullet: ABPI (InPharm) FDA Approves Eisai Med For Breast Cancer (Bloomberg News) Pfizer Signs R&D Deal With UC San Francisco (The Wall Street Journal) Merck Loses 50 Execs In India (The Economic Times) Lupus Drug To... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4172329 Tue, 16 Nov 2010 13:12:47 +0100 4172329 http://www.medworm.com/index.php?rid=4139476&cid=t_132659_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F6EU3QWfkUTE%2F A former Bristol Myers Squibb employee admitted that he stole secret formulas so he could start a company in his native India. Shalin Jhaveri, 30, pleaded guilty to stealing the trade secrets and sending them in three attachments to an e-mail to a man he thought was an investor in a pharmaceutical company that Jhaveri wanted to start in India with his father, The Syracuse Post-Standard writes. Jhaveri, who has a doctorate in chemistry from Cornell University, was a technical operations associate at Bristol-Myers and in a management training program when he decided to steal the secrets, according to prosecutors. The training program offered Jhaveri access to sensitive company info. All totaled, he took about more than 1,300 documents. The potential loss from the info he sent was $193,000, a... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4139476 Fri, 05 Nov 2010 21:45:19 +0100 4139476 http://www.medworm.com/index.php?rid=4134261&cid=t_132659_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FqODVu7AIJ5Q%2F Hello, everyone. How are you this morning? A spot of rain is falling on the Pharmalot corporate campus, but as usual, our spirits remain sunny. And why not? As one of favorite philosophers, the Morning Mayor, used to say: ‘Every brand new day should be unwrapped like a precious gift.’ So while you tug on the ribbon, please join us for a cup of stimulation and the news of the world. Hope your day goes well and do stay in touch… Dendreon Discusses Provenge Production And Revenues (Xconomy) Drugmakers See Some Benefits In GOP Gains (The Wall Street Journal) Parexel Profit Rises But Forecast Looks Bleaker (Outsourcing Pharma) PPD Expansion In Pennsylvania Gets State Aid (Philadelphia Inquirer) Covance Buys Sanofi Site In The UK (NE Business) Non-Profit Helps With Drug Costs (... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4134261 Thu, 04 Nov 2010 11:21:30 +0100 4134261 http://www.medworm.com/index.php?rid=4086514&cid=t_132659_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F45vXlctp9-U%2F Last week, a study published in The New England Journal of Medicine found there was no evidence of increased heart risk among patients who took both proton pump inhibitors such as Prilosec and the Plavix bloodthinner. The findings contradicted a warning issued last year by the FDA, which urged doctors not to combine the drugs after research suggested these heartburns med could lessen the effects of the bloodthinner and, therefore, raise the risk of a heart attack. Now, the FDA is reiterating that its warning remains intact. “We are absolutely not” changing earlier warnings to doctors and patients against taking the drugs together, Mary Ross Southworth, an FDA official who oversees cardiovascular product safety, tells The Wall Street Journal. In fact, the FDA plans to issue a re... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4086514 Wed, 20 Oct 2010 15:25:49 +0100 4086514 http://www.medworm.com/index.php?rid=4061076&cid=t_132659_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FSflQ4feRqCg%2F Last year, the FDA urged doctors not to combine proton pump inhibitors such as Prilosec and Nexium with Plavix after research suggested these heartburns med could lessen the effects of the bloodthinner and, therefore, raise the risk of a heart attack (see this). But a study published last week in The New England Journal of Medicine found the opposite result - there was no evidence of increased heart risk among patients who took both drugs compared with those taking Plavix and a placebo (see the abstract). “For the rank-and-file clinician and patient, I’d say right now I wouldn’t worry about this interaction,” Deepak Bhatt, a cardiologist at Brigham and Women’s Hospital in Boston and lead author of the study, told The Wall Street Journal. There are, however, so... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4061076 Tue, 12 Oct 2010 12:46:51 +0100 4061076 http://www.medworm.com/index.php?rid=4045394&cid=t_132659_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FHTtxY7fTDCU%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 Scrip Intelligence hired Christopher Bowe as US healthcare analyst. Before joining the information service, he worked in strategic affairs at Schering-Plough, and was previously US healthcare correspondent and Chicago co... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4045394 Fri, 08 Oct 2010 12:12:56 +0100 4045394 http://www.medworm.com/index.php?rid=4040793&cid=t_132659_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FMkF6JZmLfI8%2F There is no shock that layoffs continue, is there? In the past few months, several drugmakers disclosed plans to reduce staff or continued with previously announced cuts. Among them has been Abbott Laboratories, Bristol-Myers Squibb, Endo Pharmaceuticals, Lundbeck, Lonza, and Johnson & Johnson, among many others. And so the latest monthly tally of pharma layoffs amounts to 6.069 industry jobs lost in September, compared with just 200 in August, according to Challenger, Gray & Christmas, the outplacement consulting. Nonetheless, the industry has shed 43,334 jobs this year, which appears on track to nearly match the 58,583 that were eliminated last year (you can read the latest report here and the last monthly survey here). The only sectors to throw more people overboard so far th... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4040793 Thu, 07 Oct 2010 12:07:33 +0100 4040793 http://www.medworm.com/index.php?rid=4023133&cid=t_132659_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fp92MksnLtSA%2F For six years, Jeremy Garrity worked for Novartis promoting various cardiovascular medicines, such as Diovan and Tekturna. But he was fired in 2008 and later filed a whistleblower lawsuit, one of four that prompted the federal government to launch an investigation into off-label marketing. Yesterday, the drugmaker agreed to pay $422.5 million to settle civil and criminal charges. Garrity, who no longer works in the pharmaceutical industry, revealed in his lawsuit several interesting practices: some doctors who served as speakers read from prepared scripts; some doctors were recruited as speakers even if their English was poor; both doctor and event attendees were paid honoraria, and doctors who did not prescribe did not get paid. We spoke with the 35-year-old Garrity, who lives in the Midw... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4023133 Fri, 01 Oct 2010 18:03:01 +0100 4023133 http://www.medworm.com/index.php?rid=4018441&cid=t_132659_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_132659_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=4003434&cid=t_132659_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=3999293&cid=t_132659_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FVyEwh-7JadE%2F The nation’s medicine chest mayl be the moniker for the Garden State, but it’s no secret the pharmaceutical industry in New Jersey is shedding a tremendous number of jobs. And with ballooning deficits making it difficult for the state to offer any help, the cupboard is starting to look bare (see here). So the US Department of Labor is stepping in with a $3.6 million grant designed to assist 960 laid off workers. The grant will be administered by the New Jersey Department of Labor and Workforce Development, which wants to use the funds to leverage the out-of-work pharma talent to “create a world-class bioscience cluster” and keep those folks from moving elsewhere. As part of the plan, the state will provide workers with access to ‘dislocated worker services,&#8... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3999293 Fri, 24 Sep 2010 12:37:46 +0100 3999293 http://www.medworm.com/index.php?rid=3999296&cid=t_132659_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fj1je8kub4nc%2F And the job cuts just keep on coming. Less than two years after slashing 10 percent of its workforce, Bristol-Myers Squibb now plans to eliminate 3 percent of its headcount in the next few months, according to an email that Bristol-Myers ceo Lamberto Andreotti wrote to employees this morning. “We’ve initiated a streamlining project,” a spokeswoman confirms, who says the reduction is not targeted at any one area or country. “This is something we’ve just begun undertaking. It’s a global initiative.” The drugmaker employs about 28,000 currrently, which means 840 or so jobs will go. This is only the latest in an ongoing series of cutbacks by major drugmakers. In the past year, Merck, Pfizer, Sanofi-Aventis, Eli Lilly and Abbott Laboratories have all a... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3999296 Thu, 23 Sep 2010 21:03:54 +0100 3999296 http://www.medworm.com/index.php?rid=3987235&cid=t_132659_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FU68qlUuDW8M%2F Today is a big day for Boehringer Ingelheim. The FDA’s Cardiovascular and Renal Drugs Advisory Committee is reviewing its Pradaxa drug, which the German drugmaker hopes will win an endorsement for treating stroke prevention in patients with atrial fibrillation. That outcome appears highly likely, given that FDA reviewers took the unusual step of saying the med should be approved - albeit for only one of two doses sought by BI and without a superiority claim over Warfarin, the standard but difficult-to-take treatment (see the briefing documents here). But what does this mean for the competition? You may recall that several other large drugmakers are racing to get their own bloodthinners into the hands of the nation’s doctors - Bristol-Myers Squibb and Pfizer are developing apixaban,... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3987235 Mon, 20 Sep 2010 13:09:12 +0100 3987235 http://www.medworm.com/index.php?rid=3981017&cid=t_132659_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FiQRm-u_QnZQ%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 Advanced Clinical, a consulting and clinical research services firm, has hired Rosemarie Truman as executive vice president of solutions. In this role, the Oxford University graduate will be responsible for global growth... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3981017 Fri, 17 Sep 2010 12:14:54 +0100 3981017 http://www.medworm.com/index.php?rid=3973111&cid=t_132659_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FsNp0T-pISJQ%2F Since working dad best describes our place in the world, we do not pretend to know what all working moms want from their employers. So we dutifully glanced at Working Mother magazine to learn that several drugmakers - 11, in fact - made the latest list of the 100 best employers in the land. Which ones? Abbott Labs, AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Eli Lilly, Genentech, Johnson & Johnson, Merck, Novo Nordisk, Pfizer and Sanofi-Aventis. A notable exception is Novartis, which made the 2009 list (see here), but has since gained some notoriety for agreeing to pay a combined $402 million to settle a pair of embarassing class-action lawsuits brought by female employees who claimed the drugmaker engaged in a pattern of discrimination involving pay, promotion and pregna... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3973111 Wed, 15 Sep 2010 15:33:26 +0100 3973111 http://www.medworm.com/index.php?rid=3969183&cid=t_132659_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FXBre0J7gtNY%2F The FDA last month sent a warning letter to Bristol Myers Squibb for repeated manufacturing at its facility in Manati, Puerto Rico, and threatened that future drug approvals could be at risk, according to the letter, which you can read here. Among the problems was a failure to prevent contamination, investigate subpar batches and supplying clean gowns for the clean room. The plant, by the way, makes several drugs, including the Abilify schizophrenia med and the Orencia rheumatoid arthritis treatment. The FDA has warned the drugmaker about its plant. Last March, an inspection found workers did not comply with practices to keep areas sterile and there were similar problems noted there in past year, according to the agency letter. (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3969183 Tue, 14 Sep 2010 21:04:25 +0100 3969183 http://www.medworm.com/index.php?rid=3958061&cid=t_132659_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=3943023&cid=t_132659_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F02xdFtqOdnU%2F Continuing its string of pearls philosophy, Bristol-Myers Squibb has agreed to pay in cash for ZymoGenetics, which is developing a hepatitis C compound that was the focus of a collaboration between the two companies beginning early last year. The move is a bid by the big drugmaker, of course, to strengthen its pipeline for hepatitis C, which is forecast to a grow into a multi-billion dollar market. At the moment, the focus is largely on forthcoming treatments from Vertex Pharmaceuticals and Johnson & Johnson, which are in a race with Merck to sell the most effective new protease inhibitor to treat the affliction (see this and this). By acquiring ZymoGenetics, Bristol-Myers gets pegylated-interferon lambda, a novel interferon in Phase IIb, along with several other early-stage treatment... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3943023 Tue, 07 Sep 2010 22:16:51 +0100 3943023 http://www.medworm.com/index.php?rid=3921076&cid=t_132659_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F94A_3qfmuDs%2F The battle to prevent blood clots is heating up this week as several drugmakers begin releasing study results for their experimental drugs. At stake, of course, is a huge market for stroke prevention that is worth billions of dollars, since the new meds are designed to supplant warfarin and aspirin, which are troublesome or simply less effective. Toward that end, Bristol-Myers Squibb and Pfizer issued results showing patients taking their apixaban blood thinner were 54 percent less likely to have a stroke or damaging clot than those taking aspirin, and did not show significant signs of bleeding. Their Averroes study, which was presented at the European Society of Cardiology conference in Stockholm, involved about 5,600 people suffering atrial fibrillation and who are unable to use warfarin... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3921076 Tue, 31 Aug 2010 12:05:34 +0100 3921076 http://www.medworm.com/index.php?rid=3915290&cid=t_132659_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FT6o03SDm6QQ%2F Good morning, everyone. Nice to see you again. Hope your weekend was relaxing and refreshing. Now, of course, the routine returns with all those meetings and deadlines. It may be that time of year when many take a vacation break, but the world, of course, continues to spin. So grab a cup of stimulation and join us as we peruse some key events. Have a great day… Sanofi Experimental MS Pill Reduces Relapses (Bloomberg News) Plavix Gains From Rival Studies (The Wall Street Journal) FDA To Alter Rules On Cancer Drug Cocktails (Bloomberg News) Merck Pays For Wastewater Improvements (The Reporter) Eisai Heart Drug Looks Safe In Mid-Stage Trials (Reuters) (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3915290 Mon, 30 Aug 2010 12:02:50 +0100 3915290 http://www.medworm.com/index.php?rid=3903130&cid=t_132659_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=3854748&cid=t_132659_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fp51ONR7dpCs%2F After months of tense negotiations and negative publicity over its posture toward AIDS drug pricing for state programs, Bristol-Myers Squibb and the ADAP Crisis Task Force are close to reaching an agreement that could be announced this week, according to people familiar with the negotiations. The agreement may include price freezes, lower rebates and expedited patient assistance programs, says Ann Lefert, associate director of government relations at the National Alliance of State & Territorial AIDS Directors. The move comes as a growing number of state AIDS Drug Assistance Programs face a crisis, thanks to federal funding that has failed to keep up with demand caused by more people losing health insurance and shrinking state budgets. Some ADAPs have ballooning patient waiting lists a... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3854748 Tue, 10 Aug 2010 13:59:33 +0100 3854748 http://www.medworm.com/index.php?rid=3849071&cid=t_132659_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F14hnPhcuPm4%2F A federal appeals court has reinstated a lawsuit brought by a Bristol-Myers Squibb scientist who claims he was fired for sticking up for a subordinate who complained that she suffered sexual harassment by another scientist in her group. The lawsuit was filed in 2004 by Luis Collazo, who worked as a senior process scientist in the drugmaker’s Barceloneta, Puerto Rico, plant, but was fired in February 2003, just two weeks after he pressed human resources to address harassment claimed by Diana Hiraldo. A lower court dismissed the lawsuit after agreeing with Bristol-Myers that Collazo, who maintained he acted in connection with his supervisory responsibilities, was not protected under the Federal Labor Standards Act, because he “stepped outside” his normal role and took acti... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3849071 Mon, 09 Aug 2010 16:01:05 +0100 3849071 http://www.medworm.com/index.php?rid=3798824&cid=t_132659_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fe8k2-mp0Imw%2F Over the past few weeks, Bristol-Myers Squibb was implored to lower the price of its Reyataz AIDS drug, given the funding crisis facing a growing number of state ADAP programs, which provide AIDS and HIV drugs to the public (see here). Among those lobbying the drugmaker is the AIDS Healthcare Foundation, which this week banned Bristol reps from its 11,000 or so clinics (back story). At least one California official, it turns out, has also beseeched Bristol, but has so far been ignored. On July 9, state controller John Chiang wrote Bristol ceo Lamberto Andreotti to explain the combination of fewer available state dollars and rising prices is an “unsustainable situation.” He noted that both the California Public Employees’ Retirement System and the California State Teachers... