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 'diet pills'. Sat, 03 Sep 2011 02:28:39 +0100 http://www.medworm.com/index.php?rid=5118997&cid=t_107302_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FO0w2-RYQDAk%2F Last week, Arena Pharmaceuticals did some advance work surrounding the impending release of crucial data about its Lorqess diet pill, which was denied approval last fall by the FDA due, in part, to concerns the drug may cause tumors in rats and that efficacy was marginal. To allay those fears, the drugmaker conducted one new study and retained a group of independent pathologists to review other data (see this and this). The latest trial showed that concentrations of cerebrospinal fluid exposure were lower in human brains than in rat models given their pill (read here). The results prompted Needham analyst Alan Carr to write investors that the results “may alleviate certain FDA concerns with respect to the potential for brain tumors.” And Arena ceo Jack Lief, who has been critic... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=5118997 Wed, 10 Aug 2011 13:47:48 +0100 5118997 http://www.medworm.com/index.php?rid=4893913&cid=t_107302_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FZzoVYKju9hA%2F Four months after receiving a complete response letter from the FDA for its Contrave diet pill, Orexigen Therapeutics has now put further development on hold after receiving an “unprecedented” request for a pre-approval clinical trial that the aspiring drug developer believes “would generate significantly more information than is necessary or feasible.” As a result, Orexigen plans an appeal this month. At issue are concerns over cardiovascular risks that prompted the FDA to request a randomized, double-blind, placebo-controlled trial. In fact, the FDA told Orexigen execs that the agency plans to hold an advisory committee meeting early next year to assess cardiovascular issues with diet drugs, in general. This is only the latest indication the FDA is raising a high ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4893913 Fri, 03 Jun 2011 13:28:00 +0100 4893913 http://www.medworm.com/index.php?rid=4883760&cid=t_107302_129_f&fid=34869&url=http%3A%2F%2Fwww.diet-blog.com%2F11%2Fpopular_diet_supplement_review_quick_trim.php Quick Trim has become internationally popular in the last year thanks to the popular celebrity endorsement of the Kardashian sisters. The supplements were released in 2009 and two years later many people all over the world are using them to lose weight. However, is Quick Trim worth all the hype? Continue reading... (Source: Diet Blog) Diet Blog blogs http://www.medworm.com/rss/comments.php?id=4883760 Mon, 30 May 2011 23:00:00 +0100 4883760 http://www.medworm.com/index.php?rid=4780486&cid=t_107302_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FIjq9ZMQ6Rf4%2F Anxious to win FDA approval for its Qnexa diet pill, Vivus has come up with an unsual fallback position to overcome safety issues that have so far scuttered agency endorsement. If the results of a planned teratogenicity study are inadequate to win over regulators, the beleaguered little drugmaker plans to seek a limited indication. Very limited. This would involve allowing docs to prescribe the diet pill to “only men and women of non-child bearing potential” (read here). This might seem counterintuitive. After all, diet pills are widely sought by countless women who are still capable of conceiving. For instance, Leerink Swann analyst Steve Yoo estimates in an investor note this morning that about 50 percent of the “likely market could fall into the women of childbearing a... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4780486 Tue, 03 May 2011 13:07:13 +0100 4780486 http://www.medworm.com/index.php?rid=4715020&cid=t_107302_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=4704955&cid=t_107302_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FYQL7SG1LjBE%2F Here is a curious oversight. Anxious to see its Qnexa diet pill find its way to medicine cabinets, Vivus yesterday issued a press release touting a study in The Lancet medical journal that the drug demonstrated “significant weight loss and broad improvements in co-morbidities.” The Lancet, in its own press release, suggested “this promising new treatment has additional metabolic benefits - improving blood pressure, lipids, glycaemia, and inflammatory markers.” The upshot is that the study suggests the Qnexa diet pill could help overweight people lose more pounds than those who were given a placebo and, therefore, possibly reduce their reliance on meds for other risk factors, namely diabetes, high blood pressure or cholesterol. Such a finding is potentially noteworth... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4704955 Tue, 12 Apr 2011 13:34:56 +0100 4704955 http://www.medworm.com/index.php?rid=4566342&cid=t_107302_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FojH331Zf3Vk%2F Good morning one and all. Nice to see you again. ‘Tis the middle of the week, which means we are in the thick of those meetings and deadlines. To cope - yes - we are brewing some cups of stimulation. Two-fisted drinking is possible even while manipulating a laptop. Feel free to join us. And we would also like to invite you to a webinar we are hosting next week on disclosing physician payments. Meanwhile, here are some interesting tidbits. Have a productive day and stay in touch… Novartis COPD Drug Gets Mixed FDA Panel Verdict (Wall Street Journal) J&J Misled South Carolina About Risperdal, Lawyer Says (Bloomberg News) Combo Diet Pills Making A Comeback (MSNBC) Human Genome Lupus Drug Expected To Be Approved (Reuters) Glaxo Withdraws Sports Drink Over Mold Growth (The Groce... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4566342 Wed, 09 Mar 2011 12:40:08 +0100 4566342 http://www.medworm.com/index.php?rid=4460183&cid=t_107302_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FIscGIZzZVGw%2F For the second time in as many weeks, an aspiring maker of diet pills has cut its workforce in response to a rejection by the FDA. This time, Orexigen Therapeutics has dismissed roughly 40 percent of its staff, or 23 employees. Not huge numbers in the scheme of things, but certainly symbolic of the difficulty a trio of small companies is having as they attempt to win over a safety-conscious FDA. “We continue to believe in the potential of Contrave (its diet drug) and look forward to discussions with the FDA,” Orexigen ceo Mike Narachi says in a statement. “Unfortunately, given the near-term uncertainty of Contrave approval, we felt it prudent to consolidate and focus our resources. We are deeply grateful for the dedication and tremendous effort provided by all of our coll... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4460183 Thu, 10 Feb 2011 13:48:27 +0100 4460183 http://www.medworm.com/index.php?rid=4424448&cid=t_107302_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F4AV-BeRptIw%2F Once again affirming ongoing safety concerns about the anticipated widespread use of diet pills, the FDA issued a so-called Complete Response Letter for Contrave, a drug developed by Orexigen Therapeutics. The move comes less than two months after an FDA advisory panel recommended the pill for approval, but also voted in favor of requiring additional studies to gauge cardiovascular risks (back story). In disclosing the rejection, Orexigen ceo Michael Narachi disclosed the agency wants the drugmaker to conduct a randomized, double-blind, placebo-controlled trial. “We are surprised and extremely disappointed,” he says in a statement. Had the FDA approved Contrave, the pill would become the first new prescription diet drug to reach US consumers since 1999, when the FDA endorsed Ro... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4424448 Tue, 01 Feb 2011 13:30:49 +0100 4424448 http://www.medworm.com/index.php?rid=4419450&cid=t_107302_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FDuEhKTsDWM0%2F For the past few months, Arena Pharmaceuticals ceo Jack Lief has been at the center of controversy over the extent to which the drugmaker’s Lorqess diet pill may have links to tumors in rats and, more specifically, whether data about this possibility was disclosed correctly. Last September, he was chastised for not conveying any info prior to disclosure that was made publicly by FDA staffers, who discussed the data in documents submitted for an FDA advisory panel. After the panel voted down the drug, he argued that “we believe that (Lorqess) does not pose a cancer risk to humans at the recommended therapeutic dose…There is an immense amount of data generated in drug development. We did not, and still do not believe that the data’s relevant to humans and, as such, did not be... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4419450 Mon, 31 Jan 2011 15:37:56 +0100 4419450 http://www.medworm.com/index.php?rid=4406030&cid=t_107302_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fu6wIn052s0o%2F Reeling from setbacks in obtaining approval for its Lorqess diet pill, Arena Pharmaceutical is laying off 66 employees - about 25 percent of its workforce - and continues to maintain that a resubmission can be filed with the FDA by the end of the year. However, the drugmaker could not guarantee the deadline can be met and offered a laundry list of issues to first resolve with FDA staffers. The list includes what the drugmaker deemed as “non-clinical issues” involving ties between Lorqess and tumors in rats, a notion that has plagued Arena executives for months, especially after Arena ceo Jack Lief was criticized for failing to more thoroughly vet the topic with investors prior to the rejection by the FDA advisory panel last September (see this). In a statement, Arena says five ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4406030 Thu, 27 Jan 2011 22:34:16 +0100 4406030 http://www.medworm.com/index.php?rid=4382947&cid=t_107302_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F3w1iZjW8L30%2F If anyone thought that each new diet pill would easily pass muster with a more safety-conscious FDA, they should take a look at the hurdles that Vivus must clear. After being rejected by an FDA advisory panel last summer over cardiovascular risks and teratogenic concerns, the drugmaker must now create a database that examines the incidence of oral clefts in babies whose moms took topiramate, which is one component of its Qnexa drug (the other is phentermine, the surviving half of fen-phen). In a statement issued after a meeting this week with the FDA, Vivus notes agency officials cited six published reports of oral clefts in the UK Epilepsy and Pregnancy Register and in the North American AED Pregnancy Registry. In Qnexa trials, 15 women became pregnant and delivered normal babies, but tha... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4382947 Fri, 21 Jan 2011 16:54:09 +0100 4382947 http://www.medworm.com/index.php?rid=4305105&cid=t_107302_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F---sJ6wFY7c%2F This is hardly surprising. Given the ongoing talk at the FDA about placing greater emphasis on safety, no one should be shocked that the pace of drug approvals remains modest. Last year, 21 new drugs were approved, down from 25 in 2009 and 24 in 2008. However, the latest tally is actually higher than the 18 approvals issued in 2007. As The Wall Street Journal notes, the latest approvals included a few biologics that are expected to become sizeable sellers: Amgen won approval for Prolia, which is used to treat osteoporosis in postmenopausal women; Roche’s Genentech scored with Actemra for rheumatoid arthritis; Boehringer Ingelheim received approval for Pradaxa, a new type of bloodthinner and Novartis garnered FDA endorsement for its Gilenya multiple sclerosis pill. And how can anyone ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4305105 Mon, 03 Jan 2011 13:02:45 +0100 4305105 http://www.medworm.com/index.php?rid=4285351&cid=t_107302_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FsM8mIx_spwY%2F After meeting with FDA officials to review the recent rejection of its Lorqess diet pill, Arena Pharmaceuticals now plans to refile its application by the end of 2011. This means, of course, its drug probably not become available until 2012 and, by then, could well be the last of a new round of diet pills to arrive in pharmacies. Hardly a competitive advantage. You may recall that an FDA advisory panel voted 9-to-5 last September not to recommend approval for Lorqess over concerns the drug may cause tumors in rats and efficacy was marginal. Meanwhile, Vivus failed to win agency approval for its Qnexa pill over side effect issues (look here), although the same FDA panel more recently did endorse the Contrave drug from Orexigen Therapeutics (read this). The three-way race is being closely w... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4285351 Thu, 23 Dec 2010 14:20:57 +0100 4285351 http://www.medworm.com/index.php?rid=4281552&cid=t_107302_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FXw5i4ajxIVo%2F Hello, everyone, and top of the morning to you. Another shiny day is unfolding here on the Pharmalot corporate campus, where we are scrambling to do too many things at once. Sounds familiar, yes? To cope, we are quaffing yet another cup of stimulation. Meanwhile, here are some tidbits to help you along. Hope your day is productive and do stay in touch… Arena To Refile Obesity Drug By End Of 2011 (Reuters) Biogen And Elan Want To Update Tysabri Label (Bloomberg News) J&J Shareholders File Suit Over Manufacturing Gaffes (Bloomberg News) Novo Sales Rep Sues For Wrongful Termination (West Virginia Record) Teva And Takeda Settle Actos Patent Lawsuit (Reuters) Vertex Ends Part Of Telaprevir Study For Hepatitis C (Bloomberg News) Pharmacist Jailed For Mail Fraud (Standard Speaker) (Sou... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4281552 Wed, 22 Dec 2010 13:17:56 +0100 4281552 http://www.medworm.com/index.php?rid=4272427&cid=t_107302_129_f&fid=34869&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2Fdiet-blog%2F%7E3%2FT8j1zm5Lj7E%2Fhcg_diet_slammed_by_nutritionists_during_holiday_promotion.php HCG Diet Direct has tried to capitalise on Christmas diet anxiety by offering a holiday promotion - prompting nutritionists and health professionals to warn dieters away. The HCG Diet uses human chorionic gonadotropin (hCG), a hormone which women produce during pregnancy. By taking it, dieters trick their bodies into trying to provide food for a non-existent baby. The HCG diet has been criticised both for the use of hormone injections, and for the very low calorie limit, just 500 calories per day (a quarter of what an average woman needs).0 Comments | Continue reading... (Source: Diet Blog) Diet Blog blogs http://www.medworm.com/rss/comments.php?id=4272427 Mon, 20 Dec 2010 00:00:00 +0100 4272427 http://www.medworm.com/index.php?rid=4238145&cid=t_107302_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FGuLviF9y5LA%2F In a surprise move, the FDA’s Endocrinologic and Metabolic Advisory committee voted 13-to-7 to recommend that Orexigen Therapeutics’ Contrave diet pill be allowed on the market. If the agency follows the advice, which is not guaranteed, Contrave would become the first new prescription diet drug to reach US consumers since 1999, when the FDA approved Roche’s Xenical. The panel, however, also voted 11-to-8 that additional studies are needed to ascertain cardiovascular risks. Nonetheless, the recommendation has the potential to drastically change the weight-loss market and, perhaps, put a dent in the burgeoning population of obese people, which has become a public health issue. Despite the clamoring for new diet tools, the same FDA panel earlier this year bounced two other n... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4238145 Tue, 07 Dec 2010 21:49:42 +0100 4238145 http://www.medworm.com/index.php?rid=4225654&cid=t_107302_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FZFTHevu79xk%2F Twice this year, an FDA advisory committee refused to recommend new diet pills for marketing approval. First, Vivus failed to win approval for its Qnexa drug and the same fate then met Arena Pharmaceuticals and its Lorqess med (see here and here). Next Tuesday, however, the third in this controversial trifecta will make an appearance - Orexigen Therapeutics and its Contrave pill. Will the outcome be different? The FDA briefing documents point out some safety issues, but there do not appear to be any great surprises either, suggesting that, well, anything is possible. On one hand, four studies conducted by Orexigen demonstrated that overweight patients lost, on average, 4.2 percent more weight than patients taking a placebo. On the other hand, this falls short of the FDA guideline that ther... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4225654 Fri, 03 Dec 2010 17:47:33 +0100 4225654 http://www.medworm.com/index.php?rid=4214479&cid=t_107302_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FbftEJo2_e1I%2F The fen-phen diet pill combo may have been dismantled with the 1997 withdrawal of one of the two pills, but the episode lives on. A Florida cardiologist- 77-year-old Abdur Razzak Tai - was indicted today by for submitting fraudulent claims to a huge settlement fund that was created in the wake of massive litigation brought by tens of thousands of overweight consumers. A 13-count indictment, which charges Tai with mail fraud and wire fraud, claims he reviewed echocardiograms for more than 1,100 patients who filed claims with the American Home Product Settlement Trust (American Home Products was the former name for Wyeth, which is now owned by Pfizer and marketed one, Pondimin, or fenfluramine, one of the two fen-phen pills. Wyeth yanked Pondimin and Redux, a chemical cousin, due to serious ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4214479 Tue, 30 Nov 2010 22:38:15 +0100 4214479 http://www.medworm.com/index.php?rid=4152273&cid=t_107302_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FO1X6uNbncO0%2F When the FDA issued a complete response letter last month for the Arena Pharmaceutical diet pill, the agency cited a few reasons: pending results of a trial in 604 patients with diabetes, concerns that the pill may cause tumors in rats and efficacy was marginal (look here). There was no mention, however, of another issue that two months ago prompted an FDA advisory panel to reject the drug in a 9-to-5 vote: valvulopathy, which is heart-valve disease (see this). Now, though, that issue might just be revisited. This morning, Arena issued the results of the awaited trial for its Lorqess pill and valvulopathy cropped up again. After 52 weeks, 2.9 percent of the people on the diet drug developed valvulopathy, compared with just 0.5 percent on a placebo. Arena, however, says the trial was not po... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4152273 Tue, 09 Nov 2010 16:31:40 +0100 4152273 http://www.medworm.com/index.php?rid=4119714&cid=t_107302_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FW3v5dhlNOsg%2F Earlier this year, there was nothing short of hoopla surrounding the notion that a new trio of diet drugs may win FDA approval. Why? Obesity remains a huge health problem (no pun intended) and there hadn’t been a new prescription diet pill since Roche’s Xenical arrived in 1999. And with FDA advisory committee meetings planned, the reasoning went that the agency saw the need for a new therapy. All of which made sense, to a point. But this is an era when the FDA is under pressure to ensure that safety is a high priority. And rightfully so, given recent controversies over manipulation of clinical trial data and side effects surrounding various meds, as well as agency infighting. Diet pills, however, have merited special attention thanks to the 1997 withdrawal of part of Wyeth&#821... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4119714 Fri, 29 Oct 2010 13:09:20 +0100 4119714 http://www.medworm.com/index.php?rid=4106060&cid=t_107302_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FpHeo8jvbsAY%2F The intense bickering leading up to the FDA decision to reject - for now - the Arena Pharmaceuticals Lorqess diet pill has some angry investors looking for the proverbial silver lining. For instance, in discussing the complete response letter issued by the agency late last week, investors have noted on blogs and message boards that the drugmaker will soon report preliminary data from a clinical trial in obese diabetics and that an independent third-party will be retained to review tumor data in rats. For weeks, some investors have been railing that the FDA conducted a biased, or at least flawed review, after agency staffers released a report prior to an advisory committee meeting last month that focused on tumors in rats. To press their point, an online petition was begun. Since then, the ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4106060 Mon, 25 Oct 2010 15:22:50 +0100 4106060 http://www.medworm.com/index.php?rid=4098457&cid=t_107302_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F9e7B44LUKWI%2F Those who argued there was a ‘fat chance’ the FDA would approve the Arena diet pill were correct. The drugmaker issued a statement this morning saying the agency sent a complete response letter and the rejection can be attributed to waiting for results of a trial in patients with diabetes, concerns the Lorquess pill may cause tumors in rats and that efficacy was marginal. The outcome is hardly surprising, given the issues raised by FDA reviewers at an advisory committee meeting (look here). The session may have prompted outrage among some investors, who generated considerable attention by circulating a petition insisting FDA staff was biased, but the agency is exercising considerable caution these days over safety issues (back story). This is especially true for diet pills afte... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4098457 Sat, 23 Oct 2010 14:58:54 +0100 4098457 http://www.medworm.com/index.php?rid=4098462&cid=t_107302_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FofgMWGHYZdw%2F Today is the day that countless people - from the overweight to those overweighted in Arena Pharmaceutical stock - may learn whether the FDA will approve the drugmaker’s diet pill. Not every agency deadline is so closely watched, but this one is generating enormous attention for two reasons - diet pills have not fared well despite the rising rate of obesity and an unusual push by angry investors who believe the FDA unfairly reviewed the drug - which we were the first to report (see this). Last month, you may recall, an FDA advisory committee voted 9-to-5 that the risks of the Lorqess diet drug developed by Arena outweighed the benefits. The decision came after concerns about valvulopathy and, in particular, links to malignancies in rats at higher doses, which were revealed in FDA bri... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4098462 Fri, 22 Oct 2010 12:57:50 +0100 4098462 http://www.medworm.com/index.php?rid=4074441&cid=t_107302_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FP2wK003B2K0%2F If you thought obese humans are the only creatures on earth susceptible to harm from a diet pill, consider overweight dogs, specifically those taking Pfizer’s Slentrol pill. The FDA is planning a pharmacogenomic study to determine whether reported adverse drug events are associated with genetic variations in the dogs treated with the pill, which was approved in 2007. Why? A preliminary analysis by the FDA’s Center for Veterinary Medicine indicates potential correlations between certain dog breeds and some side effects, according to a notice in the Federal Register. The notice did not specify side effects or breeds, but Slentrol labeling shows that vomiting occurred in nearly 25 percent of the dogs, 12 percent suffered diarrhea and nearly 10 percent grew lethargic (so much for r... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4074441 Fri, 15 Oct 2010 13:04:24 +0100 4074441 http://www.medworm.com/index.php?rid=4060967&cid=t_107302_129_f&fid=34869&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2Fdiet-blog%2F%7E3%2FvgFyE_Sv0Mk%2Fdiet_drug_meridia_off_the_shelves_causes_heart_attacks_strokes.php Last Friday, the diet drug Meridia was pulled from the shelves in America by its maker, Abbott Laboratories. Meridia, a prescription drug, was known to cause a higher risk of heart attack and stroke when in trials, but scientists believed this effect might be compensated for by the weight loss benefits. It wasn't.Continue reading... (Source: Diet Blog) Diet Blog blogs http://www.medworm.com/rss/comments.php?id=4060967 Mon, 11 Oct 2010 23:00:00 +0100 4060967 http://www.medworm.com/index.php?rid=4055957&cid=t_107302_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FAN4d2O3u9_g%2F The decision late last week by the FDA to encourage Abbott Laboratories to withdraw its Meridia diet pill has obvious implications for other drugmakers seeking approval for obesity drugs. But will those companies gain or lose? The answer will depend on the extent to which the FDA sees the need to offer more options to fight fat while weighing (pun intended) pressing safety concerns. On one hand, there are few options available to overweight Americans: Roche’s Xenical, which is also sold over-the-counter by GlaxoSmithKline as Alli, and phentermine, the surviving half of the infamous fen-phen weight-loss cocktail (the other half, fenfleuramine, along with a chemically related pill were both recalled in 1997 due to serious heart and lung side effects). But these are only modestly effect... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4055957 Mon, 11 Oct 2010 12:53:29 +0100 4055957 http://www.medworm.com/index.php?rid=4031504&cid=t_107302_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FiG4QgbXyXhs%2F Last month, an FDA advisory committee voted 9-to-5 that the risks of the Lorqess diet drug developed by Arena Pharmaceuticals outweigh the benefits. That move came after concerns about valvulopathy and, in particular, links to malignancies in rats at higher doses, which were revealed in FDA briefing documents and caught some people, including Wall Street analysts, by surprise. The decision caused a stir among investors and a subsequent controversy about whether Arena properly and promptly disclosed the existence of the tumor data (look here). In comments made to Wall Street analysts following the FDA panel vote, ceo Jack Lief insisted the info was handled correctly. An FDA decision is expected later this month. Now, a petition has begun circulating the Internet in which the FDA is being as... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4031504 Mon, 04 Oct 2010 14:21:30 +0100 4031504 http://www.medworm.com/index.php?rid=4018442&cid=t_107302_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FdBRLL1FCDV0%2F Yet another lawyer may have crossed a line while pressing lawsuits against Wyeth over the withdrawal of the fen-phen diet pills. This time, George Fleming, a well-known plantiff’s attorney, is being sued by former clients who claim he improperly fed his piggy bank by charging his clients for echocardiograms that were given to thousands of other people who he ultimately did not represent. The tests were needed to determine whether an individual was harmed by the pills. In their lawsuit, which has gone to trial, 10 of Fleming’s former clients allege they learned after their 2006 settlement that about 8,100 claimants he represented were charged for echocardiograms that were given to 35,000 people who were rejected as clients, The Houston Chronicle reports. They were rejected becau... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4018442 Thu, 30 Sep 2010 15:10:48 +0100 4018442 http://www.medworm.com/index.php?rid=3981013&cid=t_107302_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F33pA4HZ1krY%2F No one at Arena Pharmaceuticals could accuse ceo Jack Lief of being a rat. In a conference call yesterday with analysts after an FDA panel rejected the drugmaker’s Lorqess diet pill due to safety concerns, Lief acknowledged that different forms of cancer had been seen in rats treated with high doses. But he stressed that “when we learned of the data, we promptly discussed it with the FDA.” But then Cowen analyst Phil Nadeau asked if the info was ever made available to the public or was the FDA briefing document released this week the first time investors might have learned of this finding. Lief replied by saying “…we believe that (Lorqess) does not pose a cancer risk to humans at the recommended therapeutic dose…There is an immense amount of data generat... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3981013 Fri, 17 Sep 2010 18:06:18 +0100 3981013 http://www.medworm.com/index.php?rid=3976706&cid=t_107302_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fc3GfNw9GHL8%2F In a decision that is not very surprising, an FDA advisory committee voted 9-to-5 that the risks of the Lorqess diet drug developed by Arena Pharmaceuticals outweigh the benefits. The move came after concerns about valvulopathy and links to malignancies in rats at higher doses, which were revealed unexpectedly in FDA briefing documents (see here). This is the second time in recent weeks that the FDA Endocrinologic and Metabolic Advisory committee has shot down a new diet drug. In July, the panel Qnexa pill developed by Vivus (see this). The vote also is a big setback for Eisai, which recently paid $50 million for the rights to sell Arena’s drug; and agreed to cough up $160 million based on development and approval milestones, and a $1.16 billion, one-time payment based on annual sal... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3976706 Thu, 16 Sep 2010 20:09:14 +0100 3976706 http://www.medworm.com/index.php?rid=3976710&cid=t_107302_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FT-EWnRbXh7I%2F At first blush, diet pills appear to be all the rage these days. There are no fewer than three new obesity drugs that have generated enormous interest - among investors and patients - this year. And for awhile, the anticipation has suggested this troubled market - which has been littered with recalls, litigation and limited effectiveness - may finally generate real progress. Recently, though, there has been as much concern as optimism. Two months ago, an FDA advisory panel voted against marketing approval for Vivus’ Qnexa pill over worries about usage by pregnant women and psychiatric side effects (back story). [Yesterday, another panel couldn't decide whether to yank Abbott Labs' much older Meridia drug, which is linked to cardiovascular risk, or issue stronger warnings]. Today, an... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3976710 Thu, 16 Sep 2010 14:00:06 +0100 3976710 http://www.medworm.com/index.php?rid=3973108&cid=t_107302_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FeGtWp6_IEtQ%2F Don’t you hate it when someone can’t made up their mind? How about an entire FDA advisory panel? That’s exactly what happened this afternoon when an FDA committee voted 8-to-8 after being confronted with the thorny question of what to do about Abbott Labs’ Meridia diet pill. Even though a recent trial called SCOUT showed Meridia patients with heart disease had a 16 percent higher chance of developing cardiovascular risks compared with those on a placebo, the Endocrinologic and Metabolic Drugs committee was, ultimately, unable to muster enough votes to decide whether the drug should be allowed to remain on the market or recommend withdrawal. The breakdown: eight members voted to keep Meridia on the market, although they also 8 agreed the pill should have a boxed warn... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3973108 Wed, 15 Sep 2010 23:18:09 +0100 3973108 http://www.medworm.com/index.php?rid=3973117&cid=t_107302_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fb2h0UB6N-As%2F Rise and shine, everyone. Another day is upon us. But this is a good thing. As one of our favorite sages, the Morning Mayor, used to say: Every brand new day should be unwrapped like a precious gift. While you tug on the ribbon, we will brew the mandatory cup of stimulation and poke around for interesting items. Here, in fact, are a few to help you get started. Have a good one and stay in touch… Roche Rules Out Merging R&D With Genentech (Reuters) Abbott To Close Canadian Baby Formula Plant (Brockville Recorder & Times) China’s BGI And Merck Form Alliance (Bio-IT World) Abbott Fights To Keep Meridia Diet Pill On The Market (Reuters) K-V Pharmaceutical Secures A $20M Loan (Fox Business) Genentech CEO Resigns From Dendreon Board (Xconomy) Cell Therapeutics Appeals FDA R... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3973117 Wed, 15 Sep 2010 11:51:18 +0100 3973117 http://www.medworm.com/index.php?rid=3965699&cid=t_107302_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FU6W3fLZnEss%2F Eight months after their European counterparts told doctors to stop prescribing Abbott Labs’ Meridia diet pill, the FDA will now ask an advisory panel meeting this Wednesday whether the drug should be withdrawn from the US market. At issue are cardiovascular risks highlighted in a trial called SCOUT that was released last November, which showed Meridida patients with heart disease had a more than 11 percent risk of cardiovascular risks compared with 10 percent of those on a placebo. Since then, the FDA has been criticized for not moving faster, although the agency had preferred to wait for full results to be issued. And so the advisory committee can now choose among four options: besides recommending withdrawal, the experts can urge continued marketing with the same labeling; continu... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3965699 Mon, 13 Sep 2010 16:40:54 +0100 3965699 http://www.medworm.com/index.php?rid=3929457&cid=t_107302_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FDY75SsEr9v8%2F After months of waiting, the final and complete results from a study about the Meridia diet pill are now available in The New England Journal of Medicine and the findings are as bad as what was suggested by the preliminary data released last November. The SCOUT study, which was financed by Abbott Labs, the company that sells the pill, shows Meridia raised heart attack and stroke risk in patients with pre-existing heart disease (read the abstract). The study examined nearly 10,000 people 55 and older with pre-existing cardiovascular disease, type 2 diabetes or both, who were given Meridia or a placebo. They also participated in a diet and exercise program. On average, Meridia was taken for more than three years and the risk of a heart attack or stroke was 16 percent higher. Those taking the... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3929457 Thu, 02 Sep 2010 12:17:27 +0100 3929457 http://www.medworm.com/index.php?rid=3896096&cid=t_107302_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FIlCjV-7MvbA%2F Preemption survives another test. A federal appeals in Ohio court last week partially reinstated a lawsuit over the Redux diet pill after deciding that FDA approval did not preempt state claims that Wyeth was negligent in marketing the drug, which was withdrawn in 1997 over links to serious heart and lung ailments. The US Court of Appeals for the Sixth Circuit reversed dismissal of negligence over Wyeth’s actions prior to the 1996 approval of Redux, as well the dismissal of punitive damages (read the ruling here). The lawsuit was filed by Mary Buchanan, who was diagnosed with primary pulmonary hypertension in 2001 and died in 2003. Her estate is pressing her claim, which accused Wyeth - now owned by Pfizer, of course - of negligence and design defects. Two years ago, a federal distr... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3896096 Mon, 23 Aug 2010 12:52:20 +0100 3896096 http://www.medworm.com/index.php?rid=3865464&cid=t_107302_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F-qsv1lAFCb0%2F And so yet another work week will soon draw to a close. And not a moment too soon, yes? This means, of course, the time is drawing near to catch up on sleep, sundry chores and spending time with some of the short people. What about you? Planning a trip to the beach or a big night out? Maybe read a book (or is that called a Kindle these days?) Whatever you do, have a great time and be safe. Catch you soon… Gene Testing May Have Saved Obesity Drug (Reuters) Sharing Data Leads To Progress On Alzheimer’s (The New York Times) Are You Ready For A World Without Antibiotics? (The Guardian) FDA Warns Glaxo’s Lamictal May Cause Meningitis (Associated Press) Roche Faces New Type Of Patent Lawsuit (Indianapolis Business Journal) (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3865464 Fri, 13 Aug 2010 11:46:29 +0100 3865464 http://www.medworm.com/index.php?rid=3831556&cid=t_107302_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F7PdyP6SApPE%2F Eight months after their counterparts in Europe told doctors to stop prescribing the Meridia diet pill, the FDA has finally scheduled an advisory committee meeting to review safety risks. A spokesman for Abbott Labs, which sells the drug, confirmed the Endocrinologic and Metabolic Drugs advisory committee will review Meridia on Sept. 15, a day before Arena Pharmaceuticals’ lorcaserin is reviewed. The move comes in the wake of a trial known as SCOUT, which emerged last November and showed an increased risk of serious, non-fatal cardiovascular events, such as stroke or heart attack, when comparing the drug with a placebo among nearly 10,000 patients. The trial was designed to assess the impact of weight loss on cardiovascular problems in a large group of overweight people taking the pi... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3831556 Fri, 06 Aug 2010 20:00:39 +0100 3831556 http://www.medworm.com/index.php?rid=3827344&cid=t_107302_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FMvtBNW3NPVU%2F A Pennsylvania court has offered another legal claim that consumers can pursue when filing product-liability lawsuits against drugmakers in the state. In a ruling involving the Redux diet pill, a Pennsylvania Superior Court panel decided that a claim of negligent design defect can be brought against Wyeth, which withdrew the drug in 1997 over links to serious heart and lung side effects. As The Legal Intelligencer notes, Pennsylvania courts have interpreted a federal allow in such a way that lawsuits do not allow strict liability claims against drugmakers for manufacturing defects or a failure to warn prescribers of risks under the learned intermediary theory. But the panel ruled that one provision Comment K of the Restatement (Second) of Torts - should not be seen as an impediment to purs... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3827344 Thu, 05 Aug 2010 17:10:43 +0100 3827344 http://www.medworm.com/index.php?rid=3758106&cid=t_107302_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FDjg7tRYJ3HQ%2F What will it take to convince a panel of experts that a diet pill is safe, not just effective? Vivus is the latest company to fail to come up with an answer. An FDA advisory committee today voted 9 to 7 to reject its Qnexa pill, which was effective in clinical trials, but worried panelists about usage by pregnant women and psychiatric side effects. These concerns were raised by agency medical reviewers (look here), given that diet drugs are widely expected to be used on a long-term basis. The outcome contradicts what some Wall Street analysts were cautiously predicting - a vote in favor of recommending approval, albeit with labeling and marketing restrictions, which would have made Qnexa the first new prescription diet pill in more than a decade. However, this has been a three-way race. Tw... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3758106 Fri, 16 Jul 2010 02:14:15 +0100 3758106 http://www.medworm.com/index.php?rid=3754072&cid=t_107302_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FpWOUBv8r4-w%2F Rise and shine, another day is on the way. Although the pace is likely to feel slower now that the FDA panel meeting on Avandia is done. Then again, there is another meeting today about a diet pill, which should be interesting. Meanwhile, please join us as we brew the mandatory cup of stimulation and scan the news of the world. Hope your day goes well and stay in touch… Thieves Steal Two Glaxo Trailers (SecuringPharma) Vivus Diet Drug Faces FDA Panel Today (Reuters) Novartis Quarterly Profit Rises (Bloomberg News) Arena’s Diet Pill Helped With Weight Loss (Bloomberg News) (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3754072 Thu, 15 Jul 2010 09:20:49 +0100 3754072 http://www.medworm.com/index.php?rid=3757991&cid=t_107302_129_f&fid=34869&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2Fdiet-blog%2F%7E3%2Fbn8_lmyqlz8%2Fweight_loss_supplements_bomb_in_major_studies.php This just in - you still have to work hard to lose fat! Two comprehensive German studies found that a broad range of weight loss supplements were no more effective than placebos. Continue reading... (Source: Diet Blog) Diet Blog blogs http://www.medworm.com/rss/comments.php?id=3757991 Wed, 14 Jul 2010 23:00:00 +0100 3757991 http://www.medworm.com/index.php?rid=3750272&cid=t_107302_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FTDsvnoJrM40%2F Will the first in a new round of diet drugs win FDA approval? The briefing documents released by the agency this morning reveal that Qnexa, which will be reviewed on Thursday by an agency panel, may cause psychiatric and cardiovascular side effects. FDA medical reviewers also believe the pill should have undergone more testing in pregnant women and they recommend warnings to avoid the possibility of fetal deformities. Why? There were 34 pregnancies during a clinical trial, despite recommendations for using two forms of birth control. For those who may not recall, Qnexa is a combo treatment - it includes phentermine, which was part of the fen-phen cocktail that was yanked in 1997, and topiramate, which is marketed as the Topamax seizure med. But phentermine can be habit forming and is contr... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3750272 Tue, 13 Jul 2010 13:23:59 +0100 3750272 http://www.medworm.com/index.php?rid=3750277&cid=t_107302_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=3718693&cid=t_107302_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FuxvU1Buf_Gg%2F More than a decade ago, the fen-phen weight-loss cocktail and a related diet pill called Redux made headlines after links to heart and lung troubles forced a recall, which eventually cost Wyeth $21 billion in charges. Other prescription drugs - Abbott’s Meridia and Roche’s Xenical - never fared well due to side effects. Sanofi-Aventis never sold Acomplia due to psychiatric side effects. And even the over-the-counter Alli pill, which is really a version of Xenical, is suspect these days thanks to concerns over liver injury (see here). Now, though, a trio of would-be diet pill makers is focusing attention anew on the long-disgraced obesity market. This is underscored by Eisai’s willingness to pay $50 million for the rights to sell Arena Pharmaceuticals’ lorcaserin in... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3718693 Thu, 01 Jul 2010 20:57:20 +0100 3718693 http://www.medworm.com/index.php?rid=3662804&cid=t_107302_129_f&fid=34869&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2Fdiet-blog%2F%7E3%2FNPu3AONo190%2Fnew_slimming_pill_capsiplex_hits_uk_shelves.php A new diet pill, Capsiplex, sold out just three days after going on sale in the UK on June 1st - with more than 50,000 packets being sold. Capsiplex, sold by the company of the same name, is the first slimming pill available in the UK which uses ingredients previously only available from the National Health Service (NHS). So, what caused this surge of demand, with Capsiplex describing sales as "greater than we could have ever expected"?Continue reading... (Source: Diet Blog) Diet Blog blogs http://www.medworm.com/rss/comments.php?id=3662804 Sun, 13 Jun 2010 23:00:00 +0100 3662804 http://www.medworm.com/index.php?rid=3610419&cid=t_107302_129_f&fid=34869&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2Fdiet-blog%2F%7E3%2FWj0YtCRaYeE%2Fmarketing_for_diet_supplements_often_deceptive.php Canary Papers Walk into a GNC or Vitamin Shoppe and you'll see row after row of super pills in brightly colored bottles claiming to eradicate all the world's ills, from blindness to athlete's foot! So then, why are we spending billions on medical cures for cancer and obesity? We already have all the magic pills we need. Yeah right. That's why the U.S. government is looking to crackdown on deceptive marketing practices for herbal and dietary supplements. Continue reading... (Source: Diet Blog) Diet Blog blogs http://www.medworm.com/rss/comments.php?id=3610419 Fri, 28 May 2010 23:00:00 +0100 3610419 http://www.medworm.com/index.php?rid=3564202&cid=t_107302_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fp-W5nW88_Ek%2F And so another working week will soon draw to a close. Already, we foresee brisk walks with the official Pharmalot mascot and cozy naps on the official Pharmalot couch. What will you do this weekend? Before getting carried away, there are those meetings and deadlines to conquer. So please join us as we quaffe a cup of stimulation and prepare for the day. And have a great weekend, whatever you do. See you soon… Pfizer And Strides Sign Deal For Oncology Drugs (Reuters) FDA Rejects Teva Petition To Block Generic Copaxone (Globes Online) How Valuable Is Arena’s Fat Pill? (Seeking Alpha) Diet Pills Are Bought Too Easily In The UK (BBC Watchdog) Florida May Tighten Psychotropic Drug Rules (Daytona Beach News-Journal) photo thx to tipiro on Flickr creative commons (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3564202 Fri, 14 May 2010 12:04:38 +0100 3564202 http://www.medworm.com/index.php?rid=3463860&cid=t_107302_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FJaZrlnZOQB4%2F Rise and shine. Another day is under way and who knows what it will bring? Perhaps opportunity will knock. Certainly, there is much to do. So grab a cup of something stimulating, or a water bottle if you prefer, and embrace the moment. To help you along, here are a few items of interest. Have a great day, everyone, and stay in touch… Roche Denies Plans To Leave The UK (Dow Jones) Obesity Drugs Await FDA Approval (The Wall Street Journal) Roche Buys Insulin Pump Maker (Reuters) Gilead Starts Late-Stage Test Of 4-In-1 HIV Drug (Associated Press) Bayer Stock Rises On Novartis Bid Rumor (Reuters) Novartis’ Gilena Slashes MS Relapse Rate (PharmaTimes) Wockhardt Looks Wobbly (Financial Express) (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3463860 Tue, 13 Apr 2010 12:00:11 +0100 3463860 http://www.medworm.com/index.php?rid=3359216&cid=t_107302_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FzEiv7-Y0wkk%2F There are gray skies hovering over the Pharmalot corporate campus this morning, but our spirits are sunny. And why not? If nothing else, the weekend is just around the corner. Yes, there are deadlines and meetings between now and then, but still, we look ahead to spending time with the short people and catching up on our to-do list. What will you do? While you ponder, here are a few items to help you along. Whatever your choice, have a nice weekend… Birth Control Pills May Help Women Live Longer (Bloomberg News) Nigerian Start-Up Fights Counterfeit Drugs (The Wall Street Journal) Arena Will Launch Diet Drug With Or Without A Partner (Reuters) Roche’s Avastin Fails Prostate Cancer Study Goal (Bloomberg News) Merck’s Vytorin Effectiveness Study To Continue (Associated Press... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3359216 Fri, 12 Mar 2010 12:35:59 +0100 3359216 http://www.medworm.com/index.php?rid=3225013&cid=t_107302_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FcwGhX8k34Sw%2F Hello, everyone. Nothing like a brisk Sunday morning to move you to curl up and catch up on some reading. Here on the sunny but quite cold Pharmalot corporate campus, we are doing just that. And, of course, quaffing a cup or three of needed stimulation. Later, we hope to take the official Pharmalot mascot for the usual constitutional. Whatever you do today, we hope it is enjoyable. Meanwhile, here are a few items to keep you fresh. Have a great time… GLAXOSMITHKLINE WILL CUT UP TO 4,000 JOBS as part of its plans to restructure its workforce and focus increasingly on emerging markets, according to The Times of London. The bulk of the cuts will be in America and Europe, and are part of the drugmaker’s efforts to shift resources away from low-growth territories into parts of the world... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3225013 Sun, 31 Jan 2010 16:17:48 +0100 3225013 http://www.medworm.com/index.php?rid=3208547&cid=t_107302_129_f&fid=34869&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2Fdiet-blog%2F%7E3%2FgAmSc0Pt9Uk%2Ffake_alli_pills_putting_dieters_in_danger.php Since Alli became licensed for over-the-counter sale, many dieters have been turning to it to give their weight loss efforts a boost. But now, the Food and Drug Administration (FDA) has warned about counterfeit products on the market. The counterfeit pills have been tested and shown to contain potentially harmful levels of sibutramine -- a drug that should only be available by prescription.Continue reading... (Source: Diet Blog) Diet Blog blogs http://www.medworm.com/rss/comments.php?id=3208547 Tue, 26 Jan 2010 00:00:00 +0100 3208547 http://www.medworm.com/index.php?rid=3197884&cid=t_107302_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FTfQz4yrm1BU%2F Two regulators, two different approaches to risk. Yesterday, the European Medicines Agency told docs to stop prescribing Abbott’s Meridia diet pill, because the risks outweigh the benefits, and decided Abbott’s license to market the pill should be suspended (look here). At the same time, the FDA added new warnings highlighting increased risks for patients with heart problems but reserves further action until full results arrive in March and a committee meeting is held (see here). The varying decisions were made after reviewing data from a trial known as SCOUT, which emerged last November and showed an increased risk of serious, non-fatal cardiovascular events, such as stroke or heart attack, when comparing the drug with a placebo among nearly 10,000 patients. The trial was desi... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3197884 Fri, 22 Jan 2010 14:48:41 +0100 3197884 http://www.medworm.com/index.php?rid=3146108&cid=t_107302_129_f&fid=34869&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2Fdiet-blog%2F%7E3%2FKmPBWamph68%2Fmost_annoying_weight_loss_scams_of_2009.php Every few months some new weight loss gimmick comes along. It gets marketed like crazy across the Internet, then in another year or so, everyone forgets about it. Thousands of desperate punters shell out serious money hoping for the miracle solution, but... no authentic success stories are forthcoming. So here's my two picks for the most annoying hard-sells of the last 12 months.Continue reading... (Source: Diet Blog) Diet Blog blogs http://www.medworm.com/rss/comments.php?id=3146108 Tue, 05 Jan 2010 00:00:00 +0100 3146108 http://www.medworm.com/index.php?rid=3108466&cid=t_107302_129_f&fid=34869&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2Fdiet-blog%2F%7E3%2F3zfsDFa66-k%2Fjillian_michaels_weight_loss_supplements.php I'm not sure what to make of this, but for a number of months now, Jillian Michaels has been pushing her own line of weight loss supplements. She has been riding a wave of success since being the Biggest Loser trainer - which led to her own weight loss program and a series of books and DVDs. Supplements are whole different thing altogether.Continue reading... (Source: Diet Blog) Diet Blog blogs http://www.medworm.com/rss/comments.php?id=3108466 Sun, 20 Dec 2009 00:00:00 +0100 3108466 http://www.medworm.com/index.php?rid=3052386&cid=t_107302_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FQYFGBiP13pw%2F Public Citizen has written the agency to urge an outright ban, citing preliminary results from the 10,000-patient SCOUT study called that showed a slightly higher risk of heart attack, stroke and death in patients taking Meridia compared with a placebo. At the time the study, which was conducted in patients who were older than 55, overweight with a history of heart disease or diabetes, was released last month, the FDA was “making no conclusions” about the findings. Both the FDA and the European Medicines Agency’s Committee for Medicinal Products for Human Use has started a safety review (see the FDA statement here, the EMEA statement here and the Public Citizen petition here). “We would hope that the science behind the results seen in this study would mandate the only ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3052386 Thu, 03 Dec 2009 15:51:43 +0100 3052386 http://www.medworm.com/index.php?rid=2950868&cid=t_107302_129_f&fid=34869&url=http%3A%2F%2Fwww.diet-blog.com%2Farchives%2F2009%2F11%2F02%2Fantioxidants_bad_for_diabetics.php Antioxidant vitamins, the once promising antidote to heart disease and cancer have become the red-headed stepchildren in the world of nutritional research. The latest bad news is that not only is it NOT effective for diabetics, it may actually worsen it. Continue reading... (Source: Diet Blog) Diet Blog blogs http://www.medworm.com/rss/comments.php?id=2950868 Mon, 02 Nov 2009 00:00:00 +0100 2950868 http://www.medworm.com/index.php?rid=2934857&cid=t_107302_129_f&fid=34869&url=http%3A%2F%2Fwww.diet-blog.com%2Farchives%2F2009%2F10%2F26%2Fcontrave_a_new_miracle_weight_loss_pill.php Drug companies know that a pot of gold is up for grabs if they can only develop a break-through weight loss drug. It looks like Contrave, one such contender, is one step closer to getting approval from the FDA which will open the drug up for sale in the USA. At the end of a 56 week treatment study 48.2% of participants lost at least 10% of their body weight. Continue reading... (Source: Diet Blog) Diet Blog blogs http://www.medworm.com/rss/comments.php?id=2934857 Mon, 26 Oct 2009 00:00:00 +0100 2934857 http://www.medworm.com/index.php?rid=2766213&cid=t_107302_131_f&fid=34989&url=http%3A%2F%2Ffeeds.b5media.com%2F%7Er%2Fb5media%2FGeneticsHealth%2F%7E3%2F2BEtNQ7gafI%2F Through the wonders of genetics, we might have a wonder drug that let us eat anything we want -without ever gaining a single pound! We can eat fatty and sugary food and we won’t even need to exercise to lose all those calories.   I’m not sure that’s such a good idea but that drug may exist in the near future, with the recent discovery of the so-called “obeso-genes”. The key lies in a gene called IKKE that acts as a master switch that control obesity, by producing a protein kinase that turns other proteins on or off. When a body is fed a high fat diet, the IKKE kinase slows down metabolism and burns less calories, and weight increases. When the gene IKKE (and thus the kinases) are deleted, metabolism speeds up and the body burns more calories. Knock-off mice that didn’t c... Genetics and Health blogs http://www.medworm.com/rss/comments.php?id=2766213 Fri, 04 Sep 2009 15:16:24 +0100 2766213 http://www.medworm.com/index.php?rid=2734301&cid=t_107302_167_f&fid=36994&url=http%3A%2F%2Fnutrition-news.blogspot.com%2F2009%2F08%2Fdangers-of-weight-loss-diet-pills.html Diet Pills Can Cause Liver Damage!News broke today of a new report on diet pills such as ALLI (the fat busting pill in the windows of almost every chemist and pharmacy in the UK) that suggests these miracle cure super magic bullet diet pills can increase the risk of liver damage.The FDA (Food and Drug Administration) is investigating reports of liver damage in patients taking diet pills containing the chemical orlistat, an ingredient in the popular over-the-counter drug Alli and its prescription version Xenical says www.newsday.comWhile the FDA has not sent out a public warning about the drug, it is looking at reports that 32 cases of serious liver damage have been identified from 1999 to 2008, including six cases of liver failure. All but two of the injuries occurred outside the United St... Healthy Eating & Nutrition News blogs http://www.medworm.com/rss/comments.php?id=2734301 Tue, 25 Aug 2009 20:32:00 +0100 2734301 http://www.medworm.com/index.php?rid=2390153&cid=t_107302_129_f&fid=34869&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2Fdiet-blog%2F%7E3%2FLumoZqywfGg%2Ffat-burning_supplement_warning.php The FDA is investigating "the potential relationship between Hydroxycut dietary supplements and liver injury or other potentially serious side effects" according to the issued warning. There has been 1 death and 23 serious incidences reported, including severe jaundice and liver damage requiring transplant as well as seizures and rhabdomyolysis. Iovate Health Sciences has responded by pulling 14 of their Hydroxycut products from the shelves. Iovate says that they had sold approximately 9 million units of the recalled products in 2008. Continue reading... (Source: Diet Blog) Diet Blog blogs http://www.medworm.com/rss/comments.php?id=2390153 Mon, 04 May 2009 04:00:00 +0100 2390153 http://www.medworm.com/index.php?rid=2349184&cid=t_107302_129_f&fid=34869&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2Fdiet-blog%2F%7E3%2FeiE3fjj7RCo%2Falli_and_appisat_approved_for_over-the-counter_sale_in_uk.php Two diet drugs, Alli and Appisat, will go on sale in chemists for the first time in the UK this week. Previously, both drugs have been prescription-only. But are they likely to help hopeful dieters - or just add to the credit crunch strain on wallets? Continue reading... (Source: Diet Blog) Diet Blog blogs http://www.medworm.com/rss/comments.php?id=2349184 Mon, 20 Apr 2009 04:00:00 +0100 2349184 http://www.medworm.com/index.php?rid=2259915&cid=t_107302_129_f&fid=34869&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2Fdiet-blog%2F%7E3%2FR8uxxCl273Y%2Fresveratrol_fountain_of_youth_or_waste_of_money.php Red wine drinkers have been toasting to better health and longer life with all of the news pieces on the miracle that is resveratrol - a component of red grape skin and some other fruits. Let's sift through the claims and hype and see where the dust settles.Continue reading... (Source: Diet Blog) Diet Blog blogs http://www.medworm.com/rss/comments.php?id=2259915 Fri, 13 Mar 2009 04:00:00 +0100 2259915 http://www.medworm.com/index.php?rid=2232649&cid=t_107302_129_f&fid=34869&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2Fdiet-blog%2F%7E3%2FgeTjBx5ENAQ%2Fxenical_diet_pill_leads_to_poorer_diet.php Flickr: arkDiet pills, they've had a rough go of it, links to heart disease, kids using them to get high, gross bowel movements and doubt as to whether they even work, a marketer's nightmare. Time for more bad news! A new study suggests the popular diet drug Orlistat, sold under the prescription name Xenical, doesn't inspire people to improve their diets, instead individuals popping Xenical are more likely to eat worse. How's that for irony.Continue reading... (Source: Diet Blog) Diet Blog blogs http://www.medworm.com/rss/comments.php?id=2232649 Fri, 27 Feb 2009 05:00:00 +0100 2232649 http://www.medworm.com/index.php?rid=2081097&cid=t_107302_129_f&fid=34869&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2Fdiet-blog%2F%7E3%2F503261182%2F28_tainted_weight_loss_pills.php The FDA recently issued a warning about a number of tainted diet supplements. Many of the products claim to be "natural" or contain only "herbal" ingredients - but actually contain pharmaceutical ingredients. An FDA analysis found that the undeclared active pharmaceutical ingredients in some of these products include sibutramine (a controlled substance), rimonabant (a drug not approved for marketing in the United States), phenytoin (an anti-seizure medication), and phenolphthalein (a solution used in chemical experiments and a suspected cancer causing agent). Some of the amounts of active pharmaceutical ingredients far exceeded the FDA-recommended levels, putting consumers' health at risk.Continue reading... (Source: Diet Blog) Diet Blog blogs http://www.medworm.com/rss/comments.php?id=2081097 Mon, 05 Jan 2009 05:00:00 +0100 2081097 http://www.medworm.com/index.php?rid=2065542&cid=t_107302_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F493246716%2F A federal appeals court has upheld the conviction of Robert Arledge for his role in swindling the drugmaker out of $6.7 million during litigation over its diet pills, which were withdrawn in 1997 over links to serious heart and lung problems, The Jackson Clarion-Ledger reports. Prosecutors say Arledge’s clients made claims of about $250,000 each even though they had no legitimate health problems caused by the pills - Pondimin, which was one-half of the fen-phen weight-loss cocktail, and Redux, its chemical cousin. He was sentenced to six years in prison and ordered to pay $5.8 million in restitution. Arledge was the only lawyer charged in a joint investigation by the Internal Revenue Service and the Federal Bureau of Investigation of fraudulent claims in a $400 million settlement fun... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=2065542 Tue, 23 Dec 2008 15:27:11 +0100 2065542 http://www.medworm.com/index.php?rid=1939691&cid=t_107302_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F443699050%2F Sanofi-Aventis is halting all human trials of its ill-fated Acomplia fat pill after authorities in several countries requested local tests be stopped. And Pfizer just disclosed that development of a similar drug is ending. The move by Sanofi comes two weeks after Sanofi suspended Acomplia sales in response to the European Medicines Agency, which noted that a study revealed obese or overweight patients taking the fat pill faced approximately double the risk of developing psychiatric disorders than patients taking a placebo (back story). The ending of those trials “compromised the feasibility” of the global clinical program, a Sanofi spokesman tells Bloomberg News. “It’s over.” Last year, the FDA failed to approve Acomplia over psychiatric side effects. The Pfiz... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1939691 Wed, 05 Nov 2008 21:50:54 +0100 1939691 http://www.medworm.com/index.php?rid=1917973&cid=t_107302_129_f&fid=34869&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2Fdiet-blog%2F%7E3%2F434523690%2Ftesofensine_new_miracle_weight_loss_drug.php Weight loss drugs have been something of a flop. Between Acomplia being ordered off the shelves for making people mad, and the lackluster performance of the other popular weight loss drugs - there hasn't been much to celebrate for the pharmaceutical companies *cue crocodile tears. That is until now... maybe.Continue reading... (Source: Diet Blog) Diet Blog blogs http://www.medworm.com/rss/comments.php?id=1917973 Tue, 28 Oct 2008 04:00:00 +0100 1917973 http://www.medworm.com/index.php?rid=1851214&cid=t_107302_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F409216462%2F The drugmaker made the decision after spending months reviewing trials showing the taranabant obesity pill caused psychiatric side effects. You may recall that a late-stage trial showed the drug didn’t yield the hoped-for weight loss of 5 percent at the 2 mg dose the drugmaker hoped to sell. The 4 mg dose achieved the desired weight loss but came with a significant catch - the dosage more than doubled instances of psychiatric side effects than a placebo. And even the 2 mg dose proved problematic: nearly twice as many patients taking it removed themselves from the trial, compared with the placebo, citing suicidal thoughts and neurological effects. Remember that the Merck pill is similar to Acomplia, the Sanofi-Aventis fat fighter that failed to win FDA approval over psychiatric side effec... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1851214 Thu, 02 Oct 2008 12:45:05 +0100 1851214 http://www.medworm.com/index.php?rid=1733961&cid=t_107302_129_f&fid=34869&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2Fdiet-blog%2F%7E3%2F375053808%2Fwhich_supplements_actually_work.php Lately I've been trying to feel better so I've been eating a lot of vitamins... do you know how many vitamins you have to eat before you feel full?... the colour of my urine is amazing..." - Steven Wright I have to admit, I'm skeptical - some would say jaded over the hundreds of thousands of "miracles in a bottle" being foisted on us with exaggerated, misleading and flat-out false claims. There are, however a few exceptions - some diamonds in the rough that are worth looking in to. Bear in mind that supplementation is highly individual and that "supplement" should imply that you are adding to an already healthy and varied diet. With this in mind, here are some supplements to consider: Continue reading... (Source: Diet Blog) Diet Blog blogs http://www.medworm.com/rss/comments.php?id=1733961 Tue, 26 Aug 2008 04:00:00 +0100 1733961 http://www.medworm.com/index.php?rid=1679379&cid=t_107302_129_f&fid=34869&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2Fdiet-blog%2F%7E3%2F356191536%2Fthe_exercise_pill.php A while back on this site, the great Crabby McSlacker posed the hypothetical question: If you could take an exercise pill, would you still workout? Well, this question may not be hypothetical for very long. A new study published in Cell, has demonstrated a 44% increase in treadmill distance in mice who didn't train. Don't put those running shoes away just yet, though...Continue reading... (Source: Diet Blog) Diet Blog blogs http://www.medworm.com/rss/comments.php?id=1679379 Tue, 05 Aug 2008 04:00:00 +0100 1679379 http://www.medworm.com/index.php?rid=1512330&cid=t_107302_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F310365720%2F Introduced to much fanfare a year ago, the Alli diet pill isn’t fattening Glaxo’s bottom line. The over-the-counter weight-loss pill has been tried by about 4 million people since then, but that is less than some Wall Streeters were expecting. Given the craving among Americans to lose weight, the preliminary figures are “pretty pretty underwhelming,” Steve Brozak, an analyst with WBB Securities, tells the Associated Press. The problem, he says, may be that the marketing campaign stresses the need to transform eating and exercise habits for it to be effective, which isn’t easy to do through advertising. And perhaps people who are willing to make lifestyle changs are less likely to be interested in diet pills, he adds. But Joe Cadle, director of marketing for G... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1512330 Thu, 12 Jun 2008 12:25:50 +0100 1512330 http://www.medworm.com/index.php?rid=1494563&cid=t_107302_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F304494409%2F Acomplia, which was rejected last year by an FDA panel, was linked to five deaths by the UK’s Medicines and Healthcare products Regulatory Agency since the pill went on sale two years ago. There were 720 reports of adverse drug reactions, some of which involved more than one side effect, bringing the total to more than 2,100. Five cases were fatal, including one suicide. The data, covering reports from the June 2006 introduction to May 9, was released on the MHRA web site. “We are working closely with the FDA to match the requirements,” Alexandre Moreau, a Sanofi vice president who oversees the marketing of diabetes products, tells Bloomberg News. “We’ve been in close contact with them. Acomplia is not for everybody so we’re working to identify the rig... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1494563 Wed, 04 Jun 2008 11:57:58 +0100 1494563 http://www.medworm.com/index.php?rid=1442864&cid=t_107302_129_f&fid=34869&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2Fdiet-blog%2F%7E3%2F290797175%2Ftop_8_most_ridiculous_weight_loss_techniques.php Obesity researcher Betty Kovacs and Self Magazine editor Erin Hobday collaborated on a NY Daily News piece that outlines the 8 most outrageous weight loss ideas. How they managed to whittle the list down to just 8 is an impressive feat! So here's the crazy 8: Continue reading... (Source: Diet Blog) Diet Blog blogs http://www.medworm.com/rss/comments.php?id=1442864 Thu, 15 May 2008 04:00:00 +0100 1442864 http://www.medworm.com/index.php?rid=1437095&cid=t_107302_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F288662958%2F One side effect of the infamous fen-phen litigation is about to be heard in a Kentucky courtroom today. A jury will decide whether three lawyers - Shirley Cunningham Jr., William Gallion and Melbourne Mills Jr. - committed a federal crime by allegedly plundering the state’s $200 million settlement for 440 people who suffered heart injuries from the once-popular diet pills, The Louisville Courier-Journal writes. A government expert says the trio violated “basic moral tenets of honesty and respect for the property of others we learn first as children.” And the prosecution will try to prove that the former lawyers defrauded their clients by taking $65 million more than they were due in what has been called one of the biggest legal frauds in US history, the paper reports. The... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1437095 Mon, 12 May 2008 12:49:39 +0100 1437095 http://www.medworm.com/index.php?rid=1426771&cid=t_107302_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F285352966%2F The drugmaker, which sells the Alli over-the-counter fat pill, has filed a citizen’s petition in hopes of convincing the FDA to change the rules governing health claims made by dietary supplement manufacturers. The gambit turns on the notion that weight-loss supplements should be vetted for claims that address a disease - and in this case, being overweight is a risk for various diseases. In its petition (look here), Glaxo argues any claims that a supplement will reduce a risk factor for disease is, in fact, a disease claim and, as a result, weight-loss supplement manufacturers should be forced to substantiate their claims through petitions before selling their own pills. Which diseases are we talking about? High cholesterol, diabetes and high blood pressure. “…many Americ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1426771 Wed, 07 May 2008 13:07:46 +0100 1426771 http://www.medworm.com/index.php?rid=1294728&cid=t_107302_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F249475283%2F That’s the implication from the latest news to dribble out of Wall Street. An analyst indicated that Merck’s experimental taranabant obesity pill didn’t yield the hoped-for weight loss of 5 percent at the 2 mg dose the drugmaker hopes to sell, according to Reuters. And this occurred in Phase III testing, according to Aileen Salares of Leerink Swann, which isn’t a good sign. The 4 mg dose achieved the desired weight loss but came with a significant catch - the dosage more than doubled instances of psychiatric side effects than a placebo. And even the 2 mg dose proved problematic: nearly twice as many patients taking it removed themselves from the trial, compared with the placebo, citing suicidal thoughts and neurological effects, according to Salares. “Safety w... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1294728 Tue, 11 Mar 2008 12:28:46 +0100 1294728 http://www.medworm.com/index.php?rid=1137215&cid=t_107302_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F213419865%2F The experimental med may help people lose some weight, but the side effects are the same ones that sunk Sanofi-Aventis diet drug last year. The findings were seen in mid-stage trials of Merck’s taranabant and reported in the latest issue of Cell Metabolism. The pill is currently being tested in a far larger late-stage trial and results are expected later this year. Like Sanofi-Aventis’s Acomplia, taranabant works by blocking cannabinoid receptors in the brain, and these are the same receptors that give people the munchies when smoking marijuana, by the way. One of the Phase II trials involved 553 obese patients who were tested for 12 weeks, Reuters writes. Patients receiving varying doses of the Merck drug lost 8 to 14 pounds of body weight, which compared favorably with weigh... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1137215 Tue, 08 Jan 2008 21:40:26 +0100 1137215 http://www.medworm.com/index.php?rid=1035594&cid=t_107302_129_f&fid=34869&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2Fdiet-blog%2F%7E3%2F187089928%2Fweight_loss_drugs_produce_minimal_results.php This just in: There is still no magic bullet for weight loss. Canadian researchers analyzed the results from 30 trials where adults with an average weight of 100 kilograms (220 lbs) took anti-obesity drugs for a year or longer. The study was published in the British Medical Journal. Continue reading... (Source: Diet Blog) Diet Blog blogs http://www.medworm.com/rss/comments.php?id=1035594 Mon, 19 Nov 2007 05:00:00 +0100 1035594 http://www.medworm.com/index.php?rid=1025375&cid=t_107302_129_f&fid=34869&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2Fdiet-blog%2F%7E3%2F184600205%2F7_ways_to_spot_a_weight_loss_scam.php In 2004, an estimated 4.8 million Americans bought bogus weight-loss supplements, patches, creams or other products – making it the top rated scam according to the Federal Trade Commission. This is further proof that there is no shortage of charlatans out there preying on people’s desperation to lose weight. I’m not exactly sure how they came up with the criteria for what constitutes a “scam”, but here are some red flags that people need to be wary of when it comes to sketchy weight loss products; Continue reading... (Source: Diet Blog) Diet Blog blogs http://www.medworm.com/rss/comments.php?id=1025375 Wed, 14 Nov 2007 05:00:00 +0100 1025375 http://www.medworm.com/index.php?rid=918906&cid=t_107302_129_f&fid=34869&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2Fdiet-blog%2F%7E3%2F164121038%2Fweight_loss_drugs_rates_of_persistence_are_terrible.php Weight loss from diet pills come with one fundamental requirement. To lose weight (and most likely maintain weight) you have to keep using them. A drug such Orlistat (or it's cutdown OTC version Alli) will decrease absorption of fat by the intestines. Less fat means less calories. Less calories means weight loss. So what happens when you stop taking the drug?Continue reading... (Source: Diet Blog) Diet Blog blogs http://www.medworm.com/rss/comments.php?id=918906 Tue, 02 Oct 2007 04:00:00 +0100 918906 http://www.medworm.com/index.php?rid=864408&cid=t_107302_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F155114479%2F The little drugmaker disclosed study results this morning indicating its experimental obesity pill doesn’t appear to cause the kind of heart-valve damage that forced Wyeth to withdraw two diet pills - one-half of the fen-phen combo and a related pill, Redux - exactly a decade ago. An independent safety-monitoring group recommended that a two-year trial of 3,100 patients continue after scans showed no increased risk of heart damage following six months on the pill, compared with a placebo. “It’s an important milestone to help us understand the safety of our drug,” Jack Lief, Arena’s ceo, tells Bloomberg News. “If we had a fen-phen type of effect on the heart, we should see it by now.” Known as lorcaserin, the drug is designed to stimulate a protein... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=864408 Tue, 11 Sep 2007 16:53:58 +0100 864408 http://www.medworm.com/index.php?rid=747347&cid=t_107302_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F135778338%2F Wyeth won a diet-drug case. A federal jury in St. Louis ruled this afternoon that Wyeth’s Pondimin, which was one-half of the infamous fen-phen weight-loss cocktail, didn’t damage a South Carolina woman’s heart. And it took just one hour to decide. The decision comes a month after another jury in St. Louis ordered Wyeth to pay $75,000 in damages to a Kansas woman who alleged fen-phen damaged her heart valves. Wyeth once faced more than 175,000 claims over the diet combination, which was pulled off the market in 1997 after it was linked to heart problems and a fatal lung disease, and has set aside more than $21 billion to cover litigation. Wyeth created a $3.75 billion national settlement program for former users in 2000 and added $1.3 billion to it in 2004. Docs wrote mo... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=747347 Fri, 20 Jul 2007 22:01:15 +0100 747347 http://www.medworm.com/index.php?rid=682811&cid=t_107302_129_f&fid=34869&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2Fdiet-blog%2F%7E3%2F126036316%2Fsymlin_hormone_injections_for_weight_loss.php A new study published in The American Journal of Physiology - Endocrinology and Metabolism shows that the Symlin hormone, currently used to treat diabetes, can help people feel fuller and reduce the desire to binge and eat high-fat foods.Continue reading... (Source: Diet Blog) Diet Blog blogs http://www.medworm.com/rss/comments.php?id=682811 Tue, 19 Jun 2007 04:00:00 +0100 682811 http://www.medworm.com/index.php?rid=675574&cid=t_107302_129_f&fid=34869&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2Fdiet-blog%2F%7E3%2F124161263%2Fzimulti_weight_loss_drug_suicidal_thoughts.php Rimonabant is a popular prescription weight loss drug that is currently available in 18 countries (under the name Acomplia - from Sanofi-Aventis). The drug has been before the FDA - awaiting approval for some time now. Some time last year I wrote a large article that discussed some of the side effects of the drug. The FDA has now released an analysis - showing why they are taking such a long time to look at Zimulti (Rimonabant).Continue reading...Comments (10) (Source: Diet Blog) Diet Blog blogs http://www.medworm.com/rss/comments.php?id=675574 Tue, 12 Jun 2007 04:00:00 +0100 675574 http://www.medworm.com/index.php?rid=675575&cid=t_107302_129_f&fid=34869&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2Fdiet-blog%2F%7E3%2F123875845%2Fnew_diet_pill_the_expanding_blob.php Wired Magazine reports on a new diet pill - a pill that expands into a gelatinous blob the "size of a tennis ball" after swallowing. Sound appetizing?Continue reading...Comments (43) (Source: Diet Blog) Diet Blog blogs http://www.medworm.com/rss/comments.php?id=675575 Mon, 11 Jun 2007 04:00:00 +0100 675575 http://www.medworm.com/index.php?rid=650951&cid=t_107302_129_f&fid=34869&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2Fdiet-blog%2F%7E3%2F121329723%2Fcla_shown_to_aid_fat_loss.php Conjugated Linoleic Acid (CLA) is back in the news again. Researchers have combined data from 18 previous studies and arrived at a conclusion: Given at a dose of 3.2 g/day, CLA produces a modest loss in body fat in humans. (from study abstract)Continue reading...Comments (8) (Source: Diet Blog) Diet Blog blogs http://www.medworm.com/rss/comments.php?id=650951 Fri, 01 Jun 2007 04:00:00 +0100 650951 http://www.medworm.com/index.php?rid=516409&cid=t_107302_129_f&fid=34869&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2Fdiet-blog%2F%7E3%2F105986059%2Fsugarest_does_it_really_block_sugar.php Sugarest is a tablet based on the Indian herb Gymnema sylvestre. You place a tablet in your mouth for a few minutes, and apparently for the next 20-30 minutes sugary foods lose their sweetness. According to the manufacturer Genotec Nutritional this is "long enough for a dieter to defeat their sugar cravings and lose their desire for sweet but fattening foods".Continue reading...Comments (4) (Source: Diet Blog) Diet Blog blogs http://www.medworm.com/rss/comments.php?id=516409 Mon, 02 Apr 2007 04:00:00 +0100 516409 http://www.medworm.com/index.php?rid=501662&cid=t_107302_129_f&fid=34869&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2Fdiet-blog%2F%7E3%2F104436048%2Fadderall_as_a_weight_loss_drug.php Adderall is an amphetamine used to treat ADD/ADHD. Like many pharmaceutical medications, some of the side effects include loss of appetite and weight loss (particularly in adolescents). A CNN story has highlighted the ethical concerns surrounding a doctors decision to prescribe the drug for the purpose of weight loss.Continue reading...Comments (5) (Source: Diet Blog) Diet Blog blogs http://www.medworm.com/rss/comments.php?id=501662 Mon, 26 Mar 2007 04:00:00 +0100 501662