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 'epogen'. Sat, 03 Sep 2011 02:30:03 +0100 http://www.medworm.com/index.php?rid=5107898&cid=t_121579_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FjT4ncXm_IJU%2F The group of drugs known as ESAs are apparently being used inappropriately in cancer patients, suggesting that the expensive treatments are being wasted and exposing patients unnecessarily to serious side effects, according to a new study in the Journal of Clinical Oncology. Specifically, the meds were administered for no more than one week in 24 percent of patients, which is an insufficient amount of time to offer a useful benefit, according to the researchers (read the abstract). Moreover, nearly eight percent of the patients received one of the drugs for more than 14 weeks, while almost 14 percent were getting the drugs when they weren’t on chemotherapy.” The meds are approved for cancer patients who are getting chemotherapy, and recommended treatment is between two and 14 w... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=5107898 Mon, 08 Aug 2011 12:55:04 +0100 5107898 http://www.medworm.com/index.php?rid=4813667&cid=t_121579_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FU-E_cUnzOJg%2F Good morning, everyone, and nice to see you again. A busy day is planned here on the Pharmalot corporate campus as we hustle to meet some deadlines and undertake our own version of R&D. No doubt, you relate. So please join us for that mandatory cup of stimulation. Meanwhile, here are some tidbits we found floating about. Hope you conquer the world and see you later… Takeda In Talks To Buy Nycomed For $12 Billion (Bloomberg News) Carl Icahn And His Big Bet On Biotech (The Boston Globe) Glaxo & Astra Hook Up With Academia For Inflammation Research (Pharma Times) Experimental AIDS Vaccine Shows Promise In Monkeys (Reuters) Shire Eyes Big Sales For New Vyvanse Uses (Reuters) Procrit And Epogen May Worsen Heart Attacks (Health Day) Docs Busted For Supplying Oxycodone Network (Th... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4813667 Thu, 12 May 2011 12:15:38 +0100 4813667 http://www.medworm.com/index.php?rid=4592695&cid=t_121579_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FQzD6otG0mCU%2F One of the big gripes among biotech investors is that Amgen has refused to pay a dividend. No matter how many times the issue has been raised, execs have refused to consider the prospect. Never mind that the stock has been battered amid a raft of struggles, notably FDA warnings over health risks associated with the Aranesp and Epogen anemia meds, concerns about reduced Medicare reimbursement and uncertainty about its pipeline and acquisition strategy (see this). At one point, the combination of setbacks and miscues resulted in Kevin Sharer being named one of the worst chief executives a few years ago (see this). Now, though, attention is focused on the possibility of a dividend since Wall Street anticipates the issue will be addressed at the upcoming annual shareholder meeting. Investors, ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4592695 Mon, 14 Mar 2011 13:59:30 +0100 4592695 http://www.medworm.com/index.php?rid=4300551&cid=t_121579_87_f&fid=39187&url=http%3A%2F%2Fgetbetterhealth.com%2Fremembering-gene-goldwasser-discoverer-of-epo-a-cure-for-anemia%2F2010.12.30 Gene Goldwasser died last week. He was 88, and he was my friend. I wrote previously about a series of conversations I conducted with Gene and Rabbi A.J. Wolf a few years ago. I met Gene one spring day after calling to invite him to sit in on a class I was teaching to a small group of medical students about social issues in healthcare. I’d read about him in a book called “The $800 Million Pill,” by Merrill Goozner. In the book, Goozner writes the story of Gene’s two-decade hunt to isolate the hormone erythropoietin (EPO). Part of the story relates how Gene tried to interest traditional big pharma companies in his discovery, only to be brushed aside. Instead, Gene wound up sharing his discovery with what became Amgen. The company went on to make a windfall from recomb... Better Health blogs http://www.medworm.com/rss/comments.php?id=4300551 Thu, 30 Dec 2010 16:00:00 +0100 4300551 http://www.medworm.com/index.php?rid=4197365&cid=t_121579_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FC9Ox0nwZNCI%2F Over the past week, word has leaked out that Amgen, a beleaguered biotech, is interested in buying Actelion Pharmaceuticals in hopes of expanding into the cardiovascular market. But a couple of fund managers say they are not impressed with the possibility and one large Amgen shareholder (see photo) complains that such a move is “faulty thinking by a hard-up executive staff.” What would Amgen get? For the most part, Actelion is a one-trick pony; the drugmaker last year derived about 85 percent of its revenue from Tracleer, a med that is used to treat pulmonary arterial hypertension and generated about $1.5 billion in sales. There are also four experimental meds in the final throes of testing, including two that are also being developed to treat PAH (see pages 17 and 18 of the an... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4197365 Tue, 23 Nov 2010 14:48:08 +0100 4197365 http://www.medworm.com/index.php?rid=4074445&cid=t_121579_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FjXyjAatMwKk%2F Good morning, everyone. Another day is on the way, but this one brings us to the weekend. And not a moment too soon, yes? Have any special plans? Watching a ball game? Picking apples? A nap on the couch? For our part, we hope to spend time with Mrs. Pharmalot and all of the Pharmalittles, and catch up with a favorite relative, too. Whatever you do, enjoy. Meanwhile, here are a few items to help you glide through the day. Have a great weekend and see you soon… CVS Fined For Allowing Meth Ingredient Sales (Associated Press) EMA Tightens Guidelines For Impartiality On Commitees (PharmaTimes) Sanofi Says MS Drug Cuts Relapses By 31 Percent (Reuters) Reckitt Fined By UK Regulators Over Heartburn Drug Supplies (Bloomberg News) FDA May Limit Anemia Drugs For Kidney Use (Associated Press) (... