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 'allergan'. Sat, 03 Sep 2011 02:08:40 +0100 http://www.medworm.com/index.php?rid=5107899&cid=t_102444_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FRkVSK5_Bu9Y%2F Good morning, everyone, and nice to see you again. We hope the weekend was invigorating. Now, of course, the time has come to resume the routine of meetings and deadlines, even if it is a slow time of year. To get started, yes, we are brewing that mandatory cup of stimulation, so feel free to join us. Meanwhile, here are some tidibts from around the world. Hope your day goes well and stay in touch… Pfizer And UCSD Collaborate On Early Drug Discovery (San Diego Union Tribune) China’s Healthcare Push May Curb Sales For Brand-Name Pharma (Bloomberg News) Nestle Eyes Pfizer Formula Milk Powder Business (Business China) EU Approves Botox For Treating Urinary Incontinence (Reuters) Takeda Pharmaceuticals Faces Rising Number Of Actos Lawsuits (Associated Press) Bayer Is Eyeing Pfizer ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=5107899 Mon, 08 Aug 2011 11:50:32 +0100 5107899 http://www.medworm.com/index.php?rid=5086556&cid=t_102444_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FRzCxW5efIfk%2F After a follow-up visit to assess eye surgery, many patients receive a little black pouch from their opthalmologist that contains a sample med, patient information, an eye patch, some useful adhesive tape and a pair of sunglasses. These handy-dandy pouches save patients the time and confusion that may occur with finding these items after a complicated procedure where immobility may be required. However, a whistleblower lawsuit that was filed earlier this year and recently unsealed alleges that Allergan, which sells several recuperative meds for people with serious eye problems or those who have undergone some form of surgery, improperly used these pouches to persuade docs to prescribe its drugs. The suit notes sample pouches were either provided for free or at below-market costs. The lawsu... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=5086556 Mon, 01 Aug 2011 15:37:28 +0100 5086556 http://www.medworm.com/index.php?rid=5008655&cid=t_102444_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2011%2F07%2Fcitizens-petition-filed-with-fda-likely.html (Source: Pharma Marketing Blog) Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=5008655 Wed, 06 Jul 2011 10:57:00 +0100 5008655 http://www.medworm.com/index.php?rid=4953363&cid=t_102444_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FFwKeDNIjZs4%2F Top of the morning to you. A shiny day is unfolding here on the Pharmalot corporate campus, where we are hustling assorted short people off to their last moments at the local school houses. This is cause for celebration. So please join us for a cup or two of stimulation. And we hope you will check out our 2 pm EDT webinar today on Social Media. Meanwhile, here are some tidbits from around the big, old world. Have a great day… European Union Approves Lilly Bydureon Diabetes Drug (Associated Press) Dentsply In Talks To Buy AstraZeneca Unit (Reuters) EMA Proposes Waiving Inspections Of US Plants Sometimes (InPharma Technologist) Calpers Taps CVS/Caremark To Manage Benefits (San Francisco Business Times) Abbott Hit By $4M Diagnostic Theft In Kentucky (Securing Pharma) Roche And Curis Ski... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4953363 Tue, 21 Jun 2011 12:04:52 +0100 4953363 http://www.medworm.com/index.php?rid=4952748&cid=t_102444_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2011%2F06%2Fmanagers-coup-how-hired-hands-got.html We have frequently discussed the perverse incentives provided to the leaders of health care organizations.  They almost never pay a penalty for presiding over organizational actions that are unethical, harmful to patients, or even criminal (e.g., see posts here and here for some very recent examples.)  However, they often collect outrageously huge compensation disproportionate to any reasonable measure of their organizations' performance.  (e.g., see posts here and here for relevant recent examples.)Now two news articles, based in turn on research studies, further illuminate how hired managers and executives have become so wealthy and unaccountable.The first news article was in the New York Times, and was in turn based on an accounting study.  In summary, a recent,... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=4952748 Tue, 21 Jun 2011 00:47:00 +0100 4952748 http://www.medworm.com/index.php?rid=4813652&cid=t_102444_140_f&fid=35439&url=http%3A%2F%2Fbipolarsoupkitchen-stephany.blogspot.com%2F2011%2F05%2Fthis-blog-is-not-affiliated-with.html (Source: soulful sepulcher) soulful sepulcher blogs http://www.medworm.com/rss/comments.php?id=4813652 Wed, 11 May 2011 02:51:00 +0100 4813652 http://www.medworm.com/index.php?rid=4789637&cid=t_102444_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=4768247&cid=t_102444_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FI0Nt9nsK-zk%2F Allergan was ordered by a federal court jury in Virginia to pay $212 million to a 67-year-old man who claimed he developed permanent brain damage after being injected with Botox to treat cramps and tremors in his hand in 2007. Douglas Ray was awarded $12 million in compensatory damages and $200 million in punitive damages, after convincing the jury Allergan failed to warn that injections could trigger an autoimmune reaction leading to brain damage. For its part, Allergan denied a failure to warn or any connection between Botox and his illness. “The verdict reached today is inconsistent with Allergan’s past and current actions to properly warn physicians and patients about the potential risks of Botox,” a spokeswoman wrote Bloomberg News. “Every known and knowable risk associat... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4768247 Fri, 29 Apr 2011 12:44:23 +0100 4768247 http://www.medworm.com/index.php?rid=4768250&cid=t_102444_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FEKnIm6NQuKw%2F Another working week is about to draw to a close. And not a moment too soon. This is, of course, the signal to daydream about weekend plans. Our modest agenda includes a family gathering, mowing the lawn (wish us luck) and promenading with the official Pharmalot mascots. What about you? Does spring cleaning beckon? How about finding recession-era bargains at a garage sale? Or maybe take a moment to think big thoughts? Whatever you do, have a great time. And see you soon… Merck Profits Top Estimates (Bloomberg News) Woman Severely Hurt By Abbott Labs Truck (Lake County News-Sun) Johnson & Johnson Prostate Cancer Drug Approved By FDA (Bloomberg News) Generic Lipitor Ruling Expected Next Week (Dow Jones) FDA Panel Recommends Vertex Hepatitis C Drug (Boston Globe) Wolter Kluwers Buy... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4768250 Fri, 29 Apr 2011 11:48:24 +0100 4768250 http://www.medworm.com/index.php?rid=4575244&cid=t_102444_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FyX0B1GekJDo%2F Earlier this week, we wrote how the European Association for the Study of the Liver had difficulty maintaining an embargo on abstracts to be reviewed at its upcoming annual conference, even though the material is freely available on the Internet (see here). Then Embargo Watch notes that the public relations firm for the EASL is Cohn & Wolfe, which also represents various drugmakers, such as Allergan, Genzyme, Sanofi-Aventis, Boehringer-Ingelheim and Merck (see this). This raises a question: how can a public relations firm equitably run the media operations for a professional society conference and simultaneously represent drugmakers who may have a great deal at stake at these conferences? You know, abstracts from one or more clients could be on display at the gathering. How can the EA... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4575244 Fri, 11 Mar 2011 16:36:35 +0100 4575244 http://www.medworm.com/index.php?rid=4566340&cid=t_102444_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FGtQ9Mzf-Fi0%2F One of the more widely visited web sites for information on numerous drugs is PubMed Health, which caters to consumers and is run by the National Center for Biotechnology Information (NCBI), a division of the National Library of Medicine at the National Institutes of Health. The site boasts that it provides up-to-date info on “diseases, conditions, injuries, drugs, supplements, treatment options, and healthy living,” along with a focus on comparative effectiveness (see this). Last week, however, the site blundered by continuing to provide info about how to use unapproved drugs that had never had undergone review by the FDA, which announced a new effort to have these meds withdrawn. Then, the site appeared to back date its revisions when the goof was brought to its attention (lo... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4566340 Wed, 09 Mar 2011 13:08:12 +0100 4566340 http://www.medworm.com/index.php?rid=4560597&cid=t_102444_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FC7Wu-i1zM6o%2F Hello, everyone, and top of the morning to you. Another shiny day is unfolding here on the Pharmalot corporate campus, where we are hustling the short people off to their various school houses for some learning. And this marathon calls for a much needed cup of stimulation - our flavor today is Cinnamon Cream Swirl. Please join us as we also peruse the news for interesting developments. As always, we encourage you to contact us if you hear of something noteworthy. Meanwhile, have a great day… FDA Warns About Abbott HIV Med In Premature Babies (Reuters) Teva Says Docs Contacted For Generic Copaxone Study (Bloomberg News) FDA Accepts Application For Astra & Bristol Diabetes Drug (Associated Press) Japan Finds No Direct Link To Vaccines And Deaths (Reuters) FTC Takes Aim At Patent T... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4560597 Tue, 08 Mar 2011 12:53:17 +0100 4560597 http://www.medworm.com/index.php?rid=4433327&cid=t_102444_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F_o_hE3aHJP4%2F For the past few months, a billboard campaign promoting the Allergan Lap Band surgical device for gastric binding - a way to lose weight - has caused a controversy in Southern California over concerns that risks are not disclosed sufficiently. The Los Angeles County public health director, in fact, wrote the FDA to ask for an investigation, prompting some negative publicity (read the letter). The billboards are actually sponsored by a marketing firm on behalf of doctors and clinics, which are, essentially, Allergan customers. The company, of course, benefits from this sort of exposure, yet initially did not appear to go out of its way to disavow the campaign. An Allergan spokeswoman told The Los Angeles Times the ads could not be regulated, because they are not Allergan ads, although a let... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4433327 Thu, 03 Feb 2011 15:07:04 +0100 4433327 http://www.medworm.com/index.php?rid=4106063&cid=t_102444_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FKtFErbiCVU8%2F There have been numerous headlines lately about healthcare fraud and whistleblowers whose lawsuits eventually prompted huge settlements with the federal government. The latest tally, however, shows that the US Department of Justice recovered over $3.1 billion in fraudulent claims in the 2010 fiscal year that can be traced to lawsuits filed under the federal False Claims Act. Specifically, there were 145 FCA cases settled in the 2010 fiscal year and the 10 largest settlements involved health care fraud, with eight involving drugmakers, according to Taxpayers Against Fraud, a non-profit that supports whistleblower lawsuits. The 10 largest cases accounted for $2.7 billion recovered. Although fiscal year 2009 actually recovered a larger pot of money - $5.6 billion. It also worth that health ca... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4106063 Mon, 25 Oct 2010 12:32:03 +0100 4106063 http://www.medworm.com/index.php?rid=4074440&cid=t_102444_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F7ystf4b3vhw%2F Just a few weeks after paying a $600 million to fine settle criminal charges that Botox was illegally marketed to treat headaches, Allergan has won FDA approval to promote the med for treating chronic migraines. The move comes despite some chatter that Allergan’s off-label marketing machine and subsequent guilty plea might influence the FDA to withhold approval. In a statement, however, the FDA notes that chronic migraines, which are defined as occuring most days of the month, are very debilitating. “This condition can greatly affect family, work, and social life, so it is important to have a variety of effective treatment options available,” says Rusty Katz, who heads the neurology products division in the FDA’s Center for Drug Evaluation and Research. There is one cav... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4074440 Fri, 15 Oct 2010 22:29:04 +0100 4074440 http://www.medworm.com/index.php?rid=4018441&cid=t_102444_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FaK3IEXLaIa8%2F Another week, another drugmaker agrees to settle off-label marketing charges brought by the federal government. This time, Novartis will pay $422.5 million for illegally promoting its Trileptal epilepsy med for unapproved uses, such as bipolar disorder and neuropathic pain, along with five other drugs - Diovan, Zelnorm, Sandostatin, Exforge and Tekturna. The fine includes roughly $237 million to settle four lawsuits brought by whistleblowers, while $185 million goes toward criminal penalties. One of the lawsuits was filed by Jeremy Garrity, a former cardiovascular sales rep, who worked for Novartis between 2002 and 2008 before being fired (you can read it here, and you can read the settlement here. Oh, and this is the guilty plea). This is the latest in a stream of settlements involving bi... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4018441 Thu, 30 Sep 2010 17:26:16 +0100 4018441 http://www.medworm.com/index.php?rid=4003434&cid=t_102444_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FpYWhwlZl3PU%2F Earlier this year, a former Pfizer exec amended his whistleblower lawsuit accusing the drugmaker of illegally scheming to boost Lipitor sales by misrepresenting product labeling and federal cholesterol guidelines; using misleading educational programs for doctors, and unlawful sampling kickback schemes that resulted in off-label marketing that allegedly defrauded Medicaid and Medicare. Jesse Polansky, who was director of outcomes management from April 2001 until July 2003, claims “thousands of physicians have prescribed Lipitor to millions of patients for whom drug therapy is not recommended, and for whom the medication could be dangerous. Millions of those improper prescriptions were ultimately paid for by various government healthcare plans, the suit charges. And in a newly filed brie... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4003434 Mon, 27 Sep 2010 15:28:45 +0100 4003434 http://www.medworm.com/index.php?rid=3973114&cid=t_102444_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F2VKEYVGzqQs%2F Just as Allergan pleads guilty to a misdemeanor for misbranding in relation to off-label promotion of its widely used Botox (see this), the drugmaker was also tagged by the FDA for running an ad for its Acuvail anti-inflammatory that the agency deemed misleading for overstating efficacy and omitting risk information. Acuvail is an non-steroidal anti-inflammatory drug, or NSAID, that is used Acuvail is used to treat pain and inflammation after cataract surgery. But a recent two-page ad - which features a row of four diamonds that range from small and dull to large and sparkly - suggests the drug has “enhanced” and is superior to other ocular NSAIDs. The FDA, however, says this isn’t so, and goes on to spank Allergan for implying Acuvail improves outcomes and patient comfort, a... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3973114 Wed, 15 Sep 2010 12:30:23 +0100 3973114 http://www.medworm.com/index.php?rid=3965700&cid=t_102444_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FMInxkLXguhg%2F When Pfizer pled guilty to off-label marketing last year and paid a whopping $2.3 billion fine, a little-known fact later emerged - a subsidiary was actually charged with the crime and, as a result, the parent company was allowed to continue doing business with Medicaid and Medicare. Of course, excluding Pfizer from such lucrative contracts can cause painful collateral damage - untold numbers of patients would be denied needed treatments and many employees could suffer (back story). However, when Allergan agreed earlier this month to plea guilty to a misdemeanor for misbranding in connection with off-label marketing of Botox and pay a $600 million fine, it was the parent company that took the heat. Under federal law, Allergan should then be excluded from doing business with the federal hea... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3965700 Mon, 13 Sep 2010 14:12:29 +0100 3965700 http://www.medworm.com/index.php?rid=3954215&cid=t_102444_87_f&fid=36050&url=http%3A%2F%2Fblisstree.com%2Flive%2Fwhy-allergans-paying-600-million-fine-for-a-botox-marketing-campaign%2F Botox is known for freezing forehead wrinkles and crow’s feet into submission (mostly on aging celebrities we like to make fun of), but it’s also a fix for other problems like excessive underarm sweating, muscle spasms, and uncontrolled blinking. The newest problem targeted by the wonder drug is severe migraines, but Allergan (the company that makes Botox) is paying millions of dollars in fines for telling consumers about it before FDA approval. Using drugs for unapproved uses isn’t a new thing – doctors legally prescribe drugs to treat ailments unrelated to their original purpose all the time – but according to the Food and Drug Administration, it’s illegal for drug companies to actually advertise those alternative uses until they’ve been approved by the ... Breastfeeding 1-2-3 blogs http://www.medworm.com/rss/comments.php?id=3954215 Thu, 09 Sep 2010 17:02:48 +0100 3954215 http://www.medworm.com/index.php?rid=3946689&cid=t_102444_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F0-LwfjUgKjs%2F Hot on the heels of the $600 million settlement Allergan reached with the US Department of Justice for off-label marketing charges over Botox, a shareholder has filed a lawsuit claiming the Allergan board should pay for the whopping fine instead of relying on the corporate treasury. In a shareholder derivative lawsuit filed in Delaware Chancery Court, the Louisiana Municipal Police Employees Retirement System claims that Allergan’s board is responsible because they breached their fiduciary duties by allowing Allergan to violate federal law with off-label marketing practices. Essentially, the pension plan argues Allergan board oversaw a calculated strategy to boost sales illegally and either willfully approved the effort or shirked their responsbilities (here is the lawsuit). Allergan... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3946689 Wed, 08 Sep 2010 12:00:43 +0100 3946689 http://www.medworm.com/index.php?rid=3938310&cid=t_102444_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2010%2F09%2Fat-end-of-summer-everybody-well-nearly.html Many US health care organizations announced legal settlements as the dog days of summer drew to a close.  The hit parade included, in order of dollar amount:Stryker CorpAs reported by Bloomberg News:Sryker Corp., a maker of artificial hips and knees, will pay $1.35 million to settle claims it marketed items without regulatory approval and misled health care providers about the use of its products, the Massachusetts attorney general said.Stryker’s biotech unit engaged in unfair and deceptive trade practices that boosted sales of products used to strengthen and promote growth of bones, Massachusetts said in a filing in state court in Boston.'Stryker Biotech subverted review procedures designed to safeguard patients and promoted uses of its products that were not shown to be safe or ef... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=3938310 Mon, 06 Sep 2010 22:11:00 +0100 3938310 http://www.medworm.com/index.php?rid=3933265&cid=t_102444_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FaKrQUrCNzEU%2F Good morning, everyone. How are you today? Slowing down just a bit, perhaps? Here in the states, of course, a three-day weekend is fast approaching. And so we will pull in the sidewalks early. We hope you have the opportunity to do the same. Meanwhile, here are a few nuggets to help you close out the week. Whatever you do over the next few days, may it be enjoyable. Cheers… Celldex Says Pfizer Ends Cancer Vaccine Deal (Reuters) Allergan Steps Up Overseas Clinical Trials (CBS News) Novartis Experimental Malaria Drug May Be First In 30 Years (Bloomberg News) Abbott Cancels Sale Of Solvay Vaccines Unit (The Wall Street Journal) Accenture And ICRI Partner On Indian Clinical Research Training (Outsourcing Pharma) (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3933265 Fri, 03 Sep 2010 12:02:08 +0100 3933265 http://www.medworm.com/index.php?rid=3929453&cid=t_102444_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2010%2F09%2Freasonable-600-fine-for-misbranding.html Allergan -- the company that markets Botox legally for wrinkles and illegally for other things -- agreed to pay $600 million in fines, including $375 million to the government as part of a Botox “misbranding” charge. Allergan admitted that its marketing of Botox from 2000 to 2005 led to intended use in treating headache, pain, muscle stiffness and juvenile cerebral palsy. Read the media stories and press releases here.Considering that Eli Lilly paid $1.41 billion to settle charges that it had improperly marketed  Zyprexa for elderly patients with dementia and that Pfizer paid $2.3 billion to settle charges that it had illegally marketed the painkiller Bextra, the $600 million Allergan has to pay seems "reasonable," which is exactly how  Larry Biegelsen, an analyst at Wells Fa... Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=3929453 Thu, 02 Sep 2010 12:52:00 +0100 3929453 http://www.medworm.com/index.php?rid=3925087&cid=t_102444_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F-nBbMQkVAB8%2F To settle a probe by the US Department of Justice, Allergan is paying $$375 million and pleading guilty to one misdemeanor count of misbranding in connection with off-label marketing of its Botox med for various unapproved uses - headache, pain, spasticity and juvenile cerebral palsy - between 2000 and 2005. Another $225 million is being paid to in fines to cover civil claims asserted by the DOJ under the False Claims Act - there were three separate whistleblower lawsuits filed by Allergan employees that prompted the government probe (read them here, here and here). In addition, the drugmaker, which denies liability for the civil claims, is required to enter into a Corporate Integrity Agreement that will be overseen by an outside party and govern its marketing practices for several years. ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3925087 Wed, 01 Sep 2010 16:12:02 +0100 3925087 http://www.medworm.com/index.php?rid=3816762&cid=t_102444_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F8wCoe6kSHgk%2F Hello, everyone, and welcome to another busy day. This may be the sleepy stretch of summer, but the world is spinning as quickly as ever, yes? And so we must prepare for still more deadlines and meetings. As you do the same, here are a few tidbits to help you along. So grab a cup of something stimulating and dig in. Have a good one and stay in touch… Allergan CEO Says Company Is Not For Sale (Dow Jones) Sanofi Shareholders Want Genzyme For $19 Billion (Reuters) Alcon Shareholders Told To Vote No On Novartis Slate (PharmaTimes) FDA Guidance Aims To Cut Residual Drug In Patches (InPharma Technologist) Will Botox Be Approved For Migraines? (Reuters) Diabetes Drugs Dispensed In UK Zooms By 43% (PharmaTimes) AstraZeneca VAT Voucher Case Rings Alarm Bells (Accountancy Age) KV Pharma Gets N... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3816762 Tue, 03 Aug 2010 11:55:41 +0100 3816762 http://www.medworm.com/index.php?rid=3750275&cid=t_102444_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FQ3eBZlyjWkI%2F The California Supreme Court has overturned a lower court decision that dismissed a price-fixing lawsuit brought by a group of pharmacies. They had charged the largest drugmakers agreed to set artificially high prices, and acted in concert to restrain reimportation of their lower-priced foreign drugs into the US and restrict price competition from generics. As a result, the drugmakers were able to maintain prices 50 to 400 percent higher than for the same drugs sold outside the US. The drugmakers - which included Abbott Labs; AstraZeneca; Novartis; Allergan; Boehringer Ingelheim; Eli Lilly; Johnson & Johnson; Janssen Pharmaceutica; Ortho McNeil; Ortho Biotech; GlaxoSmithKline; Pfizer; Hoffman-LaRoche; Aventis Pharmaceuticals; Amgen; Purdue Pharma; Merck; Bristol-Myers-Squibb, and Wyeth - a... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3750275 Tue, 13 Jul 2010 12:03:55 +0100 3750275 http://www.medworm.com/index.php?rid=3750277&cid=t_102444_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FJRV_5GQ4Oyc%2F Hello, everyone. Nice to see you again. Hope your week is going well so far. Meanwhile, another busy day lies ahead, especially as the FDA panel meeting gets under way to review Avandia. So let’s get started with a cup of stimulation and some interesting tidbits to help you along. Have a good one and stay in touch… Vivus Diet Drug Faces FDA Skepticism (Associated Press) Merck Starts Work On New Plant In China (People’s Daily) Lawsuits May Reveal More Avandia Data (Reuters) Lilly To Cut 170 Manufacturing Jobs (Indianapolis Business Journal) Global CSO Market To Hit $6.5B By 2015 (OutsourcingPharma) Clinuvel Drug Offers Relief From Sensititivity To Light (Bloomberg News) Latisse Faces Patent Challenge (The Wall Street Journal) Bristol-Myers Starts Recall Of Coumadin (Assoc... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3750277 Tue, 13 Jul 2010 12:03:03 +0100 3750277 http://www.medworm.com/index.php?rid=3577625&cid=t_102444_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FZvC-xlFlQ8g%2F In its latest aggressive move, Allergan has launched a social media campaign to promote its Lap Band surgical device for gastric binding - a way to lose weight - by encouraging at least 250,000 consumers to sign an online petition. This will be delivered to Congress in hopes of “improving access” to the surgical procedure needed for inserting the device. Essentially, Allergan wants greater reimbursement and guidelines that mention surgery as an option. And so the ‘CHOICE’ campaign (Choosing Health over Obestity Inspiring Change through Empowerment) attempts to strike a populist chord by flagging concerns about obesity and healthcare costs. For good measure, there is a Facebook page But as an added inducment, Allergan offers a contest for lap-band patients and 12 luc... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3577625 Wed, 19 May 2010 12:58:57 +0100 3577625 http://www.medworm.com/index.php?rid=3577620&cid=t_102444_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2010%2F05%2Fwill-250000-morbidity-obese-people-sign.html "Be heard!", says Allergan. "The voices of 250,000 can influence the dialogue on the obesity epidemic and help shape policies that can make a real difference in our efforts to reduce the obesity epidemic."That's the pitch of Allergan's new "social media" "C.H.O.I.C.E." ("Choosing Health over Obesity Inspiring Change through Empowerment") campaign, a core element of which is a petition to Congress to propose "legislation for obesity treatment and weight-loss surgery options like adjustable gastric banding for the morbidly obese."The petition is really an ad for weight-loss surgery. It states:"Weight-loss surgery has been proven more effective than diet and exercise alone in people 100 pounds or more overweight – and it's the only treatment proven to be effective long-term ... With less in... Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=3577620 Wed, 19 May 2010 12:28:00 +0100 3577620 http://www.medworm.com/index.php?rid=3564198&cid=t_102444_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F3EvTun6vQgU%2F An Oklahoma jury awarded $15 million in a negligent-damage verdict against Allergan in a lawsuit that was brought by Sharla Helton, a 48-year-old obstetrician and gynecologist, who suffered years of pain after getting Botox injections. Helton lost her job four years ago and blamed Botox for double vision, breathing difficulty and years of continual pains in her arms, hands and feet. The verdict is the “first step in making sure the public is aware of the actual risks of Botox. It’s a steppingstone to protect the public from what the company is hiding,” Helton tells The Orange County Register. “Hopefully, now people will wake up to the real dangers.” The jury, which did not award punitive damages, also found that Botox was not defective. Allergan plans to appeal. A key... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3564198 Fri, 14 May 2010 15:10:15 +0100 3564198 http://www.medworm.com/index.php?rid=3564014&cid=t_102444_106_f&fid=36682&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FSutureForALiving%2F%7E3%2FeyqE5SKnUA0%2Fmore-on-allergan-botox-suits.html A year ago the FDA required Allergan to add a black box warning Botox and a Risk Evaluation and Mitigation Strategy (REMS)  to it’s safety labels for all botulinum toxin products.  The agency took the action because of two main reasons.  In February, I wrote about the lawsuit in Orange County, California by a mother who alleges that the Botox treatments used to decrease muscle spasms weakened her daughters respiratory muscles, therefore causing her death. Kristen Spears’ mother has sued Allergan alleging that her daughter died from a fatal reaction to the Botox treatments Kristen received for treatment for cerebral palsy. In March, Orange County Registar ran this article by Colin Stewart:  Allergan wins Botox death trial. Yesterday Katherine Hobson, WSJ Blog, wro... Suture for a Living blogs http://www.medworm.com/rss/comments.php?id=3564014 Thu, 13 May 2010 17:01:00 +0100 3564014 http://www.medworm.com/index.php?rid=3508446&cid=t_102444_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F5kplgLzalRM%2F Back in 2002, Orphan Medical obtained FDA approval to market its Xyrem drug to treat cataplexy, which is a sudden loss of muscle tone associated with narcolepsy, although docs soon began prescribing the med to treat other conditions. And Alfred Caronia, a former Orphan sales exec, was convicted three years later of encouraging docs to engage in off-label usage. However, the Washington Legal Foundation, which has long been active in championing off-label promotion as a form of commercial free speech, has filed a brief urging the US Court of Appeals for the Second Circuit to overturn Caronia’s conviction on the grounds that the “First Amendment broadly protects the right of individuals to speak truthfully about off-label uses of FDA-approved products, even in a commercial contex... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3508446 Tue, 27 Apr 2010 13:36:01 +0100 3508446 http://www.medworm.com/index.php?rid=3499307&cid=t_102444_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FA799VVQdmuY%2F And what a plaintiff. The drugmaker wants to recover $460,000 in legal costs from Dee Spears, who unsuccessfully sued Allergan over the death of her 7-year-old daughter, Kristen, after she was administered a series of therapeutic Botox shots. She sued the drugmaker for $60 million, accusing it of concealing info about the dangers of the drug, which was used to relax the girl’s clenched limbs; she suffered from cerebral palsy (see background). But a jury in Santa Ana, California, decided last month Allergan wasn’t responsible for the girl’s death in 2007 death. And now Allergan wants its money back. “I’ve been a lawyer for 25 years, and I’ve never seen anything more outrageous than a corporation pursuing this lady for $460,000,” Spears’ attorney, Ray Chester, tel... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3499307 Fri, 23 Apr 2010 11:48:40 +0100 3499307 http://www.medworm.com/index.php?rid=3433166&cid=t_102444_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FJeVKBIafTJY%2F And so, another work week will soon draw to a close. We look forward to quiet moments with the short and not-so-short people, another walk with the Pharmalot mascot and, perhaps, a cozy nap. What about you? Anything exciting planned? Maybe there is spring cleaning to be done? While you ponder, here are a few items to help you through the day. Whatever you do, have a great time… Pfizer Pays $400K To Settle Neurontin Suicide Suit (Bloomberg News) Drugmakers Slam Germany’s Price Moves (PharmaTimes) Off-Label Conditions Take Legal Spotlight (Investor’s Business Daily) Teva Wins Patent Case On Birth Control Pill (Reuters) Allergan Licenses Drug For Nighttime Urination (Reuters) photo thx to tipiro on Flickr creative commons (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3433166 Fri, 02 Apr 2010 12:03:49 +0100 3433166 http://www.medworm.com/index.php?rid=3399173&cid=t_102444_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2010%2F03%2Fis-this-juvederm-xc-dtc-print-ad-fair.html Take a look at the Juvederm XC ad, which I found in this week's New Yorker Magazine, which (coincidentally) includes an article about treatment of wrinkles ("Face It: The Truth About Wrinkles"). The article does not mention Juvederm and hardly has anything at all to say about injection of gels into the skin.Do you think this ad is "fair and balanced"; ie, presents risk information that is "comparable in depth and detail with the claims for effectiveness or safety" as required by the Federal Food, Drug, and Cosmetic Act?FDA issues "notice of violation (NOV)" letters to drug companies when it feels that promotional pieces overly minimizes risk information.Should FDA send a NOV letter to Allergan, which markets Juvederm? "Promotional materials are misleading," said FDA in a recent letter to M... Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=3399173 Wed, 24 Mar 2010 13:10:00 +0100 3399173 http://www.medworm.com/index.php?rid=3383079&cid=t_102444_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2010%2F03%2Fdrug-companies-are-flocking-to-facebook.html More and more pharmaceutical companies are launching Facebook pages that promote their products. The latest is Allergan, which launched a celebrity Facebook campaign for Juvederm, a dermal filler used for "long-lasting correction of moderate to severe facial wrinkles and folds." Allergan also makes Botox.According to an MM&M story, "Ex-Extra host and broadcast journalist Dayna Devon will dispense personal tips to Facebook fans each week, and is sharing her experience with Juvederm through the social networking site."But why open up a Facebook page, which looks like just another product website (see screen shot below), especially if you are not going to accept and publish comments to the Wall?IMHO, Allergan and other pharma companies are not launching Facebook pages to "engage" consumer... Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=3383079 Thu, 18 Mar 2010 19:02:00 +0100 3383079 http://www.medworm.com/index.php?rid=3276079&cid=t_102444_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2010%2F02%2Fallergans-eye-popping-migraine-botox.html According to this study, Botox may be effective in the treatment of "imploding" or "eye-popping" headaches but NOT "exploding" headaches. Among all participants who responded to treatment, patients with exploding headaches experienced an average reduction in migraine frequency of 11.4 to 9.4 days per month (ie, not much improvement), whereas frequency in participants with imploding or ocular headaches reduced from an average of 7.1 days per month to 0.6 days per month.“These preliminary data are intriguing, and our results provide support for the hypothesis that patients with migraine that is characterized by imploding and ocular headaches are more responsive to botulinum toxin type A than those with migraine characterized by exploding headaches,” the authors write. “Our findings inv... Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=3276079 Mon, 15 Feb 2010 21:00:00 +0100 3276079 http://www.medworm.com/index.php?rid=3228006&cid=t_102444_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fa5Imb0EpOYg%2F A woman is suing Allergan, which makes Botox, because she believes the injectable cosmetic med led to the death of her seven-year-old daughter. Why? Botox was used to treat muscle spasms resulting from cerebral palsy, and Dee Spears charges Allergan wrongfully promoted untested and off-label uses, misrepresented Botox safety record, and failed to adequately warn health care providers of all the known risks of the product, according to court documents. At issue is the safety of the drug, especially in higher doses used to treat kids with cerebral palsy. Kristen Spears died in 2007 of respiratory failure and pneumonia, according to The Los Angeles Times, which adds that experts hired by her mom say Botox weakened muscles that controlled her breathing and swallowing, leading to respiratory fa... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3228006 Mon, 01 Feb 2010 17:04:41 +0100 3228006 http://www.medworm.com/index.php?rid=3212599&cid=t_102444_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FjuSvfPovYyY%2F Clinical trial investigators better be careful about discussing a drug with the media now that the FDA has chastised a researcher for touting an anti-wrinkling compound. The agency’s Division of Drug Marketing, Advertising, and Communications sent a warning letter to Leslie Baumann for violating regs over comments she made about Ipsen Biopharm’s Dysport to two magazines and NBC’s Today show. Baumann conducted Phase III trials of the med, which was also known as Reloxin, for treating frown lines between the eyebrows. And she excitedly told Allure in an April 2007 article that the drug “will likely come out later this year. Early data shows it may last longer and kick in faster than Botox. It will be nice to have competition on the market - the Botox people (Allergan)... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3212599 Wed, 27 Jan 2010 14:45:24 +0100 3212599 http://www.medworm.com/index.php?rid=3197885&cid=t_102444_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F_5l-Xitz6Rs%2F For those wondering about the reactions that some consumers have to DTC television ads, some decide to search for more info online. So which ads are prompting the most activity and which product sites are visited? NuvaRing and Latisse had the highest percentage of overall product website traffic driven by their DTC TV ads, according to Manhattan Research. NuvaRing, which is a contraceptive made by Merck, jumped five spots from last year to take the top ranking. And as you can see, Allergan’s new eyelash enhancement treatment, Latisse, grabbed the No. 2 spot. Unfortunately, there was no corresponding info to contrast the amount of ad spending with web traffic. In any event, here is the list of the ten brands for which DTC ads drove the most web traffic… 1. NuvaRing 2. Latisse ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3197885 Fri, 22 Jan 2010 13:19:09 +0100 3197885 http://www.medworm.com/index.php?rid=2974201&cid=t_102444_150_f&fid=34768&url=http%3A%2F%2Fpharmagossip.blogspot.com%2F2009%2F11%2Fhypotrichosis-under-lash.html Hat tip: http://blog.lib.umn.edu/schwitz/healthnews/ (Source: PharmaGossip) PharmaGossip blogs http://www.medworm.com/rss/comments.php?id=2974201 Mon, 09 Nov 2009 17:02:00 +0100 2974201 http://www.medworm.com/index.php?rid=2857574&cid=t_102444_140_f&fid=35439&url=http%3A%2F%2Fbipolarsoupkitchen-stephany.blogspot.com%2F2009%2F10%2Fallergan-makers-of-botox-and-latisse.html (Source: soulful sepulcher) soulful sepulcher blogs http://www.medworm.com/rss/comments.php?id=2857574 Fri, 02 Oct 2009 19:41:00 +0100 2857574 http://www.medworm.com/index.php?rid=2804227&cid=t_102444_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2009%2F09%2Ffda-reads-my-blog-declares-latisse-web.html On September 10, 2009, the FDA sent Allergan a notice that its Latisse Web site was misleading (see "FDA Says Allergan's Web Site for Eyelash Thickener Is Misleading"). The letter states:"the Division of Drug Marketing, Advertising, and Communications (DDMAC) has reviewed the “FAQs” and “About Safety” pages of a consumer website and a “Launch display timeline” (timeline) (APC36ON09) for LatisseTM (bimatoprost ophthalmic solution) 0.03% (Latisse) submitted by Allergan, Inc. (Allergan) under cover of Form FDA-2253. These promotional materials are misleading because they omit and minimize risks associated with Latisse. Thus, the website and timeline misbrand Latisse in violation of the Federal Food, Drug, and Cosmetic Act..." [my emphasis]Latisse is Allergan's product approved for... Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=2804227 Thu, 17 Sep 2009 13:20:00 +0100 2804227 http://www.medworm.com/index.php?rid=2448134&cid=t_102444_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2009%2F06%2Fwill-latisse-turn-brooke-shields-blue.html Long before there was a Hanna Montana there was a Wanda Nevada -- a 1979 movie starring Brooke Shields and Peter Fonda. I saw the movie yesterday.I also saw the first TV ad for Latisse starring Brooke Shields last night during a re-run of "Desperate Housewives." Latisse is Allergan's "new" drug approved by the FDA for "hypotrichosis."Hypotrichosis, according to a Wikipedia entry, "is the term dermatologists use to describe a condition of no hair growth. Unlike alopecia, which describes hair loss where formerly there was hair growth, hypotrichosis describes a situation where there wasn't any hair growth in the first place."That, however, is NOT how Allergan describes the condition. According to the "Patient Information" sheet, "Hypotrichosis is another name for having inadequate or not enou... Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=2448134 Mon, 01 Jun 2009 11:09:00 +0100 2448134 http://www.medworm.com/index.php?rid=2279765&cid=t_102444_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2009%2F03%2Fbotox-v-reloxin-market-share-battle-may.html If you thought the DTC advertising sleep aid (Lunesta v. AmbienCR v. Rozerem) advertising war was excessive, wait until Reloxin is approved for marketing by the FDA, which may happen during the second half of this year according to Bloomberg.com (see "Medicis's Reloxin May Vie With Botox in U.S. to Clear Wrinkles").“The results of the study [published in the March/April issue of Archives of Facial Plastic Surgery] show that it’s as good as Botox," Ronald Moy, the lead author of the study and a professor in the medical school at the University of California, Los Angeles, in a March 13 telephone interview. "The side effects are the same as Botox."So...how's Medicis going to capture 25 percent to 30 percent of market share from Botox as one analyst claims it will? And how will Allergan, w... Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=2279765 Tue, 17 Mar 2009 18:56:00 +0100 2279765 http://www.medworm.com/index.php?rid=1969318&cid=t_102444_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F457519071%2F Such as? Scarring and tissue damage, among other serious complications. That’s what an FDA advisory panel concluded at a meeting to review products from Allergan and Medicis Pharmaceuticals. FDA staffers told the panel that current prescribing info inaccurately describes most side effects as quickly noticeable and temporary, Bloomberg News writes. About 1.36 million women and 84,000 men opted last year to get injections of animal collagens or chemicals to smooth facial skin and reduce signs of aging, according to the American Society for Aesthetic Plastic Surgery. Briefing documents filed with the FDA listed 930 side effect reports between January 2003 and September 2008 (please see page 23) with such products as Medicis’ Restylane and Allergan’s Juvederm. Actual numbers ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1969318 Tue, 18 Nov 2008 19:19:29 +0100 1969318 http://www.medworm.com/index.php?rid=1914646&cid=t_102444_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2008%2F10%2Falergans-secret-plan-to-thwart-homeland.html I read with interest Jim Edwards' recent story about how "Allergan’s Eyelash Enhancer Makes Your Blue Eyes Brown."It appears that Allergan's strategy for expanding the market for Lumigan -- its anti-glacoma drug -- is to capitalize on one of the drug's side effects: patients’ eyelashes become longer when using it!Of course, many women love long eyelashes and spend a lot of money on cosmetics and even permanent tattooing to make their lashes longer or seem longer. In fact, according to Edwards, doctors are already using Lumigan eye drops off-label for vanity purposes (more on that below).But there's another side effect of Lumigan that may make it useful to terrorists and other criminals who seek to fool security systems that depend on iris recognition technology -- Lumigan can change th... Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=1914646 Tue, 28 Oct 2008 11:10:00 +0100 1914646 http://www.medworm.com/index.php?rid=1901506&cid=t_102444_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2008%2F10%2Fallergan-doesnt-comply-with-phrma.html Allergan, the specialty pharma company BEST known for its marketing of BOTOX, was voted the "Most Admired Specialty Company" in the Eighth Annual Med Ad News Most Admired Companies contest/poll/popularity contest.Allergan achieved this distinction among Med Ad News readers who were polled by the publication despite the fact that the company does not abide by PhRMA's DTC Guidelines that prohibit "reminder ads." Reminder ads mention the pharmaceutical brand name but not the indication or medical condition it treats (see definition here).ALL BOTOX direct-to-consumer print and TV ads are reminder ads, which are free to imply outlandish benefits -- such as "freedom of expression" (see "Botox BS Piled Higher and Deeper") -- without any counterbalancing risk information as required by FDA regulat... Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=1901506 Thu, 23 Oct 2008 11:09:00 +0100 1901506 http://www.medworm.com/index.php?rid=1788916&cid=t_102444_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F389900250%2F Or is it the other way around? Allergan, which sells the controversial wrinkle remover, may help relieve migraines. And the drugmaker plans to ask the FDA next to approve Botox for chronic migraines, based on preliminary analysis of two new studies. In other words, the message is that Botox can help your head inside and out. Allergan said the studies showed patients injected with Botox reported significantly fewer migraine days compared with those who received placebo injections, although full results will not be published until next year. Here is the statement. Whether Botox will replace aspirin remains to be seen. You may recall the FDA earlier this year warned that Botox, Botox Cosmetic (type A) and Myobloc (type B) have been linked to various adverse reactions, including respiratory fa... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1788916 Thu, 11 Sep 2008 18:43:31 +0100 1788916 http://www.medworm.com/index.php?rid=1714168&cid=t_102444_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F368299384%2F The University of Georgia and a former faculty member stand to make about $70 million from a license on an invention used for the popular Restatis eyedrops, which are sold by Allergan. But for more than a decade, Renee Kaswan, a former professor of veterinary medicine, hs been prodding the institution to be more aggressive in commercializing the invention, The Chronicle of Higher Education writes. She contends the university would be entitled to substantially more - as much as $230 million in additional cash - were it not for the deal the university’s research foundation cut with Allergan behind her back in 2003, a deal she calls naïve and shortsighted. “They got suckered,” Kaswan tells the paper. The deal allowed Allergan to reduce royalties to the university in exchang... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1714168 Mon, 18 Aug 2008 18:10:25 +0100 1714168 http://www.medworm.com/index.php?rid=1649306&cid=t_102444_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F343830430%2F Depends who you ask. But Contract Pharma magazine decided that a biopharma company is one that makes more than 40 percent of its drug revenues by selling biologic products, including biotherapeutics, vaccines and other proteins. As the mag’s editor, Gil Roth, says: No royalty-based companies allowed! (That means you, ImClone). This can be limiting, though. Gil could only find nine companies that would qualify for his Top 10 list. So to round it off, he threw in Elan, since it co-markets Tysabri with Biogen Idec. Good editors think creatively. 1 - Amgen - $14.3 billion 2 - Genentech - $9.4 billion 3 - Novo Nordisk - $7.7 billion 4 - Merck Serono - $6.1 billion 5 - Baxter BioScience - $4.6 billion 6 - Biogen Idec - $3.1 billion 7 - Genzyme - $2.8 billion 8 - CSL - $2.3 billion 9 - Alle... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1649306 Wed, 23 Jul 2008 19:06:15 +0100 1649306 http://www.medworm.com/index.php?rid=1625795&cid=t_102444_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F336292143%2F That’s what Public Citizen, the consumer advocacy group, is charging today after learning that Allergan, which markets the wrinkle-free treatment, hired two former Olympic gold medalists - swimmer Mark Spitz and gymnast Nadia Comaneci - as celebrity endorsers. Not surprisingly, Allergan’s ‘Personal Best’ campaign occurs just as the Summer Olympics begin in China. In an Allergan press release, Comaneci says she was frustrated by “those two stubborn frown lines stamped on my forehead. They looked like an ‘11′ and made me upset.” And Spitz (pictured to the right) says that, “as a financial advisor and motivational speaker, my facial expression is a very important part of my message. When I am serious, my ‘11′ makes me look angr... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1625795 Tue, 15 Jul 2008 17:51:14 +0100 1625795 http://www.medworm.com/index.php?rid=1346248&cid=t_102444_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F262845415%2F A new published last week in Nature is raising doubts about one of the hottest biotech fields known as RNAi, or RNA interference, which offers a way to turn specific genes on and off. And, of course, finding a way to turn off a gene that triggers disease is the sort of thing that attracts biotechs and drugmakers, such as Merck, which paid $1 billion to buy Sirna Therapeutics two years ago. But the study suggests that at least some drugs now being tested in clinical trials actually work not by silencing genes but by activating the immune system. And as The New York Times notes, this could mean the drugs are not really precise tools and could have unexpected side effects. “It seems to be working by a completely different mechanism that’s unrelated to the underlying premise,”’ Jayakr... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1346248 Wed, 02 Apr 2008 18:46:32 +0100 1346248 http://www.medworm.com/index.php?rid=1278316&cid=t_102444_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F245483265%2F Could this be a new wrinkle in the marketing plan? The drugmaker has received a subpoena from the US Attorney in Georgia, which is investigating the promotion of the popular wrinkle remover. In a statement, Allergen says the subpoeana “broadly requests documents regarding promotional, educational and other activities” relating to off-label promotion of Botox for treating headaches. The drugmaker notes that Botox is currently in Phase III clinical studies that investigating the use of Botox for treating headaches, a usage not approved by the FDA. Allergen intends to cooperate with the investigation, but of course, notes that docs are free to prescribe the drug off label. The news comes just one month after the FDA disclosed that Botox, Botox Cosmetic (type A) and Myobloc (type ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1278316 Tue, 04 Mar 2008 13:31:48 +0100 1278316 http://www.medworm.com/index.php?rid=1188768&cid=t_102444_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F225886910%2F A rainy day here in the nation’s medicine chest. That can only mean one thing - less time for a stroll outdoors and, so, still more time to be spent finding interesting items. Merck’s earnings will be released, for instance, which means more opportunity to hear about Vytorin. So grab the coffee or tea…. Allergan, best known for Botox, will close a plant in Ireland, eliminating 300 jobs, and transfer production to a factory in Costa Rica. The move probably will cost as much as $65 million through 2009, but the closing “has been made necessary by the high level of investment required to maintain competitiveness” at the location, Bloomberg News writes. Pfizer’s new HIV drug, Selzentry, will soon be reformulated in an effort to prevent the transmission of th... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1188768 Wed, 30 Jan 2008 12:50:08 +0100 1188768 http://www.medworm.com/index.php?rid=1175048&cid=t_102444_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F222354209%2F The consumer group has filed a petition with the FDA to “immediately increase” warnings to patients and docs about the use of botulinum toxin – available as Botox and Myobloc – because of serious adverse reactions, including deaths, linked to the drug. Unlike drug regulatory agencies in Europe, the FDA hasn’t issued any warnings about the toxin, which is used in therapeutic and cosmetic procedures, Public Citizen notes. The drug is intended to block nerve impulses to certain muscles, causing them to relax. However, in some cases, the toxin has spread to other parts of the body, causing paralysis of respiratory muscles and difficulty swallowing (dysphagia), which can lead to food or liquids entering the respiratory tract and lungs, causing aspiration pneumonia. A Publi... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1175048 Thu, 24 Jan 2008 15:09:40 +0100 1175048 http://www.medworm.com/index.php?rid=1134004&cid=t_102444_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F212779421%2F Jan Marini Skin Research, a small California company that sells a popular cosmetic product to make eyelashes look longer, is suspending US sales to avoid further trouble with the FDA and a patent battle with Allergan, The Wall Street Journal reports. Marini’s Age Intervention Eyelash Conditioner and several other companies sell eyelash products that contain ingredients that are similar to those in prescription drugs for a glaucoma. In November, FDA agents seized several thousand tubes of a similar, discontinued Marini product the agency called a “misbranded drug.” The FDA hasn’t acted against the reformulated version of the product that the Marini firm is now withdrawing from the US market, the paper writes. Jan Marini, the ceo, tells the Journal she isn’t awa... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1134004 Mon, 07 Jan 2008 20:30:08 +0100 1134004 http://www.medworm.com/index.php?rid=1035734&cid=t_102444_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F187129455%2F The company that brought us Botox - and gave new meaning to ironing out the wrinkles - is tinkering with its own Lumigan glaucoma med because a side effect is eyelash growth. In fact, this unintended consequence has set off a race among cosmetics companies to create new eyelash treatments that contain either bimatoprost - the active ingredient in Lumigan - or other so-called prostaglandins found in glaucoma drugs, The Wall Street Journal reports. The eyelash products look like mascara tubes and have a brush or tip for applying the product along the base of the lashes, and typically sell for $140 to $160 in spas and a doc’s office. At the same time, some docs are writing Lumigan off-label scripts for their cosmetic patients. But the companies pushing into this arena are already facing... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1035734 Mon, 19 Nov 2007 14:08:11 +0100 1035734 http://www.medworm.com/index.php?rid=989950&cid=t_102444_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F177158694%2F When Congress passed a bill last month requiring drug and device makers to disclose clinical trial results for all approved products, advocates of greater study disclosure cheered. But a provision that would have mandated disclosures for another group of products never made it into the final version of the bill. It would have covered products tested on patients, but dropped before marketing, The New York Times reports. “Trial sponsors can still choose to keep information about some trials confidential, creating serious ethical concerns,” Deborah Zarin, the director of ClinicalTrials.gov, tells the paper. Many experts say the recent Congressional debate underscored a troubling fact: some patients in clinical studies never learn about test results. The problem may be particularly releva... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=989950 Tue, 30 Oct 2007 12:41:04 +0100 989950 http://www.medworm.com/index.php?rid=885517&cid=t_102444_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F158591675%2F We are motoring along today. The transom is overflowing with interesting news of the world. While we prepare more items for your pleasure, here are a few to keep you occupied in the meantime. And if you haven’t already, please take our poll on whether clinical trial databases should be made available on the Internet. West Virginia Curtails Reporting Prescription Data to Drugmakers (Yahoo/AP) Allergan To Pay $370M For Esprit Pharma And Its Bladder Drug (Yahoo/Reuters) FluMist Approved For Children Two To Five Years Old (Yahoo/Reuters) Express Scripts Unit To Pay $10.5M Fine Over HGH (Yahoo/AP) Share / E-mail (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=885517 Wed, 19 Sep 2007 15:41:58 +0100 885517 http://www.medworm.com/index.php?rid=548773&cid=t_102444_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2007%2F04%2Fbotox-bs-piled-higher-and-deeper.html Have you seen the latest ads for Botox? The tag line is "freedom of expression..." The ads go on to say "Don't hold back! Express it all!" The copy writers certainly don't hold back on the exclamation points!!The not-so-subtle subliminal message is "despite what has been reported in the press and on blogs by patients (see "Botox Banality Not a Boon for TV Sitcoms"), use of Botox does not limit your range of facial expressions." To prove the point, ads like the one shown here feature a woman in several different poses, presumably showing a range of impressions.Pretty impressive evidence, wouldn't you say?I have tried to fathom the thoughts of the woman in the ad and put these in thought balloons superimposed on the ad (see image). I think I captured the essence of these expressions. Don't y... Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=548773 Tue, 17 Apr 2007 11:30:00 +0100 548773 http://www.medworm.com/index.php?rid=525575&cid=t_102444_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2007%2F04%2Fbotox-banality-not-boon-for-tv-sitcoms.html Despite extolling the ability to "express yourself" while under the influence of Botox in recent TV "reminder ads" -- which, BTW, go against the self-imposed industry ban on such ads -- TV studios are finding it increasingly difficult to find women actors who can express themselves, according to Wall Street Journal article ("The Backlash to Botox").Left, Janice Dickinson (Botox Banal) in scenes from her reality show, 'The Janice Dickinson Modeling Agency'; right, Julia Louis-Dreyfus (Botox Free) in 'The New Adventures of Old Christine.'"The rarest commodity in TV these days, say veteran casting directors: stars without Restylane-frozen faces and collagen-inflated lips."Botox Not Comical"Successful sitcoms," notes the WSJ, "including 'Old Christine,' typically feature actors and actresses w... Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=525575 Fri, 06 Apr 2007 12:00:00 +0100 525575 http://www.medworm.com/index.php?rid=478750&cid=t_102444_87_f&fid=34867&url=http%3A%2F%2Fwww.thediabetesblog.com%2F2007%2F03%2F08%2Fsupplementing-evidence-for-diabetic-neuropathy%2F Filed under: Type 1, Type 2, Childhood, Adult Onset, Lifestyle, Drugs, Research, EventsAllow me to explain my choice of photographs. I choose to spot the picturesque sunset over the Ventura Beach horizon, where I will NOT be attending the upcoming Gordon Research Conference on Oxidative Stress and Disease. For those who will be there, do me a favor and drop me a line on Section 3: Oxidative Stress and Diabetes. Here's what I've got so far... Alpha-lipoic acid is approved in Germany as a drug for the treatment of diabetic polyneuropathies. Alpha lipoic acid shows evidence of being effective in the treatment of diabetic neuropathy and may be useful in treating some other aspects of diabetes. It may help prevent the oxidation of LDL cholesterol and may be protective against oxidative stress. ... The Diabetes Blog blogs http://www.medworm.com/rss/comments.php?id=478750 Thu, 08 Mar 2007 05:00:00 +0100 478750