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 'advair'. Sat, 03 Sep 2011 02:27:17 +0100 http://www.medworm.com/index.php?rid=4911820&cid=t_93954_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FWRej8NgksWI%2F Good morning, everyone, and how are you today? A scorcher is predicted to envelope the Pharmalot corporate campus. We plan to keep cool by perusing interesting documents and chatting up interesting people. We will also break later to appear on a PhRMA panel on social media. To prepare, we are downing a few cups of stimulation - our flavor today is Southern Pecan. Meanwhile, here are some nifty tidbits from around your world. Watch out for the heat and see you soon… Pfizer Teams With Harvard In $100M Drug Discovery Deal (Bloomberg News) Merck Ends Trial Of Intercell Vaccine For MRSA (Reuters) Covidien Seeks A Buyer For Its Pharma Unit (Bloomberg News) Orphan Drug Development Success Remains Elusive (Gen New) US Seeks Prison Sentences For Device Execs (Associated Press) Glaxo Faces Adv... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4911820 Wed, 08 Jun 2011 12:00:08 +0100 4911820 http://www.medworm.com/index.php?rid=4893916&cid=t_93954_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F_PKuBogHIcg%2F And so, another working week will soon draw to a close. This is, of course, our signal to daydream about the weekend. Our agenda includes some therapeutic swimming, catching up on our reading and taking in a soccer match with the short people. And you? How about enjoying the weather with a nice bike ride? Or spending time with someone special? Perhaps thinking big thoughts is in order. Whatever you do, have a wonderful time. And be safe. See you soon… Pfizer And Hisun Pharmaceuticals Plan Generic Venture (Bloomberg News) Tianjin Tasly Pharmaceutical To Build A Factory In Maryland (CapitalVue) Drugmakers Bolster US Corporate Philanthropy (Reuters) The New Pricing Game In Germany (Business Week) Endo Sales Reps Granted Class-Action Lawsuit For Overtime (Reuters) Teva Gives Big Golden P... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4893916 Fri, 03 Jun 2011 12:03:23 +0100 4893916 http://www.medworm.com/index.php?rid=4399825&cid=t_93954_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fix8D3iySYW0%2F Good morning, everyone. Yet another snowy day here on the picturesque Pharmalot corporate campus, where we are arming ourselves with numerous shovels and cups of stimulation. Nonetheless, we intend to maintain the usual flow of interesting items and, with that in mind, here are a few tidbits to get you going. Hope your day goes well and stay in touch… Mitsubishi Tanabe Recalls Injectables Not Properly Tested (Bloomberg News) The Man Who Sold Maximuscle To Glaxo (The Daily Mail) Pfizer And Progenics Recall Relistor Injection Kits (Bloomberg News) Servier Founder Quits As Head Of Industry Group (Pharma Times) Allegra Is Approved For Over The Counter (Boston Globe) SinoPharm Plans $760M In Acquisitions (Bloomberg News) FDA Wants Data On Gilead-Tibotec HIV Drug (San Francisco Business Ti... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4399825 Wed, 26 Jan 2011 13:09:09 +0100 4399825 http://www.medworm.com/index.php?rid=4220458&cid=t_93954_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F7L5bE1wLCDc%2F Maybe GlaxoSmithKline sales reps deserve a bonus. A new survey of more than 1,800 primary care physicians ranked the drugmaker’s field force as the best, even as sales calls to these docs - which include general practitioners, family med physicians and doctors of osteopathy - fell 12 percent in the 12 months ending September 2010, compared with the previous 12-month period. On a score of 1 to 7, Glaxo’s average quality score was 5.71, up from 5.54 in 2009, according to SDI Health, a market research firm that conducted the survey. The showing catapulted Glaxo from third place last year, when the drugmaker followed Pfizer and Merck, both of which moved down a notch from the No. 1 and No. 2 slots, respectively. On a related note, in both years, 97 percent of the docs indicated they w... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4220458 Wed, 01 Dec 2010 13:01:57 +0100 4220458 http://www.medworm.com/index.php?rid=4190525&cid=t_93954_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F8S4VgXuJzVE%2F Welcome back, everyone. We hope your weekend was refreshing and put to good use. Now, of course, the routine returns, although this is a short week on this side of the pond. Nonetheless, meetings and deadlines loom, if only for a little while. So please join us as we brew the mandatory cup of stimulation and peruse the news of the world. Hope your day goes well and stay in touch… Bayer & Regeneron Eye Drugs Show Good Results (Bloomberg News) Genzyme Considers New Sanofi Deal Structure (TheStreet) FDA Approves 2nd Human Study Of Embryonic Stem Cells (Associated Press) Merck Wins Fosamax Trial (The New York Times) VR Labs To Build HQ In Florida (Fort Myers News-Press) Advair Poses Generic Hurdles (The Wall Street Journal) (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4190525 Mon, 22 Nov 2010 13:04:07 +0100 4190525 http://www.medworm.com/index.php?rid=4179523&cid=t_93954_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FggN0pc0DhfA%2F Less than a year after the FDA issued a warning about the long-term use of long-acting beta agonists, Saudi Arabian regulatory authorities have revoked marketing authorization for four such products - including GlaxoSmithKline’s Serevent and Foradil, which is sold by Novartis - over increased risks of worsening asthma symptoms, hospitalizations of children and adults, and deaths. In a statement, the SFDA says recent evidence found that LABAs were associated with increased risk of asthma-related deaths, intubation (the placement of a tube into the windpipe) and hospitalization of 2.8 percent for every 1,000 patients using a long-acting beta agonist compared to those who did not use such a medication. In analyzing data, the agency noted there were 16 deaths among LABA patients versus ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4179523 Thu, 18 Nov 2010 13:28:42 +0100 4179523 http://www.medworm.com/index.php?rid=3999295&cid=t_93954_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FTCrv077MheI%2F And so the end of another work week is near. Which means the time has come to plan your weekend activities. Anything special in the offing? How about picking apples? Or a walk in the park? We plan to watch one of the short people on the football field and catch up on some reading. Meanwhile, another day awaits. So here are a few items to help you along. And whatever you do this weekend, have a great time… Amgen And J&J Recall Some Anemia Meds (Reuters) EMA Rejects Merck KGaA’s MS Pill (Bloomberg News) Alnylam To Cut Up To 30 Percent Of Workforce (Associated Press) Sanofi-Aventis Signs Deal With Dana Farber Cancer Institute (PharmaTimes) Glaxo’s Advair Follow-Up Shows Promise In Tests (Reuters) Xanodyne Pharma Plans Staff Cuts (The Cincinnati Enquirer) EU Finds No Lin... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3999295 Fri, 24 Sep 2010 11:53:50 +0100 3999295 http://www.medworm.com/index.php?rid=3965707&cid=t_93954_151_f&fid=35818&url=http%3A%2F%2Frecoveryissexy.com%2Fhow-benzodiazepines-made-me-sick%2F This has been my experience with Benzodiazapines. I was prescribed the benzodiazepine drug Ativan by a psychiatrist for some depression I was having due to a physical attack I had at work. I was not seeking drugs, I just wanted someone to talk to. He suggested I should really try Ativan, they wouldn’t do anything but “help me”. So I did, I took .05 mg once a day and returned to his office every month for a follow-up and another script. After 4 months I tried to stop taking them and had some problems doing so. I contacted him about it and he said he needed to change my dose to 1 mg. I wasn’t sure of his decision because I wasn’t feeling well. So I picked up the script. When I got home I only took half the pill and discarded the other half keeping the dose the same. A year had pass... Recovery Is Sexy.com blogs http://www.medworm.com/rss/comments.php?id=3965707 Mon, 13 Sep 2010 15:12:00 +0100 3965707 http://www.medworm.com/index.php?rid=3625775&cid=t_93954_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FFlHBJzIb66I%2F In a much-needed effort to burnish their images, drugmakers repeat a mantra about wanting to help patients beat this or that illness, and that patient safety is a prime concern. Yet this week, we are treated to a curious spectacle in which the FDA had to order at least two companies to make anticipated labeling changes for their long-acting beta-agonists, or LABAs, which should never be used alone to treat asthma (see this). The FDA warning was expected since February, but the agency strengthened its recommendations this week (see the initial and revised alerts). But GlaxoSmithKline - which sells Advair, a $7.8 billion seller - and AstraZeneca, which markets Symbicort, a $2.3 billion product - pushed back (these drugs include a corticosteroid). And so as Reuters points out, the FDA was fo... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3625775 Thu, 03 Jun 2010 12:41:02 +0100 3625775 http://www.medworm.com/index.php?rid=3581840&cid=t_93954_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FsDS6HDFg2Xo%2F And so another day begins. Our immediate challenge is hustling the short people off to their respective schoolhouses. This calls for a cup or three of stimulation. Meanwhile, the usual meetings and deadlines loom, although we look forward to a gathering this evening of industry types. As we all prepare for what lies ahead, here are a few items to help you along. Have a good one… German Court Rules Glaxo’s Advair Patent Isn’t Valid (Reuters) Piramal Downplays Takeover Rumors (PharmaTimes) Vanda Schizophrenia Drugs Gets Bad Review (TheStreet) PhRMA Spent $7M Lobbying DC In 1st Quarter (Associated Press) Roche Diagnostics Insists It’s Growing (Indianapolis Star) (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3581840 Thu, 20 May 2010 11:47:18 +0100 3581840 http://www.medworm.com/index.php?rid=3573944&cid=t_93954_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FyWRw6FKi8nc%2F Prices for the most widely used brand-name meds jumped 9.7 during the 12-month period ending in March, according to AARP, which called the increase the largest since the organization began tracking this sort of thing in 2002. Specialty drug prices rose 9.2 percent and generics fell by 9.7 percent. AARP notes that general inflation climbed 0.3 percent during the same period. AARP then makes another comparison - the average annual cost for three generic meds declined by $51 during this period, while there was a $706 increase for three brand name drugs. “The life-saving drugs Americans need are out of reach for many because of unjustifiable price hikes,” AARP Executive Vice President John Rother says in a statement. “Consumers desperately need a competitive prescription drug market that... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3573944 Tue, 18 May 2010 12:23:54 +0100 3573944 http://www.medworm.com/index.php?rid=3526947&cid=t_93954_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FGcH7rZ8YJbU%2F Another month, another list. Once again, there is speculation about which medications will generate the most revenue over the next few years. Interestingly, the latest conclusion mirrors another recent list that suggests conventional pills will easily be eclipsed. Only two small molecules make this newest ranking, which was compiled by EvaluatePharma. Not surprisingly, one of them is AstraZeneca’s Crestor cholesterol fighter, although the newest list differs slightly from this list. And so once again, there are myriad implications raised, including the strategic direction pursued by the biggest drugmakers and the costs for patients. The percentage figure refers to sales growth from 2009 to 2016… 1. Humira (arthritis) Abbott Labs/Eisai - $10.1b; 9 percent 2. Avastin (cancer) Roc... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3526947 Mon, 03 May 2010 12:47:00 +0100 3526947 http://www.medworm.com/index.php?rid=3468018&cid=t_93954_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FZbwVlkKVymw%2F And the winner is…. Roche’s Avastin, which is used to treat various cancers. Everyone loves a list, of course, so Reuters compiled this ranking and the most interesting finding is there seems to be just one pill that will be among the biggest sellers in 2014. In other words, injectables will dominate. Assuming this is reasonably accurate, what might it say about big drugmakers? Will they spend more in the lab or strike still more deals with smaller prey developing the next big thing? Will pills become passe? And what will it mean for patient costs? Consensus sales forecasts for world’s top 10 drugs in 2014: 1. Avastin (cancer) Roche - $8.9b 2. Humira (arthritis) Abbott - $8.5b 3. Enbrel (arthritis) Pfizer - $8b 4. Crestor (cholestero... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3468018 Wed, 14 Apr 2010 15:58:25 +0100 3468018 http://www.medworm.com/index.php?rid=3378733&cid=t_93954_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FMkcn8MW5xvg%2F Hello, everyone. Another spring day here on the Pharmalot corporate campus, where the short people are slumbering and the required cup of stimulation is brewing. While we tend to the usual morning routine, here are a few items of interest. Does a busy day lie ahead? Most likely. We hope these help you on your way. Have a good one and stay in touch…. Teva’s $4.8B Bid Wins Ratiopharm (Bloomberg News) J&J CEO Got An 11 Percent Pay Hike (Associated Press) Novartis Drops Generic Advair In The US (Reuters) Pfizer Drops Patent Infringement Case Against Lilly (Reuters) J&J Alzheimer’s Drug Study May Be Delayed (Bloomberg News) Roche Bullish On Cholesterol And Melanoma Drugs (Reuters) Coffee pix thx to chichcacha flickr creative commons (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3378733 Thu, 18 Mar 2010 11:07:31 +0100 3378733 http://www.medworm.com/index.php?rid=3322438&cid=t_93954_111_f&fid=36048&url=http%3A%2F%2Ffeeds.b5media.com%2F%7Er%2Fb5media%2FAHeartyLife%2F%7E3%2FEHP0aLsDTKU%2F The FDA is not supposed to be in the business of practicing medicine. Their role related to medicine is to approve or not approve medications, and to warn doctors of potential problems with certain types of drugs. Some doctors are now expressing concern about the latest recommendation from the FDA, calling for earlier discontinuation of certain asthma drugs. The doctors, experts in the field of treating asthma, are saying that this recommendation may be very risky for some patients. They expressed their concern at press meeting held at the American Academy of Allergy, Asthma and Immunology (AAAAI) 2010 Annual Meeting. Last month, the FDA came out with warnings about using certain types of asthma medications after a certain amount of time (FDA Urging Caution with Asthma Pumps). The FDA bas... A Hearty Life blogs http://www.medworm.com/rss/comments.php?id=3322438 Tue, 02 Mar 2010 16:59:04 +0100 3322438 http://www.medworm.com/index.php?rid=3298597&cid=t_93954_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FUzO3O6B6c_M%2F Here’s an embarassing moment for Forbes. Over the past week, a physician contributed a few items to the magazine’s science blog, defending various drugs that have recently been criticized or scrutinized over safety issues. Among them were GlaxoSmithKline’s Avandia diabetes pill; asthma meds, including Glaxo’s Advair and AstraZeneca’s Symbicort; and statins, such as AstraZeneca’s Crestor. However, the site never noted that the physician, Matthew Mintz, who is listed as an associate professor of medicine in the Department of Medicine at the George Washington University Medical Center in Wash., DC, had other credentials - consulting fees or advisory board participation for Glaxo and AstraZeneca, among others (look here). In the first quarter of 2009, Glaxo ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3298597 Tue, 23 Feb 2010 12:39:24 +0100 3298597 http://www.medworm.com/index.php?rid=3287809&cid=t_93954_111_f&fid=36048&url=http%3A%2F%2Ffeeds.b5media.com%2F%7Er%2Fb5media%2FAHeartyLife%2F%7E3%2FIRWQnw1WH60%2F They seem to be everywhere: medication pumps and devices for people with asthma. For people who have asthma, these pumps and inhalers are literal life savers sometimes. Asthma medications that are inhaled by pump, disk, or inhaler, come in a couple of categories: Immediate action and prophylactic (preventative), although some medications provide a bit of both. The immediate action medications are ones such as Ventolin, which helps open the airways and allows for air exchange. The preventative ones often have long-acting beta agonist, or LABA, in them, to help keep the airway open. These medications include Advair and Symbicort, which combine LABA with corticosteroids, and Serevent and Foradi, which contain the LABA only. Because these inhaled versions of medication are everywhere, it does ... A Hearty Life blogs http://www.medworm.com/rss/comments.php?id=3287809 Fri, 19 Feb 2010 15:16:53 +0100 3287809 http://www.medworm.com/index.php?rid=3288021&cid=t_93954_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F-_UgZLt8oAw%2F And so once again, another week will soon draw to a