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4074445 Fri, 15 Oct 2010 11:41:40 +0100 4074445 http://www.medworm.com/index.php?rid=3795053&cid=t_121579_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FJqmh-OvPe3Q%2F After much anticipation, the Centers for Medicare & Medicaid Services last night issued its new rules on the bundling payment system for meds used to treat anemia. The bottom line is that after the rules goes into effect, the use of anemia drugs - notably, Amgen’s Epogen - will likely drop, which was expected. But the agency did offer one surprise: some oral meds will be exempt until 2014. Right now, Medicare pays a set fee for each dialysis treatment, but drugs such as Epogen are reimbursed separately. This sparked controversy because hospitals and clinics had more incentive to use more Epogen, which racked up $2.65 billion in sales last year. But widespread use is not only a big expense for Medicare, but also a concern ever since studies found such drugs were linked to heart ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3795053 Tue, 27 Jul 2010 14:43:05 +0100 3795053 http://www.medworm.com/index.php?rid=3672036&cid=t_121579_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FXG8ViSrcrXA%2F Rise and shine. Another day is on the way. Hello, everyone, hope all is well as you gear up for those meetings and deadlines. We can relate. To cope, we are brewing the mandatory cup of stimulation. Feel free to indulge yourself, or grab a water bottle if you prefer. Meanwhile, here are a few items to help you get started. Have a good one and stay in touch… Pay For Delays Deals Nearing A Turning Point? (Bloomberg News) FDA To Decide On Orexigen Obesity Pill In January (Reuters) Merck To Cut 800 Jobs In France (La Tribune) Merck KGgA Resumes Vaccine Trial For Lung Cancer (Reuters) UK’s NICE Refuses To Cover Roche’s Tarceva (PharmaTimes) Medicare To Review Coverage Of Anemia Drugs (Reuters) AstraZeneca May Fight Canadian Court Ruling On Nexium Generic (Bloomberg) Industry G... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3672036 Thu, 17 Jun 2010 11:55:27 +0100 3672036 http://www.medworm.com/index.php?rid=3149320&cid=t_121579_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FIsAn9nT5-Mg%2F The agency plans to hold an advisory committee meeting because studies have found that high dosages of Amgen’s Aranesp and Epogen and Johnson & Johnson’s Procrit boost the risk of heart attacks, strokes and blood clots in anemia patients with kidney disease. The purpose of the meeting, which hasn’t been scheduled yet, is to determine the appropriate dosages. Known as erythropoiesis-stimulating agents, or ESAs, the drugs boost hemoglobin levels in anemics, but the drugmakers have been plagued by cardiovascular risks that caused sales to decline. As it turns out, using large doses to cause hemoglobin to return normal levels may also increase the risk of heart attacks and strokes, instead of lowering the risk. “Randomized trials have endeavored to show that using ESA... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3149320 Thu, 07 Jan 2010 12:07:53 +0100 3149320 http://www.medworm.com/index.php?rid=3115285&cid=t_121579_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FP07ZTLAUfiw%2F A federal court in Boston ruled that Roche’s Mircera anemia drug does, indeed, infringe on Amgen’s patents and entered a permanent injunction preventing the big drugmaker from selling its med in the US, according to Amgen. The decision ends a five-year battle in which Roche lost legal maneuver after legal maneuver, including a jury trial (see here). The judgment was accompanied by Roche’s admission that Amgen patents for Aranesp and Epogen are valid. A limited license agreement will allow Roche, which already sells Mircera in Europe, can market its med in the US in 2014, according to an Amgen statement. There was no financial payment, by the way. The deal has its roots in a ruling last year by a federal judge, who suggested a licensing deal (see here). Over the past two y... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3115285 Wed, 23 Dec 2009 00:16:50 +0100 3115285 http://www.medworm.com/index.php?rid=2047632&cid=t_121579_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F487050034%2F A former Amgen patent attorney, who claims was fired last summer for complaining of “unethical and illegal practices,” can take his case to a California state court instead of being forced to go aribitration, which Amgen requries of all employees with a dispute. The ruling means that other former and current Amgen employees may have the potential to pursue claims in public court in California, where the biotech is headquartered, instead of closed-door arbitration proceedings. “Amgen required all employees to sign an arbitration agreement as a condition of employment. This allows all employees who have a dispute to go to court and have their case heard before a jury,” says Rob Henning, the lawyer for former Amgen attorney Darrell Dotson. “A recent study showed... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=2047632 Tue, 16 Dec 2008 23:04:11 +0100 2047632 http://www.medworm.com/index.php?rid=1945450&cid=t_121579_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F445453882%2F The past 18 months were not terribly kind to Kevin Sharer. There were FDA warnings over health risks associated with the Aranesp and Epogen anemia meds and reduced Medicare reimbursement. Congress is investigating marketing practices. The SEC is probing a failure to disclose that a key clinical trial ended over safety concerns. There were layoffs. And he was named one of the worst CEOs. But Kevin is unflaggingly optimistic and predicts the fallout from safety concerns and reimbursement cuts for its anemia meds should bottom out during the first half of 2009. And he tells The Wall Street Journal this should bolster Amgen’s standing as it prepares for the anticipated approval and launch of denosumab, a new drug for osteoporosis, which may receive FDA approval next year. Kevin acknowled... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1945450 Fri, 07 Nov 2008 13:05:43 +0100 1945450 http://www.medworm.com/index.php?rid=1901968&cid=t_121579_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F429089619%2F Apologies for the late send-off, but we had sundry tasks to run for Mrs. Pharmalot and one of the short people. And so we would like to leave you with a couple of items we meant to run by you earlier. Hope you have a pleasant evening and see you tomorrow… Glaxo posted better-than-expected third-quarter results after the weak British pound helped outweigh the impact of increased generic competition in the US. And the financial crisis has opened the door to potential acquisition among companies that need to sell off assets. However, ceo Andrew Witty says the drugmaker will lose a total of about $5 billion in sales as demand falls for treatments like its Coreg heart med and Wellbutrin antidepressant. And ongoing controversy surrounding its Avandia diabetes pill means the outlook for sal... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1901968 Thu, 23 Oct 2008 00:29:04 +0100 1901968 http://www.medworm.com/index.php?rid=1871102&cid=t_121579_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F417432488%2F Hello, everyone. We apologize for leaving so abruptly this afternoon, but a personal matter required that we be elsewhere. And for once, it was impossible to use the laptop. Nonetheless, we are now catching up and thought it would be worth noting a few developments. Coincidentally, they all involve a legal ruling. In any event, we hope your weekend goes well. Splendid time to pick a few apples, yes? Alabama settled Medicaid drug pricing lawsuits against Bristol-Myers Squibb and four other companies, according to Jere Beasley, a lawyer representing the state. Bristol-Myers is one of more than 70 companies the state has sued for allegedly overcharging the state’s Medicaid program, and Beasley says undisclosed settlements were reached with four other companies that were not named. A tri... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1871102 Sat, 11 Oct 2008 11:59:37 +0100 1871102 http://www.medworm.com/index.php?rid=1851208&cid=t_121579_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F409871544%2F A federal judge in Boston ruled the drugmaker infringed on Amgen’s patents with its Mircera anemia med, essentially upholding a preliminary decision issued in February. The order by US District Court Judge William Young deals a big setback to Roche, which already cut costs after its plans to market Mircera flopped and further underscores its need to takeover Genentech. The ruling caps more than a year of intense legal wrangling in which Roche lost a jury trial that found Mircera infringed on Amgen patents for its Aranesp and Epogen meds. That came shortly before Roche won FDA approval to market Mircera. Young subsequently issued a preliminary injunction barring Roche from selling Mircera. At one point, though, Young declined to issue a permanent injunction, noting it may not be in th... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1851208 Fri, 03 Oct 2008 03:21:48 +0100 1851208 http://www.medworm.com/index.php?rid=1837177&cid=t_121579_150_f&fid=34768&url=http%3A%2F%2Fpharmagossip.blogspot.com%2F2008%2F09%2Fcutting-epoetin-alfa-sales-at-stroke.html Preliminary results from a German study suggest that stroke patients' use of anti-anemia drugs such as Aranesp, Procrit and Epogen might end up boosting their risk for death, the U.S. Food and Drug Administration (FDA) warned on Friday.The goal of the study was to see if high doses of the anti-anemia drug epoetin alfa could improve the ability of stroke patients to take care of themselves after recovering from a stroke.The hope was that the drug would be neuroprotective, but use of epoetin alfa now appears linked to a near-doubling of mortality.More (Source: PharmaGossip) PharmaGossip blogs http://www.medworm.com/rss/comments.php?id=1837177 Mon, 29 Sep 2008 02:42:00 +0100 1837177 http://www.medworm.com/index.php?rid=1834807&cid=t_121579_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F403780883%2F The FDA has just issued one of its ‘‘early communications ‘ about preliminary results from a German study that is investigating whether an anti-anemia drug can improve the neurological functioning of patients who have experienced a stroke. Three months after the start of the study, 16 percent of the patients who had received the drug, epoetin alfa, had died compared to 9 percent of those patients who did not receive the drug, according to the agency. And so the FDA is conducting what it calls an ongoing safety review (here is the back story). In the US, epoetin alfa is marketed as Procrit by Johnson & Johnson, and Epogen by Amgen, and in Germany, marketed as Eprex by J&J. The drug part of the class of erythropoiesis-stimulating agents (ESAs) approved for use in ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1834807 Fri, 26 Sep 2008 13:23:49 +0100 1834807 http://www.medworm.com/index.php?rid=1809940&cid=t_121579_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F396160957%2F The health care giant’s Ortho Biotech unit issued a statement last night saying it learned of preliminary data from a study in which patients were given its drug within six hours of suffering an ischemic stroke. The trial was designed to determine whether the med could help stroke patients. In the study, which was designed and initiated by a German scientist, more patients treated with Eprex died than in the comparison group receiving a placebo. “Ortho Biotech chose to publicly communicate the results…because of what we feel are potential safety implications,” a J&J spokesman tells the Associated Press. Procrit, which is sold as Exprex outside the US and also marketed as Epogen by Amgen, is approved for treating anemia in cancer patients, people with kidney dis... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1809940 Thu, 18 Sep 2008 12:16:55 +0100 1809940 http://www.medworm.com/index.php?rid=1660995&cid=t_121579_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F348345167%2F Late Friday, the biotech released partial study results showing its experimental osteoporosis drug, denosumab, significantly reduced the risk of bone fracture in post-menopausal women in a large number of patients, triggering a rise of nearly 18 percent in its shares in after-hours trading. That’s because denosumab, which targets a protein involved with bone-destroying cells, is seen as a key to Amgen’s future since the growth of its flagship anemia drugs - Epogen and Aranesp - have faltered over safety concerns that have brought Black Box warnings. Even before the after-hours run-up to $63.49, Amgen shares have climbed about 28 percent over the last three months. In a research note this morning, Rodman & Renshaw analyst Michael King writes that “the worst is behind ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1660995 Mon, 28 Jul 2008 12:31:44 +0100 1660995 http://www.medworm.com/index.php?rid=1631579&cid=t_121579_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F337475704%2F That seems to be the betting. A federal appeals court is likely to uphold a preliminary injunction barring the sale of Roche’s Mircera in the US, but the ruling will be closely watched to see if the court addresses the so-called “public interest” issue, according to The Financial Times. Last year, a federal jury in Massachusetts found that Roche infringed Amgen patents, but damages weren’t awarded because Roche had not yet launched the product in the US. Roche did threaten to launch Mircera unless an injunction barring it from doing so was issued and so Roche is now appealing the preliminary injunction that was subsequently put in place, the paper writes. The District Court is likely to wait for the Federal Circuit to decide on Roche’s appeal before addressing the i... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1631579 Wed, 16 Jul 2008 22:19:01 +0100 1631579 http://www.medworm.com/index.php?rid=1616431&cid=t_121579_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F333092282%2F The agreement resolves litigation alleging the biotech offered illegal discounts to cancer clinics. J&J’s OrthoBiotech division had filed a lawsuit charging Amgen bundled meds - Neupogen, Neulasta and Aranesp - and, by doing so, forced the clinics to buy Aranesp instead of J&J’s Procrit. Aranesp is a longer-lasting version of Amgen’s anemia drug Epogen, which is marketed for treatment of kidney disease patients. Johnson & Johnson licensed Epogen and markets it under the Procrit brand name as a treatment for cancer patients undergoing chemotherapy. Amgen’s Neulasta and Neupogen increase production of infection-fighting white blood cells and are also used in chemo. In a statement, Amgen insists its conduct was not unlawful and it admits to no wrongdoin... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1616431 Fri, 11 Jul 2008 23:11:43 +0100 1616431 http://www.medworm.com/index.php?rid=1551903&cid=t_121579_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F321261842%2F This is an exciting thought, is it not? But before you head off, make sure you look twice, even three times, at your to-do list. And keep one eye on all those important developments. Here are a few…. Wyeth Puts Centrum Account Up For Review (Advertising Age) EMEA Warns About Anemia Drugs (Yahoo/Reuters) South Korea Rules Against Pfizer Over Lipitor Patent (Thomson Financial) Merck’s Arcoxia Needs Added Warning In Europe (Bloomberg News) (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1551903 Fri, 27 Jun 2008 11:32:37 +0100 1551903 http://www.medworm.com/index.php?rid=1362494&cid=t_121579_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F267368692%2F Scrambling to generate needed revenue, Roche has filed an appeal of a preliminary court injunction that bars US sales of its Mircera anemia med. The move comes as US District Court Judge William Young considers whether to require Amgen to license its patents to its Aranesp and Epogen drugs in return for a licensing fee. To date, Amgen has rejected Roche’s overtures and, instead, pressed for an injunction, citing its court victory last fall in which Roche’s Mircera was found to violate Amgen’s patents. In a statement, Roche says “the judge in the federal court encouraged Roche to appeal to the Federal Circuit Court of Appeals. Roche filed its notice of appeal today and plans to vigorously pursue this appeal. Roche maintains its position that all of Amgen’s patents&... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1362494 Thu, 10 Apr 2008 01:06:25 +0100 1362494 http://www.medworm.com/index.php?rid=1347617&cid=t_121579_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F263375822%2F By and large, Amgen shareholders are not a happy bunch. The biotech’s stock is down about one-third in the past year, thanks to various FDA warnings and health risks associated with its Aranesp and Epogen anemia meds, not to mention reduced Medicare reimbursement. For awhile, ceo Kevin Sharer appeared in denial, until he began slashing jobs a few months ago. The poor performance ate away at his compensation last year by 27 percent, but Sharer still managed to get $13.2 million. Not bad for a bad year. All this has frustrated Steve Silverman,* a retired insurance executive who holds an undisclosed amount of Amgen stock in a family trust. A vocal critic of Amgen management, he wants Sharer to go. He explained his views… Pharmalot: Beyond the usual sort of research, how have you g... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1347617 Thu, 03 Apr 2008 14:59:48 +0100 1347617 http://www.medworm.com/index.php?rid=1344616&cid=t_121579_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F262141492%2F It took Kevin Sharer nearly a year to admit the biotech was having a crisis, and that’s probably because he finally realized he wouldn’t get as much money as he had in the past. His 2007 compensation was down nearly 29 percent - to $13.2 million - from $18.6 million the year before, according to the proxy filed with the Securities and Exchange Commission. Of course, that’s still a lot of money, isn’t it? Especially for a company with a laundry list of problems and embarassments - an FDA panel urged tighter restrictions for its Aranesp flagship med after studies found increased risks of cardiovascular disease, tumor growth and death. Congress is investigating the marketing and safety of several of its drugs. The SEC is probing its failure to tell Wall Street that a k... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1344616 Tue, 01 Apr 2008 18:50:25 +0100 1344616 http://www.medworm.com/index.php?rid=1329202&cid=t_121579_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F258502152%2F The federal judge overseeing the patent battle between Amgen and Roche has ordered that an expert be appointed to recommend how to compare the dosing and prices of their anemia drugs, Reuters reports. Last October, a federal court jury in Boston found that patents on Amgen’s anemia drugs were valid and that Roche’s Mircera, which has since been approved by the FDA for treating anemia in kidney disease patients, infringed three patents. But US District Court Judge William Young declined to issue a permanent injunction barring Mircera sales in the US and may instead impose a licensing deal allowing Roche to launch its drug - which is administered less often than Amgen’s Epogen and Aranesp - if certain terms are met. Roche offered to pay a 22.5 percent royalty to Amgen and a... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1329202 Wed, 26 Mar 2008 19:21:47 +0100 1329202 http://www.medworm.com/index.php?rid=1311464&cid=t_121579_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F253804186%2F After being called the equivalent of a snake oil salesman, Roche execs accepted terms imposed by a federal judge in order to begin selling their new Mircera anemia medication. The tentative arrangement follows Roche’s defeat last October in a Boston courtroom, where the drugmaker was found to have violated patents on Amgen’s best-selling Aranesp and Epogen drugs. In November, however, Roche won FDA approval to sell Mircera and, hoping to bolster its 2008 budget with fresh revenue, worked with US District Court Judge William Young to negotiate a deal with Amgen. And so Roche has agreed to pay Amgen a royalty of 22.5 percent of US sales, compared with the 20 percent offer that Amgen rejected. Roche must also guarantee it won’t charge higher prices than Amgen. Amgen, however... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1311464 Tue, 18 Mar 2008 18:56:31 +0100 1311464 http://www.medworm.com/index.php?rid=1301893&cid=t_121579_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F250991696%2F A closely watched FDA panel meeting ends with not-such-great news for Amgen and Johnson & Johnson. The drugmakers can continue marketing their anemia meds for cancer patients, but the current use should be restricted over concerns the drugs can increase the risk of tumor growth and death. However, the panel decided against completely restricting use in cancer patients, which Wall Street feared might have happened. The voting: By a 13-to-1 margin, the advisory committee decided the drugmakers should market their meds for use in cancer patients undergoing chemo. But the vote was 11-to-2 for restricing use in curative patients - those with early-stage cancer whose treatments may provide a cure. And the committee voted 9-to-5 in recommending the meds shouldn’t be used in patients w... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1301893 Thu, 13 Mar 2008 21:48:56 +0100 1301893 http://www.medworm.com/index.php?rid=1297940&cid=t_121579_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F250085312%2F How’s this for imagery? For more than two decades as an oncologist, Richard Pazdur frequently delivered bad news to patients. Once, a dying man grabbed his coat and begged him to try even more chemotherapy. But the doc says he declined, because he believed further treatment wouldn’t help. The patient died less than an hour later. This sets the tone for a profile in The Wall Street Journal, which writes that Pazdur, 55, still makes life-or-death judgments - and gets a lot of criticism as a result. That’s because each decision affects millions of Americans. Pazdur heads the FDA’s Office of Oncologic Drugs, which makes him the gatekeeper for any new cancer med that goes on the US market - and an estimated 30 percent of all drugs that are in an advanced stage of develop... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1297940 Wed, 12 Mar 2008 11:55:19 +0100 1297940 http://www.medworm.com/index.php?rid=1287937&cid=t_121579_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F247703118%2F Big drugmakers are ponying up over the AWP, or average wholesale price scandal, according to a statement by attorneys who filed the case. For those unfamiliar, the stated AWP is used to set the price paid by consumers making Medicare Part B co-payments, as well as Medicare, insurers and other third-party payors that shell out for a drug. The lawsuit charged that consumers and third-party payors paid more than they should have because the drugmakers used false AWP reporting. The issue has embroiled the entire industry. The latest settlement involves Abbott Labs, Amgen, Sanofi-Aventis, Baxter Healthcare, Bayer, Dey, Fujisawa, Pfizer’s Pharmacia unit, Watson Pharmaceuticals, Gensia Sicor Pharmaceuticals and ZLB Behring. And the drugs covered in the settlement include Aranesp, Epogen, Ne... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1287937 Sat, 08 Mar 2008 01:56:34 +0100 1287937 http://www.medworm.com/index.php?rid=1287938&cid=t_121579_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F247683441%2F Amgen expanded the Black Box warnings about the risks of death and tumor growth with its blockbuster anemia drugs, Aranesp and Epogen. The warnings come less than a week before an FDA advisory committee meets to discuss the risks associated with these meds, a group known as ESAa and which also includes Johnson & Johnson’s Procrit. Specifically, the warning says the drugs, which are used to treat anemia in patients with kidney failure and on chemotherapy, increased death and accelerated tumor growth in patients with early stage breast cancer and cervical cancer. Earlier labeling warned of similar risks in other types of cancer. The label notes the problems occurred when docs treated patients with elevated levels of the drugs, according to Amgen’s statement. (more…) (... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1287938 Sat, 08 Mar 2008 01:11:22 +0100 1287938 http://www.medworm.com/index.php?rid=1286451&cid=t_121579_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F247377723%2F An FDA advisory committee will meet next Thursday to review the latest evidence of risk for cancer patients who are treated with widely used anemia meds - Amgen’s Aranesp and Epogen, Johnson & Johnson’s Procrit. The same panel met last May, but since then, new data was given the FDA from several studies showing increased risks of death or faster tumor growth. (Look here). So Wall Street is betting that the drugs, known as ESAs, may face added restrictions. One possibility - the FDA may advise docs not to prescribe the meds for patients with breast cancer, or any cancer, according to Bloomberg News. The drugs were already restricted last year, after being tied to higher risks of heart attack, stroke and death at high doses. The FDA then told docs to use the lowest possible ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1286451 Fri, 07 Mar 2008 13:25:54 +0100 1286451 http://www.medworm.com/index.php?rid=1258587&cid=t_121579_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F241717668%2F Treating anemia with ESAs, otherwise known as erythropoiesis-stimulating agents, is associated with an increased risk of venous thromboembolism (blood clots in the deep veins of the legs or in the lungs) and death among patients with cancer, according to an article in the lateset issue of the Journal of the American Medical Association. Amgen’s Epogen and Aranesp, and Johnson & Johnson’s Procrit are widely used to treat anemia in patients with cancer. Some studies have indicated that there may be a higher risk of venous thromboembolism (VTE) with these medications, but it has not been known if there is an associated increased risk of death, according to the article. The study examined the rate of blood clots and death associated with ESA administration for treatment of an... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1258587 Tue, 26 Feb 2008 21:27:05 +0100 1258587 http://www.medworm.com/index.php?rid=1128857&cid=t_121579_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F210651068%2F The agency says it’s received new data from two studies that provide further evidence of the risks of anemia drugs, which are also known as erythropoiesis-stimulating agents, or ESAs. The studies show that patients with breast or advanced cervical cancers who received ESAs to treat anemia caused by chemotherapy died sooner or had more rapid tumor growth than similar patients who didn’t receive the anemia drug, the FDA says. These two studies were not among the six studies that were described in revised labeling last November, which strengthened warnings about ESAs in cancer patients. Taken together, all eight studies show more rapid tumor growth or shortened survival when patients with breast, non-small cell lung, head and neck, lymphoid or cervical cancers received ESAs compared t... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1128857 Thu, 03 Jan 2008 18:03:04 +0100 1128857 http://www.medworm.com/index.php?rid=1072405&cid=t_121579_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F195737938%2Fdrug_warnings_and_withdrawls_f_1.html FiercePharma has compiled a list of the top 10 drugs to have who have had approval either withdrawn or been forced to add stronger warning labels, by the FDA, with respect to their pharmaceutical products.  