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3798824 Wed, 28 Jul 2010 12:13:17 +0100 3798824 http://www.medworm.com/index.php?rid=3795057&cid=t_132659_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FtNjuEH7SYfI%2F The AIDS Healthcare Foundation, which runs free AIDS clinics in various countries, including more than a dozen in the US, took the step over what it calls “unacceptable” pricing of the drugmaker’s Reyetaz AIDS medication. The move comes in response to the funding crisis at many state ADAP programs that provide AIDS and HIV drugs to the public (see here). Nearly 1,900 people are on ADAP waiting lists for AIDS meds and some states are raising eligibility requirements that are shutting out even more people from the programs. In response, some drugmakers are taking steps to lower pricing, such as providing greater rebates, according to The AIDS Institute advocacy group. But AHF says Bristol is not. “…the high price charged for Reyataz is contributing to a crisis ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3795057 Tue, 27 Jul 2010 11:51:35 +0100 3795057 http://www.medworm.com/index.php?rid=3750275&cid=t_132659_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=3750277&cid=t_132659_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FJRV_5GQ4Oyc%2F Hello, everyone. Nice to see you again. Hope your week is going well so far. Meanwhile, another busy day lies ahead, especially as the FDA panel meeting gets under way to review Avandia. So let’s get started with a cup of stimulation and some interesting tidbits to help you along. Have a good one and stay in touch… Vivus Diet Drug Faces FDA Skepticism (Associated Press) Merck Starts Work On New Plant In China (People’s Daily) Lawsuits May Reveal More Avandia Data (Reuters) Lilly To Cut 170 Manufacturing Jobs (Indianapolis Business Journal) Global CSO Market To Hit $6.5B By 2015 (OutsourcingPharma) Clinuvel Drug Offers Relief From Sensititivity To Light (Bloomberg News) Latisse Faces Patent Challenge (The Wall Street Journal) Bristol-Myers Starts Recall Of Coumadin (Assoc... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3750277 Tue, 13 Jul 2010 12:03:03 +0100 3750277 http://www.medworm.com/index.php?rid=3718695&cid=t_132659_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=3718698&cid=t_132659_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fh68KkPeH3gU%2F Rise and shine, everyone. Another day is on the way. This means, of course, that meetings and deadlines beckon. Never mind that a holiday weekend is just around the corner. To cope, we are brewing the mandatory cup of stimulation, and enjoying an unexpectedly cool breeze. So please join us as we peruse the news of the world. Good luck today and catch you soon… AstraZeneca Loses Bid To Overturn Antitrust Fine (Dow Jones) Biogen Names Exelisis’ George Scangos As CEO (Bloomberg News) Recession Hurts Funding For AIDS Drug Program (New York Times) FDA Issues Latest List Of Drug With Possible Risks (Reuters) Quebec To Cut Generic Drug Prices (PharmaTimes) USPTO Denies Request To Re-Examine Plavix Patent (Dow Jones) Michigan Grows CROs (Xconomy) Calistoga Raises $40M To Fund Drug Tria... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3718698 Thu, 01 Jul 2010 11:56:22 +0100 3718698 http://www.medworm.com/index.php?rid=3710791&cid=t_132659_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FK2wtFNQoH2Q%2F Rick Lane and Frederick Schiff struck a deal in which they will avoid criminal prosecution for an alleged scheme to artificially inflate financial results reported by Bristol-Myers Squibb The former execs will pay a combined $400,000 to a shareholder settlement fund and, in return, criminal charges will be dropped under a deferred prosecution agreement with federal prosecutors in New Jersey. The charges actually get tossed in 12 months if they stick to the deal, which was approved today by US District Court Judge Faith Hochburg, and stay out of trouble. Under the agreements, the men are barred from serving as a ceo or cfo of a public company for two years (read theSchiff deal and the Lane deal). The government alleged the execs failed to tell investors that Bristol in 2000 and 2001 gave wh... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3710791 Tue, 29 Jun 2010 20:37:41 +0100 3710791 http://www.medworm.com/index.php?rid=3683872&cid=t_132659_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FEPyViqp86VU%2F And the answer is…. GlaxoSmithKline, which led its counterparts in a host of variables that formed the second-ever Access to Medicine Index. European drugmakers, in fact, bested US rivals in making medicines available to people in developing countries, although the foundation that runs the project says this lead is shrinking. The index is designed to offer investors a way to compare pharma’s social responsibility records by measuring 106 indicators that examined activities across seven criteria such as philanthropy, patents, pricing and management (see more here). The latest report - the first was issued in 2008 - covers 27 companies, including 20 brand-name drugmakers and seven generics manufacturers, which have their own list and was topped by Ranbaxy Labs, now owned by Daiic... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3683872 Mon, 21 Jun 2010 12:45:18 +0100 3683872 http://www.medworm.com/index.php?rid=3666229&cid=t_132659_150_f&fid=38374&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FePharmaSummit%2F%7E3%2FrK5RMrCJQDk%2Ftop-25-dtc-marketers-at-multi-channel.html Priya Brooks, one of the keynote speakers at this year's Multi Channel Pharma Marketing Conference was recently named among the Top 25 DTC Marketers. Currently at Bristol-Myers Squibb, she currently works on direct to consumer advertising on the Abilify brand.Her passion is the business: digging deep to uncover customer insights and to create a strategic foundation, creative platform and communications plan that make a connection with patients and drives response.We're also delighted to welcome Robert Maresca, who is the Consumer Brand Manager of Symbicort at AstraZeneca.While working on the Symbicort brand, Maresca has been part of a team that has won a number of AstraZeneca awards, including the Presidential Excellence Award for Brand of the Year and the “Accoladz” award for DTC Adve... ePharma Summit blogs http://www.medworm.com/rss/comments.php?id=3666229 Tue, 15 Jun 2010 15:42:00 +0100 3666229 http://www.medworm.com/index.php?rid=3659157&cid=t_132659_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FjA9j-WiJtWE%2F A new analysis of five previous studies involving about 60,000 patients found links between angiotensin receptor blockers, or ARBs, which are widely used blood pressure drugs, to an increased risk of cancer. Specifically, 7.2 percent of patients on an ARB were diagnosed with cancer compared with 6 percent on a placebo, which was deemed statistically significant. The study, which was published in The Lancet Oncology, determined that one extra cancer case will occur for every 105 people taking the meds for about four years, although there isn’t enough info to know if the risk disappears after the drugs are stopped. Interestingly, there was no difference in the rate of cancer deaths in people on the drugs compared to those not on them. “The risk for the individual patient is mode... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3659157 Mon, 14 Jun 2010 12:15:47 +0100 3659157 http://www.medworm.com/index.php?rid=3652691&cid=t_132659_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FtbeaniQzUXk%2F And so another working week is about to draw to a close. What are your plans for the weekend? Ours include promenading with the official Pharmalot mascots, a round of (miniature) golf with the shortest of short people and pulling weeds that are springing up around the corporate campus. Whatever you choose to do, we hope your plans are exciting. Meanwhile, another day beckons. Here are a few items to help you along. Enjoy… Why Patients Don’t Get The Shingles Vaccine (The New York Times) Lilly’s Lechleiter Says US Loses Innovation Edge (Crain’s Detroit Business) Drugmakers To Form Alzheimer’s Data Coalition (The Wall Street Journal) Bristol-Myers To Price Drugs Lower In India (The Hindu Business Line) European Drugmakers Concerned About Market Access (PharmaTime... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3652691 Fri, 11 Jun 2010 11:56:17 +0100 3652691 http://www.medworm.com/index.php?rid=3641324&cid=t_132659_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FtdTeQqjkVeo%2F Nothing like invoking the fate of thousands of babies to draw attention to a problem. That’s the tactic taken this week by Unitaid, the United Nations affiliate, to convince Bristol-Myers Squibb not to proceed with plans this month to close a plant in France that makes Videx, a move that could threaten the lives of up to 7,000 babies, according to a letter the group writes in The Lancet. “Closing the factory means that 4,000 – 7,000 babies currently enrolled in treatment plans in developing countries through UNITAID could be left without the medicines they need. (Videx) is the last therapeutic option for these babies and without it they could die,” Unitaid writes. “We understand that closure of the plant will take place in June of this year, with no plans for resu... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3641324 Tue, 08 Jun 2010 12:20:35 +0100 3641324 http://www.medworm.com/index.php?rid=3636019&cid=t_132659_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fh0HyKefJllM%2F In its latest effort to lower the cost of HIV drugs, the AIDS Healthcare Foundation is now mailing postcards directly to the homes of Bristol-Myers Squibb employees in the Princeton, NJ, area - where the drugmaker has its main laboratory complex - that feature a picture of ceo Lamberto Andreotti stuffing a $20 bill into his pocket as many more bills fall out of the sky behind him (read the text here). The average wholesale price for Reyataz is $13,046 a year, according to AHF, which adds that other “commonly precribed” first-line AIDS drugs are priced $3,000 to $5,400 less. AHF also accuses the drugmaker of raising the price of Reyataz several times - since it was approved in 2003, the price has increased more than 25 percent. The drug, by the way, must be taken with at least t... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3636019 Mon, 07 Jun 2010 13:58:38 +0100 3636019 http://www.medworm.com/index.php?rid=3636022&cid=t_132659_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FYlH8912kI7U%2F A big star of the American Society of Clinical Oncology meeting this past weekend was ipilumumab, a drug that was designed to enhance the immune system and Bristol-Myers Squibb presented data showing patients with advanced melanoma lived significantly longer on the treatment. There were some caveats, though, such as serious side effects and that the study compared the medicine to a vaccine, not a placebo, suggesting an issue with the vaccine led to the outcome. The study, which followed 676 patients who failed to benefit from two existing treatments -interleukin-2 or dacarbazine, found that patients taking ipilimumab lived an average of 10 months, compared with 6.4 months (read the study in The New England Journal of Medicine). Immune therapy may be controversial, but some Wall Street anal... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3636022 Mon, 07 Jun 2010 12:19:56 +0100 3636022 http://www.medworm.com/index.php?rid=3636023&cid=t_132659_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F9hbKmLSytOc%2F Welcome back, everyone. We hope the weekend was pleasant and refreshing. Now, of course, the routine returns as meetings and deadlines beckon. As we ease in with a mandatory cup of stimulation, here are a few items to help you along. Have a good day and stay in touch… Grifols To Pay $3.4B For Talecris (Bloomberg News) Roche’s Avastin Improved Survival In Ovarian Cancer (Reuters) Merck Strikes Wastewater Deal With Pa. Town (The Reporter) Bristol-Myers’ Melanoma Drug Improves Survival (Bloomberg News) A Look At AstraZeneca’s Plant In China (The Telegraph) Former Wyeth Employees Mourn Plant Closing (The Rockland Journal News) Novartis MS Pill Faces Safety Concerns (Reuters) Erbitux Fails To Stop Early-Stage Colon Cancer (Bloomberg News) Drugmakers Spend Billions On Fre... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3636023 Mon, 07 Jun 2010 11:44:08 +0100 3636023 http://www.medworm.com/index.php?rid=3581836&cid=t_132659_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fx3xcHLRFS7Y%2F The French Competition Authority is investigating allegations made by Teva Sante, a unit of Teva Pharmaceuticals, that Sanofi-Aventis disparaged generic versions of its best-selling Plavix bloodthinner, and deliberately attempted to restrict generic access to the marketplace. In its November 2009 complaint, Teva charged that Sanofi’s communications with doctors and pharmacists emphasized differences between Plavix and generics, including Teva’s 75mg version, without revealing the differences. However, Sanofi failed to say the differences have no therapeutic significance or effect on safety or efficacy (see the statement). Sanofi’s communications with scientists and practitioners emphasised differences between Plavix and competing generics, including Teva’s clopidogrel 7... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3581836 Thu, 20 May 2010 15:22:58 +0100 3581836 http://www.medworm.com/index.php?rid=3585836&cid=t_132659_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fx3xcHLRFS7Y%2F The French Competition Authority is investigating allegations made by Teva Sante, a unit of Teva Pharmaceuticals, that Sanofi-Aventis disparaged generic versions of its best-selling Plavix bloodthinner, and deliberately attempted to restrict generic access to the marketplace. In its November 2009 complaint, Teva charged that Sanofi’s communications with doctors and pharmacists emphasized differences between Plavix and generics, including Teva’s 75mg version, without revealing the differences. However, Sanofi failed to say the differences have no therapeutic significance or effect on safety or efficacy (see the statement). Sanofi’s communications with scientists and practitioners emphasised differences between Plavix and competing generics, including Teva’s clopidogrel 7... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3585836 Thu, 20 May 2010 15:22:03 +0100 3585836 http://www.medworm.com/index.php?rid=3573944&cid=t_132659_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FyWRw6FKi8nc%2F Prices for the most widely used brand-name meds jumped 9.7 during the 12-month period ending in March, according to AARP, which called the increase the largest since the organization began tracking this sort of thing in 2002. Specialty drug prices rose 9.2 percent and generics fell by 9.7 percent. AARP notes that general inflation climbed 0.3 percent during the same period. AARP then makes another comparison - the average annual cost for three generic meds declined by $51 during this period, while there was a $706 increase for three brand name drugs. “The life-saving drugs Americans need are out of reach for many because of unjustifiable price hikes,” AARP Executive Vice President John Rother says in a statement. “Consumers desperately need a competitive prescription drug market that... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3573944 Tue, 18 May 2010 12:23:54 +0100 3573944 http://www.medworm.com/index.php?rid=3573948&cid=t_132659_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FFw_XdWx5yHE%2F In the midst of mergers that are causing thousands of job cuts and empty facilities throughout New Jersey (see here), Governor Chris Christie is proposing budget cuts that have the state’s biotechs in a frenzy. And so one big trade group, BioNJ, is testifying today before the assembly budget committee in hopes of preventing moves that some fear would further deplete what was once proudly called the nation’s medicine chest. One of Christie’s ideas is to cut in half the $60 million in funding for the Technology Business Tax Certificate Transfer Program, which enables unprofitable, but promising biotechs to turn net operating losses and R&D tax credits into capital. The other proposal causing a stir is the planned elimination of all funding for the New Jersey Commission... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3573948 Mon, 17 May 2010 16:42:13 +0100 3573948 http://www.medworm.com/index.php?rid=3534104&cid=t_132659_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FcX71wf9ixiQ%2F Another shiny day here on the Pharmalot corporate campus, where this is much to do. You know the drill - meetings, deadlines and a blizzard of emails. Nonetheless, our spirits are equally sunny. So as prepare the required cup of stimulation, join us as we sift through the news of the world. Have a great day and do stay in touch… King Pharmaceuticals Profit Falls Short (Reuters) Aftermath Of The Intermune Debacle (TheStreet) KV Pharma Gets A Positive Manufacturing Review (Reuters) Covance Cuts Guidance On Late-Stage Delays (OutsourcingPharma) J&J Failed To Safeguard Children’s Tylenol (Bloomberg News) Merck And Ariad Restructure Agreement (MarketWatch) Drugmakers Agree To Cut Australia’s Drug Bill (Bloomberg News) Bristol-Myers To Repurchase $3B In Stock (Associated P... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3534104 Wed, 05 May 2010 11:50:38 +0100 3534104 http://www.medworm.com/index.php?rid=3526947&cid=t_132659_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FGcH7rZ8YJbU%2F Another month, another list. Once again, there is speculation about which medications will generate the most revenue over the next few years. Interestingly, the latest conclusion mirrors another recent list that suggests conventional pills will easily be eclipsed. Only two small molecules make this newest ranking, which was compiled by EvaluatePharma. Not surprisingly, one of them is AstraZeneca’s Crestor cholesterol fighter, although the newest list differs slightly from this list. And so once again, there are myriad implications raised, including the strategic direction pursued by the biggest drugmakers and the costs for patients. The percentage figure refers to sales growth from 2009 to 2016… 1. Humira (arthritis) Abbott Labs/Eisai - $10.1b; 9 percent 2. Avastin (cancer) Roc... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3526947 Mon, 03 May 2010 12:47:00 +0100 3526947 http://www.medworm.com/index.php?rid=3524456&cid=t_132659_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F7J6geuwn3d8%2F Hello, everyone. Nothing like a sunny Sunday morning to catch up on some reading. Here on the shiny Pharmalot corporate campus, we are doing just that. And, of course, quaffing a cup or three of needed stimulation. Later, we hope to take the official Pharmalot mascot for the usual constitutional. Whatever you do today, we hope it is enjoyable. Meanwhile, here are a few items to keep you fresh. Have a great time… Bristol-Myers Squibb chose to lob some bad news over the weekend that it received a complete response letter from the FDA concerning its belatacept medication for kidney transplantation. In disclosing the setback, the drugmaker says no new clinical trials were requested, but the FDA does want 36-month data from ongoing Phase III studies to further evaluate long-term effects. The ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3524456 Sun, 02 May 2010 16:47:26 +0100 3524456 http://www.medworm.com/index.php?rid=3515637&cid=t_132659_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F1I3fCofJeb8%2F Hello, everyone, nice to see you again. The sun is shining here on the Pharmalot corporate campus as we scurry about, attempting to hustle one of the short people to the local school house. This calls for another cup of stimulation, of course. Meanwhile, more meetings and deadlines loom. So as you ready yourself for another day, here are a few items to help you along. Have a good one and stay in touch… Viagra Patent In Brazil Expires In June (Associated Press) AstraZeneca Exceeds Q1 Expectations (Reuters) Bristol-Myers Reports Big Quarterly Gain (Associated Press) Sanofi Sees Modest Effect From Healthcare Reform (Bloomberg News) Bayer Raises Financial Outlook (Bloomberg News) Australia Pays More For Generic Statins (PharmaTimes) Fate Of UK Pfizer Plant Uncertain (Leinster Leader) MDL... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3515637 Thu, 29 Apr 2010 11:54:26 +0100 3515637 http://www.medworm.com/index.php?rid=3515639&cid=t_132659_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FyPZffgAk_4I%2F The latest chapter in the saga involving the National Alliance on Mental Illness, or NAMI, and the amount of money accepted from the pharmaceutical industry has millions being contributed to NAMI state chapters. And Chuck Grassley, the ranking Republican on the Senate Finance Committee, who has been probing the relationship between patient groups and drugmakers and how this may influence the practice of medicine, wants to know what the national organization is doing to make the state chapters more transparent, and how the money is used. You may recall that a majority of donations made to NAMI, a big advocacy group, have come from drugmakers in recent years. And the disclosure comes after protracted criticism of NAMI for coordinating lobbying efforts with drug makers and pushing legislatio... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3515639 Wed, 28 Apr 2010 18:59:52 +0100 3515639 http://www.medworm.com/index.php?rid=3511780&cid=t_132659_150_f&fid=38374&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FePharmaSummit%2F%7E3%2F0M0CHYvQrGo%2Fsave-date-multi-channel-pharma.html (Source: ePharma Summit) ePharma Summit blogs http://www.medworm.com/rss/comments.php?id=3511780 Wed, 28 Apr 2010 14:40:00 +0100 3511780 http://www.medworm.com/index.php?rid=3468018&cid=t_132659_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FZbwVlkKVymw%2F And the winner is…. Roche’s Avastin, which is used to treat various cancers. Everyone loves a list, of course, so Reuters compiled this ranking and the most interesting finding is there seems to be just one pill that will be among the biggest sellers in 2014. In other words, injectables will dominate. Assuming this is reasonably accurate, what might it say about big drugmakers? Will they spend more in the lab or strike still more deals with smaller prey developing the next big thing? Will pills become passe? And what will it mean for patient costs? Consensus sales forecasts for world’s top 10 drugs in 2014: 1. Avastin (cancer) Roche - $8.9b 2. Humira (arthritis) Abbott - $8.5b 3. Enbrel (arthritis) Pfizer - $8b 4. Crestor (cholestero... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3468018 Wed, 14 Apr 2010 15:58:25 +0100 3468018 http://www.medworm.com/index.php?rid=3454198&cid=t_132659_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FHQM_IUWAu4Q%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 we hope to make a regular feature. Send us a photo and we will spotlight a different person each week. This time around, we note that Dendreon hired Varun Nanda as senior vice president of global commercial operations. He most recently served as the senior vice president and global head of oncology at Roche/Genentech. Nanda arrives, of course, in time ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3454198 Fri, 09 Apr 2010 12:37:44 +0100 3454198 http://www.medworm.com/index.php?rid=3449141&cid=t_132659_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FnMVsG-Me73I%2F Fred Schiff, a former Bristol-Myers Squibb chief financial officer, won a federal appeals court ruling that limits the criminal fraud case brought against him by the U.S. Justice Department to whether he made misstatements on investor conference calls, Reuters reports. So prosecutors are barred from introducing evidence that he failed to tell investors about an alleged improper practice known as channel stuffing to bolster revenue by giving financial incentives to wholesalers, or to explain an April 2002 plunge in the drugmaker’s stock price after the scheme became known. A spokeswoman for US Attorney Paul Fishman says options are being considered (here’s some background). “We have felt from the beginning that this prosecution was misguided and the case should never have ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3449141 Thu, 08 Apr 2010 12:28:56 +0100 3449141 http://www.medworm.com/index.php?rid=3443983&cid=t_132659_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FPHedEVOSc7Y%2F Good morning, everyone. Hope your week is going well. We are on an altered scheduled, as it so happens, but have a nifty system to keep you abreast of developments. And so here are a few that we hope will ease your day. Meanwhile, we are grabbing the required cup of stimulation - we go nowhere without one - and invite you to do the same. Stay in touch… Prescription Drug Overdoses Rise In The US (Reuters) Sanofi Chemo Drug Pact Should Draw FTC Scrutiny (Seeking Alpha) AIDS Group Asks Bristol To Cut Drug Price (press release) UK Cuts Swine Flu Vaccine Order (Associated Press) Merck Drug Shows Promise In Pelvic Cancer Patients (Reuters) Clearstone To Close New Jersey Lab (OutsourcingPharma) (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3443983 Wed, 07 Apr 2010 12:16:20 +0100 3443983 http://www.medworm.com/index.php?rid=3420758&cid=t_132659_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F3siamx0eDUw%2F This is a list of the top 20 drugmakers, ranked by global prescription drug sales for the 12 months ended Sept. 30, 2009, according to IMS Health, which prepared this for Reuters. The dollar sales are in billions and, next to that, is the percent change from the year-over-year period. As you can see, though, the results don’t include the mergers between Merck and Schering-Plough, and Pfizer and Wyeth, since these weren’t consummated until later in the year. 1 - Pfizer - $41.7 billion - (0.8) 2 - Novartis - $36.7 billion - 7.0 3 - Sanofi-Aventis - $35.1 billion - 3.3 4 - GlaxoSmithKline - $34.3 billion - (3.4) 5 - AstraZeneca - $33.2 billion - 7.8 6 - Roche - $31.3 billion - 8.6 7 - Johnson & Johnson - $26.9 bi... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3420758 Mon, 29 Mar 2010 16:43:51 +0100 3420758 http://www.medworm.com/index.php?rid=3350568&cid=t_132659_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FWd4iws7642I%2F A pleasant morning here on the Pharmalot corporate campus. After a recent spell of snow, spring appears to have finally bloomed. And that makes it a bit easier to cope with those mid-week deadlines and meetings, yes? So grab a cup of something stimulating and dig in for another day. Here are a few interesting items to help you on your way. Cheers, everyone… Abbott Bests Biogen With Bid For Facet Biotech (Bloomberg) Bristol-Myers’ CEO 2009 Pay Was Down 22 Percent (Associated Press) Sandoz Names Don DeGolyer To Heads US Ops (Chain Drug Review) Novartis Takes Option On Transgene Cancer Vaccine (Reuters) Lilly, Amylin Diabetes Drug Await FDA OK (The Wall Street Journal) Teva Pharmaceuticals Names Phillip Frost As Chairman (Associated Press) Coffee pix thx to chichcacha flickr creat... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3350568 Wed, 10 Mar 2010 12:24:03 +0100 3350568 http://www.medworm.com/index.php?rid=3335571&cid=t_132659_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FBAgceXWWKfs%2F And so another week will soon draw to a close. We hope yours was productive. And though another work day still lies ahead, there is that temptation to look toward the weekend. What will you do? A movie? A walk in the woods? Ease the economic crisis with a shopping binge? We look forward to taking Mrs. Pharmalot on a date. Meanwhile, here are a few interesting items while you ponder the choices. Have a nice time, whatever you do… Astellas Needs To Raise Its OSI Offer (Bloomberg News) Bristol & Pfizer’s Blood Thinner Stopped Clots (Bloomberg News) Drug Abuse Bills Proceed In West Virginia (Associated Press) Shire Wins Five-Year Exclusivity For Vyvanse (PharmaTimes) Bristol-Myers Previews Its Pipeline (Associated Press) Merck Sues To Block Generic Vytorin (Bloomberg) Glaxo Co... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3335571 Fri, 05 Mar 2010 12:14:15 +0100 3335571 http://www.medworm.com/index.php?rid=3327296&cid=t_132659_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FxL_FuYu9llY%2F For the past couple of years, Wall Street was periodically filled with speculation that Bristol-Myers Squibb would look to merge. A regular possibility named was Eli Lilly, partly because Bristol-Myers chief executive Jim Cornelius is a former Lilly exec and maintains ties to Indianapolis, where Lilly is headquartered. Of course, that hasn’t happened and now, as expected, Cornelius, 66, is vacating the corner office and being replaced by Lamberto Andreotti, 59, who has spent 12 years at the drugmaker, most recently as president and chief operating officer (see statement). But he faces the same problem - the loss of $11 billion in revenue to generic competition by 2016, notably the Plavix bloodthinner in 2012. To prepare for this patent cliffhanger, Cornelius touted a ’string of... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3327296 Wed, 03 Mar 2010 13:15:11 +0100 3327296 http://www.medworm.com/index.php?rid=3322631&cid=t_132659_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fgk0Ehz8014k%2F Good morning, everyone. Nice to see you again. We are hustling about this morning, attempting to hustle short people off to the schoolhouse. A worthy, if challenging, endeavor. Wish us luck. Meanwhile, another day beckons and so we present you the usual menu of interesting items to help you along. We hope your own day goes well. So dig in and persevere… A Flood Of False-Mark Patent Lawsuits (Chicago Tribune) Pfizer Layoffs May Yield A Tax Bill (St. Louis Post-Dispatch) UCB Sees A Weaker 2010 (Reuters) AstraZeneca Issues Online Communications Guidelines (press release) Intercell Forecasts A Loss For The Year (Bloomberg) FDA Panel Backs Bristol Transplant Drug (Reuters) Philippines To Cut Prices On Nearly 100 Meds (PharmaTimes) More Pfizer Layoffs In Upstate NY (WPTZ) (Source: Pharmalo... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3322631 Tue, 02 Mar 2010 11:56:46 +0100 3322631 http://www.medworm.com/index.php?rid=3280188&cid=t_132659_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FSyufe-jDOIc%2F The Bristol-Myers Squibb employee who was recently charged with stealing trade secrets was the “naive” victim of an FBI sting operation, according to his lawyer, during a hearing that will determine whether Shalin Jhaveri, 29, should be released from jail, The Syracuse Post-Standard reports. Assistant US Attorney Gregory West argued in a detention hearing Jhaveri would pose a danger to the community because he may have access to more stolen computer data that he could send to business partners in his home country of India. West also argued Jhaveri posed a risk of fleeing the country because he had no ties to the community and might run to avoid prison, the paper writes. Jhaveri was charged two weeks ago with stealing trade secrets while working at the drugmaker’s East Syracus... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3280188 Wed, 17 Feb 2010 15:51:57 +0100 3280188 http://www.medworm.com/index.php?rid=3280191&cid=t_132659_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FylbxT40fUZM%2F Open your Glucophage and take a whiff. A group of family physicians in Georgia was surprised to learn many of their diabetes patients had stopped taking metformin because it smelled like “dead fish,” according to a clinical observation published Monday in the Annals of Internal Medicine (look here). And they want to warn other docs to be on the lookout for what are being called stinky drugs. “A physician may prescribe a drug and as far as seeing the drug, they may never have seen the tablet before and certainly never tried smelling it,” J. Russell May, a co-author of the clinical observation and a professor at the University of Georgia College of Pharmacy in Athens. Ga., tells ABC News. His colleagues’ patients stopped taking the med because they assumed the ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3280191 Wed, 17 Feb 2010 12:57:34 +0100 3280191 http://www.medworm.com/index.php?rid=3254722&cid=t_132659_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FZ8O21d4mzQ8%2F The National Institute for Health and Clinical Excellent declined to recommend two expensive cancer drugs from Novartis and another from Bristol-Myers Squibb from being used within the state-run health service, Reuters writes. NICE rebuffed Afinitor as a second-line treatment for kidney cancer, adding there was limited data about how long it could extend life. And the agency declined to recommend Tasigna and Bristol’s Sprycel for chronic myeloid leukaemia in patients who are intolerant to Gleevec - an older drug from Novartis - because effectiveness evidence was “very poor” and their cost was “extremely high”. “It would be heartening to hear that the pharmaceutical company manufacturers are prepared to share some of the very high cost of the drugs with ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3254722 Tue, 09 Feb 2010 12:36:48 +0100 3254722 http://www.medworm.com/index.php?rid=3239812&cid=t_132659_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fuf0mGBZc_A4%2F And he hoped to use the info to set up a pharmaceutical company in India. Shalin Jhaveri, 29, worked as a technical operations associated since November 2007, but was fired the Bristol-Myers’ Syracuse, NY, facility this week, Reuters reports. “Jhaveri stole numerous trade secrets as part of a plan to establish a pharmaceutical firm in his native India which would compete with Bristol-Myers Squibb in various markets around the world,” the Justice Department said in a statement, according to Reuters. He was arrested and ordered held without bail ahead of a detention hearing on Monday. He could face up to 10 years in prison and a $250,000 fine. He was accused of taking more than 1,300 documents from the company that he spent hours over the course of several days downloading... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3239812 Thu, 04 Feb 2010 14:39:40 +0100 3239812 http://www.medworm.com/index.php?rid=3239814&cid=t_132659_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FWnuPE8iSFS0%2F Amid all the cutbacks drugmakers are undertaking, Bristol-Myers Squibb is now freezing salaries this year across the board and also eliminating the future deferral of vacation time, according to a communication that ceo Jim Cornelius sent to employees yesterday. Bonuses, however, won’t be hit, which would seem to favor execs (look here). A spokesman confirmed the move but declined further comment. The belt tightening, which garnered some choice comments on CafePharma, comes as most every big drugmaker is shedding employees - GlaxoSmithKline, Pfizer, AstraZeneca, Merck and Lilly have all taken such steps. Like others, Bristol is bracing for the 2012 patent expiration of Plavix, the $8 billion blood thinner it co-markets with Sanofi. The the WSJ health blog also reported this item. (So... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3239814 Thu, 04 Feb 2010 13:18:18 +0100 3239814 http://www.medworm.com/index.php?rid=3142831&cid=t_132659_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FYDsWID7KjMQ%2F In an attempt to dissect the profitability of big drugs - and gauge their contribution to a drugmaker’s overall profit and loss - Sanford Bernstein analyst Tim Anderson recently crunched some numbers showing, among other things, that roughly 30 of the 52 drugs he examined have pretax margins that are 70 percent or higher. This compares to the average drug company pretax margin of about 32 percent. His point: a big drug may only account for 10 percent of a company’s total sales, but its contribution to pretax profits could be twice as large. And as patent cliffs loom, this is important. Here are the drugs offering the biggest payback: 1 - Effexor (Pfizer) 87 percent 2 - Arimidex (AstraZeneca) 85 percent 3 - Femara (Novartis) 84 percent 4 - Detrol (Pfizer) 84 percent 5 - Gemzar ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3142831 Tue, 05 Jan 2010 14:44:08 +0100 3142831 http://www.medworm.com/index.php?rid=3084979&cid=t_132659_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FBaUgmc45_fA%2F Jean-Marc Huet, who joined the drugmaker in mid-2008 as senior vice president and chief financial officer, as it tried to dig its way out of several holes, is leaving this month to return to Europe, according to a statement (that’s Huet in the picture). At the time Huet arrived, Bristol-Myers was emerging from the loss of its former chief executive, Peter Dolan, and several other execs amid an accounting scandal. Jim Cornelius, the drugmaker’s current ceo, has tried to refocus by cutting deals with other drugmakers and pursuing a so-called ’string of pearls’ strategy that involves select acquisitions. There was also an eye-opening $275 million charge for investing in sub-prime securities, which occurred just before the previous cfo departed (see here). As a former G... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3084979 Mon, 14 Dec 2009 14:05:58 +0100 3084979 http://www.medworm.com/index.php?rid=3071466&cid=t_132659_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FLlpwzU6UBgw%2F An FDA official says the agency is considering strengthening the labels to warn about weight gain and diabetes amid concerns the impact could be stronger in children compared to adults, Dow Jones writes. Tom Laughren, who heads the FDA’s division of psychiatric products, says the agency asked drugmakers to provide all their info on metabolic side effects such as increases in blood glucose, which can cause diabetes, and blood cholesterol levels which can lead to cardiovascular problems over time. The labels already mention weight gain and related problems, but Laughren says the FDA is considering putting all the info in the warnings section, which is tantamount to a stronger label. He made his comments yesterday at a pediatric advisory committee meeting held to review the safety of s... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3071466 Wed, 09 Dec 2009 13:43:43 +0100 3071466 http://www.medworm.com/index.php?rid=3067311&cid=t_132659_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FRGLhdD9MPuw%2F And welcome to another sunny day. The skies are clear here on the Pharmalot corporate campus, which we always take as a good sign. And we are especially encouraged this morning by the latest news that a cup of stimulation or two is a good thing (see here). So while you consider this tidbit, here are a few more items to spark your engines. Have a good day, everyone… Roche Ends Development Deal With Actelion (Reuters) Ranbaxy Sells A Stake In Japanese JV (In-pharmaTechnologist) Tranzyme To Research Drugs For Bristol-Myers (Associated Press) AstraZeneca To Cover Some Patient Co-Pays (Associated Press) Coffee courtesy of Flickr Creative Commons chichcacha (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3067311 Tue, 08 Dec 2009 13:01:04 +0100 3067311 http://www.medworm.com/index.php?rid=3056881&cid=t_132659_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FHWofFH4gJ24%2F The ties between New Jersey government and the pharmaceutical industry grow a wee bit closer with the announcement that Christopher Christie has hired Richard Bagger (see photo), a senior vice president for worldwide public affairs at Pfizer, as his chief of staff. Formerly a direct report to Pfizer chief executive Jeff Kindler and a well-regarded staffer, Bagger has been co-chairing Christie’s transition task force on budget and taxes. The Republican served in the NJ state Senate in 2002 and 2003, and the assembly for 10 years before that. He was previously an attorney for Blue Cross and Blue Shield of New Jersey and worked at the politically connected law firm of McCarter & English. With its vast employment and tax payments, pharma has always had warm relations with NJ governm... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3056881 Fri, 04 Dec 2009 13:48:46 +0100 3056881 http://www.medworm.com/index.php?rid=3026905&cid=t_132659_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F537xBMO1vWw%2F ‘Tis the middle of the week, but this is a short one in the US due to the Thanksgiving holiday. What will you be doing? At our place, Mrs. Pharmalot has graciously volunteered to cook a few birds (we opted for duck and cornish hen this year) and we are celebrating the long weekend with two more installments of our ‘Let’s-See-Them-Before-They-Die’ concert series (see here and here). Meanwhile, though, there is work to be done. So once again, we have gathered a few items of interest. Have a nice day everyone and enjoy… Novartis Strikes Licensing Deal With Incyte (Reuters) Contract Manufacturing Market To Hit $34B By 2014 (OutsourcingPharma) Bristol-Myers Won’t Take Tax Hit For Mead Johnson Split (CFO.com) Pfizer To Expand R&D In China (Reuters) Roche See... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3026905 Wed, 25 Nov 2009 13:24:16 +0100 3026905 http://www.medworm.com/index.php?rid=3023411&cid=t_132659_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fx7OkCwU8iGw%2F The price Medicaid paid for the bloodthinner rose 12 percent “immediately” after direct-to-consumer ads began in 2001, and those higher costs added $207 million to Medicaid spending in 27 states during the next four years, even as prescriptions rose at a constant rate, according to a study in the Archives of Internal Medicine. Pharmacy data from Medicaid programs in 27 states revealed that Plavix sales rose steadily since it was launched and the trend remained constant between 1999 and 2005. But the cost to Medicaid rose by $207 million after ads started running in 2002. And guess what? The price of Plavix was hiked price 12 percent, or 40 cents a pill, when a $350 million ad campaign began. “Payers and policy makers should be very concerned about the potential for drug advertising ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3023411 Tue, 24 Nov 2009 13:25:01 +0100 3023411 http://www.medworm.com/index.php?rid=3019234&cid=t_132659_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FtqORbrPPWwI%2F Hello, everyone. And welcome to a shorter working week, at least here in the states. Although, we suspect the next couple of days will be jam-packed, as everyone tries to squeeze a lot of work into not a lot of time. In any event, time to grab a cup of stimulation and dig in. Hope your day goes well… Merck-Sorono Opening R&D Hub In China (The Wall Street Journal) Abbott’s Meridia Linked To Cardiovascular Events (PharmaTimes) Pfizer Must Pay $6.3M In Damages Over Prempro (Bloomberg) FDA OKs Abilify For Child Autism Irritability (Reuters) Coffee courtesy of Flickr Creative Commons chichcacha (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3019234 Mon, 23 Nov 2009 13:05:38 +0100 3019234 http://www.medworm.com/index.php?rid=2977571&cid=t_132659_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FxYomIRth_jw%2F Top of the morning, everyone. And a pleasant one, it is. Of course, rousting one of the short people from bed is proving challenging today - those of you with adolescents may understand. Still, we soldier on. And that calls for a cup of stimulation or two. While we brace ourselves, here are a few items to help you ease in to your own routine. Have a great day… Bristol Buys Rights to RA Drug (Associated Press) Pfizer In Partnership With BMP In China (Reuters) Glaxo To Donate 50M H1N1 Vaccine Doses To WHO (Reuters) (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=2977571 Tue, 10 Nov 2009 13:01:11 +0100 2977571 http://www.medworm.com/index.php?rid=2977574&cid=t_132659_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fn9EXinVDdso%2F There are five of them - Harvard University, Yale University, Brown University, the University of Pennsylvania and Boston University - will release a pledge to encourage companies to give poor countries better access to drugs and medical products based on discoveries made on their campuses, Bloomberg News reports. Their promise is supposed to guide how drugs developed by scientists at their universities are licensed to companies, a Harvard spokesman tells Bloomberg, adding that the schools signed their pledge after campus student groups pushed for policies to make new drugs available at low cost to poor patients. The statement commits the schools to make “vigorous efforts” to promote global access to drugs through licensing strategies, Bloomberg writes. For example, the schools will w... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=2977574 Mon, 09 Nov 2009 13:42:32 +0100 2977574 http://www.medworm.com/index.php?rid=2954799&cid=t_132659_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FLp6ua8yH_VM%2F Good morning, everyone. Nice to see you again. The sun is shining here on the Pharmalot corporate campus and we are busy bundling short people off to the school house. And like you, we will be focused on meetings and what-not, but will keep an eye out for interesting items to pass along. Here, in fact, are a few interesting developments. See you later… Novartis To Invest $1B In China R&D (The Wall Street Journal) Teva Quarterly Profit Rises (Reuters) Bristol-Myers, Sanofi Win Plavix Court Ruling (Bloomberg) Quintiles Ink Clinical Deal With AstraZeneca (OutsourcingPharma) Crucell Profits Falls 22 Percent (Reuters) (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=2954799 Tue, 03 Nov 2009 11:47:36 +0100 2954799 http://www.medworm.com/index.php?rid=2939559&cid=t_132659_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FolKsJTYHnyw%2F Nursing homes throughout Illinois are being dosed with powerful psychotropic drugs, leading to tremors, dangerous lethargy and a higher risk of harmful falls or even death, according to an investigation by The Chicago Tribune. Thousands of elderly and disabled people have been affected, many of them drugged without their consent or without a legitimate psychiatric diagnosis that would justify treatment, according to state and federal inspection reports reviewed by the paper. The Trib identified 1,200 violations at Illinois nursing homes involving psychotropic medications since 2001. Those infractions affected 2,900 patients, the paper writes, adding that the actual numbers are likely far higher because regulators inspect some facilities just once every 15 months, and even then they usually... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=2939559 Thu, 29 Oct 2009 12:54:55 +0100 2939559 http://www.medworm.com/index.php?rid=2934951&cid=t_132659_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F2yEljf_YhnM%2F Anywhere from 10 to 19 pounds on the Lilly pill. A study in the Journal of the American Medical Association found kids’ weight zoomed in the first three months on antipsychotics, often leading to elevated cholesterol and triglycerides levels. Weight gain is a known side effect but, as Forbes reminds us, the results are noteworthy because there were far greater increases than seen in many previous trials. Researchers tracked 272 children between the ages of 4 and 19 who started taking various brand-name antipsychotic drugs for the first time between 2001 and 2007. They found weight gains varied by drug but appeared to be widespread across the entire class. AstraZeneca’s Seroquel, Bristol-Myers Squibb’s Abilify and Johnson & Johnson’s Risperdal caused weight gain... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=2934951 Tue, 27 Oct 2009 21:38:07 +0100 2934951 http://www.medworm.com/index.php?rid=2931290&cid=t_132659_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FWCsYDfXmScc%2F Good morning, everyone. Nice to see you again. The rain clouds are hovering over the Pharmalot corporate campus, but our spirits are sunny. And why not? We are here to enjoy another day and that counts for a lot. So while we reach for another cup of stimulation, here are some of the latest items to help you on your way. Hope your day is swell… FDA Approves Glaxo & Genmab Leukemia Drug (Reuters) ZymoGenetics Gets $70M For Starting Hep C Study (Associated Press) Arena Tries To Position Its Obesity Pill (Xconomy.com) (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=2931290 Tue, 27 Oct 2009 12:06:52 +0100 2931290 http://www.medworm.com/index.php?rid=2912528&cid=t_132659_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F5rKWsFTlpSs%2F Another day, another downsizing. Unfortunately. The latest round will take place in Evansville, where the drug maker plans to permanently close a quality control facility effective Dec. 31 and also reduce its work force in Mount Vernon, The Evansville Courier & Press reports. In a Worker Adjustment and Retraining Notification Act (WARN) filing this week with the Indiana Department of Workforce Development, Bristol disclosed that it anticipates 113 full-time employees will lose their jobs. Of those, 79 are employed at Evansville and 34 at Mount Vernon, according to the filing. “I’m totally surprised by this news,” Steve Fuelling, a member of the Mount Vernon City Council, tells the paper. “I thought the company was as solid as a rock.” Actually, Steve, with patent expirations... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=2912528 Wed, 21 Oct 2009 11:31:26 +0100 2912528 http://www.medworm.com/index.php?rid=2899193&cid=t_132659_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F4Nh-NkSCl3I%2F Now who’s schizophrenic? Just six months after extending its contract with Otsuka Pharmaceutical to market the Abilify anti-psychotic, the big drugmaker has cut about 25 percent of its Abilify sales team, according to Bloomberg, which notes the pill is the company’s second-biggest seller. The move happened this week, according to a Bristol-Myers spokesman, who declined to provide specific numbers. “We’re evaluating our resources and determining the most appropriate structure for our sales force,” he told Bloomberg. “It’s an important product for both companies.” Speculation on CafePharma, where reps love to dish the industry dirt, suggests Otsuka will fill the void and may hire some Bristol-Myers reps. Bristol-Myers sells Abilify in the US and sever... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=2899193 Fri, 16 Oct 2009 12:59:54 +0100 2899193 http://www.medworm.com/index.php?rid=2886740&cid=t_132659_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FsJGLCefFxFY%2F During this year’s third quarter, eight of the biggest drug makers undertook hefty price increases - the average among this group was 8.7 percent, easily outdistancing the core Consumer Price Index of 1.4 percent, according to a recent research report by Credit Suisse analyst Catherine Arnold. Who led the pack? Schering-Plough (soon to be bought by Merck) with a 12.8 percent hike, while Abbott imposed a 4.4 increase (Abbott’s price hikes have, in fact, been declining over the past year, the report notes). What about the others? Merck upped the ante by 9.9 percent; Wyeth (soon to be part of Pfizer) drove prices higher by 9.3 percent; Lilly was at 9.1 percent; Bristol-Myers Squibb prices rose 8.9 percent; Johnson & Johnson increased prices by 7.8 percent, and Pfizer prices r... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=2886740 Tue, 13 Oct 2009 13:10:41 +0100 2886740 http://www.medworm.com/index.php?rid=2256083&cid=t_132659_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2009%2F03%2Fblogscan-example-of-spinning-clinical.html On the Clinical Psychology and Psychiatry blog, the anonymous blogger did a great job analyzing an article supported by pharmaceutical companies, and authored by in part pharmaceutical company employees, with the assistance of a medical education and communications company (MECC). The article ignored data about outcomes which were unfavorable to the companies' product, and dubbed a drug "well tolerated" even though a number of uncomfortable symptoms occurred two to four times as often on the drug as on placebo. This is a reminder of how often these days clinical research studies are spun in favor of the vested interests of their commercial sponsors. (Source: Health Care Renewal) Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=2256083 Tue, 10 Mar 2009 15:48:00 +0100 2256083 http://www.medworm.com/index.php?rid=2240797&cid=t_132659_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2009%2F03%2Fharvard-medical-students-against.html An article by Duff Wilson in the New York Times this week provided a new look at the pervasiveness of financial relationships among academic medicine and health care corporations, and the beginnings of resistance to them.The Scope of the RelationshipsMany individual Harvard Medical faculty members receive tens or even hundreds of thousands of dollars a year through industry consulting and speaking fees. Under the school’s disclosure rules, about 1,600 of 8,900 professors and lecturers have reported to the dean that they or a family member had a financial interest in a business related to their teaching, research or clinical care. The reports show 149 with financial ties to Pfizer and 130 with Merck.The rules, though, do not require them to report specific amounts received for speaking or... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=2240797 Fri, 06 Mar 2009 18:17:00 +0100 2240797 http://www.medworm.com/index.php?rid=2513162&cid=t_132659_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2Fpharmalot%2F%7E3%2F7YDACfQLsXk%2F The drugmaker reached a deal with 50 state attorneys general after being accused of violating court orders in two earlier lawsuits, in which it settled state charges of unlawfully depriving consumer of cheaper generic versions of its Buspar and Taxol drugs. Under those deals, Bristol paid the states $150 million, and also agreed to avoid any similar anti-competitive conduct, to notify the states of any patent litigation settlements with generic drug rivals and to provide the states with yearly compliance reports (see statement from the Kentucky attorney general). Some background: In March 2006, the drugmaker reached a settlement with Apotex, a generic rival, in a patent infringement lawsuit involving its Plavix bloodthinner. The deal triggered notification obligations under the earlier co... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=2513162 Tue, 23 Dec 2008 21:03:43 +0100 2513162 http://www.medworm.com/index.php?rid=2047634&cid=t_132659_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F487073171%2F Last year, the drugmaker announced a large reorganization that would eliminate some 4,300 jobs, or 10 percent of its workforce, by 2010, along with plant closings, reducing the number of products and selling off some businesses (back story here and here). Now, Bristol-Myers is shedding another 10 percent, starting with 800 so far, including scientists. The drugmaker employs about 37,000 people in total. A spokeswoman confirms the cuts are being made and sends us this statement: “We are reducing the global Bristol-Myers Squibb workforce as part of our previously announced second wave of productivity initiatives designed to enhance our ability to address the significant challenges and uncertainties our company faces in the short- and long-term. “Headcount reductions associated w... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=2047634 Tue, 16 Dec 2008 19:55:18 +0100 2047634 http://www.medworm.com/index.php?rid=2040408&cid=t_132659_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F485487340%2F Welcome back. We hope your weekend was enjoyable, or at least relaxing. Now, of course, the routine returns. And as always, there is much to do. So grab your morning coffee, or whatever, and dig in. Have a good day, everyone… Par Pharmaceutical CFO Resigns (Yahoo/AP) Schering-Plough Hepatitis C Drug Approved For Kids (Yahoo/AP) Bayer To Increase R&D Spending (PharmaTimes) Bristol, Sanofi Win Plavix Patent Battle (Bloomberg News) (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=2040408 Mon, 15 Dec 2008 12:04:05 +0100 2040408