close. We hope this has been a productive stretch, although today is not yet history. Still, this may be a good time to ponder the weekend activities. Any interesting plans? We plan to huddle with some of our favorite humans and, of course, walk the dog. While you consider your own possibilities, here are a few items to help you close out the week. Have a nice time, everyone… Merck To Consolidate Media Spending (AdWeek) FDA Issues Warnings On Long-Acting Beta Agonists (Bloomberg News) Novartis’ Tasigna Gets FDA Priority Review (Reuters) Roche Wins Approval To Market Rituxan For CLL (Bloomberg News) Novavax Presents Swine Flu Data (Associated Press) AIDS Vaccine Effect May Wear Off (Reuters) (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3288021 Fri, 19 Feb 2010 12:57:38 +0100 3288021 http://www.medworm.com/index.php?rid=3172203&cid=t_93954_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F79WEYfGWBKA%2F Another day, another deadline. But this is a busy world, after all. And what better way to prepare than to keep up with events. So, as you gird for the challenges ahead, here are a few items to help you along. As for us, we will reach for our usual cup of stimulation. Have a good day, everyone… FDA Issues New Guidance To IRBs On Multi-Site Trials (OutsourcingPharma) US Pharmacopeia Recalls New Edition Of USP-NF (statement) Glaxo Forms Global Media Team (PR Week) Blood Pressure Drugs May Cut Dementia Risk (Bloomberg News) Glaxo Sees Little Generic Threat To Advair (Reuters) (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3172203 Thu, 14 Jan 2010 12:01:24 +0100 3172203 http://www.medworm.com/index.php?rid=2977569&cid=t_93954_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FAJal4KDWV30%2F Judging by a recent survey, that may seem to be the case. Direct-to-consumer ads are mentioned mostly by docs to increase patient acceptance for a medicine that’s already been chosen. But unaided - or spontaneous - mention by patients or actual patient requests for a specific med is a rare phenomenon, according to the survey by Verilogue. The firm tracked brand requests coupled with a reference to specific ad campaigns across 12,500 doctor-patient conversations from 2008 and covered 20 disease states and 46 different branded prescription drugs. Overall, DTC ‘pull-through’ in conversations in a doc’s office is low - just 3 percent - and specific patient requests for advertised med are even lower - .002 percent. Significantly, the most frequently pulled-through brand... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=2977569 Tue, 10 Nov 2009 13:20:15 +0100 2977569 http://www.medworm.com/index.php?rid=2033592&cid=t_93954_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F482015108%2F A two-day meeting yields good news and bad news - Glaxo’s Serevent and Novartis’ Foradil both pose serious risks that outweigh their benefits for treating adults, adolescents and children with asthma, an FDA advisory committee decided. At the same time, Glaxo’s Advair and AstraZeneca’s Symbicort, both of which are much more widely used, have acceptable safety profiles for asthma patients. The panel reportedly voted 27-0 that Advair benefits outweighed its risks, and the committee voted 23-3, with one member abstaining, in saying the benefits outweighed the risks in adolescents ages 12 to 17 years old. Advair, by the way, is Glaxo’s biggest-selling med. The drugs are known as long-acting beta-agonists, or LABAs, and are used when asthma patients find their symp... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=2033592 Thu, 11 Dec 2008 21:00:20 +0100 2033592 http://www.medworm.com/index.php?rid=2018094&cid=t_93954_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F476110210%2F In an advance of an advisory committee meeting next week, FDA staffers are recommending approval be withdrawn for several asthma meds known as long-acting beta agonists, or LABAs, for children younger than 18 years old, due to an increased risk of asthma-related deaths and attacks (back story here and here on FDA concerns and requests for more data). The drugs include Glaxo’s Advair and Serevent, AstraZeneca’s Symbicort and Novartis’ Foradil, which Schering-Plough markets in the US. The FDA staffers, in fact, also urge yanking approval of Serevent and Foradil for asthma in people of all ages and question whether LABAs should still be approved for treating ashtma (these are the FDA briefing materials). Serevent and Foradil contain LABAs only, while Advair and Symbicort com... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=2018094 Fri, 05 Dec 2008 22:24:51 +0100 2018094 http://www.medworm.com/index.php?rid=1859771&cid=t_93954_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F412971120%2F In an ideal world, free samples would help uninsured patients get a jump on treatment they may not otherwise be able to obtain. But a new study in Pediatrics finds that free samples are not making their way to poor and uninsured children and, moreover, pose significant safety considerations (here is the abtract). The researchers analyzed data on 10,295 US residents who were younger than 18 years old from the 2004 Medical Expenditure Panel Survey, and found 10 percent of children who received prescription meds - and 4.9 percent of all children - received one free drug sample that year. Specifically, kids whose family incomes were below 200 percent of the poverty level, were no more likely to receive free samples than those with incomes of 400 percent of the poverty level (3.8 percent vs 5.... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1859771 Mon, 06 Oct 2008 17:09:23 +0100 1859771 http://www.medworm.com/index.php?rid=1834804&cid=t_93954_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F404052694%2F What better time to take a break than on a Friday afternoon? So go ahead, take a stroll around the grounds. Grab a cup of coffee. Annoy the person in the office to next to yours. And, of course, catch up on some news of the world before getting back to business… Glaxo’s Advair To Lose Sales To Spiriva (Yahoo/Reuters) Germany’s Merck Starts Arbitration Against ImClone (Reuters) Savient Pharma Remains Silent On Buyout Partner (Reuters) (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1834804 Fri, 26 Sep 2008 19:32:43 +0100 1834804 http://www.medworm.com/index.php?rid=1655668&cid=t_93954_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F346159144%2F The drugmaker is laying off 90 workers, or 10 percent of its headcount, at its manufacturing plant in Zebulon, North Carolina, The Triangle Business Journal reports. The move brings employment at the plant to between 850 and 900, down from 1,350 a year ago. The most recent major layoffs before the current round took place were in February, when 70 jobs were eliminated. Glaxo has been steadily cutting its workforce in the region since October 2007, when the drugmaker announced a cost-cutting program to save $1.4 billion across the globe by 2010. Workers from sales reps to mid-level managers to R&D staffers have been cut from Research Triangle Park, where employment has fallen to an estimated 4,500 workers from 5,000 a year earlier. The Zebulon plant mostly makes the Advair DISKUS, an... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1655668 Sat, 26 Jul 2008 00:41:26 +0100 1655668 http://www.medworm.com/index.php?rid=1538302&cid=t_93954_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F318039755%2F That’s the headline on a piece in the latest issue of Men’s Health, which usually spends time looking for erogenous zones and workout equipment. Now, though, the mag writes that it sifted through the Physicians’ Desk Reference and then asked some docs, “Which medications would you skip?” Their list is supposedly your second opinion and if you’re on any of these, MH writes, talk to your doc. Okay, so which drugs? Here goes…Advair, Avandia, Celebrex, Ketek, Prilosec, Nexium, Visine Original and Pseudoephedrine. Want to know why? Look here for the explanation… (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1538302 Mon, 23 Jun 2008 11:29:19 +0100 1538302 http://www.medworm.com/index.php?rid=1512329&cid=t_93954_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F310409734%2F For the past few years, safety questions have hovered over Advair, a long-acting beta agonist that includes a steroid and a $6 billion seller. An FDA alert was issued in 2005; last November, an FDA panel recommended more warnings for kids both Advair and Glaxo’s Serevent, which doesn’t include a steroid; and the agency asked drugmakres for more data as a prelude to an advisory committee meeting later this year. In an attempt to get out in front of the controversy, Glaxo sponsored a review in the Annals of Internal Medicine shows that Advair decreases the risk of severe side effects, doesn’t appear to alter the risk for hospitalization, and may not change the risk for asthma-related deaths when compared with the use of steroids alone. In reaching this conclusion, the resea... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1512329 Thu, 12 Jun 2008 13:45:27 +0100 1512329 http://www.medworm.com/index.php?rid=1280991&cid=t_93954_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F246267441%2F The FDA wants more info from the drugmakers about their long-acting beta agonists in order “to further evaluate the safety” of these asthma meds. You may recall the agency asked the drugmakers to provide info from controlled clinical trials. The drugs include Glaxo’s Advair and Serevent; Novartis’ Foradil; AstraZeneca’s Symbicort; Mylan’s Perforomist, and Sepracor’s Brovana. The drugmakers say it will take several months to submit the info, according to a notice on the FDA web site. Meanwhile, the agency plans to hold an advisory committee meeting in the fall or winter to review the risks and benefits in adults and children in the fall or winter 2008. Last November, an FDA panel recommended more warnings for kids for Advair and Serevent, which both... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1280991 Wed, 05 Mar 2008 18:13:43 +0100 1280991 http://www.medworm.com/index.php?rid=1057469&cid=t_93954_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F192026900%2F That’s what an FDA panel recommended this afternoon for Advair and Serevent, which both contain the same active ingredient. The advisory committee also urged the agency to move quickly with another safety review of the drugs - including Foradil, a Novartis med that’s sold in the US by Schering-Plough - after one panel member questioned safe use in children. The drugs are used for long-term prevention of asthma in kids and adults. “It’s an urgent public health issue. You need to move forward soon,” Marsha Rappley, chairwoman of the FDA’s pediatric advisory committee and dean of Michigan State University’s College of Human Medicine, told FDA staffers at the meeting, according to The Wall Street Journal. This isn’t the first time the drugs have ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1057469 Wed, 28 Nov 2007 20:42:13 +0100 1057469 http://www.medworm.com/index.php?rid=1051274&cid=t_93954_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F190894909%2Ffda_probing_advair_and_sereven.html The U.S. Food and Drug Administration staff posted documents containing concerns about rare and potentially fatal side effects of Advair and Serevent when used by children.Used to treat asthma, GlaxoSmithKline stated that they are confident that the benefits of Advair and Serevent outweight any risks. Nine cases of adverse event in children under 16 were reported, including 5 deaths, since GSK was granted pediatric exclusivity in March 2006 according to papers posted on the FDA website.Advair, GSK's biggest product with sales of $6.8M worldwide, contains servent, a long-acting beta agonist that is used to ease breathing. The company stated that it had provided clinical data that it believes proves the safety of both products."GSK has submitted a thorough safety review of salmetero... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=1051274 Mon, 26 Nov 2007 21:00:43 +0100 1051274 http://www.medworm.com/index.php?rid=1048038&cid=t_93954_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F189697339%2F Agency medical staffers aren’t so sure and they’re recommending a more in-depth safety review of Serevent and Advair, according to documents posted on the FDA website in advance of a pediatric advisory committee meeting this coming week. These are Glaxo’s biggest-selling meds, by the way. Although FDA staffers didn’t identify side effects unique to kids, they did find five deaths among nine adverse-event reports in children during a 13-month review Serevent. Three of the nine cases were associated with overdoses. Both meds, which contain the active ingredient salmeterol, already carry a Black Box warning about a risk of asthma-related death. “There is no available pediatric data to indicate that the increased risk of asthma death and life-threatening exacerba... