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 'cro'. Sat, 03 Sep 2011 02:39:57 +0100 http://www.medworm.com/index.php?rid=5182320&cid=t_179125_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FscEadyD2R4s%2F As technology makes the world smaller, monitoring clinical trials no longer requires traveling to a destination to check up on the investigators. Much of this work can be done remotely and the FDA, in fact, wants to encourage sponsors to undertake more of what the agency calls risk-based monitoring in order to match international standards articulated by the International Conference on Harmonisation. And so the agency has just issued new guidance for drugmakers and contract research organizations, or CROs, to help sort out the variables that would determine when centralized monitoring would be preferable over on-site monitoring. The primary focus, the FDA notes, should be on steps that protect human subjects, while maintaining data integrity and compliance with regulations. Despite advance... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=5182320 Thu, 01 Sep 2011 14:50:37 +0100 5182320 http://www.medworm.com/index.php?rid=5182323&cid=t_179125_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FvMmVEzuXRy0%2F Top of the morning to you. And yet another shiny day is unfolding over the Pharmalot corporate campus, where the short people and the official mascots appear to be snoozing indefinitely. This rare treat gives us more time this morning to brew those mandatory cups of stimulation and poke around for interesting items. So here they are. Meanwhile, we will get back to conducting our own version of R&D. So keep us in mind if you hear something interesting. Have a great day… Sanofi Strikes Deal To Make Generic Lipitor (Reuters) FDA And Drugmakers Agree On 6 Percent PDUFA Fee Hike (Wall Street Journal) XOMA CEO Resigns (Reuters) Baxter Sues Teva To Enforce Propofol Liability (Bloomberg News) Death Rate Rises In Clinical Trials In India (The Tribune) Contract Pharmaceuticals To Lay Off ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=5182323 Thu, 01 Sep 2011 12:08:48 +0100 5182323 http://www.medworm.com/index.php?rid=5086557&cid=t_179125_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F9bdN0mPFRfU%2F Last week, the FDA announced that any clinical tests conducted between April 2005 and June 2010 by a contract research organization called Cetero Research may have to be reevaluated because two FDA inspections and an outside audit found falsified data and manipulated samples. In explaining its move, the agency maintained there were “significant instances” of misconduct. The agency says Cetero failed to conduct an adequate internal investigation to determine the extent and impact of the violations, and did not take sufficient steps to assure data integrity during those five years. And so drugmakers must check their databases for trials that were used to support New Drug Applications and Abbreviated New Drug Applications - and may have to repeat or confirm results (back story). For its ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=5086557 Mon, 01 Aug 2011 13:30:19 +0100 5086557 http://www.medworm.com/index.php?rid=5069821&cid=t_179125_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FixYMOtPCKNc%2F THIS POST RAN LAST NIGHT, BUT FOR THOSE WHO DID NOT KNOW… This is every drugmaker’s nightmare. The pharmaceutical industry has been put on alert by the FDA that any clinical tests conducted between April 2005 and June 2010 by a contract research organization called Cetero Research may have to be reevaluated because two FDA inspections and an outside audit found falsified data and manipulated samples. There were “significant instances” of misconduct, the FDA says. “This misconduct appears to be significant enough to cast doubt on the data generated…If the foundation of the laboratory is corrupt, then the data generated will be also,” according to the auditor. The FDA adds that Cetero also failed to conduct an adequate internal investigation to determine the... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=5069821 Wed, 27 Jul 2011 11:42:35 +0100 5069821 http://www.medworm.com/index.php?rid=5069825&cid=t_179125_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FRqwvmj9MSCs%2F As drugmakers scramble to replenish their pipelines, they are encountering all sorts of difficulties, including rising costs for clinical trials. And this is happening across all phases. Why? There is increasing competition for trial sites and clinical research organizations that can yield reliable, high quality data, according to a recent survey. And so, 32 percent of those surveyed pointed to higher costs for enrolling patients and 25 percent cited vendor fees. Expenses for recruiting trial sites was named by 14 percent, followed by 12 percent who fingered technology costs, according to Cutting Edge Information, which surveyed 21 drugmakers, 12 biotechs, nine device makers and 23 contract research organizations. Meanwhile, staffing for drug development is rising. For instance, Phase IV ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=5069825 Tue, 26 Jul 2011 14:39:41 +0100 5069825 http://www.medworm.com/index.php?rid=4968905&cid=t_179125_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FkCs8X6zlPB8%2F