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 'acomplia'. Sat, 03 Sep 2011 02:37:02 +0100 http://www.medworm.com/index.php?rid=4664476&cid=t_108385_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FxYlfDINAsQc%2F And so, another working week is about to end. This is, of course, the celebrated signal to daydream about weekend plans. Our agenda includes watching one of the short people in a lacrosse match, dining with some of our favorite relatives and promenade with the official Pharmalot mascots. And you? Maybe you can watch that movie you never saw or catch up on some reading. How about spending time with a special someone? Whatever you do, be safe and enjoy. Catch you soon… Sanofi Faces Shareholder Suit Over Acomplia Data (Reuters) Japan Nuclear Crisis Adds Urgency To Radiation Drugs (New York Times) The Rise In Stolen Pharmaceuticals (Fortune) Paxil May Make Adults More Suicidal (Reuters) Fire Damages Roche Warehouse In Hungary (Budapest Business Journal) Fertility Drug May Be Linked To Fa... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4664476 Fri, 01 Apr 2011 11:49:14 +0100 4664476 http://www.medworm.com/index.php?rid=4424448&cid=t_108385_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=4238145&cid=t_108385_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=4183538&cid=t_108385_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FyBd3vLakqQw%2F First, some drugmakers caught the transparency bug. Now, a big regulator has been infected. As of next week, the European Medicines Agency will provide clinical trial data on request for every drug that has been reviewed, and hopes to publish reports on its web site within five years, according to Bloomberg News. The move came in response to a long-standing request from researchers at the Nordic Cochrane Centre for trial reports on three obesity drugs - Roche’s Xenical, Abbott Lab’s Meridia and Sanofi-Aventis’ Acomplia - in hopes of determining whether published data corresponded with the detailed reports submitted to the EMA, the news service continues. The researchers sought the reports in June 2007, just after an FDA panel rejected Acomplia over suicide concerns (see this). Th... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4183538 Fri, 19 Nov 2010 14:01:16 +0100 4183538 http://www.medworm.com/index.php?rid=4003436&cid=t_108385_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FebX3i3LnNno%2F Suicide has become a big issue in drug development in recent years. Consider the controversy over links to various antidepressants, notably in youngsters, and then the spate of reports involving meds for epilepsy, obesity, acne and smoking cessation (see here, here, here and here). The FDA, however, is concerned the signals largely stemmed from retrospective meta-analyses and spontaneous adverse event reports. And so the agency is considering a more deliberate approach toward clinical study and has issued a guidance with this explanation: “Given the wide range of drugs involved, it is reasonable to consider whether prospective assessments for suicidality should be included in clinical trials involving at least selected drugs for non-psychiatric indications.” “There are tw... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4003436 Mon, 27 Sep 2010 13:02:45 +0100 4003436 http://www.medworm.com/index.php?rid=3865464&cid=t_108385_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_108385_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=3645053&cid=t_108385_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FjrKPyYmQRNQ%2F For the second time in two months, the European Medicines Agency has been criticized by its ombudsman for refusing to release data about drugs. Last month, Nikiforos Diamandouros chastised the EMA for refusing to release documents containing suspected adverse reactions caused by Accutane (background). This time, he upbraided the agency for not allowing outside investigators access to clinical trial data on two obesity pills - Acomplis, which was withdrawn by Sanofi-Aventis, and orlistat, which is sold as Xenical by Roche and as Alli, an over-the-counter med marketed by GlaxoSmithKline. Researchers at the Nordic Cochrane Centre wanted to conduct an independent analysis given that, in their view, biased reporting on drug trials was common, according to Diamandouros. But the EMA refused to pr... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3645053 Wed, 09 Jun 2010 13:21:12 +0100 3645053 http://www.medworm.com/index.php?rid=2006399&cid=t_108385_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F471240103%2F What will Chris do? Look for him to do some cost cutting. The 48-year-old, who was passed over for the top job at Glaxo, today takes over from Gerard le Fur, who was ousted in September after setbacks with the Acomplia obesity pill and the Plavix blood thinner, Bloomberg News writes. Sanofi, which is based in Paris, lags in cost cutting and introducing new meds to replace big-sellers facing generic competition, the news service writes. Viehbacher, who is credited with uniting Glaxo’s North American operations after a merger with SmithKline Beecham eight years ago, is well suited to overhaul Sanofi’s performance, according to Bob Ingram, a former Viehbacher mentor. “He really created a unified culture,” Ingram tells Bloomberg. Sanofi’s problems began four years ago during a ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=2006399 Mon, 01 Dec 2008 12:16:05 +0100 2006399 http://www.medworm.com/index.php?rid=1939691&cid=t_108385_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=1906165&cid=t_108385_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F429843041%2F The move comes after the European Medicines Agency 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. The drugmaker will “immediately” start talks with countries outside the European Union where Acomplia is sold to suspend sales there as well, according to a statement. The pill has been sold in 18 EU countries for two years. (Listen to the conference call). According to the EMEA, “new data from post-marketing experience and ongoing clinical trials indicated that serious psychiatric disorders may be more common than in the clinical trials used in the initial assessment of the medicine,” and that “these psychiatric side effects could ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1906165 Thu, 23 Oct 2008 17:23:31 +0100 1906165 http://www.medworm.com/index.php?rid=1901470&cid=t_108385_150_f&fid=34768&url=http%3A%2F%2Fpharmagossip.blogspot.com%2F2008%2F10%2Fsanofi-aventis-acomplia-this-just-in.html Back stories here.French pharmaceutical company Sanofi-Aventis temporarily suspended sales of anti-obesity drug Acomplia in Europe, the company said Thursday, after health authorities said the drug's risks outweigh its benefits.Sanofi-Aventis will "immediately" start talks with non-EU countries where the drug is available to have sales suspended there as well, the company said in a statement.The decision follows a recommendation from the London-based European Medicines Agency, which earlier Thursday said a study had revealed obese or overweight patients taking Acomplia were at approximately double the risk of developing psychiatric disorders than those taking a placebo.MoreInsider says: Just as Insider predicted nearly a year ago. (Source: PharmaGossip) PharmaGossip blogs http://www.medworm.com/rss/comments.php?id=1901470 Thu, 23 Oct 2008 16:38:00 +0100 1901470 http://www.medworm.com/index.php?rid=1556512&cid=t_108385_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F323189744%2F So what else is new? In yet another round-up that discusses the slow rate of approvals compared with the number of FDA warnings, rejections and delays, The Wall Street Journal gathers some recent developments to re-examine the issue once again. Last year, the FDA approved 19 new meds, the fewest in 24 years, and announced about 75 new or revised Black Box warnings, which was twice the number in 2004. The number of approvable letters, which postpone FDA decisions pending more data, increased by 40 percent last year, according to Sagient Research, the paper writes. Meanwhile, pharma grouses the European Medicines Agency has approved several drugs that haven’t passed muster with the FDA, including Galvus, Prexige and Acomplia. The FDA has delayed approval of Glaxo’s HPV vaccine, ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1556512 Mon, 30 Jun 2008 11:42:48 +0100 1556512 http://www.medworm.com/index.php?rid=1494563&cid=t_108385_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=1327603&cid=t_108385_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F258253610%2F The middle of the week is here and that can mean only one thing - plenty to do. Meetings, deadlines, projects. The list is long. So is ours. All of which tells us that the time has come for our daily cup of stimulation as we peruse the news of the world. Here are some of the latest developments to help you keep up. Hope your day goes well… Pfizer Sues Ranbaxy To Delay Generic Lipitor, Caduet (Bloomberg News) Sanofi Strikes Deal To Market Lilly’s Cialis In US (Bloomberg News) NIH Vows To Back AIDS Research (The Baltimore Sun) Denmark, France & Italy Recall Heparin (The Wall Street Journal) UK’s NICE Approves Sanofi’s Acomplia Diet Pill (Yahoo/Reuters) Vioxx Deadline Extended By One Month (BusinessWeek) (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1327603 Wed, 26 Mar 2008 10:58:57 +0100 1327603 http://www.medworm.com/index.php?rid=1294728&cid=t_108385_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=1286448&cid=t_108385_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F247454539%2F The quest to find the magic diet pill knows no limits. Of course, the path is littered with failures in the form of embarassing side effects, heart and lung damage, suicides, lawsuits and, more recently, FDA rejection. Think fen-phen. Think Acomplia. Think Xenical and orange undies. But the obsession with looking slimmer and the adverse consequences brought on by excess weight - high cholesterol, high blood pressure, diabetes - make obesity too compelling - translation: potentially profitable - to ignore. And so BusinessWeek takes a look at three of the more interesting prospects that are currently intriguing researchers, investors and, soon enough, regulators. Whether any will succeed, well, don’t give up your diet yet. Take Vivus, a small company that is testing Qnexa, a mix of phe... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1286448 Fri, 07 Mar 2008 16:10:48 +0100 1286448 http://www.medworm.com/index.php?rid=1175051&cid=t_108385_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F222264192%2F The new rules represent one of the most profound changes of the past 16 years to regulations governing drug development. But since the F.D.A.’s oversight of experimental medicines is done in secret, the agency’s shift has not been announced publicly, The New York Times reports. The drug industry, however, is keenly aware of the change. Makers of drugs to treat obesity, urinary incontinence, epilepsy, smoking cessation, depression and many other conditions are being asked for the first time by the FDA to put a comprehensive suicide assessment into their trials, the paper writes. In recent months, the FDA sent letters - but wouldn’t say how many - to drugmakers requiring they use such a scale. Merck, Sanofi-Aventis and Eli Lilly are all using a detailed suicide assessment in clini... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1175051 Thu, 24 Jan 2008 12:31:29 +0100 1175051 http://www.medworm.com/index.php?rid=1137215&cid=t_108385_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=1129500&cid=t_108385_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F211087445%2F The short work week is drawing to a close. By now, though, you most likely have settled back into your routine. We know we have. As you ready for the next meeting and report, grab a cup of something hot and catch up with these… Takeda Seeks FDA Approval For Actos Follow-Up (Bloomberg News) Sanofi Pooh-Poohs Lawsuit Charging Acomplia Data Was Hidden (Reuters) Drugmakers Vie For Magic Weight-Loss Pill (MSNBC/AP) Share / E-mail (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1129500 Fri, 04 Jan 2008 12:11:26 +0100 1129500 http://www.medworm.com/index.php?rid=1031219&cid=t_108385_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F185767165%2F The fat pill, which an FDA panel rejected earlier this year over concerns about psychiatric side effects, is once again being linked to depression. Patients given Acomplia had more than twice the risk of depression and anxiety, according to a meta-analysisr published in The Lancet medical journal. Danish researchers reviewed four studies featuring 4,105 patients and found that people taking 20 milligrams per day of the drug were 2.5 times more likely to discontinue treatment due to depressive disorders and three times more likely to stop because of anxiety than those given a placebo. The dangers may be even greater during real-world usage, because patients with a history of psychiatric disorders were excluded from the trials. Acomplia was approved in Europe last year, although the pill isn... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1031219 Fri, 16 Nov 2007 13:16:51 +0100 1031219 http://www.medworm.com/index.php?rid=1025487&cid=t_108385_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F184640687%2F As we gaze out the window, the large number of falling leaves is matched only by the volume of events to track. We hope to make it easy for you by sifting through the piles. Here are a few that we found…. Roche And Ventana Finally Start Talking (Bloomberg News) Schering-Plough’s Hassan Is Cautious About HDL Drugs (Yahoo/Reuters) Sanofi Says EU Backs Diabetes Testing On Acomplia Label (Forbes/AFX/Thomson) Share / E-mail (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1025487 Wed, 14 Nov 2007 11:56:31 +0100 1025487 http://www.medworm.com/index.php?rid=950971&cid=t_108385_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F170096941%2F Since becoming ceo nine months ago, Gerard Le Fur has avoided talking much about anything, despite the failure to win FDA approval for Acomplia, the weight-loss pill, and a thin product pipeline. Charges that Sanofi-Aventis lacked transparency prompted his decision to hold an R&D day last month, the drugmaker’s first attempt to explain in detail the group’s portfolio of experimental drugs since Sanofi’s merger with Aventis in 2004. “We are not very chatty as a company. I’m a backstage person – it’s a genetic thing,” Le Fur tells The Financial Times in an interview in which he hinted at costcutting and an appetite for fresh acquisitions. “We were not transparent enough. We have to admit to our errors, to be more Anglo-Saxon and more communicative.” But even the ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=950971 Mon, 15 Oct 2007 11:04:37 +0100 950971 http://www.medworm.com/index.php?rid=876186&cid=t_108385_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F157551370%2F The drugmaker held an analyst briefing in Paris, but had little to offer. Although the late-stage pipeline is growing and 31 drugs could be submitted to regulators by 2010, the discussion was a downer. A successor to the Lovenox blood clotter and another for irregular heartbeat show promise but probably won’t be available before 2011. Sanofi stopped testing a new med for Alzheimer’s disease. And a depression drug showed liver side effects. “We expected good news today, but there is nothing,” Franck Hennin, a fund manager at Richelieu Finance in Paris, which oversees $5 billion including Sanofi shares, tells Bloomberg News. “It’s disappointing. The pipeline has trouble delivering. They need to buy new molecules from biotechnology companies.” Sanofi... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=876186 Mon, 17 Sep 2007 11:10:00 +0100 876186 http://www.medworm.com/index.php?rid=789375&cid=t_108385_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F142349314%2F That’s the concern after hearing the Sanofi-Aventis diet pill, which is linked to suicide, is becoming popular in generic form in India. Six Indian generic drugmakers, including Cipla and Ranbaxy Labs, are exploiting a loophole in local patent laws, selling copies under names like Slimona and Defat, and the pills are sold without prescription for as little as 12 cents, Bloomberg News reports. If these over-the-counter knocks offs, which are being used without supervision, cause an increase in suicides, the FDA is unlikely to ever approve Acomplia. Two months ago, an FDA panel rejected the diet pill over this issue and Sanofi subsequently withdrew its application. “This is going to be potentially disastrous,” Jeff Mechanik, an endocrinologist at Mt. Sinai Hospital in New Y... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=789375 Thu, 09 Aug 2007 12:51:32 +0100 789375 http://www.medworm.com/index.php?rid=728698&cid=t_108385_150_f&fid=35781&url=http%3A%2F%2Fwww.qdinformation.com%2Fqdisblog%2F2007%2F07%2F06%2Fsanofi-withdraws-obesity-pill-from-fda-consideration%2F Faced with an advisory panel that unanimously had safety concerns, Sanofi has decided to withdrawal their NDA for Accomplia (rimonabant). Sanofi Withdraws Obesity Pill From FDA - Forbes.com: Sanofi stated they had plans to resubmit the NDA at “a later date”. It should also be noted that Sanofi plans to use the name Zimulti in the US. It will be interesting to keep an eye on this. I have my own doubts that it will ever get approved in the US. Technorati Tags: Acomplia, Zimulti, Rimonabant, Sanofi, Sanofi-Aventis Copyright © 2007 QDIS Blog. This Feed is for personal non-commercial use only. If you are not reading this material in your news aggregator, the site you are looking at is guilty of copyright infringement. Please contact legal@qdinformation.com so we can take action... QDIS Blog blogs http://www.medworm.com/rss/comments.php?id=728698 Fri, 06 Jul 2007 20:31:27 +0100 728698 http://www.medworm.com/index.php?rid=675614&cid=t_108385_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2007%2F06%2Ffda-zimulti-non-acomplia.html As reported in the Wall Street Journal Health Blog, an FDA advisory panel unanimously rejected Zimulti:By a unanimous vote, a panel of experts convened by the FDA just rejected Sanofi-Aventis's weight-loss drug, known in Europe as Acomplia, Dow Jones reports.The drug has been associated with psychiatric side effects including depression and an increased risk of suicidal thoughts. In a presentation to the panel today, Sanofi officials argued that patients at risk of psychiatric problems could be screened to not receive the drug. The drug has been approved for sale in Europe, but has not been approved here due to concerns over its side effects.Of course, the FDA could approve the drug application anyway since these advisory board decisions are non-binding. Although I don't think this is like... Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=675614 Wed, 13 Jun 2007 20:53:00 +0100 675614 http://www.medworm.com/index.php?rid=728710&cid=t_108385_150_f&fid=35781&url=http%3A%2F%2Fwww.qdinformation.com%2Fqdisblog%2F2007%2F05%2F25%2Fsanofis-acomplia-copied-in-india%2F Seems three Indian companies have already moved to copy Sanofi’s Acomplia (rimonabant) before it is even for sale in Europe and the US. The companies identified are Sun Pharmaceuticals, Torrent Pharma and Zydus Cadila. Sanofi’s Acomplia already copied in India - paper: It should be noted that India patent law does not require them to respect patents on drugs developed prior to 1995. The claim is that these companies are only making it for the Indian market but I find this suspect. Once sold in India, it will be hard to control its sales to other countries. This is likely what these companies are betting on. They are unlikely to go head to head with Sanofi but more likely to throw up their hands and say, we only sold to distributors in India and that they have no control over wh... QDIS Blog blogs http://www.medworm.com/rss/comments.php?id=728710 Fri, 25 May 2007 16:53:49 +0100 728710 http://www.medworm.com/index.php?rid=587923&cid=t_108385_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2007%2F05%2Fyummi-its-zimulti.html According to the Acomplia Report, "It's now official. If diet drug Acomplia (rimonabant) is ultimately approved for sale in the United States, the prescription diet pill will go on the U.S. market not as Acomplia but as Zimulti."While this is bad news for the Acomplia Report, which will have to change it's name, I guess, and is perhaps a mild setback for Sanofi-Aventis, which plans to market the diabetes drug in the US, it is definitely good news for bloggers like the jokers over at the Wall Street Journal Health Blog who quipped "To us, the new name seems to promise a mysterious Italian delicacy — 'We'd like the Zimulti with clams, please" (see "What’s in a Name? Too Much for Acomplia").The WSJ guys think Zimulti is a good name for an Italian main course, whereas I think it's a great ... Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=587923 Thu, 03 May 2007 16:34:00 +0100 587923 http://www.medworm.com/index.php?rid=509329&cid=t_108385_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2007%2F03%2Facomplia-not-for-gun-totting-bikini.html (Source: Pharma Marketing Blog) Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=509329 Thu, 29 Mar 2007 11:10:00 +0100 509329