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1048038 Sat, 24 Nov 2007 07:09:28 +0100 1048038 http://www.medworm.com/index.php?rid=788410&cid=t_93954_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F142045050%2F JP Garnier and his team may have difficulty breathing today. The agency mailed Glaxo a ‘not approvable’ letter for its Advair Diskus inhalable med in patients with chronic obstructive pulmonary disease, or COPD, a common lung disorder that makes it hard to breath. Glaxo estimates about 20 million people in the US suffer from some form of the disease. In a statement issued this morning, Glaxo says the FDA letter raised concerns about proposed dosing levels, and that Glaxo officials plan to meet with the agency to discuss data on side effects connected with Advair, as well as data concerning the existing lower dose 250/50 version. “We are very surprised and disappointed by this FDA decision particularly given the outcome of the FDA advisory committee meeting earlier this ye... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=788410 Wed, 08 Aug 2007 16:37:36 +0100 788410 http://www.medworm.com/index.php?rid=488436&cid=t_93954_117_f&fid=34444&url=http%3A%2F%2Fblogs.webmd.com%2Fallergies-and-asthma%2F2007%2F03%2Ftorch-towards-revolution-in-copd-health.html Last month, the long-awaited results of the TORCH study of Advair (aka Seretide outside the U.S.)(TM) for patients with moderate to severe COPD were published, but were no doubt disappointing to patients with COPD and investors who own GSK stock. Optimists spun the results as "positive" with a 17% relative reduction in death rates for those taking the combination inhaler for 3 years when compared to those taking the placebo inhaler. However, the absolute difference in deaths during the 3 years from any and all causes was only 2.6% (12.6% vs 15.2%) and this small difference was not statistically significant.An Advair Diskus 500/50mcg (the high dose used by the TORCH study) costs about $270 per month. The drug was associated with a lower hospitalization rate for COPD exacerbations, but 32 pa... Allergies and Asthma blogs http://www.medworm.com/rss/comments.php?id=488436 Tue, 20 Mar 2007 04:00:00 +0100 488436 http://www.medworm.com/index.php?rid=438175&cid=t_93954_117_f&fid=34444&url=http%3A%2F%2Fblogs.webmd.com%2Fallergies-and-asthma%2F2006%2F01%2Fasthma-long-acting-bronchodilators.html What's the place of long-acting bronchodilators in treating asthma? Here's an interesting discussion about whether the risks outweigh the benefits.Serevent was one one of the five dangerous drugs mentioned by an FDA division director last year when he testified to Congress, and it subsequently got a "black box warning" on the label. There are now three long-acting bronchodilator (LAB) inhalers available by prescription in the United States: Serevent (salmeterol), Foradil (formoterol), and Spiriva (tiotropium). Since inhaled corticosteroids (ICSs) are also frequently prescribed for patients with asthma and COPD, the combination of a LAB and ICS makes treatment more convenient for patients who need both types of medications (and faster for the doctor to write a prescription for one drug inst... Allergies and Asthma blogs http://www.medworm.com/rss/comments.php?id=438175 Mon, 02 Jan 2006 05:00:00 +0100 438175 http://www.medworm.com/index.php?rid=438176&cid=t_93954_117_f&fid=34444&url=http%3A%2F%2Fblogs.webmd.com%2Fallergies-and-asthma%2F2005%2F12%2Ftoo-many-asthma-medications.html Folks with asthma are often taking 2 or 3 asthma medications every day, even when they have been in the green zone of good control for many months. Most of the time, they can work with their doctor to successfully discontinue one or two of those expensive medications and remain in good control.Brooke, a 12 year old girl with mild asthma since age 5 gets a cold in February which "goes to her chest," causing coughing spasms followed by wheezing and shortness of breath, relieved by her albuterol rescue inhaler. During the next 3 days her asthma does not improve and she requires albuterol every 4-6 hours. So her mom takes her to the pediatrician in their Dallas suburb. She hears wheezing, measures a peak flow of 60% of predicted, and agrees that Brooke's asthma is worse (into the yellow zone o... Allergies and Asthma blogs http://www.medworm.com/rss/comments.php?id=438176 Tue, 27 Dec 2005 05:00:00 +0100 438176