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 'fosamax'. Sat, 03 Sep 2011 02:09:21 +0100 http://www.medworm.com/index.php?rid=5174750&cid=t_108498_125_f&fid=34819&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FFullosseousflapsDentalBlog%2F%7E3%2FGBeiLGazlTE%2F Osteonecrosis of the Jaw (ONJ) Another oral bisphosphonate (Fosamax with ONJ) lawsuit trial set. The next trial date for a Fosamax lawsuit involving jaw necrosis is scheduled to begin early next month. The Fosamax trial will involve a complaint brought by Linda Secrest, of Florida, who alleges that Merck failed to adequately warn that side effects of Fosamax, the popular osteoporosis drug, can lead to severe jaw bone decay. Trial is scheduled to begin on September 7, in the U.S. District Court for the Southern District of New York. Fosamax is an osteoporosis drug that belongs to a family of similar medications known as bisphosphonates. Long-term use of oral bisphosphonates has been linked to an increased risk of serious and debilitating jaw problems, known as osteonecrosis of the jaw. The... FullosseousFlap's Dental Blog blogs http://www.medworm.com/rss/comments.php?id=5174750 Mon, 29 Aug 2011 18:27:46 +0100 5174750 http://www.medworm.com/index.php?rid=5051241&cid=t_108498_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FNb6v9O_OLc8%2F Being blinded by science is something of a preoccupation these days and so less than a year after dueling studies reached differing conclusions that oral bisphosphonates are linked to esophageal cancer, the FDA has weighed in and - for now - declared that no such risk exists. However, the agency cautiously noted no risk was found “at this time” and its review is ongoing. In reaching its preliminary decision, the FDA reviewed two epidemiologic studies - one reviewed the UK General Practice Research Database and found no increase in the risk of esophageal cancer (see this). The second study found a doubling of the risk among patients who had 10 or more prescriptions of the drugs, or who had taken the drugs over three years (read more here and here). The drugs, by the way, are use... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=5051241 Thu, 21 Jul 2011 17:48:39 +0100 5051241 http://www.medworm.com/index.php?rid=4478157&cid=t_108498_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FyEiOE2hyMY4%2F In the latest test of its legal strategy over damages attributed to Fosamax, a New Jersey state court jury decided that the osteoporosis med did not cause Alison Rosenberg, 67, to develop jaw damage known as osteonecrosis. This was the first state court trial to reach a verdict and only the fourth to go to trial. Merck previously won two of three lawsuits that reached federal juries. In reaching its decision, the jury in Superior Court in Atlantic City determined that Rosenberg, who used the med from 1999 to 2006, did not develop osteonecrosis due to Fosamax, that Merck did provide adequate warnings to her doctor and that her doc would have changed the prescription if proper warnings were communicated (read the Merck statement). The verdict is likely to encourage Merck to continue battlin... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4478157 Mon, 14 Feb 2011 16:50:20 +0100 4478157 http://www.medworm.com/index.php?rid=4460185&cid=t_108498_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FcHs7oSEPblk%2F Good morning, everyone, and nice to see you again. Yet another deep freeze has descended on the Pharmalot corporate campus, but we manage to keep warm with our mandatory cup of stimulation and stimulating news. On that note, we offer you a smattering of tidbits to get you started. We hope your day goes well and your goals are accomplished. Have a good one… Novartis Moves To Prevent Execution Drug From Reaching US (Reuters) Botox Use For Migraines Is Questioned (BBC News) Novartis And Pfizer Drugs Boost Lung Function In COPD Patients (Reuters) Medical Device Makers Shun The US (New York Times) J&J Negotiates Hip Replacements With Lawyers (Bloomberg News) Black Rock To Provide Data Merck Wants For Vytorin Defense (Dow Jones) Shire Pharma Earnings Match Expectations (Reuters) IFPMA... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4460185 Thu, 10 Feb 2011 13:09:18 +0100 4460185 http://www.medworm.com/index.php?rid=4197364&cid=t_108498_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FMDvwLgbHjVA%2F A North Carolina jury decided that Novartis failed to adequately warn about the risks of its Zometa and Aredia bone-strengthening meds and awarded $12.8 million to Rita Fussman, whose family claimed she suffered jawbone damage while dying of breast cancer last year, Bloomberg News reports. The award, however, will be reduced by about $800,000 in accordance with state law. This was the third such lawsuit to go to trial over the Novartis drugs. Last month, a New Jersey jury rejected claims by a woman who similarly charged the meds caused her jaw damage (see this). And last October, a Montana jury ordered Novartis to pay $3.2 million in damages to a cancer patient who made the same claims (back story). This same dispute, by the way, plagues Merck, which last week won a trial involving its Fos... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4197364 Tue, 23 Nov 2010 17:03:54 +0100 4197364 http://www.medworm.com/index.php?rid=4190525&cid=t_108498_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=4040795&cid=t_108498_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F33h3HL2Lq1Q%2F Gary Douglas has not had a good week. First, he saw an $8 million damage award for winning a case against Merck over its Fosamax osteoporosis med set aside, with his client asked to choose between starting a new trial or accepting $1.5 million instead. Then, he was sanctioned for saying all sorts of things that ticked off US District Court Judge John Keenan who, nonetheless, levied a rather modest $2,500 fine, partly because other lawyers, even some adversaries, wrote letters attesting to his veracity. But why was he sanctioned? He was a bad boy. Keenan writes Douglas referred to another trial when he should not have done so. He attacked the FDA during his summation over the way the agency is funded. He characterized the FDA and the pharmaceutical industry for having an “incestuous r... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4040795 Thu, 07 Oct 2010 12:06:10 +0100 4040795 http://www.medworm.com/index.php?rid=3965696&cid=t_108498_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F4d1Gfj-MM7I%2F Six months after the FDA determined there is no link between bisphosphonates and thigh-bone fractures, a task force says otherwise. Convened by the American Society of Bone and Mineral Research, the 26-person panel reviewed 310 cases of atypical femur fractures and found that 94 percent, or 291 patients, had taken the drugs, most for more than five years. This is the same task force report the FDA has been waiting to see before issuing recommendations (back story). The panel also found that more than a quarter of patients who experienced atypical femur fractures in one leg experienced a fracture in the other leg as well. On the other hand, the panel pointed out that atypical femur fractures represent less than one percent of hip and thigh fractures overall and therefore are very uncommon. ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3965696 Tue, 14 Sep 2010 12:05:33 +0100 3965696 http://www.medworm.com/index.php?rid=3740827&cid=t_108498_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FfsvLQ4i0GJM%2F Gary Douglas may have beat Merck in an important Fosamax trial last month, but can he beat sanctions for his behavior during closing arguments? The attorney, who helped Shrley Boles win $8 million in compensatory damages (back story here), was chastised in a stinging order by US District Court Judge John Keenan for a variety of alleged shenanigans during his recent summation. “During the trial of this hard fought case, Mr. Douglas repeatedly acted in an inappropriate manner before the jury and made several improper and/or factually incorrect arguments in summation after having been admonished,” Keenan writes in an order. Such as? Douglas claimed the FDA has an “incestuous” relations with drugmakers and offers cursory reviews and expedited approvals “in exchang... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3740827 Fri, 09 Jul 2010 11:49:00 +0100 3740827 http://www.medworm.com/index.php?rid=3699701&cid=t_108498_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FuBy9eefvW9E%2F In replay of a courtroom battle that ended in a mistrial last fall, a federal jury today voted unanimously that Merck’s Fosamax osteoporosis drug was responsible for causing jawbone deterioration suffered by a Florida woman, who was awarded $8 million in compensatory damages (here is the lawsuit). Merck, which argued 71-year-old Shirley Boles was at increased risk for dental and jaw problems if she was not taking Fosamax, quickly indicated it would appeal the decision. “We disagree with the jury’s verdict. We believe the jury verdict was a result of the plaintiff’s counsel’s gross mischaracteraization, and inflammatory and prejudicial remarks,” Paul Strain, an attorney representing Merck, tells us. “We believe the court, from his remarks, made it clear he... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3699701 Sat, 26 Jun 2010 01:01:11 +0100 3699701 http://www.medworm.com/index.php?rid=3699703&cid=t_108498_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FqmL_7AMPh1Q%2F This may be a bad break for drugmakers. Wellpoint is using comparative effectiveness to make it more difficult for its members to use the Boniva osteoporosis drug after its own research found greater fractures, lower compliance and higher costs than other meds, according to Dow Jones. The insurer studied 26,000 members on osteo meds, comparing Boniva, which is marketed by Roche and GlaxoSmithKline with Actonel, which is sold by Sanofi-Aventis and Warner Chilcott, and Merck’s Fosamax. Although randomized clinical trials suggest the drugs should be equivalent, WellPoint data found differences. Now, WellPoint other drugs must be tried before Boniva is approved. The drug remains where on Tier 3, or non-preferred level, on the formulary. WellPoint actually made the change last year, Dow J... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3699703 Fri, 25 Jun 2010 13:57:57 +0100 3699703 http://www.medworm.com/index.php?rid=3621954&cid=t_108498_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FbRL2qPVcAhw%2F After months of delay, Amgen finally won FDA approval for Prolia, an injectable treatment for postmenopausal women with osteoporosis who are at high risk for fractures. The endorsement is a big boost for the biotech, which has been counting on Prolia to reverse a series of setbacks over the past few years, notably a decline in sales of some of its largest-selling products, Aranesp and Enbrel. Some Wall Street estimates suggest peak annual sales could reach $1 billion or so, although Amgen will face some challenges along the way - convincing patients that a twice-a-year shot is better than taking a pill once a month, such as generic versions of Roche’s Boniva or Merck’s Fosamax. “The drug will be competing against generic pills and osteoporosis is not a deblitatiing diseas... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3621954 Tue, 01 Jun 2010 21:54:37 +0100 3621954 http://www.medworm.com/index.php?rid=3617947&cid=t_108498_117_f&fid=37824&url=http%3A%2F%2Fwww.doctorkalitenko.com%2Fblog%2Fgeneral-health%2Fjaw-necrosis-and-fosamax-go-hand-in-hand Fosamax, a biophosphonate, is very commonly used for osteoporosis. It works by slowing bone loss and increasing bone mass, and yet did you know that it can cause jaw necrosis? fosamaxThe warning initially had been that cancer patients on the drug were more at risk, but now it seems that if you had recent dental work on infections, you are at a higher risk as well. How can this FDA approved medication be associated with pain, swelling, infection and exposed bone in the jaw? And even though the FDA approved the drug in 1995, it took them until 2008 to issue this statement: “FDA is highlighting the possibility of severe and sometimes incapacitating bone, joint, and/or muscle (musculoskeletal) pain in patients taking bisphosphonates. Although severe musculoskeletal pain is included in the p... Doctor Kalitenko antiaging blog blogs http://www.medworm.com/rss/comments.php?id=3617947 Mon, 31 May 2010 19:48:51 +0100 3617947 http://www.medworm.com/index.php?rid=3573944&cid=t_108498_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=3552544&cid=t_108498_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FW504akoKAi4%2F The drugmaker lost a round in court when a New Jersey state judge denied a motion for summary judgment in a lawsuit brought by a woman who claims the risks associated with the Zometa bone-strengthening drug were not disclosed properly or completely. The ruling suggests Novartis may now face a large number of trials - about 550 lawsuits are stacked up in federal court in Tennessee and 150 are queued up in New Jersey. In reaching her conclusion, Superior Court Judge Jessica Mayer determined that Jane Bessmer, who suffered from breast cancer and was treated with two intravenous bisphosphonates - Zometa and Aredia - sufficiently argued that Novartis may have failed to warn about the risks associated with the drugs. Bisphosphonates have been linked to osteonecrosis, which is the painful death o... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3552544 Tue, 11 May 2010 13:24:52 +0100 3552544 http://www.medworm.com/index.php?rid=3538388&cid=t_108498_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FyGcf5W19uQc%2F A federal court jury voted unanimously today that Merck’s Fosamax osteoporosis drug did not cause the dental and jaw injuries suffered by Louise Maley of Muncie, Indiana (here is her lawsuit). This was the second bellwether case over whether Merck failed to warn docs and patients that Fosamax may cause osteonecrosis, which is the painful death of jawbone tissue. “Unfortunately, the plaintiff had multiple medical conditions that cause people to develop the jaw and dental problems she claims she has, regardless of whether they were taking Fosamax,” says Merck lawyer Christy Jones of Butler, Snow, O’Mara, Stevens & Cannada, in a statement. The drugmaker denies acting improperly. Merck, which faces 978 such lawsuits in state and federal courts, won a dismissal of a pre... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3538388 Wed, 05 May 2010 21:32:04 +0100 3538388 http://www.medworm.com/index.php?rid=3416320&cid=t_108498_150_f&fid=34768&url=http%3A%2F%2Fpharmagossip.blogspot.com%2F2010%2F03%2Fmany-people-believe-that-these-drugs.html John Mack asks some tough questions of bisphosphonates.Check the comments as well! (Source: PharmaGossip) PharmaGossip blogs http://www.medworm.com/rss/comments.php?id=3416320 Sun, 28 Mar 2010 17:35:00 +0100 3416320 http://www.medworm.com/index.php?rid=3354580&cid=t_108498_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F0pFji5IXzRE%2F Two years after issuing warnings about a group of meds known as bisphosphonates, the FDA has determined there is no link between the drugs and thigh-bone fractures (see here). These meds include Merck’s Fosamax, Novartis’ Zometa and Reclast; Procter & Gamble’s Actonel, and Boniva, which is marketed by Glaxo and Roche. The matter, however, isn’t quite settled. The agency is continuing to work with outside experts, including the American Society of Bone and Mineral Research Subtrochanteric Femoral Fracture Task Force, to gather more info. And two new studies released this week at the annual meeting of the American Academy of Orthopaedic Surgeons found bones of some post-menopausal women who take the meds on a long-term basis to prevent osteoporosis can stop rejuvenating and ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3354580 