Earlier this week, Medco Health Solutions, the big pharmacy benefits manager, struck an unusual deal with Sanofi to help the drugmaker navigate the path from laboratory to formulary placement. Specifically, Medco will provide input on clinical trial design, help develop comparative effectiveness data and review usage of existing medications to improve patient adherence. The move reflects a growing awareness among drugmakers that designing and testing a compound for FDA approval is no longer the only key hurdle to winning sales and market share. We spoke with Robert Epstein, Medco’s clinical research and development officer, about the deal… Pharmalot: You’re saying this is the first deal of this sort. But the problems you hope to address aren’t new, right? Epstein: It’s been very ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4968905 Fri, 24 Jun 2011 17:25:12 +0100 4968905 http://www.medworm.com/index.php?rid=4893914&cid=t_179125_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FS1JlIDgJ9No%2F File this under failing the test. A doctor and a clinical research coordinator working for a contract research organization hired by the former Schering-Plough were indicted by the feds for falsifying study data. The clinical trial was designed to test a tablet the drugmaker was developing to treat allergies. Wayne Spencer, 73, a licensed physician and the principal investigator, and Lisa Sharp, 48, the clinical director of clinical trials at Lee Research Institute, were charged with one count of conspiracy, three counts of mail fraud, and one count of falsifying information required by the FDA. The crimes are alleged to have occurred from January 2010 to May 2010. The study was to have enrolled patients at least 50 years who suffer from ragweed-induced allergy symptoms. Employees at the C... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4893914 Fri, 03 Jun 2011 12:34:02 +0100 4893914 http://www.medworm.com/index.php?rid=4789642&cid=t_179125_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FKd3ujMNjWQI%2F A shift among drugmakers to prefer existing patients, rather than healthy volunteers, for early stage trials, is forcing Parexel, one of the largest contract research organizations, to close offices and eliminate jobs. Specifically, the CRO is cutting up to 30 per cent of Phase I capacity and around 300 jobs, or about 3 per cent of its 10,350 workforce, according to a filing with the Securities and Exchange Commission. Other factors are at work, though. The CRO acknowledged that some clients delayed the start of large projects, underscoring the weakness of the pharmaceutical pipeline. Meanwhile, as Outsourcing Pharma points out, Parexel execs believe the shift away from trials in healthy volunteers is permanent, or at least demand will be lower for the foreseeable future. “We believ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4789642 Wed, 04 May 2011 12:09:52 +0100 4789642 http://www.medworm.com/index.php?rid=4704957&cid=t_179125_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FTqt7VZfCzXA%2F For those who had any doubt about where R&D money is headed…look east. As in the Far East. A recent survey of 241 execs from drugmakers and biotechs finds that R&D budgets are rising just 1 percent overall this year. Meanwhile, outsourcing is expected to rise 11 percent, to 41 percent of the R&D undertaken, and most companies favor investing more of their clinical work in China. There is a price to pay, though. In the three-month period prior to the survey, price increases by contract research organizations outnumbered decreases by a 5-to-1 ratio. Looked at another way, 35 percent of the drugmakers and biotechs reported a price hike from CROs, compared with 6 percent that reported a price drop, according to the survey by RW Baird, the Wall Street brokerage. “We ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4704957 Tue, 12 Apr 2011 12:08:46 +0100 4704957 http://www.medworm.com/index.php?rid=4696954&cid=t_179125_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F3Eb37NoKR6k%2F Hello, everyone, and nice to see you again. We hope the weekend was refreshing and enjoyable. Now, though, the routine of meetings and deadlines has returned. To cope, yes, we are brewing that mandatory cup of stimulation. Meanwhile, here are some tidbits to get you going. Let us know if you hear anything interesting and have a great, productive day… Endo Pharma Buying American Medical For $2.6 Billion (Associated Press) Intercell Suspends Trial For MRSA Vaccine (Bloomberg News) Actress Sues Lilly For Using Her Face In Prozac Ad (New York Post) Novartis Stops Tasigna Trial In Patients With GIST (Reuters) Inspiration Pharma Eyes Plant In Ireland And 500 Jobs (Irish Post) Merck KGgA Considers Job Cuts At Serono Unit (Reuters) Merck And Sun Pharma Near Generics Deal (LiveMint) British M... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4696954 Mon, 11 Apr 2011 11:51:13 +0100 4696954 http://www.medworm.com/index.php?rid=3505136&cid=t_179125_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fvq3oMKtlz6o%2F Industry expansion in China continues unabated as Charles River Laboratories agreed to buy WuXi Pharma Tech, a Chinese outsourcing services firm. The deal would apparently be the largest foreign takeover of a Chinese company and, significantly, would give Charles River testing facilities in Shanghai, Suzhou and Tianjin in China, where labor and laboratory costs are cheaper (see statement). Overall, the CRO market in China is growing up to 30 percent a year, according to Jinsong Du, an analyst in Hong Kong at Credit Suisse. “This is a vote of confidence that China will be the main location for drug R&D outsourcing in the future,” he tells Bloomberg News, adding that Charles River gets to eliminate a potential competitor in the process. Du also notes Charles River gets a “very... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3505136 Mon, 26 Apr 2010 12:23:52 +0100 3505136 http://www.medworm.com/index.php?rid=3283721&cid=t_179125_129_f&fid=36036&url=http%3A%2F%2Fwww.everydayhealth.com%2Fblog%2Fkelly-building-a-crohns-disease-community%2Fbreakfast-with-crohns-disease%2F I think that I have mentioned before that I have been experimenting with my diet for the last year in an effort to improve my Crohn’s symptoms.  I have eliminated all dairy products and now use only Rice milk because it causes the least amount of trouble and tastes good.  I am also limiting the amount of gluten that I eat.  I still eat some items that have a little bit of gluten, but have for the most part deleted that out of my diet too.  I also don’t eat a lot of fiber because it seems to make matters worse.  Once you get rid of dairy, gluten and fiber, there are not a lot of choices left for breakfast. For the last year, I have been eating Trix for breakfast.  I recently discovered Berry Berry Kix and have switched to that instead because it has a lot less sugar.  I don�... Life with Crohn's blogs http://www.medworm.com/rss/comments.php?id=3283721 Wed, 17 Feb 2010 19:26:52 +0100 3283721 http://www.medworm.com/index.php?rid=2657762&cid=t_179125_122_f&fid=34755&url=http%3A%2F%2Fneuropsychological.blogspot.com%2F2009%2F07%2Fupcoming-industry-conference-social.html e-patient Connections 2009Health marketingMeeting website (Source: BrainBlog) BrainBlog blogs http://www.medworm.com/rss/comments.php?id=2657762 Thu, 30 Jul 2009 19:52:00 +0100 2657762 http://www.medworm.com/index.php?rid=2092494&cid=t_179125_97_f&fid=34618&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmHouse%2F%7E3%2FDhNC8d-Yu6I%2Fclinical-research-outsourcing-india.html Recent report of RNCOS projects a huge growth for clinical trial outsourcing business in India. Their new report titled 'Booming clinical trials market in India' is very optimistic about India to emerge as the dominant destination in coming years.According to our analysis, India is one of the most economical destinations for conducting global clinical trials. Companies can save a substantial amount in India on both staff and utilities. For instance, the salary of a clinical research associate is only 13% of that in the US and 17% and 19% as that in the UK and Germany respectively. Similarly, the cost of a biostatistician in India is only 15%, 18% and 17% as that in the US, UK and Germany respectively. Companies also save substantially on utilities and land while setting up their operations... Pharm House blogs http://www.medworm.com/rss/comments.php?id=2092494 Fri, 09 Jan 2009 15:58:00 +0100 2092494 http://www.medworm.com/index.php?rid=1686525&cid=t_179125_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F357448262%2F This is all about lowering R&D costs. So here’s the deal: Lilly will sell its Greenfield Laboratories site in Indiana and transfer operations to Covance, a big contract research organization, for an up-front payment of $50 million, and the two companies are also signing a 10-year service agreement worth about $1.6 billion. As a result, Covance will assume responsibility for Lilly’s toxicology testing and other R&D support activities at the 460-acre site. The deal builds on an existing agreement in which Covance already conducts pre-clinical toxicology, early-stage clinical work and Phase II and III trial support. About 260 Lilly 260 jobs will shift to Covance and another 225 will be shifted to other Lilly sites in the state. This “represents an innovative approa... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1686525 Wed, 06 Aug 2008 14:23:45 +0100 1686525 http://www.medworm.com/index.php?rid=1389201&cid=t_179125_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F274655469%2F The huge cost and complexity of testing potential new medical products - a forbidding burden for fledgling Silicon Valley biotech firms - has given birth to an army of entrepreneurs offering to do the tests for others. Hundreds of contract research organizations have cropped up over the past two decades around the world, creating a multibillion-dollar industry that many people say provides an essential service and is bound to expand. But some say the trend has a troublesome side, according to The San Jose Mercury News. “There has been tremendous growth in the industry,” Brad Zaro, who runs Clinimetrics, a CRO in San Jose, tells the paper. Unfortunately, he adds, many of those jumping into the field “are unqualified.” The FDA has found cause for concern, too. In rece... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1389201 Mon, 21 Apr 2008 12:04:34 +0100 1389201