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 drugs'. Sat, 03 Sep 2011 02:37:59 +0100 http://www.medworm.com/index.php?rid=5158994&cid=t_120760_87_f&fid=39187&url=http%3A%2F%2Fgetbetterhealth.com%2Fdrug-shown-to-protect-obese-mice-from-the-diseases-of-obesity%2F2011.08.25 I usually choose not to write about the “new new scientific thing” that gets picked up by the press,  because early research is usually not reproducible and good science takes a long time to validate as true.  But since we know that mice and rats that are kept on low-calorie diets live 30% longer (and healthier) than their fat cohorts, I was interested in a new research compound, SRT-1720,  that was shown to protect obese mice from diseases of obesity.  Fat mice lived 44% longer if they were given this drug. The “designer” drug works by (more…) *This blog post was originally published at EverythingHealth* (Source: Better Health) Better Health blogs http://www.medworm.com/rss/comments.php?id=5158994 Thu, 25 Aug 2011 14:00:00 +0100 5158994 http://www.medworm.com/index.php?rid=5118997&cid=t_120760_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_120760_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=4715020&cid=t_120760_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_120760_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=4460183&cid=t_120760_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_120760_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_120760_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=4382947&cid=t_120760_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=4285351&cid=t_120760_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=4238145&cid=t_120760_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_120760_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=4152273&cid=t_120760_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_120760_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_120760_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_120760_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_120760_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_120760_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=4055957&cid=t_120760_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=3981013&cid=t_120760_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_120760_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_120760_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_120760_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_120760_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_120760_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=3929455&cid=t_120760_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FUCck3j0Uy_E%2F For the second time this summer, a Japanese drugmaker has agreed to pay $50 million upfront for the rights to a forthcoming diet pill. This time, Takeda Pharmaceuticals is giving Orexigen Therapeutics $50 million for exclusive North American marketing rights (but co-promotion in the US) for Contrave and another $1 billion for meeting regulatory and sales milestones, along with double-digit royalties (see statement). Just a few weeks ago, Eisai paid $50 million for the rights to sell Arena Pharmaceuticals’ lorcaserin in the US; another $160 million based on development and approval milestones, and a $1.16 billion, one-time payment that may follow based on annual sales. Neither pill has been approved - an FDA advisory panel will review Arena’s lorcaserin on Sept. 16, while Orexigen&... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3929455 Thu, 02 Sep 2010 13:13:44 +0100 3929455 http://www.medworm.com/index.php?rid=3929457&cid=t_120760_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=3831556&cid=t_120760_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_120760_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_120760_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_120760_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=3750272&cid=t_120760_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_120760_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_120760_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=3564202&cid=t_120760_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=1437095&cid=t_120760_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=1408276&cid=t_120760_133_f&fid=35096&url=http%3A%2F%2Ffeeds.b5media.com%2F%7Er%2Fb5media%2FAutismVox%2F%7E3%2F280551889%2F “Detoxifying” a child’s body of “heavy metals” via chelation is an alternative, and not uncontroversial, treatment for autism. It is based on the belief that exposure to environmental toxins is one factor behind the increase in the number of children diagnosed with autism in the past decade-plus. This book talks about the dangers of heavy metal poisoning; this book provides a “protocol” for treating such “poisoning”; these liquid vitamins are said to provide “natural detoxification.” The Body Ecology Diet is offering a three-day workshop to “take the mystery out of autism”; the workshop is “designed to help parents have a basic understanding of our 7 principles, like cleansing, acid/alkaline, principle of u... Autism Vox blogs http://www.medworm.com/rss/comments.php?id=1408276 Wed, 30 Apr 2008 05:10:46 +0100 1408276 http://www.medworm.com/index.php?rid=1137215&cid=t_120760_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=1012468&cid=t_120760_134_f&fid=36049&url=http%3A%2F%2Ffeeds.b5media.com%2F%7Er%2Fb5media%2FDiabetesNotes%2F%7E3%2F181195890%2F America’s tweens more than doubled their use of type-2 diabetes medications between 2002 and 2005, with girls between 10 and 14 years of age showing a 166 percent increase. The likely cause: Obesity, which is closely associated with Type 2 diabetes. This is so darn scary! Oh, we have to do something now about this epidemic in our children. Please, I beg you to teach your kids about nutrition and the risks of heart disease and diabetes as well as the complications that go along with them. My kids eat happy Meals just like every other kid but they also understand the importance of fruits, veggies and exercise! Not that they always conform to my wishes but I think of it as laying the groundwork if you will. You know? What do you do to teach your children about the importance of a health... Diabetes Notes blogs http://www.medworm.com/rss/comments.php?id=1012468 Wed, 07 Nov 2007 17:57:23 +0100 1012468 http://www.medworm.com/index.php?rid=864408&cid=t_120760_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=631583&cid=t_120760_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2007%2F05%2Falli-ad-campaign-promises-honesty-but.html Do you have a "extra pair of pants" with you today! GSK recommends you do when starting a regimen of its over-the-counter diet pill alli! But you might also sh*t your pants when you hear how much GSK is spending on its Alli ad campaign this year -- $150 million!I think I read that right in the WSJ article "Company Touts Over-The-Counter Diet Pill."But the year is nearly half over! On an annual basis then, GSK is spending closer to $300 million promoting this product!I've blogged about the pooping-in-pants side effect of alli before (see "Alli Oops! I Just Pooped Myself!"). It's going to take some effective marketing BS to counteract that!And what's GSK marketing strategy?Is Alli Honesty the Best Policy?"We've done everything to go out of our way to be honest," said Steve Burton, vice presi... Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=631583 Wed, 23 May 2007 11:17:00 +0100 631583