Thu, 11 Mar 2010 13:42:45 +0100 3354580 http://www.medworm.com/index.php?rid=3228009&cid=t_108498_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F6b_ZGVYohXY%2F And welcome to the working week. Hope your weekend was relaxing and fruitful, although most likely, it went too fast, yes? Sigh… Well, once again, you must steel yourself for those meetings and deadlines. To help you cope, we have assembled a few interesting items. So dig in and the day will speed by. Meanwhile, please stay in touch…. Cephalon To Buy Mepha Generic Maker For $590M (Reuters) Prices For Commonly Prescribed Meds Drop In Ireland (IrishTimes) Judge Refuses To Dismiss Fosamax Case (Reuters) Philippines To Release Second List Of Drug Price Cuts (Bloomberg) Defense Aims At Causation In HRT Opening Arguments (Law.com) (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3228009 Mon, 01 Feb 2010 12:58:48 +0100 3228009 http://www.medworm.com/index.php?rid=3115282&cid=t_108498_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fpd0hZv77gYo%2F Did you know that ostopenia is considered by many physicians to be normal thinning of bones as aging occurs? And that in 1992 a group of osteoporisis experts met in Rome and decided arbitrarily who should be treated for ostopenia? Essentially, they created a new category and never imagined the term would become a marketing cry for Merck to sell Fosamax. But NPR reports that’s what happened. Along the way, Merck wanted to increase the market for its drug, but that required scanning, an expensive and inconvenient procedure. So Merck created a nonprofit called the Bone Measurement Institute to push for alternative scanning solutions, such as smaller, cheaper machines. The drugmaker allegedly bullied makers of bigger scanners and offered financing to docs to encourage purchases of the n... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3115282 Wed, 23 Dec 2009 16:39:17 +0100 3115282 http://www.medworm.com/index.php?rid=3084983&cid=t_108498_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F2elcGgpqA5g%2F Welcome to the working week. We hope your weekend was pleasant, although now, it’s just a memory, isn’t it? And so the time has come for another round of meetings, deadlines and projects. To get you started, here are a few items of interest. So grab a bottle of water or a cup of something stimulating and dig in. Have a good day, folks… Cubist Buys Calixa Therapeutics For $402.5M (PharmaTimes) Merck Loses Effort To Dismiss 24 Fosamax Cases (Reuters) Chemgenex Signs Deal With Hospira (The Australian) Patheon Consolidates Puerto Rican Facilities (Outsourcing Pharma) (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3084983 Mon, 14 Dec 2009 13:03:06 +0100 3084983 http://www.medworm.com/index.php?rid=3023413&cid=t_108498_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F6LwbdU2EhRo%2F This was to have been the second bellwether case against the drugmaker, which has been accused in some 1,000 lawsuits of failing to warn docs and patients its Fosamax osteoporosis med may cause osteonecrosis, or the painful death of jawbone tissue. In his opinion, US District Judge John Keenan wrote that experts for Bessie Flemings, a Mississippi resident, couldn’t prove Fosamax caused her injury. The trial was set to begin in January. Last September, he declared a mistrial in the first case to go to trial afrter a jury failed to reach a unanimous verdict. Flemings, 74, was prescribed Fosamax in December 1997, when she was diagnosed with osteoporosis, but had a history of chronic obstructive pulmonary disease, and “continues to smoke cigarettes even though she is now dependent on ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3023413 Tue, 24 Nov 2009 13:24:43 +0100 3023413 http://www.medworm.com/index.php?rid=2389732&cid=t_108498_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2009%2F05%2Fblogscan-merck-hired-elsevier-to-create.html You just can't make this stuff up. On the Respectful Insolence blog, Orac recounted how pharmaceutical giant Merck hired medical publishing giant Elsevier to create what appeared to be a peer-reviewed journal, but theAustralasian Journal of Bone and Joint Medicine really was just a marketing outlet. The goal was to market Fosamax and Vioxx. This is another bizarre variant on the stealth marketing theme, taken to quite an extreme. And the pharmaceutical companies wonder why people don't trust them? ADDENDUM (4 May, 2009) - Dr Aubrey Blumsohn is back online on his Scientific Misconduct Blog, and noted the academic luminaries who were willing to serve on the editorial board of this fake peer-reviewed journal. (Source: Health Care Renewal) Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=2389732 Mon, 04 May 2009 16:38:00 +0100 2389732 http://www.medworm.com/index.php?rid=2097998&cid=t_108498_111_f&fid=36048&url=http%3A%2F%2Ffeeds.b5media.com%2F%7Er%2Fb5media%2FAHeartyLife%2F%7E3%2FwOuytFeTUQc%2F Women with osteoporosis, that are taking or have taken Fosamax, should ask their health care provider about an alternative treatment. Patient’s that are taking or have taken Fosamax are twice as likely to develop an irregular heartbeat. The risk is higher for those that have a family history of heart failure. There is an 86% higher risk for atrial fibrillation, for patient’s that have taken Fosamax. A