The list is based on 2006 worldwide sales so ranking does not necessarily include the big new makers.1. Antidepressants - Various companies - "Black" box warning regarding increased risk of suicidal thoughts.2. Epogen/Aranesp - Amgen - "Black" box warning of heart and vascular risk at higher doses3. Zyprexa - Lilly - Warning of weight gain and metabolic problems4. Avandia - Glaxo - "Black" box warning of heart failure and heart attack5. Actos - Takeda - "Black" box warning of heart failure6. Provigil - Cephalon - Waning of Stevens-J... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=1072405 Wed, 05 Dec 2007 20:00:41 +0100 1072405 http://www.medworm.com/index.php?rid=1068797&cid=t_121579_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F194961311%2F In case you missed it, this has been quite a year for high-profile safety news. And so FiercePharma has compiled a list for the cocktail set, who want to keep track of such things. These are the 10 biggest drugs that were withdrawn or were issued new warnings by the FDA this year. The drugs are ranked by 2006 worldwide sales, which explains why such headline grabbers as Bayer’s Trasylol doesn’t appear - sales were already tanking on bad news. 1. Antidepressants - Various companies 2. Epogen/Aranesp - Amgen 3. Zyprexa - Lilly 4. Avandia - Glaxo 5. Actos - Takeda 6. Provigil - Cephalon 7. Zelnorm - Novartis 8. Byetta - Amylin 9. Xolair - Genentech 10. Fentora - Cephalon Source: FiercePharma Share / E-mail (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1068797 Tue, 04 Dec 2007 14:15:23 +0100 1068797 http://www.medworm.com/index.php?rid=1033101&cid=t_121579_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F186001564%2F Sally Katzen, a former deputy director at the White House budget office during the Clinton administration, has been retained to help the embattled biotech lobby the federal government on Medicare coverage and reimbursement, according to a disclosure posted online Tuesday by the Senate’s public records office, the Associated Press reports. The move comes as Amgen is in the thick of a fight to convince the Centers for Medicare & Medicaid to reverse a new coverage decision, or NCD, that reduces reimbursement for its biggest meds - the Aranesp and Epogen anemia fighters. The biotech, which claims the new guidelines could hurt cancer patients, has had some success with its lobbying. Members of both the House and Senate have sent letters to Medicare and introduced bills to roll back t... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1033101 Fri, 16 Nov 2007 22:33:18 +0100 1033101 http://www.medworm.com/index.php?rid=1017855&cid=t_121579_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F182441235%2F Now you see it. Now you don’t. Until Friday, the biotech was funding a site called ProtectCancerPatients.org, which was devoted to overturning a recent Medicare decision to reduce reimbursement for Amgen’s big sellers, Aranesp and Epogen. Earlier this week, the company, which is actively lobbying Congress to force a reversal, formally petitioned the Centers For Medicare & Medicaid to change its bureaucratic mind. “This website is the online headquarters of a national campaign to protect cancer patients on Medicare from a decision denying them needed medicines,” the site reads. “Our goal is to convince the Administration to reverse a recent decision which would effectively deny senior citizen cancer patients’ coverage and access to drugs prescribed b... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1017855 Sat, 10 Nov 2007 00:12:15 +0100 1017855 http://www.medworm.com/index.php?rid=1014988&cid=t_121579_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F181758597%2Fepogen_procrit_and_aranesp_get_fda_labeling_changes.html "The U.S. Food and Drug Administration today approved revised boxed warnings and other safety-related product labeling changes for erythropoiesis-stimulating agents (ESAs), which treat certain types of anemia. These new statements address the risks that the drugs Aranesp, Epogen and Procrit pose to patients with cancer and patients with chronic kidney failure."For patients with cancer the box warning now includes that ESAs caused tumor growth and shortened survival time in patients with advance breast, head and neck, lumphoid and non-small cell lung cancer.For patients with chronic kidney failure the new box warning states the ESAs should be used to maintain a hemoglobin level between 10 g/dl to 12 g/dl. Higher levels increase the risk for death and serious cardiovascular occurre... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=1014988 Thu, 08 Nov 2007 18:00:10 +0100 1014988 http://www.medworm.com/index.php?rid=1015066&cid=t_121579_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F181677360%2F The biotech made several changes to the warning labels on its EPO drugs, Aranesp and Epogen, and six new clinical trials are being proposed to assess their safety in treating chemotherapy-induced anemia in specific types of tumors. The revised labels say therapy should end following the completion of chemotherapy, and patient dosing should be adjusted to achieve and maintain the lowest hemoglobin level possible to avoid a blood transfusion. The warnings also state that the hemoglobin level should not exceed the upper safety limit of 12 grams per deciliter of blood. The changes to the boxed warnings include additional language in the indications and usage section, addition of an oncology study to the warnings section, and clarification of the hemoglobin range for chronic renal failure patie... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1015066 Thu, 08 Nov 2007 15:13:10 +0100 1015066 http://www.medworm.com/index.php?rid=972852&cid=t_121579_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F173879248%2F A rare bit of good news for the beleaguered biotech, which is laying off employees, grappling with lower Medicare reimbursement and responding to government probes. A federal jury in Boston decided that a key patent on its best-selling Arnaesp and Epogen anemia meds is valid, which means Roche may be prevented from selling its own version. Called Mircera, Roche’s drug is due to receive FDA approval next month. Earlier this month, William Burns, who heads Roche’s pharma business, told analysts on a conference call that the Swiss drugmaker wouldn’t attempt to launch Mircera in the US if Amgen were to win the trial, Reuters reminds us. UPDATE: However, a Roche spokeswoman says the drugmakers is “evaluating…legal options, including the possibility of an appeal.&#8... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=972852 Tue, 23 Oct 2007 16:03:05 +0100 972852 http://www.medworm.com/index.php?rid=964756&cid=t_121579_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F172109131%2F The big insurer is taking a cue from Medicare and tightening reimbursement on Amgen’s Aranesp and Epogen, as well as Johnson & Johnson’s Procrit meds, according to The Los Angeles Times. The move comes just three months after Medicare greatly lowered the maximum dose for which it would provide reimbursement for the drugs. The restrictions follow studies that raised concerns the meds may be harmful to some patients and controversy over higher dosages administered by some docs. And other insurers are expected to follow suit. “Aetna is likely to be the first of many insurers to change their guidelines,” Bear, Stearns biotech analyst Mark Schoenebaum tells the paper. Aetna’s new policy is less restrictive than Medicare’s but severe nonetheless, the Ti... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=964756 Fri, 19 Oct 2007 14:56:40 +0100 964756 http://www.medworm.com/index.php?rid=925507&cid=t_121579_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F164743800%2F Less than a month, after the US Senate passed a resolution requesting the Centers for Medicare and Medicaid Services reconsider its decision to place tougher reimbursement restrictions on anemia drugs used by chemo patients, two congressional reps have introduced a bill to overturn the CMS move, The Hill reports. Anna Eshoo, a California Democrat, and Mike Rogers, a Michigan Republican, introduced legislation that maintains the CMS revised payment policy puts patients at risk by restricting Medicare coverage of EPO drugs - Amgen’s Aranesp and Epogen, and Johnson & Johnson’s Procrit. Medicare proposed the new guidelines after the FDA added warnings to the drug labels in March over concerns that usage at high levels can increase risk of blood clots, heart attack and death. A... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=925507 Wed, 03 Oct 2007 15:13:30 +0100 925507 http://www.medworm.com/index.php?rid=908785&cid=t_121579_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F162085546%2F The crisis continues for Amgen ceo Kevin Sharer. Now, the European Medicines Agency, or EMEA, is proposing special warnings and reduced dosing recommendations for Amgen’s top-selling Aranesp and Epogen, as well as Johnson & Johnson’s Procrit (or Eprex). New prescribing info may say studies show more deaths associated with increased dosing of anemia meds and that the drugs haven’t been shown to improve overall survival in cancer patients with anemia. An EMEA panel recommends that anemia drugs be given to boost hemoglobin levels to 10 to 12 grams per deciliter of blood, according to an Amgen statement. Previously guidance ranged from 11 to 14 grams, in kidney failure patients; the ceiling was 13 for cancer patients. Earlier this month, an FDA panel voted to keep the m... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=908785 Thu, 27 Sep 2007 17:40:39 +0100 908785 http://www.medworm.com/index.php?rid=903796&cid=t_121579_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F161074404%2F The biotech, which last month announced plans to slash between 2,200 and 2,600 positions, is now saying 2,200 employees will, in fact, lose their jobs and that includes about 675 layoffs at its headquarters in Thousand Oaks, Ca., The Ventura County Star reports. The cuts follow an extraordinary number of setbacks - the FDA issued strict warnings on Aranesp and Epogen. Congress is investigating the marketing and safety of the drugs. The Securities and Exchange Commission is probing a failure to tell Wall Street that a key clinical trial ended over safety concerns, which only became known after an industry newsletter published the details. Worst of all, Medicare reduced reimbursement for the drugs. Oh yes, Amgen is postponing a $1 billion plant in Ireland. Until last month, though, ceo Kevin... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=903796 Tue, 25 Sep 2007 13:27:54 +0100 903796 http://www.medworm.com/index.php?rid=883875&cid=t_121579_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F158526828%2F Raise the hemoglobin levels, if you’re a physician? Introduce legislation to influence Medicare reimbursement, if you’re a lawmaker? Hike EPO prices, if you run a dialysis center? Depends who gets one of these handy timekeepers, of course. Whatever one’s role in life, these clocks will help you keep on the straight and narrow. We note, though, that Procrit clock has an added feature - it has an alarm, which is much more useful for preparing for contingencies. Perhaps Amgen’s ceo, Kevin Sharer, should have included an alarm on his own Epogen model. Then he could set it for December and declare that his unfortunate crisis is over - just in time to ensure his annual bonus remains intact. Share / E-mail (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=883875 Wed, 19 Sep 2007 12:41:42 +0100 883875 http://www.medworm.com/index.php?rid=864404&cid=t_121579_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F155216400%2F This is a big win for Amgen and Johnson & Johnson. The FDA advisory committee voted 14 to 5 in deciding that anemia meds don’t need changes in recommended doses to protect kidney patients. The panel determined that the drugs should continue to be given to boost hemoglobin to 12 grams a deciliter of blood for kidney patients on dialysis and for those who don’t receive the treatment, Bloomberg News reports. The panel decided against lowering the recommended dose to 11 grams, which would likely have depressed drug sales. Studies have shown the drugs raised the risk of heart attack, stroke and death at high doses, and other evidence suggested a greater need for transfusions and risk of death at low doses, Bloomberg writes. The drugs, marketed as Amgen’s Epogen and Arane... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=864404 Tue, 11 Sep 2007 21:30:11 +0100 864404 http://www.medworm.com/index.php?rid=858562&cid=t_121579_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F154674545%2F The Amgen ceo sought to reassure investors at the Bear Stearns Healthcare Conference today the biotech can overcome a laundry list of problems with Medicare and the FDA concerning its anemia drugs, which may be widely restricted. “We’re a company that obviously has more than our share of challenges right now,” Kevin Sharer told the Wall Street crowd, the Associated Press reports. “We have a new reality in the business and its not a completely predictable dynamic.” And he added Amgen plans to continue disputing the Medicare decision to restrict reimbursement on the Aranesp and Epogen drugs, which are used to treat chemo patients with anemia or kidney failure. An FDA panel meets tomorrow to discuss safety issues. But defiant as ever, Sharer said Amgen “can... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=858562 Mon, 10 Sep 2007 17:22:04 +0100 858562 http://www.medworm.com/index.php?rid=844131&cid=t_121579_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F152562006%2F The biotech’s investors were quite pleased this morning after the US Senate passed a resolution requesting the Centers for Medicare and Medicaid Services reconsider its decision to place tougher reimbursement restrictions on anemia drugs used by chemo patients - Amgen’s Epogen and Aranesp, as well as Johnson & Johnson’s Procrit, the Associated Press reports. Medicare proposed the new guidelines after the FDA added warnings to the drug labels in March over concerns that usage at high levels - more than 10 grams per deciliter - can increase risk of blood clots, heart attack and death. An FDA panel in May also called for restrictions. Cancer docs, however, have argued that higher levels are necessary to stabilize many patients and the current FDA labeling cites a higher... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=844131 Wed, 05 Sep 2007 15:49:00 +0100 844131 http://www.medworm.com/index.php?rid=811315&cid=t_121579_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F146313850%2F The biotech was doing damage control today, trying to reassure investors that commercial insurers aren’t likely to cut coverage for its Aranesp and Epogen anemia meds in the same way that Medicare did so for elderly and disabled cancer patients. Speaking on a conference call hosted by Deutsche Bank, Amgen execs maintained private insurers, who account for about 60 percent of Amgen’s anemia business, have been reluctant to cut coverage for cancer-related treatments, Reuters reports. In other words, Amgen execs - who last week announced a 14 percent job cut, facilities closings and reduced earnings this year - are trying to say that the worst may be over. Then again…European Commission regulators are considering a label change for the drugs, much as the FDA did last March, ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=811315 Tue, 21 Aug 2007 00:47:16 +0100 811315 http://www.medworm.com/index.php?rid=781334&cid=t_121579_87_f&fid=34865&url=http%3A%2F%2Fwww.thecancerblog.com%2F2007%2F08%2F06%2Famgen-challenges-new-medicare-policy-for-anemia-drugs-for-cancer%2F Filed under: Politics, Daily newsLast Monday, the Centers for Medicare and Medicaid Services relaxed some of the limits that it had proposed in May for the use of anemia drugs in cancer patients, in the face of an outcry from cancer patients and their physicians.However, CMS said it is still going to deny payment for drugs like Aranesp and Epogen from Amgen and Procrit from Johnson & Johnson if a patient's hemoglobin level is greater than 10 grams per deciliter. Physicians generally aim for a hemoglobin level of 10 to 12 g/deciliter in their cancer patients. Normal range is 12 to 18 g/deciliter.Amgen is challenging this new limit, saying that such a limit will increase the need for blood transfusions. The company also noted such limits contradict the FDA's approved labeling for the dru... The Cancer Blog blogs http://www.medworm.com/rss/comments.php?id=781334 Mon, 06 Aug 2007 04:00:00 +0100 781334 http://www.medworm.com/index.php?rid=769223&cid=t_121579_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F139191427%2F In a move that is good news for Amgen and Johnson & Johnson, Medicare late yesterday decided to ease some of its proposed restrictions on the use of the popular anemia meds sold by the two drugmakers. The agency was eyeing tightened usage over concerns the anemia drugs - Amgen’s Aranesp and Epogen, and J&J’s Procrit - may worsen cancer in some patients. Even so, usage is still expected to be curtailed. Last May, the Center for Medicare & Medicaid Services proposed limiting coverage, which worried Wall Street. But the agency then received more than 2,600 comments, many from doctors and patient groups who argued the proposal was draconian, lacked scientific evidence and could harm patients. “CMS blinked,” Geoff Porges, an analyst with Sanford Bernstein,... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=769223 Tue, 31 Jul 2007 11:03:09 +0100 769223 http://www.medworm.com/index.php?rid=767706&cid=t_121579_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F139022484%2F A busy day, thanks primarily to Avandia, of course. Who says the summer is a slow time? There’s always a lot of pharma, as our name implies. With that in mind, here are a few items to tide you over until the morning approaches… Patients taking Takeda’s Actos diabetes drug were less likely to suffer a heart attack or need their arteries cleared than those taking Glaxo’s Avandia, a new study finds. The study was discussed at today’s FDA advisory panel meeting to review Avandia. You can read more at Bloomberg News. The difficulties in generating, and relying on, a meta-analysis are discussed in a piece by BusinessWeek. The issuey illustrates the hard choices researchers must make when analyzing batches of studies. “The biggest issue is how to go about selec... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=767706 Tue, 31 Jul 2007 00:41:47 +0100 767706 http://www.medworm.com/index.php?rid=744964&cid=t_121579_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F135309109%2F Two FDA advisory committees - Cardiovascular and Renal Drugs and Drug Safety and Risk Management - will hold a joint meeting on Sept. 11 to review the risks and benefits of those controversial EPO drugs. These include Amgen’s Aranesp and Epogen, and Johnson & Johnson’s Procrit, which are used for anemia in chronic renal failure. Two months ago, an FDA panel recommended tougher warnings, more safety studies and caution on usage. That followed a March public health advisory, which included the addition of Black Box warnings about the risk of serious side effects with aggressive dosing by docs who, in some cases, reportedly receive inducements by the manufacturers. Share / E-mail (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=744964 Thu, 19 Jul 2007 15:07:04 +0100 744964 http://www.medworm.com/index.php?rid=736399&cid=t_121579_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F134159500%2F More bad news for Amgen. Blue Shield of California, the nonprofit insurer with 3.3 million members, is limiting payments for anemia meds, which at high doses are linked to heart attacks and stroke. Docs are now required to wait until a patient’s anemia is just short of requiring a transfusion before using Amgen’s Aranesp and Epogen, or Johnson & Johnson’s Procrit. But the new policy, which Bloomberg News reports was posted online on July 2, also says Procrit was the group’s preferred med. The decision is the first of several attempts by health plans to lower expenditures for the drugs. In May, CMS, which paid $2 billion last year for Epogen alone, proposed similar limits that may begin next month. And Bloomberg notes that analysts say FDA safety warnings on t... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=736399 Mon, 16 Jul 2007 10:31:56 +0100 736399