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 'glaxosmithkline'. Sat, 03 Sep 2011 01:50:28 +0100 http://www.medworm.com/index.php?rid=5174861&cid=t_100576_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fu5t0safiHH4%2F Going green may not always be easy. To lower electrical use, GlaxoSmithKline wants to construct a pair of 390-feet high wind turbines at its 45-acre site in Montrose, Scotland, where active pharmaceutical ingredients are made. When the ‘on’ switch is flicked in two years, the turbines should generate six megawatts of electricity, which is enough power for 3,000 homes, and any excess energy could be delivered to the National Grid. Here is how a Glaxo spokesman explains the proposed operation to The Courier: “All of the electricity would go in to a local network and any surplus that GSK would generate over and above its immediate needs to operate the site offsets the carbon dioxide, the greenhouse gas, which the combined heat and power unit currently operating on the site p... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=5174861 Mon, 29 Aug 2011 16:54:09 +0100 5174861 http://www.medworm.com/index.php?rid=5159832&cid=t_100576_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FMZZz09zPr9Q%2F Despite strong endorsements from public health officials, teenage vaccination rates for the HPV vaccine are trailing the other two vaccines recommended for teens and pre-teens, according to the Centers for Disease Control and Prevention. The two vaccines approved to combat the human papillomavirus are Gardasil, which is sold by Merck, and Cervarix, which is sold by GlaxoSmithKline. To be specific, coverage was 49 percent for one dose of HPV vaccine; 63 percent for MenACWY, which protects against meningococcal meningitis; and 69 percent for the TDP vaccine, which guards against tetanus, diptheria and pertussis. Meanwhile, coverage increases for Tdap and MenACWY vaccines grew 13.3 percent and 9.1 percent, respectively. For girls who received the recommended three doses of HPV vaccine, covera... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=5159832 Fri, 26 Aug 2011 12:25:02 +0100 5159832 http://www.medworm.com/index.php?rid=5159835&cid=t_100576_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FQexqt8C-1RI%2F A new analysis of more than 1,000 medical journal articles found that relatively few health problems are caused by or clearly associated with vaccines, according to a report released today by the Institute of Medicine. An expert committee reviewed scientific literature on possible side effects and found what it calls convincing evidence that vaccines can cause 14 specific adverse events - such as seizures, brain inflammation and fainting - but concluded that these occur rarely. “What we found is that there is very little evidence that vaccines cause adverse events, and most of the adverse events that there is evidence for tend to be time-limited,” Ellen Wright Clayton, director of the Center for Biomedical Ethics and Society at Vanderbilt University and the IOM committe chair, ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=5159835 Thu, 25 Aug 2011 17:20:13 +0100 5159835 http://www.medworm.com/index.php?rid=5159840&cid=t_100576_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F0qGTbAcfmZ0%2F Six months after a federal appeals court decided a pair of GlaxoSmithKline sales reps are not eligible for overtime pay, they are now asking the US Supreme Court to review their case. And the implications for the pharmaceutical industry are likely to be far-reaching, given that drugmakers have been laying off thousands of sales reps as part of a massive wave of cost cutting in recent years. The petition, however, is not surprising, because there has been a split among appeals courts over this issue. Last year, the US Court of Appeals for the Second Circuit ruled that Novartis reps are entitled to overtime (back story), and the Supreme Court earlier this year declined to review the decision (see here). That ruling came just two weeks after the US Court of Appeals for the Ninth Circuit ruled... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=5159840 Thu, 25 Aug 2011 12:07:40 +0100 5159840 http://www.medworm.com/index.php?rid=5125968&cid=t_100576_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FgEUN4aYZF2A%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 Acucela hired Michelle Carpenter as senior vp for regulatory affairs and development operations. Most recently, she executive director for regulatory affairs at Dow Pharmaceutical Sciences. Before that, she was vp of regulatory affairs at Oculu... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=5125968 Fri, 12 Aug 2011 12:11:41 +0100 5125968 http://www.medworm.com/index.php?rid=5107893&cid=t_100576_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FXpncqmok5No%2F Rise and shine. Another day is on the way. And it looks to be a sunny one here on the Pharmalot corporate campus, where we are brewing a delicious cup of mandatory stimulation. Our flavor today is Southern Pecan. Please join us. After all, there is much to do as meetings and deadlines beckon. You know the score, so time to dig in. Meanwhile, here are some tidbits. Have a great day and let us know if you hear of something interesting… FDA Approval Of Roche Melanoma Drug May Come Early (Reuters) Pfizer Sends Israeli Sniffing Dogs To Finland (The Jerusalem Post) Revlimid Side Effects Linked To Protein In Study (Reuters) Valeant Pharma Eyes Medicis For Another Acquisition (Pharma Times) Merck And J&J Sit On Piles Of Cash (The Star-Ledger of New Jersey) Lexicon Tumor Drug Shows Posit... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=5107893 Tue, 09 Aug 2011 12:06:27 +0100 5107893 http://www.medworm.com/index.php?rid=5078033&cid=t_100576_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F4GCHU9DVWGQ%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 Sanofi hired Anne Whitaker as president of its US pharmacuetical operations. Previously, she worked at GlaxoSmithKline, where she was senior vice president and business unit head for cardiovascular, metabolic and urology since 2009. She joined ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=5078033 Fri, 29 Jul 2011 12:29:16 +0100 5078033 http://www.medworm.com/index.php?rid=5062501&cid=t_100576_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FBxxWwaHNRcQ%2F Hello, everyone. How was your weekend? We apologize for the delay this morning but the Pharmalot corporate campus was without juice, so we have had to switch to our Red Alert mode. We trust you understand. To cope, we are downing unusually large cups of stimulation. Meanwhile, here are some tidbits. And the usual flow of interesting items will soon appear. Have a great day… Bayer’s Xarelto Bloodthinner Matched Warfarin In Safety Study (Bloomberg News) FDA Rejects J&J’s Simponi For Additional Use (Associated Press) Prescription Drug Prices To Plunge As Patents Expire (Associated Press) Medicis CEO In The Spotlight After Deaths At His Mansion (Los Angeles Times) Express Scripts Deal With Medco Could Pressure Pharma (Dow Jones) Lupin And Medicis Sign R&D Agreement ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=5062501 Mon, 25 Jul 2011 13:48:52 +0100 5062501 http://www.medworm.com/index.php?rid=5051235&cid=t_100576_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F0aGEPpZ3D4M%2F Several months after a curious link was observed between the GlaxoSmithKline pandemic flu vaccine known as Pandremix and unexplained cases of narcolepsy emerged in Finland and Sweden, the European Medicines Agency has decided to restrict usage. Specifically, those younger than 20 years old should use Pandemrix only in the absence of seasonal trivalent flu vaccines, and if immunization against H1N1 swine flu is still needed. An example would be those at risk of complications from infection, according to the EMA (read here). However, the EMA notes that, for now, the benefits continue to outweigh the risks. Over 31 million doses of Pandemrix have been administered worldwide in 47 countries, according to Glaxo. And a total of 335 cases of narcolepsy in people vaccinated with Pandemrix have bee... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=5051235 Fri, 22 Jul 2011 12:52:53 +0100 5051235 http://www.medworm.com/index.php?rid=5051238&cid=t_100576_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=5028849&cid=t_100576_131_f&fid=34989&url=http%3A%2F%2Ffeeds.b5media.com%2F%7Er%2Fb5media%2FGeneticsHealth%2F%7E3%2FJaj2jx6EZQQ%2F It’s one thing to suspect the psychiatric and pharmaceutical industries of shady ties, and a more frustrating thing entirely to see a University of Pennsylvania professor of psychiatry say colleagues let GlaxoSmithKline add their names to a report they had nothing to do with which “unduly promotes” one of it’s own antidepressant drugs, Paxil. The professor, Jay Amsterdam, claims his co-workers and department chair, essentially, sold their academic credentials to the highest bidder. A letter from his lawyer said “most if not all” of the study’s academic authors never reviewed nor even saw the report before it went to press, and were handpicked by GSK to lend credibility to the over-hyped results of its Paxil study. [Call in Julia Roberts and Denzel—this is the stuff good con... Genetics and Health blogs http://www.medworm.com/rss/comments.php?id=5028849 Thu, 14 Jul 2011 19:41:27 +0100 5028849 http://www.medworm.com/index.php?rid=5029211&cid=t_100576_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F2TajULYXlqU%2F Last month, a widely publicized study raised concerns about the safety of the blockbuster Spiriva inhaler that is used to treat chronic obstructive pulmonary disease. The meta-analysis published in the British Medical Journal found that, when administered in the mist form known as Respimat, there was a 52 percent increase in mortality risk compared with a placebo (see here). Not surprisingly, Boehringer Ingelheim, which makes the inhaler, disagreed. And in disputing the findings, the drugmaker made a point of saying the results were not based on new clinical evidence and that the meta-analysis relied on already publicly available data. BI also maintained that “robust evidence” has also been published about the safety of the older, powder version known as HandiHaler (read the statement)... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=5029211 Thu, 14 Jul 2011 16:25:23 +0100 5029211 http://www.medworm.com/index.php?rid=5029214&cid=t_100576_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FAAIOYoMxzQQ%2F In yet another victory for sales reps, a federal judge ruled that a Boehringer-Ingelheim rep is not exempt from overtime provisions of the Fair Labor Standards Act and should be paid overtime. The ruling, which came in the form of a summary judgment and is now headed to trial to determine damages, is the latest in a highly contentious decision that has divided courts across the country For the past few years, a growing number of sales reps have argued they were unfairly denied overtime and nearly every drugmaker has been taken to court (look here and here). The US Department of Labor, however, has sided with the reps, arguing that many of the biggest drugmakers have misinterpreted the Fair Labor Standards Act. Here is the issue: the FLSA overtime compensation requirement does not apply to ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=5029214 Thu, 14 Jul 2011 12:50:06 +0100 5029214 http://www.medworm.com/index.php?rid=5008662&cid=t_100576_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fjg8EpAu81jA%2F And so, another working week will soon draw to a close. As always, this is the signal to daydream about weekend plans. Our agenda calls for a dip in the pool, a little yardwork, hanging with assorted short people and catching up on some interesting R&D. What about you? Is a day at the beach in order? Or a drive in the country? Maybe catching up on some sleep or thinking big thoughts? Whatever you do, have a good time and be safe. Meanwhile, here are some tidbits. See you soon… Bayer Loses European Patent For Yasmin (Reuters) PETA Proposes Procter & Gamble Stop Animal Testing (Dayton Business Journal) Republicans Complain FDA Review Procedures Slow Innovation (Bloomberg News) Bydureon Diabetes Med Passed The Test In Heart Trial (Reuters) FDA Bans Imports From Dr. Reddy&#8217... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=5008662 Fri, 08 Jul 2011 12:04:58 +0100 5008662 http://www.medworm.com/index.php?rid=4992989&cid=t_100576_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=4992991&cid=t_100576_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FrcQNRvANhJM%2F Once again, the vaccines for thwarting HPV, notably Merck’s Gardasil, are causing a stir. In the latest dust up, the California Catholic Conference is urging state residents to contact their legislators to oppose a bill that would remove parental consent for vaccinating children 12 and older against sexually transmitted diseases. Although California law already allows children 12 and older to consent to treatment for sexually transmitted diseases without involvement from their parents, the proposed bill would expand that right to immunizations (read the bill here). In an action alert, the bishops’ group warns parents that “minors do not have adequate judgment to make a decision about a vaccine that as of January 15, 2011, had 21,171 adverse reactions and 91 deaths report... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4992991 Fri, 01 Jul 2011 15:10:17 +0100 4992991 http://www.medworm.com/index.php?rid=4992993&cid=t_100576_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fe5AHzRsT-Fg%2F Pipelines are shriveling. Revenue is falling. Plants are closing. Employees are being shown the door. Signs of an industry in decline, to be sure. Not that pharma lacks the commitment to attempt a turnaround, but these developments reflect, in part, the ascendance of the finance team. In the view of industry veteran and consultant Daniel Hoffman, this emphasis on numbers crunching threatens to turn pharma into a version of the US auto industry. And since we like mixing things up, we asked him to write what amounts to a guest column. Why? We like the idea of livening up the usual menu of items with input from a loyal reader, but also one who has experience in the trenches and a refreshing point of view. We hope you enjoy this contribution. Here are his thoughts… Control of Pharma Oper... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4992993 Fri, 01 Jul 2011 13:20:38 +0100 4992993 http://www.medworm.com/index.php?rid=4992994&cid=t_100576_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FQp-xlA4Oic4%2F Few topics are more contentious than ghostwriting - the mysterious practice in which an article lands in a medical journal with the names of various authors who, as it turns out, had little or nothing to do with the substance of the publication. The issue has caused several scandals for several drugmakers and medical journals, causing embarrassment and turmoil. However, keeping track can be difficult. So the Project On Government Oversight, a watchdog group that regularly probes the topic, has compiled a handy primer on recent episodes (read here, here, here, here and here), as well as the steps taken by various universities and government agencies to cope with the problem. In case you were wondering, though, allegations have been reported for the following journals: The American Journal ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4992994 Fri, 01 Jul 2011 12:30:53 +0100 4992994 http://www.medworm.com/index.php?rid=4992996&cid=t_100576_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FIKpuqSGxcXI%2F Good morning, everyone. And how are you today? Another beautiful morning is rising over the Pharmalot corporate campus. However, we will be rolling in the sidewalks early as we prepare for a long weekend on this side of the pond. Our modest agenda includes a dip in the pool, hanging with the short people, catching up on some research (with thanks to our sources) and one of our favorite sports - hunting for mice. What about you? Anything special planned? Maybe a ride in the country, a barbecue in the backyard or how about a day at the beach? This will be Independence Day, after all, so perhaps this is a good time to think of suggestions for trimming the national debt. The symbolism is heavy, yes? Whatever you do, have a great time and be safe. See you soon… Glaxo Kicks Off Sale Of OTC... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4992996 Fri, 01 Jul 2011 11:50:16 +0100 4992996 http://www.medworm.com/index.php?rid=4968910&cid=t_100576_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FgM3gcg5rFkc%2F As an outgrowth of manufacturing fraud to which GlaxoSmithKline pled guilty last year, the drugmaker has now agreed to pay $40.8 million to 37 US states and the District of Columbia. This comes on top of a $750 million payment to settle criminal and civil charges related to numerous production problems - contaminated meds, mislabeled packaging and incorrect dosages - at a facility in Cidra, Puerto Rico. Under terms of the agreement, Glaxo and its SB Pharmco Puerto Rico unit will each share in the total payout. “Drug manufacturers have a responsibility to engage in strict quality control, and to ensure the products they send to market are pure and unadulterated,” New Jersey Attorney General Paula Dow says in a statement. “We are committed to ensuring they meet that respon... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4968910 Thu, 23 Jun 2011 19:29:29 +0100 4968910 http://www.medworm.com/index.php?rid=4960328&cid=t_100576_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=4960330&cid=t_100576_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FeV33sONHAAI%2F Now you see recusal, now you don’t. For the past couple of years, National Institute of Mental Health director Tom Insel has found himself at the center of a furious controversy over conflicts of interest involving academic researchers who simultaneously receive NIH funding and do work for drugmakers. At one point, he was ensnared in a probe by the US Senate Finance Committee. What prompted this attention was a long-standing relationship with Charles Nemeroff, a former Emory University psychiatry department chair who accepted sizeable consulting fees from GlaxoSmithKline at the same time he was the primary investigator on an NIH-funded grant for research into a Glaxo drug. The revelation sparked a probe by the US Department of Health and Human Services Office of Inspector General. Ne... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4960330 Wed, 22 Jun 2011 13:32:59 +0100 4960330 http://www.medworm.com/index.php?rid=4945197&cid=t_100576_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=4921756&cid=t_100576_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FNUIRNwzYmTg%2F Hospitals in Taiwan are suspending use of the Augmentin pediatric antibiotic made by GlaxoSmithKline after detecting high levels of DIDP, a chemical used to make plastics more flexible but was banned for use in food and drinks. And health officials in Hong Kong ordered the drugmaker to recall supplies that were made in France after testing found DIDP levels twice what they say is permitted in Europe. In Taiwan, authorities are looking at whether a strawberry-flavored version of the drug, which is often prescribed to children, might have been contaminated by artificial flavoring, since jam makers were recently under investigation for using materials containing banned chemicals as fixative agents to keep flavoring and fragrances smelling fresh, The Taipei Times writes. Kang Jaw-Jou, director... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4921756 Thu, 09 Jun 2011 15:47:46 +0100 4921756 http://www.medworm.com/index.php?rid=4911820&cid=t_100576_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FWRej8NgksWI%2F Good morning, everyone, and how are you today? A scorcher is predicted to envelope the Pharmalot corporate campus. We plan to keep cool by perusing interesting documents and chatting up interesting people. We will also break later to appear on a PhRMA panel on social media. To prepare, we are downing a few cups of stimulation - our flavor today is Southern Pecan. Meanwhile, here are some nifty tidbits from around your world. Watch out for the heat and see you soon… Pfizer Teams With Harvard In $100M Drug Discovery Deal (Bloomberg News) Merck Ends Trial Of Intercell Vaccine For MRSA (Reuters) Covidien Seeks A Buyer For Its Pharma Unit (Bloomberg News) Orphan Drug Development Success Remains Elusive (Gen New) US Seeks Prison Sentences For Device Execs (Associated Press) Glaxo Faces Adv... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4911820 Wed, 08 Jun 2011 12:00:08 +0100 4911820 http://www.medworm.com/index.php?rid=4911489&cid=t_100576_87_f&fid=39261&url=http%3A%2F%2Fvactruth.com%2F2011%2F06%2F07%2Fglaxosmithkline-schemes-with-gavi-to-offer-rotavirus-vaccine-at-reduced-costs-to-third-world%2F According to an article released in the Times yesterday, the Global Alliance for Vaccines and Immunization (GAVI) have linked up none other than GlaxoSmithKline to sell cheap, left over vaccines. How the scheme works is by GAVI agreeing to purchase significant volumes of vaccines over a number of years – in this case 125 million doses of Rotarix between now and 2016. UK’s Prime Minister David Cameron is due to host the GAVI conference in London next week to discuss how to raise more than £2.25 billion for immunization programmes over the next four years. This is because GlaxoSmithKline have lowered the price of their rotavirus vaccine for the third world. Andrew Witty, chief executive for GlaxoSmithKline told the Times that the drug companies decision to offer the vaccine at a ‘... vactruth.com blogs http://www.medworm.com/rss/comments.php?id=4911489 Tue, 07 Jun 2011 14:22:16 +0100 4911489 http://www.medworm.com/index.php?rid=4902693&cid=t_100576_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F7xm5seVkAgw%2F Several big drugmakers have agreed to slash prices on some of their vaccines, which are distributed to poor people in developing countries by the Global Alliance for Vaccines and Immunizations, the non-profit that was established by Bill Gates. The move comes just days before a widely anticipated GAVI board meeting that will address, in part, plans to raise $3.7 billion in needed funds. The price cuts are being offered by Merck, GlaxoSmithKline, Johnson & Johnson’s Crucell unit, Sanofi Pasteur’s Shantha Biotechnics, Bharat Biotech and the Serum Institute, and should help GAVI reduce the funding gap for commitments that run until 2015. The effort involves vaccines to combat rotavirus and HPV, as well as diphtheria, tetanus, pertussis, hepatitis B, and Haemophilus influenzae... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4902693 Mon, 06 Jun 2011 15:38:52 +0100 4902693 http://www.medworm.com/index.php?rid=4893916&cid=t_100576_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F_PKuBogHIcg%2F And so, another working week will soon draw to a close. This is, of course, our signal to daydream about the weekend. Our agenda includes some therapeutic swimming, catching up on our reading and taking in a soccer match with the short people. And you? How about enjoying the weather with a nice bike ride? Or spending time with someone special? Perhaps thinking big thoughts is in order. Whatever you do, have a wonderful time. And be safe. See you soon… Pfizer And Hisun Pharmaceuticals Plan Generic Venture (Bloomberg News) Tianjin Tasly Pharmaceutical To Build A Factory In Maryland (CapitalVue) Drugmakers Bolster US Corporate Philanthropy (Reuters) The New Pricing Game In Germany (Business Week) Endo Sales Reps Granted Class-Action Lawsuit For Overtime (Reuters) Teva Gives Big Golden P... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4893916 Fri, 03 Jun 2011 12:03:23 +0100 4893916 http://www.medworm.com/index.php?rid=4872473&cid=t_100576_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FliBV1h4EAXA%2F File this under sticking point. The Global Alliance for Vaccines and Immunizations is coming under fire because a large vaccine maker that provides most of its income is about to become a pharma representative on its board. The move is prompting concerns about conflicts of interest amid demands for lower vaccine prices, The Financial Times writes. In July, Johnson & Johnson’s recently acquired Crucell unit will replace GlaxoSmithKline on the GAVI board (see this), which next month meets in London in hopes of raising $3.7 billion. But some non-governmental organizations say GAVI, which last year sent $825 million in donor funds to vaccination programs in poor countries, is not doing enough to lower prices paid for vaccines. “We think some conflicts are too big to manage,”... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4872473 Fri, 27 May 2011 13:02:26 +0100 4872473 http://www.medworm.com/index.php?rid=4862919&cid=t_100576_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FFTY9Q97A1IU%2F After months of intense debate, the US Securities and Exchange Commission has finally announced rules to implement the whistleblower provisions in the Dodd-Frank Wall Street Reform and Consumer Protection Act. And the final version is a rebuff to many companies - including several drugmakers, such as Pfizer and GlaxoSmithKline - which lobbied for constraints. Here’s why: under the rules, employees will not be required to first report concerns internally to their employers before going to the government. Many large companies fought for the requirement, but advocates objected over concerns that legitimate problems may not be properly investigated and that employees might face retaliation (back stories here and here). “Not requiring internal reporting before providing information... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4862919 Wed, 25 May 2011 19:59:09 +0100 4862919 http://www.medworm.com/index.php?rid=4853220&cid=t_100576_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F_HzGxgsWQUM%2F As countless researchers and marketers gear up for the American Society of Clinical Oncology meeting in early June to review breakthroughs and close calls, one issue may warrant further inspection - the cost of these cancer meds and how patients are reacting. Why? A new analysis shows that 10 percent of patients are abandoning prescriptions for their oral cancer drugs. The reasons: higher cost-sharing for insurance coverage, a larger number of overall prescriptions for different medications, Medicare coverage and incomes, according to Avalere Health, which reviewed pharmacy transaction data between 2007 and 2009, and will present its paper at ASCO next month. The study was published in the Journal of Oncology Practice and American Journal of Managed Care (here is the abstract). To be speci... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4853220 Mon, 23 May 2011 12:54:56 +0100 4853220 http://www.medworm.com/index.php?rid=4848154&cid=t_100576_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=4841983&cid=t_100576_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FwGS0Lq_faZk%2F For the second time in the past year, a study has been released indicating that the little blue impotence pill can not only make one hard, but hard of hearing. To be specific, the trio of popular meds for erectile dysfunction - Viagra, Cialis and Levitra - were linked to 47 suspected cases of sensorineural hearing loss – a rapid loss of hearing in one or both ears that can become permanent, according to a study in The Laryngoscope. The UK researchers reviewed info from published literature and regulatory reports around the globe for incidents that may have been triggered by the pills. They found that hearing loss occurred within 24 hours of ingestion in nearly 67 percent of the cases, with Pfizer’s Viagra accounting for more than half of the total. The average age of those affected... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4841983 Thu, 19 May 2011 12:52:19 +0100 4841983 http://www.medworm.com/index.php?rid=4841988&cid=t_100576_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FBLRCl_3VzoU%2F Last September, the FDA decided to allow the controversial Avandia diabetes pill to remain on the market. The move came after more than three years of debate over the cardiovascular risks of the which the GlaxoSmithKline drug and charges that the drugmaker failed to sufficiently disclose clinical trial data showing the magnitude of those risks (back stories here, here and here). Nonetheless, the agency made clear there would significant restrictions on accessibility to patients who are unable to control their illness by using other meds. For instance, doctors will have to document patient eligibility and patients will have to review statements describing CV safety concerns associated with Avandia and acknowledge they understand the risks. Today, though, the FDA announced the Risk Evaluatio... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4841988 Wed, 18 May 2011 23:02:52 +0100 4841988 http://www.medworm.com/index.php?rid=4829301&cid=t_100576_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FlA5ZtOLK-m0%2F Good morning, everyone. A spot of rain is falling on the Pharmalot corporate campus this morning, but our spirits remain sunny. After all, as 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 take a moment to scan the news of the world. Hope your day goes well and you remain dry… Merck To Close Inspire HQ And Lay Off Workers (Raleigh News-Observer) Gingrich Says Alzheimer’s Research Will Save US Money (Associated Press) Pfizer Lung Cancer Drug To Get FDA Priority Review (Reuters) Mylan Must Pay $24M To Ipsen Over Pill Marketing (Bloomberg News) Actos Diabetes Drug Linked To Bladder Cancer (Reuters) Alexion To Expand Plant And Add Jobs In Rhode Island (WPRI) Gla... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4829301 Tue, 17 May 2011 11:52:04 +0100 4829301 http://www.medworm.com/index.php?rid=4821146&cid=t_100576_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F7KSZTBkkGu8%2F Two months ago, Pfizer disclosed that talks are under way with the US Department of Justice to settle charges the drugmaker committed fraud against government health programs by failing to report discounts and rebates for its Protonix heartburn med. And at the time, Pfizer also disclosed the feds alleged its potential liability is more than $2 billion (see here). How are the talks going? Well, the US Attorney in Boston has just asked for a trial date to be set sometime in the first half of 2012 (read the motion). This might seem like a long time from now, but the move suggests the government is attempting to pressure the drugmaker to resolve the charges over the next few months or face the unpleasant prospect of going to trial. Given its track record, the drugmaker might just choose to set... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4821146 Fri, 13 May 2011 16:37:29 +0100 4821146 http://www.medworm.com/index.php?rid=4821154&cid=t_100576_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FQ0LpPMQNTz8%2F Earlier this week, US District Court Judge Roger Titus acquitted former GlaxoSmithKline lawyer Lauren Stevens of obstructing an FDA probe into alleged off-label marketing of an antidepressant and making false statements to the agency. The surprise move, which came after the same judge tossed an earlier indictment a few weeks ago, was seen by many as a blow to the federal government and its effort to hold some pharma execs accountable for breaking the law (read the transcript of his remarks here). In the aftermath, there was debate about several details, notably the extent to which Stevens fully provided materials to the FDA, as required. We spoke with J. Patrick Fitzsimmons, a lead partner in the life sciences and health care practice group at the Baker & Daniels law firm and a former... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4821154 Thu, 12 May 2011 12:52:01 +0100 4821154 http://www.medworm.com/index.php?rid=4813667&cid=t_100576_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FU-E_cUnzOJg%2F Good morning, everyone, and nice to see you again. A busy day is planned here on the Pharmalot corporate campus as we hustle to meet some deadlines and undertake our own version of R&D. No doubt, you relate. So please join us for that mandatory cup of stimulation. Meanwhile, here are some tidbits we found floating about. Hope you conquer the world and see you later… Takeda In Talks To Buy Nycomed For $12 Billion (Bloomberg News) Carl Icahn And His Big Bet On Biotech (The Boston Globe) Glaxo & Astra Hook Up With Academia For Inflammation Research (Pharma Times) Experimental AIDS Vaccine Shows Promise In Monkeys (Reuters) Shire Eyes Big Sales For New Vyvanse Uses (Reuters) Procrit And Epogen May Worsen Heart Attacks (Health Day) Docs Busted For Supplying Oxycodone Network (Th... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4813667 Thu, 12 May 2011 12:15:38 +0100 4813667 http://www.medworm.com/index.php?rid=4813673&cid=t_100576_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FKFG5mW_h5VQ%2F The decision this morning by US District Court Judge to toss the charges against former GlaxoSmithKline lawyer Lauren Stevens, who was indicted for obstructing an FDA probe into off-label marketing of the Wellbutrin SR antidepressant and making false statements to the agency, surprised many people who had been following the case. Why did he do so? Courtesy of the court transcript, you can read his explanation…. “During the government’s case, which is now concluded, the Court heard extensive testimony of both FDA and GSK officials and, to put it mildly, a large volume of documentary evidence. Very significant portions of the documents placed before the Court were what would otherwise be privileged attorney-client documents. They were obtained by the United States as a resu... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4813673 Tue, 10 May 2011 20:39:43 +0100 4813673 http://www.medworm.com/index.php?rid=4813674&cid=t_100576_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FiyekkSeE81Q%2F In a stunning blow to the federal government and its effort to hold some pharma execs accountable for breaking the law, a federal trial judge this morning threw out a closely watched case against former GlaxoSmithKline lawyer Lauren Stevens, who was accused of obstructing an FDA investigation into whether the drugmaker illegally marketed its Wellbutrin SR antidepressant as a diet drug. US District Court Judge Roger Titus acquitted Stevens without sending the case to the jury, which he called a “first” in his seven and a half years on the bench, according to Dow Jones. “I conclude on the basis of the record before me that only with a jaundiced eye and with an inference of guilt that’s inconsistent with the presumption of innocence could a reasonable jury ever convict... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4813674 Tue, 10 May 2011 15:52:38 +0100 4813674 http://www.medworm.com/index.php?rid=4803523&cid=t_100576_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F50hNZC-vxRU%2F On the eve of presenting her defense, former GlaxoSmithKline lawyer Lauren Stevens has asked a federal judge to toss the indictment in which she is charged with obstructing an FDA probe into off-label marketing of the Wellbutrin SR antidepressant and making false statements to the agency. If US District Court Judge Roger Titus denies her request, the Stevens team will call its witnesses today. The case is being closely watched for several reasons: it offers the unusual spectacle in which the feds are attempting to make an example of a pharma employee, the proceedings peel back the curtain on the internal machinations that occur when the FDA undertakes a probe and, finally, the trial is pitting the former Glaxo lawyer against some of her former colleages, including lawyers at the King &#038... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4803523 Tue, 10 May 2011 12:36:40 +0100 4803523 http://www.medworm.com/index.php?rid=4795058&cid=t_100576_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=4789637&cid=t_100576_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FcIcZrWjZnAo%2F Good morning and nice to see you again. A busy morning here on the Pharmalot corporate campus, where we have been hustling various short people off to the local school house for some learning. To cope, we are, of course, sipping that needed cup of stimulation. Please feel free to join us. Meanwhile, we are gearing up for another busy day of phone calls and our own version of R&D. And so here are some tidbits as you gear up for your own challenges. Hope all goes well and be in touch… Allergan Licenses Drug For Retinal Disease (Reuters) Osteoporosis Drug Linked To Rare Thigh Fractures (Wall Street Journal) Ranbaxy May Pay $1B Fine For Manufacturing Problems (Economic Times) Glaxo Is Ready To Settle Another 1,000 Avandia Lawsuits (Bloomberg News) Merck And Astra Asthma Pills As Goo... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4789637 Thu, 05 May 2011 12:09:04 +0100 4789637 http://www.medworm.com/index.php?rid=4780482&cid=t_100576_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FglOPQaumNQs%2F Over the past nine months, GlaxoSmithKline has paid at least $120 million to resolve more than 100 lawsuits claiming some of its Poligrip products caused neurological disorders because the denture cream contains zinc, according to Bloomberg News. The lawsuits allege the drugmaker failed to warn consumers about zinc-related health risks. The disclosure comes just three months after Glaxo began warning consumers about denture creams that contain zinc, and took “voluntary, precautionary” steps to end manufacturing and supplying these denture adhesives due to “health risks associated with long-term excessive use.” Plaintiff attorneys have argued there was no warning for people who apply excessive denture cream to hold ill-fitting dentures, and this can cause problems as severe as ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4780482 Tue, 03 May 2011 20:06:35 +0100 4780482 http://www.medworm.com/index.php?rid=4775601&cid=t_100576_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FEBgixMvO-Qc%2F Back in 2001, the Journal of the American Academy of Child and Adolescent Psychiatry published a paper concluding the Paxil antidepressant was “generally well tolerated and effective for major depression in adolescents.” But the study, known as 329, was later discredited amid charges that outcomes were conflated, unflattering results were omitted and ghostwriting was involved. The details became known more than two years ago as documents emerged from investigations by UK regulators (look here) and the former New York Attorney General (read this), as well as lawsuits charging GlaxoSmithKline hid the risks of its Paxil pill. More recently, there was a call for the paper to be retracted (read here). One of the 22 co-authors was Stan Kutcher, a physician who is running for the Canadian par... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4775601 Mon, 02 May 2011 14:49:06 +0100 4775601 http://www.medworm.com/index.php?rid=4775603&cid=t_100576_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F9Hp2iHli9Ik%2F With all that money the US Treasury is collecting from health care fraud (see here), a new study urges the Australian government to pass legislation that would emulate the US False Claims Act and enable whistleblowers to file lawsuits. A couple of reasons are cited for this conclusion. There is growing government spending on meds - from roughly $3.5 billion in the 1998-99 fiscal year to $9 billion in 2009-10 - and Australia has entered a “period of financial stringency.” The other is that the “Australian pharmaceutical market is unlikely to be immune from US-style false claims and fraud, if only because most of the major drug companies proven to have engaged in such conduct against the US government also dominate the Australian market,” according to the study, which... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4775603 Mon, 02 May 2011 12:53:44 +0100 4775603 http://www.medworm.com/index.php?rid=4762936&cid=t_100576_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FAEspvdtrmw4%2F Less than a month after the FDA refused to approve the Gardasil vaccine for preventing HPV in women ages 27 to 45, Health Canada has gone in the other direction and issued an endorsement. Although Canada is a smaller market than the US, the approval is a notable step for Merck, which has been counting on a larger demographic target to boost sorely needed vaccine revenue. In the US, Merck has been repeatedly frustrated in trying to widen the market for Gardasil. Last year, the FDA postponed a decision about approval for women ages 26 to 45 after Merck had submitted additional data. The submission was made after the agency three years ago refused to approve the vaccine for this same age bracket and, instead, sought data on a 48-month study (back story). In Canada, Gardasil is now approved to... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4762936 Thu, 28 Apr 2011 16:32:43 +0100 4762936 http://www.medworm.com/index.php?rid=4759037&cid=t_100576_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FjN4MWwL9A3g%2F After months of anticipation, the trial of former GlaxoSmithKline lawyer Lauren Stevens, who was indicted for last November for obstructing an FDA probe into off-label marketing of the Wellbutrin SR antidepressant and making false statements to the agency, has finally gotten under way. And in their opening remarks, federal prosecutors says she was a “lawyer who went too far.” “This is a case about a lawyer who put loyalty to her company above fidelity to the truth and to the law,” Patrick Jasperse, a Justice Department lawyer, charged during opening statements today in a federal court in Greenbelt, Maryland. “This is a case about a lawyer who went too far, from aggressively representing her company to breaking the law.” To be specific, Stevens, 61, is charged with one coun... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4759037 Wed, 27 Apr 2011 19:53:09 +0100 4759037 http://www.medworm.com/index.php?rid=4753972&cid=t_100576_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fb_qg-ukLNv0%2F The ongoing refusal by Johnson & Johnson to partipicate in the Medicines Patent Pool, which is an initiative designed to streamline patent licensing for producing generics of patented HIV meds and offering lower prices in poor countries, has now generated a scolding from Doctors Without Borders, the international humanitarian organization. In a statement, the group accuses the health care giant of turning its corporate back on HIV patients by undermining access to key AIDS drugs. J&J holds patents on rilpivirine, which is being developed as a first-line HIV treatment, as well as darunavir and etravirine, two meds that treat HIV patients who have become resistent to other drugs. The missive appears carefully timed. Later this week, J&J will hold it annual shareholder meeting,... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4753972 Tue, 26 Apr 2011 12:28:30 +0100 4753972 http://www.medworm.com/index.php?rid=4747884&cid=t_100576_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FOqLKBxtiNWQ%2F The trial of former GlaxoSmithKline lawyer Lauren Stevens gets under way this week and federal prosecutors hope to force a Glaxo exec to testify, according to documents filed in federal court last week. The feds are trying to compel James Millar, a vp of strategic pricing, contracting and marketing to take the stand in their quest to convict Stevens of obstruction of justice. Stevens, you may recall, was first indicted last November for obstructing an FDA probe into off-label marketing of the Wellbutrin SR antidepressant and making false statements to the agency. More recently, the indictment was tossed, because prosecutors incorrectly portrayed her defense to a grand jury. However, they subsequently issued another indictment earlier this month (back story). The feds want Millar to be comp... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4747884 Mon, 25 Apr 2011 12:35:59 +0100 4747884 http://www.medworm.com/index.php?rid=4747887&cid=t_100576_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FScX2CHW6fmI%2F Welcome back, everyone. Nice to see you again after a much-needed break. Hope your own time off was pleasant. Now, of course, the routine of meetings and deadlines has returned. To cope, we are brewing a mandatory cup of stimulation - our flavor today is Wild Mountain Blueberry. Please join us as we catch up with the recent news of the world. And so, here are some tidbits to help your day get started. Stay in touch… FDA Staff Raises Safety Concern With Merck Hepatitis C Drug (Reuters) Vertex Hopes FDA Panel Will OK Its Hep C Treatment (Boston Globe) AstraZeneca To Demolish R&D Facility (Delaware Online) Eisai Aricept Patch For Alzheimer’s Fails To Win FDA Approval (Bloomberg News) Sun Pharma To Sell Merck Diabetes Drugs In India (Reuters) Dr. Reddy’s To Sell Pfizer A... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4747887 Mon, 25 Apr 2011 12:01:51 +0100 4747887 http://www.medworm.com/index.php?rid=4724262&cid=t_100576_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FeHY6DN5Y0og%2F Hard to believe, yes? But even we take a break now and then. While we have our laptop and Blackberry with us and will, periodically, check on interesting developments, regular posting will not occur this week. We apologize for any inconvenience, but we promised Mrs. Pharmalot and The Short People (that famous, non-existent ’60’s group) that we would focus on their desires. Meanwhile, we hope you enjoy any holidays that you may celebrate. Have a great time, everyone, and see you in a few days… Synthes Confirms Aquisition Talks With Johnson & Johnson (Bloomberg News) Will Amgen Declare A Dividend On Thursday? (Reuters) EU Proceeds With Plan To Cut Patent Costs By 80 Percent (Pharma Times) Merck Scientist Sees Potential HIV Vaccine As Distant Goal (Dow Jones) FDA Warns Patients Ove... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4724262 Mon, 18 Apr 2011 13:00:40 +0100 4724262 http://www.medworm.com/index.php?rid=4715016&cid=t_100576_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FYiEPmFQ6yMo%2F And so another work week will soon draw to a close. This means, of course, the time has come to daydream about weekend plans. Our agenda includes spring cleaning, taking one of our short people to a soccer match and catching up on some sleep. What about you? Anything special planned? A walk in the park? Reaching out to an old friend? Maybe planning the rest of your life? Whatever you do, have a great time. Meanwhile, here are some tidbits. Catch you soon… EU Backs Boehringer Pradaxa Stroke Prevention Drug (Reuters) US Will Negotiate Medicare Drug Prices: Obama (Pharma Times) EU OKs Bydureon Diabetes Med From Lilly & Amylin (Reuters) Genzyme MS Drug Shows Promising Five-Year Results (Mass High Tech) Glaxo To Sell Plant And Eliminate 250 Jobs (Memphis Business Journal) Glaxo To Se... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4715016 Fri, 15 Apr 2011 11:33:47 +0100 4715016 http://www.medworm.com/index.php?rid=4714693&cid=t_100576_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2011%2F04%2Fthird-rail-that-no-one-wishes-to.html DiscussionWhile the data from this case-study were limited, they do suggest that major private foundations that support global health, and by extension, health care, services, and policy research may have institutional conflicts of interest, and their leaders may have personal conflicts of interest. It is possible that these conflicts have steered global health policy to favor vested interests, particularly towards approaches that depend on drugs and devices, perhaps instead of more effective ones using less technology.Furthermore, it is possible that that these conflicts of interest have helped create the anechoic effect.  Conflicts of interest could have pushed the foundations in directions that favored specific vested interests, and away from... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=4714693 Thu, 14 Apr 2011 20:11:00 +0100 4714693 http://www.medworm.com/index.php?rid=4715018&cid=t_100576_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FVldtIyn_Hk8%2F If at first you don’t succeed…indict, indict again. Federal prosecutors have filed a new indictment against Lauren Stevens, a former GlaxoSmithKline lawyer who was first indicted last November for obstructing an FDA probe into off-label marketing of the Wellbutrin SR antidepressant and making false statements to the agency (back story). The new indictment is not at all surprising. Last month, her lawyers succeeded in convincing a federal judge to toss the initial indictment, because federal prosecutors incorrectly portrayed her defense to a grand jury. However, US District Court Judge Roger Titus also ruled the government can seek a new indictment (read here). Central to the ruling was her contention that she received advice from other Glaxo lawyers, including the King & S... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4715018 Thu, 14 Apr 2011 18:34:33 +0100 4715018 http://www.medworm.com/index.php?rid=4715020&cid=t_100576_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FcEBOhpGUe_M%2F For the second time in five years, Public Citizen is petitioning the FDA to ban the Xenical prescription diet pill sold by Roche, which is also marketed in a lower-dose, over-the-counter version as Alli by GlaxoSmithKline. The latest move comes after a report earlier this week that linked the drug to kidney stones and pancreatic damage. The watchdog group identified 47 cases of acute pancreatitis and 73 kidney stones among patients taking either the prescription version or the over-the-counter form. Last year, the FDA added warnings to Xenical and Alli about rare reports of liver damage - 12 reports of severe liver toxicity associated with Xenical and one domestic case for Alli. Two of the patients died of liver failure and three required liver transplants. Public Citizen wants the manufac... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4715020 Thu, 14 Apr 2011 14:49:30 +0100 4715020 http://www.medworm.com/index.php?rid=4709422&cid=t_100576_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F2O5tLCPGn9c%2F Major philanthropic foundations, such as the Bill & Melinda Gates Foudation, regularly make the news with their donations and initiatives aimed at improving global health. But there is an aspect to their efforts that may be overlooked - such organizations can have links with drugmakers that could constitute a conflict of interest, according to an analysis published in PLoS Medicine. The researchers examined the five largest US private and/or family foundations that focus considerably on global health - besides the Gates Foundation, the list included the Ford Foundation; W K Kellogg Foundation; the Rockefeller Foundation and the Robert Wood Johnson Foundation, which is a philanthropic outgrowth of a Johnson & Johnson founder. They analyzed publicly available endowment disclosures... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4709422 Wed, 13 Apr 2011 14:06:18 +0100 4709422 http://www.medworm.com/index.php?rid=4709424&cid=t_100576_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FpR8BdZuodiU%2F Hello, everyone, and nice to see you again. A spot of rain is falling on the Pharmalot corporate campus, but as you know, our spirits are as sunny as ever and reinforced by a bit of wisdom from the Morning Mayor: ‘Every brand new day should be unwrapped like a precious gift.’ So while we down our cup of stimulation, we present the news of the world in hopes this will help you cope with those meetings and deadlines. Have a great day and give someone a big smile… BioSante Says FDA Accepts Filing For Male Testerone Gel (Reuters) Merck To Outsource Work Done At Pennsylvania Plant (The Daily Item) Novartis Drug Wins FDA Panel OK For Rare Pancreatic Tumors (Bloomberg News) Pfizer Drug Wins FDA Committee Backing For Pancreatic Cancer (Bloomberg News) Roche’s Xenical Diet P... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4709424 Wed, 13 Apr 2011 12:12:07 +0100 4709424 http://www.medworm.com/index.php?rid=4704956&cid=t_100576_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FPhLfP23_6gY%2F File this under The Case of The Missing Book. When last seen, Scientific Therapeutics Information was at the center of an ongoing controversy over an allegedly ghostwritten book - yes, an entire book - that was published in 1999 by the American Psychiatric Association. Funding came from a grant provided by SmithKline Beecham, which is now part of GlaxoSmithKline (back story). The listed co-authors were Charles Nemeroff, who chairs the psychiatry department at the University of Miami medical school, and Alan Schatzberg, who until recently chaired the psychiatry department at the Stanford University School of Medicine. Both men were at the center of a long-running probe by the US Senate Finance Committee into undisclosed conflicts of interest among academic researchers. They were also regul... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4704956 Tue, 12 Apr 2011 12:13:27 +0100 4704956 http://www.medworm.com/index.php?rid=4704958&cid=t_100576_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FhWBKw4PwEO0%2F Top of the morning to you. Gray skies are hovering over the Pharmalot corporate campus this morning, where we are hustling the short people off to the school house for some learning and quaffing our usual cup of stimulation - our flavor today is Mocha Fudge Nut. Please join us. While you do, here are some tidbits from around your universe. We hope your day is productive and rewarding. Meanwhile, let us know of anything interesting or unusual. Have a great one… Study Reveals New Target For Antidepressants (Reuters) Teva MS Pill Reduces Relapses Less Most Injectables (Bloomberg News) Glaxo Moving More Jobs To Scotland (Scotland Herald) FDA Approves Merck Skin Cancer Drug (Reuters) Biogen MS Pill Shows Promise In Study (Associated Press) UK Docs May Consider Cost When Prescribing Off-La... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4704958 Tue, 12 Apr 2011 12:07:42 +0100 4704958 http://www.medworm.com/index.php?rid=4704589&cid=t_100576_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2011%2F04%2Fthem-or-your-lying-eyes.html …THEM OR YOUR LYING EYES? A few days ago I discussed stonewalling by the American Psychiatric Association over charges that they were partners in a ghostwritten textbook. The issue resonated with many people, including Daniel Carlat, John Nardo, the POGO blog, Alison Bass, Ed Silverman, and others. The APA has not seen its way clear to releasing key documents that might clear up the charges. By stonewalling, the APA just does more damage to its image and credibility. They come across as uninterested in transparency, and they appear to be fighting a rearguard action to defend the indefensible. What kind of key documents could the APA have released? In our letter last January we suggested several, including the contract involving the American Psychiatric Press, the medical communications c... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=4704589 Tue, 12 Apr 2011 04:18:00 +0100 4704589 http://www.medworm.com/index.php?rid=4684755&cid=t_100576_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fd10VVkKY8lg%2F In yet another twist in the ongoing battle over sales reps and overtime pay, the US Department of Labor has filed an amicus curiae brief in support of two GlaxoSmithKline reps, who recently lost a case in which a federal appeals court ruled they are not eligible for overtime pay. The Labor Department, however, wants the entire appeals court to rehear the case if the appeals panel declines to do so. Two months ago, the US Court of Appeals for the Ninth Circuit reached its decision after determining that pharmaceutical sales reps are exempt from relevant provisions of the Fair Labor Standards Act and, therefore, should not be paid overtime (see this and this). That decision affirmed a lower court ruling issued in November 2009 (which you can read here) and, significantly, contradicted a Labo... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4684755 Thu, 07 Apr 2011 19:14:12 +0100 4684755 http://www.medworm.com/index.php?rid=4684758&cid=t_100576_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FDD9bzsNsVtU%2F Is there a link between antidepressants and breast and ovarian cancer? A new meta-analysis of 61 trials identified a connection in nearly 33 percent of the epidemiological and pre-clinical studies conducted between 1965 and 2010 found an association between cancer and antidepressants. And the link was stronger among women using selective serotonin reuptake inhibitors, or SSRIs. Moreover, the study found researchers with industry ties were significantly less likely than researchers without those affiliations to conclude antidepressants increase the risk of breast or ovarian cancer. The authors of the meta-analysis, which was published this week in PLoS Medicine, suggest the findings raise public health and policy issues, “because there is increasing evidence that financial ties among... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4684758 Thu, 07 Apr 2011 14:29:41 +0100 4684758 http://www.medworm.com/index.php?rid=4684761&cid=t_100576_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F7VtbjQj12Pw%2F Good morning, everyone. Another brand new day is on the way. Of course, this calls for a hearty cup of stimluation - our flavor today is Cinnamon Cream Swirl. Feel free to grab one yourself, or a bottle of water if you prefer, and join us as we peruse the news of the world. As always, we appreciate tips and hints and allegations. So send them our way. Meanwhile, have a great day and see you soon… J&J May Do $10B Deals To Bolster Growth (Bloomberg News) Synthetic Drugs Send Thousands To Emergency Rooms (Associated Press) Merck’s Dutch R&D Unit To Keep Some Jobs After All (Reuters) The Valent Pharma CEO And His Acquisition Binge (Bloomberg News) Where Are The ImClone Alumni? (Xconomy) FDA Approves Restless Legs Syndrome Med (Reuters) AstraZeneca Wins FDA Approval Of Thy... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4684761 Thu, 07 Apr 2011 12:03:32 +0100 4684761 http://www.medworm.com/index.php?rid=4684762&cid=t_100576_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FxvsJhjRYHqc%2F In a setback to Merck, the FDA has refused to approve the use of the Gardasil vaccine for preventing HPV in women ages 27 to 45, a market the drugmaker has been counting on to boost sorely needed vaccine revenue. In a brief statement, Merck says prescribing info was updated to indicate Gardasil has not demonstrated to prevent HPV-related cervical cancer in women older than 26. The drugmaker has been repeatedly frustrated in its quest to widen the market for Gardasil. Last year, the FDA postponed a decision about approval for women ages 26 to 45 after Merck had submitted additional data. The submission was made after the agency three years ago refused to approve the vaccine for this same age bracket and, instead, sought data on a 48-month study (back story). The vaccine is already approved ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4684762 Wed, 06 Apr 2011 22:11:21 +0100 4684762 http://www.medworm.com/index.php?rid=4676731&cid=t_100576_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2011%2F04%2Fwho-you-gonna-believe.html WHO YOU GONNA BELIEVE? Ghostwriting Charges and Stonewalling at the American Psychiatric Association The American Psychiatric Association came under a searchlight this past December over allegations of ghostwriting. The story originated with a public letter from Project on Government Oversight (POGO) to the Director of NIH, and it was picked up by Duff Wilson writing in the New York Times. The book was Recognition and Treatment of Psychiatric Disorders: A Psychopharmacology Handbook for Primary Care. The named authors were Charles Nemeroff, now chairman of psychiatry at the University of Miami, and Alan Schatzberg, formerly chairman of psychiatry at Stanford University. Both are well known for ethical controversy – see here and here. Soon, these allegations were being dissected in the bl... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=4676731 Tue, 05 Apr 2011 04:44:00 +0100 4676731 http://www.medworm.com/index.php?rid=4677114&cid=t_100576_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FC_g_bkDy5kM%2F Hello, everyone, and welcome to the working week. We hope the weekend was relaxing. Now, of course, the routine of meetings and deadlines resume. This calls, of course, for a cup or two of stimulation. So please join us as we indulge. Meanwhile, here are a few tidbits to get you started. Have a great day and keep us in mind if you hear something interesting. See you later… Dendreon Faces Investor Uprising Led By Small Shareholder (Xconomy) Vivus Diet Pill Has Heart Benefits (Bloomberg News) BASF Raises API And Excipient Prices 10 Percent (InPharma Technologist) Antidepressants Linked To Narrowed Arteries In Older Men (Bloomberg News) Glaxo Faces Talent War In Emerging Markets (Bloomberg News) Cipla Seeks Voluntary License To Make Merck AIDS Drug (MoneyControl) FDA Staff Backs Efficac... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4677114 Mon, 04 Apr 2011 11:48:39 +0100 4677114 http://www.medworm.com/index.php?rid=4664478&cid=t_100576_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FAtThd9VPuIs%2F Which big drugmakers are perceived by cash-hungry biotechs as the best potential partner for doing a deal? A recent survey indicates that Merck scored highest among 17 individual attributes, such as being able to value to a compound and offering sales and marketing muscle, and has the most favorable overall impression. But Roche notched the highest average score and was mentioned most often as a desirable top partner. “Roche has been writing the playbook on how to run an effective partnership organization – training staff, clarifying its message and, in general, in the way it deals with partners at negotiations,” says Simon Goodall, a partner and managing director at Boston Consulting Group, which gathered responses from 95 biotech chief executives and business development he... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4664478 Thu, 31 Mar 2011 14:29:56 +0100 4664478 http://www.medworm.com/index.php?rid=4658618&cid=t_100576_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FZAJe68L6mfg%2F A federal jury rejected charges by GlaxoSmithKline that Abbott Laboratories with stifling competition and creating an illegal monopoly after more than quadrupling the price of its Norvir med, which is used in AIDS cocktails. However, Abbott was ordered to pay $3.4 million for breaching licensing contracts. This is a far cry from the $571 million that Glaxo sought in damages, though. Here’s 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 (back story). Gl... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4658618 Wed, 30 Mar 2011 23:27:47 +0100 4658618 http://www.medworm.com/index.php?rid=4658627&cid=t_100576_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_100576_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_100576_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=4653608&cid=t_100576_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fer8yKF-x980%2F Good morning, everyone. Another shiny day is unfolding here on the Pharmalot corporate campus, where we are, once again, hustling the short people off to the schoolhouse. We are also preparing for a podcast later today, so wish us luck. Meanwhile, please join us for the much-needed cup of stimulation and a quick scan of the news of the world. Hope your day is productive. See you soon… FDA Asks Maker Of Tainted Wipes To Stop Production (MSNBC) Medicaid Spent Extra $329M On Brand-Name Drugs: Report (Bloomberg News) Cephalon To Make Takeover Bid For ChemGenex (Associated Press) Closing Arguments Set In Merck Contamination Case (Sacramento Bee) None Hurt At Catalent Packaging Facility Fire In The UK (Outsourcing Pharma) Florida Gov To Hunt Down Pill Mills (Florida Times-Union) High-Dose ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4653608 Tue, 29 Mar 2011 11:50:43 +0100 4653608 http://www.medworm.com/index.php?rid=4636660&cid=t_100576_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=4631647&cid=t_100576_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FuCyov5GWRe4%2F A draft version of a bill that was discussed yesterday in the North Carolina General Assembly would protect drugmakers and and those selling medications from liability in lawsuits so long as the med was approved by any state or federal government agency. Opponents of the bill, which is expected to be introduced formally this week, maintain the provisions are among the most restrictive in the nation and would, effectively, prevent state citizens from recovering damages from any harm. The only exceptions contained in the proposed legislation refer to those who continue to sell a med after a government agency ordered a withdrawal or alter the med in a way that would have avoided an alleged injury, intentionally withheld or misrepresented info that led to approval by a government agency, or br... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4631647 Thu, 24 Mar 2011 12:50:17 +0100 4631647 http://www.medworm.com/index.php?rid=4627016&cid=t_100576_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FjJLp-JZWBq4%2F The attorneys for Lauren Stevens have succeeded in convincing a federal judge to toss an indictment that charged her with obstructing an FDA probe into off-label marketing of Wellbutrin SR, because federal prosecutors incorrectly portrayed her defense to a grand jury. However, US District Court Judge Roger Titus also ruled the government can seek a new indictment. At the heart of the ruling is her contention that she received advice from other Glaxo lawyers, including the King & Spalding law firm that regularly works for the drugmaker. Stevens wants to offer what is known as ‘advice of counsel’ defense, although prosecutors argue this should not be permitted, because it might confuse a jury (back story here, here, here and here). In his order, Titus wrote that prosecutors gave &#8... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4627016 Wed, 23 Mar 2011 21:51:54 +0100 4627016 http://www.medworm.com/index.php?rid=4627023&cid=t_100576_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FQC6EHv3GSyQ%2F Good morning, everyone. A spot of snow is falling on the Pharmalot corporate campus today. So much for spring. Nonetheless, we persevere thanks, in part, to a cup of stimulation - our flavor today is Southern Pecan. Meanwhile, we are gearing up for those meetings and deadlines, and trust you are doing the same. To help you along, here are some tidbits from around the world. Hope you have a productive day and catch you soon… Novartis Must Wait Longer For FDA Decision On COPD Drug (Reuters) Glaxo Scraps Plan To Market Prostate Cancer Med (Associated Press) Former Pfizer CEO And His Severance (Associated Press) Medicare Ordered To Pay For Off-Label Drugs (American Medical News) Bristol Pays CEO Andreotti $11M In Compensation (Associated Press) Gilead HIV Drug Meets Main Trial Goal (Reut... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4627023 Wed, 23 Mar 2011 12:05:07 +0100 4627023 http://www.medworm.com/index.php?rid=4611000&cid=t_100576_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FwHXDWgDDgYA%2F In the name of saving money and, theoretically, raising productivity, GlaxoSmithKline is experimenting with what is called a new ‘open office environment.’ To wit, employees no longer have an assigned desk or telephone. Instead, they plant themselves in a different spot most days, which means no family photos, tchotchkes or racy photos of favorite movie stars. And they have to be neat, too - the desk du jour must be left clean every day. No crumbs or inappropriate personal items allowed. How is it going? “It was a big adjustment,” Shelby Bryant, an administrative assistant who has worked for the drugmaker for 18 years, tells The Sun News. “There were a lot of distractions, and it was hard to stay focused.” But she maintains there are advantages - more c... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4611000 Fri, 18 Mar 2011 14:28:23 +0100 4611000 http://www.medworm.com/index.php?rid=4611001&cid=t_100576_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F-Fna623g0RI%2F In their ongoing quest to save former GlaxoSmithKline lawyer Lauren Stevens from serving jail time, her attorneys may have succeeded in convincing a federal judge to toss the indictment. Why? They raised doubts about the extent to which federal prosecutors correctly portrayed her defense to a grand jury, according to court documents. And so US District Judge Roger Titus will issue a ruling in which he may instruct the feds to issue a new indictment and begin new grand jury proceedings. You may recall that Stevens, who was indicted for obstructing an FDA probe into off-label marketing of Wellbutrin SR, indicated in recent court filings that she received advice from other Glaxo lawyers, including the King & Spalding law firm that regularly works for the drugmaker. She wants to offer wha... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4611001 Fri, 18 Mar 2011 12:52:00 +0100 4611001 http://www.medworm.com/index.php?rid=4600792&cid=t_100576_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FNv54Gsv6Djw%2F Joining its rivals, Novartis is the latest global drugmaker to shed jobs in the UK. To be specific, 550 positions from a facility in West Sussex, which employs a total of 950 people, will be eliminated over the next two years as manufacturing is discontinued at the site. Gastrointestinal research will be shifted elsewhere, although a respiratory research group that employs about 330 will remain. “With significant changes in health-care systems aimed to contain or cut cost, this critical assessment and the subsequent potential changes to the Novartis UK organization are key to maintain significant investment in innovative drugs and our research efforts in the UK,” Sue Webb, Novartis general manager for the UK and Ireland, says in a statement, according to the BBC. This is the l... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4600792 Wed, 16 Mar 2011 20:52:28 +0100 4600792 http://www.medworm.com/index.php?rid=4600798&cid=t_100576_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FNPe3p37WgVo%2F Hello, everyone, and nice to see you again. A spot of rain is falling on the Pharmalot corporate campus, but our spirits remain sunny. Of course, a cup or two of stimulation can help - our flavor this morning is Rain Forest Nut. Meanwhile, there are meetings and deadlines that await. So here are some interesting items to help you along. Have a great day and do stay in touch… Pfizer To Move Antibacterials Research To Shanghai (The Day) Abbott CEO Compensation Fell 2.5 Percent Last Year (Dow Jones) DEA Seizes Execution Drug In Georgia (Associated Press) Japan Nuclear Catastrophe Spurs Debate Over Radiation Pills (Bloomberg News) Those $4 Rx Programs Can Save US Billions (Reuters) Cephalon Sues US Over Fentora Generic Approval (Bloomberg News) Aegerion Receives Orphan Status For Lipid D... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4600798 Wed, 16 Mar 2011 11:53:04 +0100 4600798 http://www.medworm.com/index.php?rid=4592688&cid=t_100576_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=4575246&cid=t_100576_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FDiD_H2Gzp3I%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 MCS Healthcare Public Relations promoted Brian Thompson to senior vp, which means he will also join the agency’s executive committee. For the past five years, he has worked with several drugmakers to promote meds in various therapeutic areas,... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4575246 Fri, 11 Mar 2011 12:39:14 +0100 4575246 http://www.medworm.com/index.php?rid=4570761&cid=t_100576_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FzGaMvXkB8L0%2F After weeks of anticipation and furious lobbying, Canada’s House of Commons passed a bill called C-393, which was designed to allow generic versions of patented AIDS meds to be sent to developing countries. The bill was conceived to amend a 2004 law called Canada’s Access to Medicines Regime, which proved ineffective. Since its passage six years ago, only one license was ever issued and this involved exporting just one order of an AIDS med to Rwanda. However, the legislation, which the pharmaceutical industry has fought over concerns that intellectual property rights would be undermined, still has another hurdle to clear, because it must still be approved by the Senate before becoming law. And the Senate is controlled by the Conservative Party, and supporters are now ramping up th... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4570761 Thu, 10 Mar 2011 14:01:41 +0100 4570761 http://www.medworm.com/index.php?rid=4570762&cid=t_100576_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FP1ew3fxxnEE%2F Every so often, a new approval generates significant attention. And the FDA endorsement of Benlysta, the first new treatment for lupus in 56 years, is one of those moments. The injectable med, which will be marketed by Human Genome Sciences and GlaxoSmithKline, is forecast to generate at least $2 billion in annual sales thanks to a $35,000 price tag, despite cautionary language for certain patients. The med, which will actually about cost $40,000 in the first year, will become available later this month. There is no REMS requirement or Black Box warning, which heartened Wall Street. Nonetheless, insurance reimbursement remains somewhat fuzzy. Meanwhile, Human Genome Sciences agreed to conduct another clinical trial in African-American lupus patients. Here’s why… “As expec... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4570762 Thu, 10 Mar 2011 13:40:03 +0100 4570762 http://www.medworm.com/index.php?rid=4570763&cid=t_100576_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FNmT5C8tDVOY%2F Hello, everyone, and nice to see you again. A spot of rain is falling on the Pharmalot corporate campus, but our spirits remain sunny thanks to the Morning Mayor, who would always 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 help us scan the news of the world. Hope your day goes well and do stay in touch… FDA Approves First New Lupus Drug In 56 Years (Associated Press) Vertex Moves Ahead With Epilepsy Drug (Boston Business Journal) J&J Hip Replacement Has 49 Percent UK Failure Rate (Bloomberg News) Epizyme And Eisai Form A Partnership (Boston Globe) FDA OKs Hospira Generic Of Taxotere Cancer Med (Reuters) Quintiles Eyes More Deals With Credit Facility (Outsourcing Phar... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4570763 Thu, 10 Mar 2011 12:59:47 +0100 4570763 http://www.medworm.com/index.php?rid=4549940&cid=t_100576_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fb1ZPBPi-rZM%2F And so another work week will soon draw to a close. This means, of course, that the time has come to daydream about weekend plans. Our agenda includes watching our shortest person in a martial arts tournament, dancing with Mrs. Pharmalot to cajun music, promenading with the official Pharmalot mascots and, as usual, catching up on sundry chores. What about you? Perhaps there will be time to see a picture show? Update your Facebook page? Get a jump on spring cleaning? Whatever you do, have fun. Meanwhile, here is the news of the world. See you soon… FDA Strengthens Birth Defect Warning For Topamax (Associated Press) Organon Workers Protest Merck Plan To Shut Plant (DutchNews) High-Profile Lawyer Sentenced For Running Internet Pharmacy (Miami Herald) Pfizer To Help Aurobindo With FDA Pr... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4549940 Fri, 04 Mar 2011 13:07:31 +0100 4549940 http://www.medworm.com/index.php?rid=4545252&cid=t_100576_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FgKTyXRkHZp0%2F For those who wonder why drugmakers shy away from head-to-head studies, consider the plight of Amylin Pharmaceuticals, Eli Lilly and Alkermes. A newly released study shows their forthcoming Bydureon diabetes med - a once-weekly injectable that is designed to supplant the twice-a-day Byetta - failed to lower blood sugar as effectively as a rival drug, Novo Nordisk’s Victoza. The results are causing investors to pound Amylin stock - shares were down about 25 percent all morning - as some analysts now question the ability of the drugmakers to successfully win FDA approval for the med anytime soon. The agency, you may recall, last year requested more info on manufacturing and a risk mitigation plan. Meanwhile, Victoza has been available more than a year. The bottom line: Patients who too... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4545252 Thu, 03 Mar 2011 20:18:12 +0100 4545252 http://www.medworm.com/index.php?rid=4545255&cid=t_100576_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fj7-yb8Q-oVg%2F Rise and shine, everyone, another shiny day is on the way. What lies in store? Meetings and deadlines, no doubt, and we relate. To cope, we are brewing our mandatory cup of stimulation and invite you to join us. Meanwhile, we will pause to hustle one of the short people off to the local schoolhouse. So here are a few tidbits. Also, please note that we posted some items last night, but placed them above our morning greeting in the event some people did not see them. Have a great day and stay in touch… Traditional Drug Discovery Model Is Ripe For Reform (Nature) McKesson Fights $212M Pricing Fine Levied By Arizona (Courthouse News) Lilly To Outsource Bioanalytical Work (Pharma Times) Eisai To Cut 900 Jobs Over Five Years (Bloomberg News) Panel Told No Guarantees Against Unethical Resea... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4545255 Thu, 03 Mar 2011 12:00:30 +0100 4545255 http://www.medworm.com/index.php?rid=4532568&cid=t_100576_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F0FTiBAYhJQY%2F In December 2003, Abbott Labs raised the price of its Norvir AIDS drug, which is commonly used in HIV drug cocktails, by 400 percent, infuriating the AIDS community. But patients were not the only ones who were angered - GlaxoSmithKline, the Rite-Aid pharmacy chain and several wholesalers claim Abbott wanted to crowd them out of the market and a trial has just begun over $1.5 billion in damages. Abbott sells a combo pill called Kaletra that includes Norvir and its own protease inhibitor. The lawsuit claims Abbott raised Norvir’s price - but not the Kaletra price - 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 over the market for protease inhib... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4532568 Tue, 01 Mar 2011 13:39:15 +0100 4532568 http://www.medworm.com/index.php?rid=4532214&cid=t_100576_87_f&fid=39261&url=http%3A%2F%2Fvactruth.com%2F2011%2F03%2F01%2Fthe-2009-pandemic-flu-conspiracies-investigation%2F Excerpted from Vaccines & Vaccinations: The Need for Congressional Investigation, Co-editors: Catherine J Frompovich and Laraine C Abbey-Katzev. Entire free pdf available by email request to: cfj@catherinejfrompovich.com   Conflict of Interest   The 2009 Pandemic Flu “Conspiracies” Investigation WHO and the Pandemic Flu “conspiracies” British Medical Journal 3 June 2010 A joint investigation by the BMJ and the Bureau of Investigative Journalism has uncovered evidence that raises troubling questions about how WHO managed conflicts of interest among the scientists who advised its pandemic planning, and about the transparency of the science underlying its advice to governments. Was it appropriate for WHO to take advice from experts who had declarable financial and resear... vactruth.com blogs http://www.medworm.com/rss/comments.php?id=4532214 Tue, 01 Mar 2011 13:26:23 +0100 4532214 http://www.medworm.com/index.php?rid=4532569&cid=t_100576_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FyUS59WunmL4%2F About 6,000 ‘blue chip’ jobs are leaving the UK as Pfizer, Glaxo and AstraZeneca gradually shutter operations. The development hit home when Pfizer recently decided to close its Sandwich facility, eliminating 2,400 positions, a move that came just after weeks the government claimed pharma is a big part of the future (see here and here). But many jobs will eventually find their way to other shores which are more competitive, according to Thom Thorp of Eli Lilly. “I’m concerned about the future of pharma in the UK ….” Confederation British Industry director general John Cridland tells the UK’s Channel 4. “I think government has taken the sector a little bit for granted. I’ll say it on behalf of the sector. They need to feel loved and wanted. The UK is n... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4532569 Tue, 01 Mar 2011 13:03:55 +0100 4532569 http://www.medworm.com/index.php?rid=4532571&cid=t_100576_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=4517349&cid=t_100576_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F4_NEzIn-bR0%2F In an interesting bit of legal jousting, former Glaxo lawyer Lauren Stevens is demanding that the feds name any and all Glaxo lawyers - whether their are legal staffers or outside counsel - who may somehow be complicit in obstructing an FDA probe into off-label marketing of the Wellbutrin SR antidepressant. Stevens, you may recall, was the only person indicted on this charge last November (here is the indictment). Recently, Stevens indicated in court filings that she received advice from other Glaxo lawyers, including the King & Spalding law firm that regularly works for the drugmaker. The feds, however, argue this is not a kosher defense and that such a maneuver would confuse a jury, because lawyers with whom she conferred would, effectively, be asked to offer opinions, not actual ex... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4517349 Thu, 24 Feb 2011 16:25:01 +0100 4517349 http://www.medworm.com/index.php?rid=4512613&cid=t_100576_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fc--MjGyqugU%2F Earlier this month, a Medicaid managed care provider in Ohio agreed to pay $26 million to settle a whistleblower lawsuit brought by former employees, who alleged that assessments of adults and children with special needs were never conducted, but data was submitted anyway to the state Medicaid program for reimbursement. What has this episode to do with drugmakers? Well, the state of Ohio collected $10 million of the total $26 million paid by CareSource, the managed care provider. And Ohio attorney general Mike DeWine then bemoaned publicly that the state would have received more money if there was a False Claims Act statute on its books (look here). In general, such a law would allow Ohio to collect a bigger payday each time it participates in a whistleblower settlement. And in an era of i... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4512613 Wed, 23 Feb 2011 16:28:43 +0100 4512613 http://www.medworm.com/index.php?rid=4501788&cid=t_100576_140_f&fid=35772&url=http%3A%2F%2Fshutah.wordpress.com%2F2011%2F02%2F20%2F2011-ssri-related-deaths%2F It’s Sunday, 20 February 2011 51 days into the year 43 incidents listed already   SSRI Related Deaths 2011   Does anyone care? HOW LONG MUST THIS LIST GET BEFORE GOVERNMENTS AND PHARMACEUTICAL COMPANIES ACKNOWLEDGE THE GLOBAL PROBLEMS SURROUNDING SSRIs? IT’S NOT ABOUT MONEY, STOCKS, SHARES! IT’S ABOUT HUMAN LIFE STOP * LOOK * LISTEN [...] (Source: SEROXAT WEBLOG) SEROXAT WEBLOG blogs http://www.medworm.com/rss/comments.php?id=4501788 Sun, 20 Feb 2011 11:25:12 +0100 4501788 http://www.medworm.com/index.php?rid=4495401&cid=t_100576_140_f&fid=35772&url=http%3A%2F%2Fshutah.wordpress.com%2F2011%2F02%2F19%2Fcrusaders-highly-deserved-recognition%2F Surely, one of the proudest moment’s in Bob Fiddaman’s quest for justice in the eternal fight against SSRI’s . As Bob writes in his blog “What could piss off GlaxoSmithKline more than Bob Fiddaman getting an award for basically highlighting their dark history?” Way to go Fiddy!!!!!! [Click the pic to read the full story] [...] (Source: SEROXAT WEBLOG) SEROXAT WEBLOG blogs http://www.medworm.com/rss/comments.php?id=4495401 Sat, 19 Feb 2011 10:00:57 +0100 4495401 http://www.medworm.com/index.php?rid=4489976&cid=t_100576_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FDU0KCuEeJA8%2F Yet another state attorney general has filed a lawsuit charging GlaxoSmithKline with fraudulently marketing its controversial Avandia diabetes pill. This time, Louisiana Attorney General Buddy Caldwell has gone to court; a few months earlier, his counterpart in Utah did the same (back story). At issue is the allegation that the drugmaker knowingly marketed a pill that caused harm to citizens, leading a state Medicaid program to dramatically overpay. In the lawsuit, Louisiana’s AG claims his state’s Medicaid program paid Glaxo approximately $36 million for “fraudulently induced Avandia reimbursements” since 1999, due to “grossly excessive prices” charged by the drugmaker for a medication that was described as “life-threatening, medically unnecessary... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4489976 Thu, 17 Feb 2011 13:39:28 +0100 4489976 http://www.medworm.com/index.php?rid=4489977&cid=t_100576_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FTtqj3J1HvPI%2F Hello and nice to see you again. Having successfully deposited one of the short people at the local schoolhouse, we are celebrating with yet another cup of stimulation. Please join us or grab a bottle of water, if you prefer, and get ready for another day of meetings and deadlines and who-knows-what-else. Meanwhile, here are some fresh tidbits. Have a good one and stay in touch… China To Help Domestic Drugmakers Expand Overseas (Global Times) AstraZeneca Pays $150M To Settle More Seroquel Lawsuits (Bloomberg News) Amgen Haunted By Medicare Worries (Forbes) Glaxo Cuts Neuroscience Jobs In North Carolina (MedCity News) UK’s NICE Endorses Celgene Blood Cancer Med (Reuters) Allergan Wins Wider Use For Lap-Band Device (Wall Street Journal) EU Parliament Approves Tougher Counterfeit ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4489977 Thu, 17 Feb 2011 13:03:30 +0100 4489977 http://www.medworm.com/index.php?rid=4478154&cid=t_100576_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FsV05nxGEdwk%2F In the latest twist in the ongoing battle over sales reps and overtime pay, a federal appeals court yesterday ruled that two Glaxo reps are exempt from relevant provisions of the Fair Labor Standards Act and, therefore, should not be paid overtime. The decision affirms a lower court ruling issued in November 2009 (which you can read here) and, significantly, contradicts a US Labor Department brief filed in this and other cases supporting overtime pay for sales reps (read the brief here). The latest decision suggests, once again, that the issue could eventually reach the US Supreme Court, since courts across the country have been so divided. Last summer, the US Court of Appeals for the Second Circuit ruled that Novartis reps are entitled to overtime (back story). Here is a primer: The FLSA�... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4478154 Tue, 15 Feb 2011 13:22:14 +0100 4478154 http://www.medworm.com/index.php?rid=4464700&cid=t_100576_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FfOGdCiWoKCM%2F Three years ago, a study was published in the Neurology journal indicating that excessive use of denture adhesive creams containing zinc can cause serious neurologic disease and a deficiency of copper. However, the study was actually completed two years earlier, but publication was delayed thanks to a peer reviewer, who allegedly had ties to Procter & Gamble, which sells Fixodent, one of the widely used denture creams. In his review, Kenneth Shay, a dentist, called any link between excessive use of denture cream and neurological disease “little more than speculation,” and carped that the study authors “don’t understand the nature of the material they are writing about,” according to an ABC News report, which aired the other evening and noted that Shay was... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4464700 Fri, 11 Feb 2011 18:07:45 +0100 4464700 http://www.medworm.com/index.php?rid=4464703&cid=t_100576_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FXls5p_i7mWo%2F After publicly chastisting the pharmaceutical industry for failing to partipicate in the Medicines Patent Pool, which is an initiative designed to streamline patent licensing for producing generics of patented HIV neds and lower prices in poor countries, several drugmakers are now holding talks about licensing arrangements. Among those in negotiations are Gilead Sciences, Sequoia Pharmaceuticals and ViiV Healthcare, a joint venture between Pfizer and GlaxoSmithKline, according to a statement from MPP, which adds that Roche is about to do the same. Non-committal replies, however, were received from Bristol-Myers Squibb, Abbott Laboratories and Boehringer-Ingelheim, while Merck rejected any arrangement. The responses come after MPP, which received a boost when the National Institutes for Hea... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4464703 Fri, 11 Feb 2011 14:13:16 +0100 4464703 http://www.medworm.com/index.php?rid=4455483&cid=t_100576_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FaOtUw--GIO0%2F Three months ago, former GlaxoSmithKline attorney Lauren Stevens was indicted for allegedly obstructing an FDA probe into off-label marketing of Wellbutrin SR. More recently, she filed an interesting motion indicating she will argue in court that King & Spalding, a major law firm that works for Glaxo, had provided her with advice while she was employed by the drugmaker (see here and here). The motion raised the delicious spectacle of a courtroom filled with attorneys all pointing fingers at one another (a situation ripe for a sitcom, perhaps). Not surprisingly, the feds indicated they would attempt to prevent Stevens from mounting a defense that lays blame on other lawyers - whether they were Glaxo staffers or outside counsel. As far as the feds are concerned, Stevens is the culprit. ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4455483 Wed, 09 Feb 2011 16:08:22 +0100 4455483 http://www.medworm.com/index.php?rid=4455486&cid=t_100576_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FuT2spYvGiGQ%2F Pfizer has agreed to pay about $330 million to settle more than 2,200 lawsuits charging its Prempro hormone replacement therapy caused women to develop breast cancer, embracing a strategy used by several other drugmakers to cap the cost of growing product-liability litigation that can worry investors. The cases settled for an average of about $150,000, according to Bloomberg News, which first reported the settlement, although a Pfizer spokesman disputed the figures. The move came after a Pennsylvania appeals court reinstated $1.7 million in compensatory damages and $8.6 million in punitive damages against Pfizer in a lawsuit filed by an Arkansas woman, who alleged its Wyeth unit failed to warn that Prempro could cause her to develop breast cancer. The settlement comes just weeks after Ian ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4455486 Wed, 09 Feb 2011 13:09:42 +0100 4455486 http://www.medworm.com/index.php?rid=4450519&cid=t_100576_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F9T71D5oU0mg%2F After reviewing data generated by researchers from Finland, the World Health Organization agrees that a curious link between the GlaxoSmithKline pandemic flu vaccine and narcolepsy should be investigated. And so the European Centre for Disease Prevention and Control is now conducting epidemiological studies of narcolepsy and pandemic influenza vaccines…plural. The move comes after Finland’s National Narcolepsy Task Force last week reported an increased risk of narcolepsy among 4 to 19-year-olds who were vaccinated with Glaxo’s Pandemrix. A similar increase in cases have also been reported in Sweden and Iceland. However, the Finnish researchers conceded the findings were inconclusive and more research was needed (look here). The report generated controversy not only because of... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4450519 Tue, 08 Feb 2011 16:20:21 +0100 4450519 http://www.medworm.com/index.php?rid=4450523&cid=t_100576_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FujKHiAQXNLE%2F Hello, everyone, and welcome to a brand new day. Here on the Pharmalot corporate campus we are getting our start by hustling our short people off to the local school houses. And you? No doubt, you are readying for another round of meetings and deadlines. To help you along, we have gathered some tidbits. Meanwhile, please join us for a cup of stimulation. Hope your day goes well and stay in touch… Merck-Serono Opens R&D Site, Adding 100 Jobs (Boston Business Journal) Roche’s Avastin Works In Late-Stage Trial For Ovarian Cancer (Reuters) Teva Earnings Miss Analyst Estimates (Bloomberg News) Has RNAi Fever Cooled? (The New York Times) Black Box Warnings Are Applied Inconsistently (Health Day) Glaxo To Move Philadelphia Offices, Denies Job Cuts (Philadelphia Inquirer) Schizoph... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4450523 Tue, 08 Feb 2011 13:06:18 +0100 4450523 http://www.medworm.com/index.php?rid=4436943&cid=t_100576_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F0k6J1WAEXRY%2F And so, another working week will soon draw to a close. This means, of course, that we can begin daydreaming about weekend activities. Our agenda includes taking the shortest of short people to the bowling alley, watching a big soccer match from the UK with short person No. 2 and dining out with Mrs. Pharmalot, not necessarily in that order. What about you? Catch up on some reading, perhaps, or maybe take in a good movie? What about visiting the hardware store to replace your worn out shovel? Whatever you do, have a good time and be safe. Meanwhile, here are some tidbits. See you soon… Hedge Fund Wants Actelion CEO To Quit (Reuters) Vanda’s Vanapt Falls Flat (The Street) Pfizer Employees In Manila Upset Over Labor Negotiations (Bulatlat) MicroChips Starts First Clinical Trial I... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4436943 Fri, 04 Feb 2011 12:53:04 +0100 4436943 http://www.medworm.com/index.php?rid=4433330&cid=t_100576_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FZnvAWxo_J08%2F Rise and shine, everyone. Another day is on the way. And here on the frosty Pharmalot corporate campus we are bounding with energy thanks to the ritual cup of stimulation, or three. The special flavor today is Golden French Toast. Of course, this makes it all the more possible to hunt down those interesting tidbits. Here are a few to help you get started. Hope your day goes well and do stay in touch… Komen Advocacy Group Is Cautious On Avastin (Wall Street Journal) Merck 2011 Misses Estimate And Takes $1.7M Drug Write-Off (Bloomberg News) Teva Receives FDA Warning Letter For Jerusalem Plant (Reuters) Merck’s Gardasil Prevents HPV And Genital Warts In Men (Bloomberg News) Glaxo Profits Slump On Legal Costs And Avandia Slowdown (PharmaTimes) Painkiller Prescription Errors Due To ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4433330 Thu, 03 Feb 2011 13:12:59 +0100 4433330 http://www.medworm.com/index.php?rid=4424442&cid=t_100576_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FXAVTiWtRAPo%2F Five months after the European Medicines Agency began a review of the GlaxoSmithKline pandemic vaccine over ties to narcolepsy, the World Health Organization is doing the same. The impetus is a report from Finnish researchers who found an increased risk of narcolepsy among 4 to 19-year-olds who were vaccinated with Pandemrix. A study by Finland’s National Narcolepsy Task Force indicates vaccination “contributed to the observed increase in incidence of narcolepsy” compared to those in the same age group who were not given Pandremix. However, report also suggested the increase was likely due to a “joint effect of the vaccine and some other factor.” Consequently, more research is needed, since a similar increase has not been reported in other countries, except fo... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4424442 Tue, 01 Feb 2011 16:46:02 +0100 4424442 http://www.medworm.com/index.php?rid=4424446&cid=t_100576_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F9T5uMwVXXjQ%2F The list of product web sites that manage to get consumers to actually do something contains some very familiar names, such as Viagra, Nexium, Yaz and Lunesta. Of course, these are used to treat rather common concerns and all have, at one time or another, been widely advertised. Yet they also share something else in common - often, coupons are available, according to a recent survey that found, on average, 74 percent of consumers took some type of action after visiting a product web site. In other words, coupons appear to act as a motivator for following up in some fashion. “One thing we see when looking at satisfaction in years past is that there seems to be a high correlation beween satisfaction and a coupon,” says Meredith Ressi, president of Manhattan Research, which canvas... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4424446 Tue, 01 Feb 2011 14:04:32 +0100 4424446 http://www.medworm.com/index.php?rid=4419448&cid=t_100576_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FpH4MJviIAEo%2F A 51-year-old father of two children plans to file a lawsuit in a French court tomorrow because the GlaxoSmithKline drug he took to treat his Parkinson’s disease caused him to develop impulse control disorders. Specifically, he became hooked on gay sex and gambling. The med in question is Requip, which is known to cause compulsive behaviors (see this). But lawyers for Didier Jambart tell Agence France Presse that he began taken Requip in 2003 and stopped two years later, but that an appropriate warning did not appear on the package insert until 2006. By then, he had attempted suicide three times, allegedly became addicted to Internet gambling, lost his family savings, and stole to feed his habit. He also exposed himself on the Internet and took to cross-dressing. And finally, at leas... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4419448 Mon, 31 Jan 2011 22:29:57 +0100 4419448 http://www.medworm.com/index.php?rid=4419409&cid=t_100576_140_f&fid=35772&url=http%3A%2F%2Fshutah.wordpress.com%2F2011%2F01%2F31%2Fgsk-gives-in-last-minute-deal-in-avandia-suit%2F A federal court in Philadelphia was all set to hear a liability lawsuit against GlaxoSmithKline today, but an 11th-hour settlement took that case right off the docket. GSK made a deal with the family of Avandia patient James Burford to resolve claims that the diabetes drug caused his fatal heart attack. GSK recently took a $3.5 [...] (Source: SEROXAT WEBLOG) SEROXAT WEBLOG blogs http://www.medworm.com/rss/comments.php?id=4419409 Mon, 31 Jan 2011 18:21:31 +0100 4419409 http://www.medworm.com/index.php?rid=4419453&cid=t_100576_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FXql_GCjRfw8%2F Welcome to the working week. We hope your weekend was refreshing and relaxing. Now, of course, the time has come to resume the routine of meetings and deadlines. To cope, we are, once again, armed with a cup of stimulation - our flavor today is chocolate raspberry truffle - and invite you to join us. Meanwhile, here are some interesting tidbits to begin the day. Hope your day goes well and do stay in touch. We enjoy hearing what goes on in your world… FDA OKs Novartis Meningitis Vaccine In Children, No Infants (Bloomberg News) Radiologist Wins $482M In Stent Patent Suit Against J&J (Star-Ledger of NJ) Pfizer Order To Pay $142M Over Neurontin Marketing Is Upheld (MarketWatch) Glaxo Settles Avandia Suit On Eve Of Trial (Bloomberg News) Dr. Reddy’s Gets Court Approval To Sell... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4419453 Mon, 31 Jan 2011 12:51:11 +0100 4419453 http://www.medworm.com/index.php?rid=4411722&cid=t_100576_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FNXZC9JGOTcQ%2F In a bid to make HIV meds more accessible to poor countries, the Tibotec unit of Johnson & Johnson yesterday announced a licensing deal with several generic drugmakers to manufacture, market and distribute an investigational an HIV med in India, sub-Saharan Africa and Least Developed Countries (which ones are these, you ask? Here is the list). The drug in question is a non-nucleoside reverse transcriptase inhibitor. The generic drugmakers, including Hetero Drugs, Matrix Laboratories and Aspen Pharmacare, will be entitled to manufacture a once-daily 25 mg version of Tibotec’s TMC278 as a single agent med and a fixed-dose combo product. In exchange, the companies will pay royalties of two percent to five percent, limit their gross profit margins and will be responsible for regulat... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4411722 Fri, 28 Jan 2011 13:23:59 +0100 4411722 http://www.medworm.com/index.php?rid=4411725&cid=t_100576_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fm_6xhh7VWFQ%2F And so another week will soon draw to a close, which means the time has come to daydream, just a little, about the weekend. Anything special planned? We hope to catch up on our reading and spend time with Mrs. Pharmalot. And we also want to kvell since one of our short people is celebrating another milestone. How about you? Will you take in a movie? Find a good restaurant? Buy a new shovel, perhaps? Whatever your fancy, have a great time, and be safe. Meanwhile, here are some tidbits. See you soon… New Cypress Bioscience Owners Oust CEO (San Diego Union Tribune) Glaxo And Actelion End Development Of Insomnia Pill (Bloomberg News) Bayer And Zydus Cadila Form JV To Sell Drugs In India (Business Standard) Sanofi-Aventis Cancer Drug Has Little Effect In Study (Associated Press) Are Cipla... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4411725 Fri, 28 Jan 2011 13:14:21 +0100 4411725 http://www.medworm.com/index.php?rid=4406036&cid=t_100576_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FQi1kO4OIQZc%2F Hello, everyone. And how are you today? Yet another pile of snow has descended on the Pharmalot corporate campus, where we have a shovel in one hand and a cup of stimulation in the other. Nonetheless, we will not be deterred from foraging for interesting news and assorted developments. And so here are a few tidbits to get us all started. Enjoy, and we hope your day goes well… AstraZeneca To Double Stock Buybacks Amid Drug Setbacks (Bloomberg News) Lilly Profit And Sales Beat Wall Street Forecasts (Reuters) Off-Label Prescribing To Children Is Widespread In Europe (PharmaTimes) FDA Denies Additional Indication For Glaxo’s Avodart (Reuters) Data Exclusivity Remains Hurdle To EU-India Free Trade Deal (Business Standard) Novartis Profit Falls And Vaccine Sales Slide (Bloomberg News... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4406036 Thu, 27 Jan 2011 12:56:53 +0100 4406036 http://www.medworm.com/index.php?rid=4399822&cid=t_100576_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FYUnyDo-9nKo%2F For the past year, several big drugmakers have been embracing Russia as one of the next emerging markets in which to invest. Sanofi-Aventis, AstraZeneca, GlaxoSmithKline, Novartis, Novo Nordisk, Nycomed, Pfizer and Servier, among others, have previously announced intentions or are possible plans to establish or expand manufacturing facilities there (back story). But apparently few are moving fast enough for Prime Minister Vladimir Putin, who issued what amounts to a warning on the Russian government website to drugmakers that do not help expand the domestic market: “There will be restrictions for (global drugmakers) in the Russian market if they do not launch production and transfer technology,” according to In-Pharma Technologist. Then, sounding a little bit like a watchdog from a... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4399822 Wed, 26 Jan 2011 14:10:22 +0100 4399822 http://www.medworm.com/index.php?rid=4399825&cid=t_100576_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fix8D3iySYW0%2F Good morning, everyone. Yet another snowy day here on the picturesque Pharmalot corporate campus, where we are arming ourselves with numerous shovels and cups of stimulation. Nonetheless, we intend to maintain the usual flow of interesting items and, with that in mind, here are a few tidbits to get you going. Hope your day goes well and stay in touch… Mitsubishi Tanabe Recalls Injectables Not Properly Tested (Bloomberg News) The Man Who Sold Maximuscle To Glaxo (The Daily Mail) Pfizer And Progenics Recall Relistor Injection Kits (Bloomberg News) Servier Founder Quits As Head Of Industry Group (Pharma Times) Allegra Is Approved For Over The Counter (Boston Globe) SinoPharm Plans $760M In Acquisitions (Bloomberg News) FDA Wants Data On Gilead-Tibotec HIV Drug (San Francisco Business Ti... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4399825 Wed, 26 Jan 2011 13:09:09 +0100 4399825 http://www.medworm.com/index.php?rid=4399798&cid=t_100576_140_f&fid=35772&url=http%3A%2F%2Fshutah.wordpress.com%2F2011%2F01%2F25%2Fglaxo-avandia-settlement-latest-news%2F Oh Dear!!  GSK in the spotlight a lot this week. Reports said Monday thatGlaxoSmithKline is bound to face a multi-district litigation amounting to an estimated $3.4 billion against its anti-diabetes drug, Avandia. According to the reports, a number of pending litigations against Avandia, an oral anti-diabetic agent which acts primarily by increasing insulin sensitivity, are filed in different states [...] (Source: SEROXAT WEBLOG) SEROXAT WEBLOG blogs http://www.medworm.com/rss/comments.php?id=4399798 Tue, 25 Jan 2011 22:15:04 +0100 4399798 http://www.medworm.com/index.php?rid=4399799&cid=t_100576_140_f&fid=35772&url=http%3A%2F%2Fshutah.wordpress.com%2F2011%2F01%2F25%2Fgsk-pulls-ed-ads-to-help-rehab-its-image%2F Whoopy bloody dooooo!!!  Not before time that they [GSK] started to take some responsibility for their actions (inactions)!!!! GlaxoSmithKline is pulling ads for its erectile dysfunction drug Levitra. And it’s making a big show of that choice; North American President Deirdre Connelly said it’s part of the company’s new push to be more transparent and [...] (Source: SEROXAT WEBLOG) SEROXAT WEBLOG blogs http://www.medworm.com/rss/comments.php?id=4399799 Tue, 25 Jan 2011 20:53:33 +0100 4399799 http://www.medworm.com/index.php?rid=4394745&cid=t_100576_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F_7QrOOCsZeA%2F For those of you who like to play connect the dots, consider that shortly before US Health & Human Services Secretary Kathleen Sebelius crowed yesterday about her department recovering billions from healthcare fraud last year (watch this), the head of GlaxoSmithKline’s US pharma business addressed this trend before a crowd of pharma execs and attorneys by rhetorically asking: “What’s going on? Why is this happening?” The timing was precious. The HHS, which is looking to score points on Capitol Hill for its healthcare fraud initiative, could hardly have overlooked that a two-day pharma industry conference devoted to compliance is being held nearby. Of course, Glaxo’s Deidre Connelly had her own agenda - she used her speech as a carefully calibrated opportunity... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4394745 Tue, 25 Jan 2011 13:24:16 +0100 4394745 http://www.medworm.com/index.php?rid=4394749&cid=t_100576_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F1ZHiWpuTtoc%2F A decade ago, the Journal of the American Academy of Child and Adolescent Psychiatry published a paper concluding the Paxil antidepressant, which is sold by GlaxoSmithKline, was “generally well tolerated and effective for major depression in adolescents.” But the study has since been discredited amid charges that primary and secondary outcomes were conflated, selective results were reported and ghostwriting was involved (background here and here). The details became known more than two years ago as documents emerged from investigations (see this) and lawsuits charging GlaxoSmithKline hid the risks of its Paxil pill. By then, the FDA required Glaxo to place a Black Box warning about suicidality in youngsters and UK regulators recommended the drug not be given to those under 18 years... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4394749 Mon, 24 Jan 2011 14:46:52 +0100 4394749 http://www.medworm.com/index.php?rid=4386438&cid=t_100576_140_f&fid=35772&url=http%3A%2F%2Fshutah.wordpress.com%2F2011%2F01%2F22%2Fpossible-legal-action-quote-from-10-years-ago%2F Sarah Boseley, health editor The Guardian, Monday 10 December 2001 10.15 GMT More than 60 people in Britain who say they have become hooked on the anti-depressant Seroxat – a drug in the Prozac class – are exploring the possibility of legal action against the pharmaceutical company which they claim failed to warn doctors that [...] (Source: SEROXAT WEBLOG) SEROXAT WEBLOG blogs http://www.medworm.com/rss/comments.php?id=4386438 Sat, 22 Jan 2011 22:50:21 +0100 4386438 http://www.medworm.com/index.php?rid=4382938&cid=t_100576_140_f&fid=35772&url=http%3A%2F%2Fshutah.wordpress.com%2F2011%2F01%2F21%2Fresearchers-call-on-journal-to-retract-notorious-paxil-study%2F Researchers call on journal to retract notorious Paxil study The retraction of questionable scientific papers seems to be on the rise, due in large part to increased media scrutiny of scientific misconduct and conflicts of interest among researchers who fail to disclose they have skin in the game, i.e. lucrative financial ties to the drug and medical device companies whose products they are studying. Indeed, retractions are becoming so common that Ivan Oransky,executive editor of Reuters Health News, has started a popular new blog called Retraction Watch.Sad to say, actual retractions may be the tip of the iceberg. Consider the 2001 study of Paxil in adolescents, the subject of the book, Side Effects. According to a recent article in theBritish Medical Journal, two academic researchers... SEROXAT WEBLOG blogs http://www.medworm.com/rss/comments.php?id=4382938 Fri, 21 Jan 2011 23:13:26 +0100 4382938 http://www.medworm.com/index.php?rid=4377787&cid=t_100576_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=4372233&cid=t_100576_140_f&fid=35772&url=http%3A%2F%2Fshutah.wordpress.com%2F2011%2F01%2F19%2Fglaxo-stung-by-legal-bill%2F GSK shareholders are hit by costly legal settlements. If big really is beautiful, then you don’t get much more attractive than pharmaceutical giantGlaxoSmithKline Glaxo the global giant By any measure, GSK is a powerhouse. The world’s fourth-largest drug-maker recorded annual sales of over £28 billion in 2009 and posted a post-tax profit of £5.7 billion. GSK employs nearly 100,000 people and paid over £2.2 billion in corporate taxes last year, so it’s one of the biggest corporate contributors to HM Treasury’s coffers. Furthermore, with a market capitalisation of over £61 billion, the blue-chip firm’s shares are very widely held, featuring at the heart of many UK-focused portfolios, both private and institutional. So, when GSK stumbles, it has an impact on ... SEROXAT WEBLOG blogs http://www.medworm.com/rss/comments.php?id=4372233 Wed, 19 Jan 2011 23:59:09 +0100 4372233 http://www.medworm.com/index.php?rid=4372249&cid=t_100576_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F0MCrR9F3g5k%2F Hello, everyone. Gray skies are enveloping the Pharmalot corporate campus this morning, but our spirits remain sunny. Why? Every so often we like to remind you of what the Morning Mayor would say: Every brand new day should be unwrapped like a precious gift. While you tug on the ribbon, please join us for a cup of stimulation and a gander at the news of the world. Hope your day goes well and drop us a line if you spot something interesting. Cheers… Pfizer Strikes Antibody Deal With Theraclone (New York Times) The Pfizer Model For Hiring Law Firms, A Year Later (American Lawyer) Roche Responds To The FDA Over Avastin (San Francisco Business Times) UK’s NICE Changes Mind Over Alzheimer’s Drugs (The Telegraph) Roche Melanoma Drug Helps Patients Live Longer: Study (Reuters) D... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4372249 Wed, 19 Jan 2011 12:49:23 +0100 4372249 http://www.medworm.com/index.php?rid=4361281&cid=t_100576_140_f&fid=35772&url=http%3A%2F%2Fshutah.wordpress.com%2F2011%2F01%2F18%2Flegal-no-go-area%2F Is this fair? The BBC has been told that Legal aid cuts will make it impossible to challenge pharmaceutical companies in the courts. The government plans to cut the legal aid budget by £350m which means lawyers representing claimants against drug companies will be unlikely to get funding in England and Wales. The current alternative is a mixture of no-win no-fee agreements with lawyers, and insurance against a patient losing and being liable for the winning side’s substantial costs. The government is currently consulting on its proposals and insists reforms will be fair. Listen to the programme and share your comments below. Thank you. Tagged: Big Pharma, GlaxoSmithKline, GSK, Litigation, Paxil, Seroxat (Source: SEROXAT WEBLOG) SEROXAT WEBLOG blogs http://www.medworm.com/rss/comments.php?id=4361281 Tue, 18 Jan 2011 21:06:09 +0100 4361281 http://www.medworm.com/index.php?rid=4360928&cid=t_100576_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2011%2F01%2Fim-not-here-to-sell-drugs-then-why-use.html In October, 2010, we discussed a series of reports by Pro Publica and multiple other respected news organizations about payments by seven pharmaceutical companies to thousands of doctors.  Industry often claims that they only pay the best and the brightest physicians and academics to provide education relevant to their products.  However, the ProPublica et al report suggested that they mainly recruited physicians who already showed their favor to their products by prescribing them often, but soothed their consciences by dubbing them "thought leaders" or "key opinion leaders."  While some of the physicians were well-known academics, others had notably blemished records.  Since then, news media around the US have looked into interactions among local physici... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=4360928 Tue, 18 Jan 2011 17:59:00 +0100 4360928 http://www.medworm.com/index.php?rid=4361307&cid=t_100576_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F68N9TIKTP08%2F Misbehavior may be considered a cost of doing business in some quarters, but the numbers are beginning to add up at GlaxoSmithKline. The drugmaker is now taking a $3.4 billion charge to cover the cost of product-liability litigation and investigations into its handling of the controversial Avandia diabetes pill, which European regulators banned last fall, while the FDA opted for tougher marketing restrictions. To date, Glaxo has now taken more than $6 billion in charges to cover ongoing legal problems stemming from the drug (see here), which was linked to an increased risk of heart attacks in a widely debated analysis published in 2007. Since then, Glaxo has come under fire for failing to disclose clinical trial data, prompting an extensive US Senate Finance Committee investigation. The d... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4361307 Tue, 18 Jan 2011 13:16:57 +0100 4361307 http://www.medworm.com/index.php?rid=4349674&cid=t_100576_140_f&fid=35772&url=http%3A%2F%2Fshutah.wordpress.com%2F2011%2F01%2F14%2Fgsk-pays-out-136000-drug-settlement%2F AG: Vermont to receive $136,000 drug settlement – Bloomberg. (Source: SEROXAT WEBLOG) SEROXAT WEBLOG blogs http://www.medworm.com/rss/comments.php?id=4349674 Fri, 14 Jan 2011 23:24:46 +0100 4349674 http://www.medworm.com/index.php?rid=4349700&cid=t_100576_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=4331243&cid=t_100576_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FWZ2gg18cax0%2F Welcome to another working week, everyone, and nice to see you again. We hope your weekend was refreshing and pleasant. Now, though, the time has come to resume the routine as those meetings and deadlines loom. To cope, we are brewing our mandatory cup of stimulation. As always, we invite you to join us. Meanwhile, here are some tidbits to help you get going. Have a great day and stay in touch… Gilead Extends Length Of HIV Drug Study (Associated Press) GlaxoSmithKline And Epizyme Sign Development Deal (The Boston Globe) Lilly Pancreas Drug Questioned By FDA Staff (Reuters) Sanofi-Aventis and Genzyme Still Have ‘Significant’ Differences (Bloomberg News) J&J Bid For Smith & Nephew Wasn’t Disclosed (Reuters) Genentech Sued Over Raptiva Links To Brain Disease... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4331243 Mon, 10 Jan 2011 12:54:12 +0100 4331243 http://www.medworm.com/index.php?rid=4327060&cid=t_100576_140_f&fid=35772&url=http%3A%2F%2Fshutah.wordpress.com%2F2011%2F01%2F09%2Fpsychiatrist-on-payroll-of-glaxo-pleads-guilty-to-research-fraud%2F NaturalNews, November 29,2010 Dr Maria Palazzo …… sentenced to 13 months in prison after pleading guilty to committing research fraud in trials of the company’s antidepressant Paxil on children. http://www.cchrint.org/tag/maria-carmen-palazzo/ GlaxoSmithKline, manufacturer of Paxil, paid Palazzo $5,000 for every child she enrolled in the study. (Source: SEROXAT WEBLOG) SEROXAT WEBLOG blogs http://www.medworm.com/rss/comments.php?id=4327060 Sun, 09 Jan 2011 11:48:34 +0100 4327060 http://www.medworm.com/index.php?rid=4318547&cid=t_100576_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fgi-3YqGN11Q%2F Those big payouts given pharma whistleblowers have attracted a new sort of attention - hedge funds. To wit, one fund manager believes these cases are attractive investment opportunities, given the huge sums that drugmakers have been paying the US Treasury to settle charges of off-label marketing and, more recently, manufacturing fraud (see this about GlaxoSmithKline). “The investment community is already looking at those kinds of opportunities,” David Desser, managing director of Juris Capital, a hedge fund that specializes in litigation finance, tells the the Royal Society of Chemistry’s ChemWorld. Essentially, this is a new class of assets that can be monetized and by, essentially, underwriting the whistleblower during the process, funds may receive big cuts. Here&#8217... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4318547 Thu, 06 Jan 2011 13:51:35 +0100 4318547 http://www.medworm.com/index.php?rid=4309851&cid=t_100576_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FOeVXELaM3qA%2F Yet another big drugmaker faces a job action in Europe. This time, nine unions that represent Sanofi-Aventis workers in France plan to strike tomorrow over plans to eliminate more than 900 jobs. “The reality is that these job cuts are part of a vast 2 billion-euro savings plan that group management wants to achieve by 2013. All the group’s business are affected,” the unions said in a statement. A Sanofi spokesman tells Reuters the drugmaker had not announced any new job cuts since unveiling a reorganisation of its French commercial division last month, which would lead to 575 out of 2,800 jobs that will be cut by the end of this year. The unions say they tallied 916 jobs by adding 575 plus 260 unoccupied posts and 81 staffers who are expected to change roles. The unions a... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4309851 Tue, 04 Jan 2011 13:35:36 +0100 4309851 http://www.medworm.com/index.php?rid=4305104&cid=t_100576_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FojG7UAB1hsw%2F Three months ago, GlaxoSmithKline agreed to pay $750 million fine to settle disturbing charges concerning numerous production problems that took place several years ago at a now-shuttered facility in Cidra, Puerto Rico - contaminated meds, mislabeled packaging and incorrect dosages involving various prescription meds. The fine, which includes a $150 million criminal penalty, was the result of a whistleblower lawsuit brought by Cheryl Eckard, a former global quality assurance manager (you can read the lawsuit and other documents here). Since the settlement was announced in October, Eckard largely maintained her silence, but last night, she appeared on 60 Minutes. Watch the clip and you will learn how she encountered execs who were indifferent to the problems. And you can listen to this phon... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4305104 Mon, 03 Jan 2011 13:16:38 +0100 4305104 http://www.medworm.com/index.php?rid=4294995&cid=t_100576_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FYkvQFA5AtbU%2F Hard to believe, yes? But even we take a few days off now and then. While we have our laptop with us and will, periodically, check on interesting developments, regular posting will not occur this week. We apologize for any inconvenience, but we promised Mrs. Pharmalot and The Short People (that famous, non-existent ’60’s group) that we would focus on their desires. Have a great time, everyone… Regeneron Halts Painkiller Project After Bone Death (Bloomberg News) Roche And Vietnamese Health Minister Argue Over Patent (VietnamNet) Relying On Patient Clues After Cancer Drugs Fail (New York Times) Doctors Question Journal Articles (Milwaukee Journal-Sentinel) Glaxo Offers UK Rebate If Pfizer Drug Is Better (Reuters) EMA Launches Public SME Registry (PharmaTimes) pic thx to nicole/mealy mo... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4294995 Tue, 28 Dec 2010 13:30:46 +0100 4294995 http://www.medworm.com/index.php?rid=4281548&cid=t_100576_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FrOAswC7HSE0%2F And so the spectacle begins. Former GlaxoSmithKline attorney Lauren Stevens, who was recently indicted for obstructing an FDA probe into off-label marketing of Wellbutrin SR, is now pointing fingers at King & Spalding, a major law firm that she will argue in court had provided her with advice while she was employed by the drugmaker (see page 3). As a result, she will offer what is known as ‘advice of counsel’ defense, although federal prosecutors are arguing the defense should not be permitted. In their motion, they maintain advice of counsel is a defense “only to specific intent crimes” in which defendants must be proven to have “willfully” violated the law. But obstruction of justice, they insist, is not such a crime. The trial, which will be held... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4281548 Thu, 23 Dec 2010 01:02:53 +0100 4281548 http://www.medworm.com/index.php?rid=4277957&cid=t_100576_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FcvdSbe-ci1k%2F At a time when tens of thousands of industry jobs are being eliminated, union membership can offer a different perspective. And so more than 200 workers at GlaxoSmithKline’s consumer healthcare division in Gloucester will vote tomorrow on whether they should begin a strike. What’s the beef? A 0 - that is a zero - percent pay hike offered by the drugmaker. The Unite union, which represents engineers, administrators, analysts and warehouse workers, say the employees were given a “measly” 1.2 per cent pay increase last year. Although talks have been under way since June, Unite says GSK refuses to budge. We have asked Glaxo for comment, but a spokeswoman says there will be no comment and will update you accordingly. Balloting closes next month, by the way. “It is ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4277957 Tue, 21 Dec 2010 16:09:56 +0100 4277957