study at University of Washington found that 3% of the women in their study of new cases of atrial fibrillation may be due to their use of the drug Fosamax. When you have a question about any medication that is prescribed for you, don’t hesitate to ask your health care provider about side effects. Make sure that you always get a printout of the side effects of the prescriptions at you... A Hearty Life blogs http://www.medworm.com/rss/comments.php?id=2097998 Mon, 12 Jan 2009 21:32:34 +0100 2097998 http://www.medworm.com/index.php?rid=2094830&cid=t_108498_87_f&fid=34935&url=http%3A%2F%2Fmedicine.com.my%2Fwp%2F%3Fp%3D5821 strWebsiteID = window.document.location.toString();strSplitWeb = strWebsiteID.split("/")strWebsiteID = strSplitWeb[2];document.write(”“); from the Malaysian Medical Resources Smoke-Free Laws Reduce Hospitalizations for Heart Attack, Fosomax Increases Risk of Osteonecrosis of the Jaw, 15% of Dementia Patients Are Under 65 Years of Age (Source: Malaysian Medical Resources) Malaysian Medical Resources blogs http://www.medworm.com/rss/comments.php?id=2094830 Sat, 10 Jan 2009 05:00:00 +0100 2094830 http://www.medworm.com/index.php?rid=2074164&cid=t_108498_87_f&fid=34935&url=http%3A%2F%2Fmedicine.com.my%2Fwp%2F%3Fp%3D5754 Osteonecrosis of the jaw (ONJ) has been previously linked to Intravenous bisphosphanates. Now a recent study shows that there is a link to oral bisphosphanates, particularly Fosamax which is commonly prescribed for osteoporosis. This is the first large institutional study in the U.S. to investigate the relationship between oral bisphosphonate use and jaw bone death, said principal investigator Parish Sedghizadeh, assistant professor of clinical dentistry with the USC School of Dentistry. After controlling for referral bias, nine of 208 healthy School of Dentistry patients who take or have taken Fosamax for any length of time were diagnosed with osteonecrosis of the jaw (ONJ). The study’s results are in contrast to drug makers’ prior assertions that bisphosphonate-related ONJ ri... Malaysian Medical Resources blogs http://www.medworm.com/rss/comments.php?id=2074164 Fri, 02 Jan 2009 05:00:00 +0100 2074164 http://www.medworm.com/index.php?rid=2074390&cid=t_108498_136_f&fid=35294&url=http%3A%2F%2Fwww.psa-rising.com%2Fblog%2F2009%2F01%2Fbisphosphonates%2F Recent stories on bisphosphonate side effects might be signaling the advent of a new, superior drug, but will Halozyme’s rHuPH20 enzyme solve the problem of jaw necrosis? Drug development companies operate within the overall consumer culture. We all want better drugs, better everything. Generic Fosamax (alendronate) now costs just $4 at Wal-Mart, Kroger and [...] (Source: psa-rising.com/blog) psa-rising.com/blog blogs http://www.medworm.com/rss/comments.php?id=2074390 Thu, 01 Jan 2009 06:40:48 +0100 2074390 http://www.medworm.com/index.php?rid=2074391&cid=t_108498_136_f&fid=35294&url=http%3A%2F%2Fwww.psa-rising.com%2Fblog%2F2008%2F12%2Ffosamax-linked-to-esophageal-cancer%2F Diane Wysowski of the FDA’s division of drug risk assessment says researchers should check into potential links between oral bisphosphonate drugs and cancer of the esophagus. Merck’s oral osteoporosis drug Fosamax may carry a risk for esophageal cancer, Wysowski writes in a letter to January I 2009 New England Journal of Medicine. Bisphosphonates are a class [...] (Source: psa-rising.com/blog) psa-rising.com/blog blogs http://www.medworm.com/rss/comments.php?id=2074391 Thu, 01 Jan 2009 00:41:27 +0100 2074391 http://www.medworm.com/index.php?rid=1798523&cid=t_108498_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F393518130%2F The important data is released tomorrow, but the biotech has other study results to share about denosumab - subcutaneous injections every six months achieved significantly greater increases in bone mineral density compared with Merck’s Fosamax at all sites measured. For the primary endpoint, denosumab resulted in significant increases in BMD at the total hip - 1.9 percent versus 1.05 percent (here is the statement). This may encourage Amgen employees and investors, but the big issue is whether denosumab significantly reduced the risk of spine fracture in a three-year trial of 7,800 post-menopausal women. Amgen released partial results this summer, but never disclosed how much the risk was reduced. That’s what everyone is waiting to hear on Tuesday at the annual meeting of the Ameri... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1798523 Mon, 15 Sep 2008 22:39:48 +0100 1798523 http://www.medworm.com/index.php?rid=1790484&cid=t_108498_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F390987933%2F Next Tuesday, the struggling biotech releases data about denosumab, an experimental osteoporosis drug, and the data could make the difference between a multi-billion-dollar med and an also-ran in a crowded field. No small moment for a company that has staggered from setback to setback with its existing meds. “Denosumab is a mega-blockbuster opportunity and will now emerge as the principal long-term value driver,” Morgan Stanley analyst Steven Harr wrote in a recent research note, Reuters reports. “We see a high probability of regulatory success given data to date.” Two months ago, Amgen reported denosumab significantly reduced the risk of spine fracture in a three-year trial of 7,800 post-menopausal women, but never disclosed exactly how much the risk was reduced. T... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1790484 Fri, 12 Sep 2008 21:02:46 +0100 1790484 http://www.medworm.com/index.php?rid=1454779&cid=t_108498_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F293841932%2F Another busy day comes to an end. We hope yours was productive and even meaningful. Now, though, the time has come to gather assorted children and loose ends, so we can take stock and prepare for another day. Hope your evening is pleasant and see you in the morning… Amgen’s Denosumab Protects Bone Density: Study (Yahoo/Reuters) Novartis Stock Jumps On Promise Of Kidney Cancer Med (Yahoo/AP) Shingle Victims’ Relatives Should Get Zostavax: Study (Bloomberg News) What Pharma Is Donating To Asian Disasters (Yahoo/AP) (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1454779 Mon, 19 May 2008 23:30:46 +0100 1454779 http://www.medworm.com/index.php?rid=1407333&cid=t_108498_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F280048592%2F Nice to see you again. As the rain moves away from the nation’s medicine chest, we have been scurrying to deposit short people at schools and gather items of interest. Now, we are settling down with our beloved cup of stimulation. So take a pause and join us. And best of luck today… Medco Profit Beats Wall Street Estimates (Yahoo/AP) FTC’s Cephalon Suit Moved To State Court (Yahoo/Reuters) Fosamax Linked To Atrial Fibrillation - Again (Seattle Post-Intelligencer) Lundbeck Names Wyeth Exec As CEO (Reuters) (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1407333 Tue, 29 Apr 2008 12:08:49 +0100 1407333 http://www.medworm.com/index.php?rid=1405444&cid=t_108498_111_f&fid=36048&url=http%3A%2F%2Ffeeds.b5media.com%2F%7Er%2Fb5media%2FAHeartyLife%2F%7E3%2F279739501%2F Women who have used Fosamax are nearly twice as likely to develop the most common kind of chronically irregular heartbeat (atrial fibrillation) than are those who have never used it, according to research from Group Health and the University of Washington. They are saying that women that have used the commonly prescribed osteoporosis medication Fosamax have an over 85% higher chance of developing atrial fibrillation then those that have never used the medication. Now, should you run upstairs and flush your Foamax? No indeed. If you have a high risk for a-fib such as a history of an irregular heart beat, high blood pressure, history of a stroke or symptoms of a “fluttering” heart or palpitations you should make an appointment to discuss matters with your doctor. Make sure the be... A Hearty Life blogs http://www.medworm.com/rss/comments.php?id=1405444 Tue, 29 Apr 2008 00:53:02 +0100 1405444 http://www.medworm.com/index.php?rid=1316798&cid=t_108498_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F254860073%2F Researchers report that long-term use of its Fosamax osteoporosis drug is associated with unusual fractures of the thigh bone, HealthDay writes. The fractures were low-energy fractures, meaning that they all occurred from a fall from standing height or less, and the bone cracks were in an unusual horizontal pattern. About one-third of women with these types of fractures were on long-term therapy to prevent osteoporosis, and of these women, two-thirds were taking Fosamax for an average of more than seven years. Fifteen women were included in the analysis. The average time on Fosamax was 5.4 years before they experienced the unusual femur fracture. Of these 15, 10 women had similar, atypical fractures. These women had been taking Fosamax for an average of 7.3 years, while the remaining five... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1316798 Thu, 20 Mar 2008 11:29:29 +0100 1316798 http://www.medworm.com/index.php?rid=1216524&cid=t_108498_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F231210557%2Fteva_gets_fda_approval_for_gen.html Teva Pharmaceuticals USA has received U.S. Food and Drug Administration approval to manufacture generic Fosamax.Alendronate sodium tablets are indicated for the treatment of osteoporosis, a condition that causes thinning and weakening of the bones.Approved dosages will be available in three once-daily dosages of 5 milligrams, 10 milligrams and 40 milligrams and the two once weekly dosages of 35 milligrams and 70 milligrams."The FDA works to assure the safety and efficacy of generic drugs through a rigorous scientific and regulatory process," said Gary J. Buehler, R.Ph, director of the FDA's Office of Generic Drugs. "These approvals will provide generic options for patients who take Fosamax for their osteoporosis."Generic manufacturers must show that a generic drug h... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=1216524 Thu, 07 Feb 2008 20:00:35 +0100 1216524 http://www.medworm.com/index.php?rid=1212314&cid=t_108498_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F230492766%2F Another busy day. We hardly know where to turn first. And so while we sort things out, we thought the following items may be of interest. Hope your day is going smoothly and you have a chance to take a well-deserved break… Biogen Quarterly Profits Surge (The Street.com) Three Generic Versions Of Fosamax Are Launched (Yahoo/AP) Perrigo Reports Big Sales Gains (The Grand Rapids Press) CeNeS Gets Takeover Approach (The International Herald Tribune) Alpharma To Sell API Unit (MarketWatch) (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1212314 Wed, 06 Feb 2008 19:57:15 +0100 1212314 http://www.medworm.com/index.php?rid=1188766&cid=t_108498_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F225910793%2F The drugmaker took a charge of $4.85 billion to cover the settlment and, as a result, lost $1.6 billion, or 75 cents a share, compared with net income of $473.9 million, or 22 cents, a year earlier. Excluding the Vioxx settlement and ongoing restructuring charges, which involved eliminating 7,200 jobs and closing several plants over the past two years, Merck had a profit of 80 cents, exceeding its forecasts. Merck ceo Dick Clark will discuss the results in a teleconference shortly and we will pass along the details. Meanwhile, here are a few nuggets from the Merck statement: - Merck won $455 million from an insurance arbitration award related to Vioxx litigation coverage; - Marketing and administrative expenses recorded in 2006 include $673 million in reserves for future legal defense cost... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1188766 Wed, 30 Jan 2008 13:40:50 +0100 1188766 http://www.medworm.com/index.php?rid=1182986&cid=t_108498_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F224776168%2F The allegations and concerns that the drugmaker’s osteoporisis med may cause problems in the jaw - known as osteonecrosis - are well known at this point. Now, though, a new issue has emerged. A Connecticut woman named JoAnn Moranski has sued Merck and claimed that Fosamax caused multiple stress fractures and suppressed bone regeneration in her legs, according to The Wall Street Journal. She took the med between 1996 and 2006; her lawsuit was filed in a New Jersey state court. More than 400 people already have sued Merck alleging that Fosamax causes a bone-wasting condition known as osteonecrosis of the jaw. Fosamax, which loses its US patent protection next month, generated sales of nearly $3 billion in 2007. (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1182986 Mon, 28 Jan 2008 20:29:53 +0100 1182986 http://www.medworm.com/index.php?rid=1134007&cid=t_108498_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F212705996%2F The agency is urging doctors to be on the lookout for the “possibility of severe and sometimes incapacitating bone, joint, and/or muscle (musculoskeletal) pain” in patients taking a group of meds known as bisphosphonates. These include Merck’s Fosamax, Novartis’ Zometa and Reclast; Procter & Gamble’s Actonel and Boniva, which is marketed by Glaxo and Roche. Although severe musculoskeletal pain is included in the prescribing information for all bisphosphonates, the association between bisphosphonates and severe musculoskeletal pain may be overlooked by healthcare professionals, delaying diagnosis, prolonging pain and/or impairment, and necessitating the use of analgesics, the FDA cautions on its web site. The severe musculoskeletal pain may occur within da... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1134007 Mon, 07 Jan 2008 17:55:44 +0100 1134007 http://www.medworm.com/index.php?rid=1103604&cid=t_108498_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F202299725%2F The sun is shining and the temperature is warming. This can only mean that the time has come to stretch the legs, grab something to eat and take stock of the world. Here are some of the items we found…. Pfizer Buys CovX, Terms Not Disclosed (Yahoo/AP) Novartis To Close Vienna Research Facility (EUX.TV) Epix Pharma Stock Surges On Alzheimer’s Med Study (Bloomberg News) Newer Osteo Meds No Better, But Fewer Side Effects (Yahoo/Reuters) Share / E-mail (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1103604 Tue, 18 Dec 2007 17:44:14 +0100 1103604 http://www.medworm.com/index.php?rid=1070378&cid=t_108498_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F195008447%2F To be precise, this is a pre-tax charge to cover investigations by federal and state authorities - specifically, the Department of Justice and the Texas attorney general - concerning ”marketing and selling activities, including nominal pricing programs and samples.” This little nugget was tucked inside this morning’s lengthy press release discussing next year’s earnings guidance, which seems to be disappointing investors. Merck says 2008 earnings will be between $3.28 to $3.38 a share, but the median forecast of 20 analysts in a Bloomberg News survey was $3.36. That’s cutting it close. Anyway, back to the main event. What is nominal pricing? A drugmaker offers a steep discount of 90 percent or more to a hospital in exchange for guaranteed market share of certa... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1070378 Tue, 04 Dec 2007 15:46:40 +0100 1070378 http://www.medworm.com/index.php?rid=1064957&cid=t_108498_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F194060582%2F When we last saw you, we mentioned something about raking leaves. Now, though, the leaves are nowhere to be found - they are covered by a slight dusting of snow. So rather than wield our rake, we chose to wield our laptop and bring you a few of the latest doings. Here they are… Glaxo will offer $4 million retention packages and seats on the board to the two execs who lost out on succeeding JP Garnier as ceo, The Times of London reports. The offer, which has already been put to Glaxo shareholders, was made after Glaxo two months ago picked Andrew Witty ahead of his two internal rivals, Chris Viehbacher, president of US pharma, and David Stout, president of pharma operations. Shares will be handed out to Viehbacher and Stout over two to three years, and there is also likely to be a sma... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1064957 Sun, 02 Dec 2007 23:30:25 +0100 1064957 http://www.medworm.com/index.php?rid=1063010&cid=t_108498_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F193247012%2F And so we turn our attention to other matters, such as raking leaves and spending time with our short people. We may even read a book. And you? Whatever your passion, we hope you enjoy the time. Meanwhile, here are a few items to help you stay abreast, even as other activities beckon… Amgen’s Aranesp Data Disappoints (TheStreet.com) Fosamax Users Seek Class-Action Lawsuit Status (Yahoo/AP) King Pharma Options Up On Takeover Speculation (Yahoo/Reuters) DEA Move May Not Hurt Cardinal Health (Yahoo/AP) UK’s NHS Calls For Redirecting Cancer Med Expenditures (BBC) Share / E-mail (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1063010 Sat, 01 Dec 2007 01:16:58 +0100 1063010 http://www.medworm.com/index.php?rid=919097&cid=t_108498_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F163968368%2F We apologize for delay since our last post, and the late sign-off, as well. We were meeting with a few people from, well, we shouldn’t say. But we do try to get out and about now and then, if only to hear the latest about whomever and whatever. So we appreciate your patience. Now, we will attempt to recharge before resuming the routine in the morning. Sleep well, everyone. We look forward to seeing you again shortly… FDA To Review Affect Of Osteoporosis Drugs On The Heart (Bloomberg News) Increased Options Activity In Bristol-Myers Squibb (The Wall Street Journal - subscription required) Glaxo’s Cervarix Priced At Same Level As Gardasil In The UK (Yahoo/Reuters) Share / E-mail (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=919097 Tue, 02 Oct 2007 01:10:59 +0100 919097 http://www.medworm.com/index.php?rid=883878&cid=t_108498_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F158495176%2F And so another day begins. There is much to do this morning. Meanwhile, we wonder if Congress will ever make progress on the FDA reform legislation. Here are a few items to captivate you while we await word from DC…. Alnylam And Merck End Collaboration For RNAi (Yahoo/AP) Novartis Paid Ricchetti $120K To Lobby Washington (Yahoo/AP) Merck Plays Catch-Up With Successor To Fosamax (The Star-Ledger of New Jersey) Teva Wins Expanded Contract With German Health Insurer (Yahoo/Reuters) Merck KgGA Plans More Takeovers To Boost Sales (Bloomberg News) Encysive Says Court Dismisses Securities Lawsuit (Yahoo/AP) Germany’s Evotec To Pay $152 Million For Renovis (Yahoo/Reuters) Abbott Reduces Board To 12 Directors (Yahoo/AP) Merck’s New HIV Drugs Suppressed Virus Through 48 Weeks (Bloo... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=883878 Wed, 19 Sep 2007 11:03:50 +0100 883878 http://www.medworm.com/index.php?rid=814341&cid=t_108498_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F146621119%2F It ain’t easy getting a new med out the door. But some marketing plans work better than others. In the US, for instance, only half of all launches are considered a success. Of course, sales reps are a big factor in the US, because docs wield so much decision-making power about scrips. In any event, IMS Health has analyzed product launches and come up with a list of those deemed to be the most successful. So which ones were they? 1 - Lipitor 2 - Viagra 3 - Avandia 4 - Zyprexa 5 - Fosamax Each succeeded for different reasons, of course. Viagra was unique - the first sexual dysfunction drug and who doesn’t pay attention to sex? By contrast, osteoporosis isn’t sexy at all, but Merck raised patient awareness of the disease and that can certainly generate scrips. And as Jon Le... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=814341 Tue, 21 Aug 2007 19:26:41 +0100 814341 http://www.medworm.com/index.php?rid=511180&cid=t_108498_87_f&fid=34865&url=http%3A%2F%2Fwww.thecancerblog.com%2F2007%2F03%2F30%2Ffosamax-prevents-bone-loss-in-prostate-cancer-patients%2F Filed under: Prostate Cancer, Drug, Clinical Trials, ResearchHormonal therapy for prostate cancer can cause many side effects, one being bone loss. The goal of the hormonal therapy is to reduce the levels of the male hormones, called androgens, in the body. The main androgen is testosterone. Androgens can stimulate prostate cells to grow and lowering the levels often makes prostate cancer cells shrink or grow more slowly. The Annals of Internal Medicine published an article that says Fosamax (alendronate) can prevent and even reverse bone loss associated with hormonal treatment for prostate cancer. A trial was conducted that showed after one year bone density had increased among patients treated with Fosamax but had decreased among patients who received a placebo. If you are receiving hor... The Cancer Blog blogs http://www.medworm.com/rss/comments.php?id=511180 Fri, 30 Mar 2007 04:00:00 +0100 511180