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 'fda'. Sat, 03 Sep 2011 01:48:21 +0100 http://www.medworm.com/index.php?rid=5181742&cid=t_96265_87_f&fid=36224&url=http%3A%2F%2Ffeeds.wsjonline.com%2F%7Er%2Fwsj%2Fhealth%2Ffeed%2F%7E3%2FWtTkmF-1j1A%2F Cancer Among 9/11 Responders: Research published in the Lancet finds that firefighters who worked at Ground Zero after the 9/11 attacks were 19% more likely to later develop cancer than firefighters who didn’t work at the site, the WSJ reports. Still, experts and study authors said the study isn’t definitive and that it will take many years for data on cancer incidence to accumulate. In addition, the number of cases wasn’t large enough to draw conclusions about the rates of specific cancers, the paper says. Pulling “Firepot” Fuel: Reports of burns have led to the recall of gel fuel used in outdoor “firepot” decorations by nine companies, the Associated Press reports. The head of the Consumer Product Safety Commission says consumers should stop using the f... WSJ.com: Health Blog blogs http://www.medworm.com/rss/comments.php?id=5181742 Fri, 02 Sep 2011 12:25:31 +0100 5181742 http://www.medworm.com/index.php?rid=5182316&cid=t_96265_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Ff5uWuvV6ctE%2F Once again, a web page is deemed problematic by the FDA. In a letter sent by the agency earlier this week, Pfizer was chastised because its Lipitor web page made misleading representations and suggestions about several other drugs. The issue came to light, by the way, thanks to the FDA ‘Bad Ad’ program, which encourages people to file complaints about troublesome promotions (see this). What exactly did the FDA find objectionable. In its letter, the Division of Drug Marketing, Advertising, and Communications noted that the Lipitor webpage contained a link that led to a webpage about Lipitor which contained a “Click to Continue” link. This took the visitors to individual product websites for Caduet and Chantix, and to the prescribing information for Norvasc. However, Pfizer ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=5182316 Fri, 02 Sep 2011 12:21:40 +0100 5182316 http://www.medworm.com/index.php?rid=5182318&cid=t_96265_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FsjdNNNUnuXs%2F And so, another working week will soon draw to a close. To celebrate, we are rolling in the sidewalks very early to get a jump on the long holiday weekend. Our plans, though, are modest. We hope to take in some tennis with one of the short people and, otherwise, catch up on some reading. But what about you? Those of you affected by the storm, no doubt, can use a spot of rest. Elsewhere, this may be an opportunity to enjoy a day outside, spend time with someone special or simply count your blessings. Whatever you do, be safe and have fun. See you soon… FDA May Get Two More Months To Review Drugs (Reuters) Pfizer To Move Research Units To Leased MIT Space (Boston Globe) Lilly May Partner With Turkish Generic Drugmaker (Reuters) EU OKs Approval For Expanded Use Of Roche’s Tarceva ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=5182318 Fri, 02 Sep 2011 11:31:57 +0100 5182318 http://www.medworm.com/index.php?rid=5182312&cid=t_96265_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2011%2F09%2Fpharma-walks-devices-balk-when-it-comes.html (Source: Pharma Marketing Blog) Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=5182312 Thu, 01 Sep 2011 19:24:00 +0100 5182312 http://www.medworm.com/index.php?rid=5182320&cid=t_96265_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FscEadyD2R4s%2F As technology makes the world smaller, monitoring clinical trials no longer requires traveling to a destination to check up on the investigators. Much of this work can be done remotely and the FDA, in fact, wants to encourage sponsors to undertake more of what the agency calls risk-based monitoring in order to match international standards articulated by the International Conference on Harmonisation. And so the agency has just issued new guidance for drugmakers and contract research organizations, or CROs, to help sort out the variables that would determine when centralized monitoring would be preferable over on-site monitoring. The primary focus, the FDA notes, should be on steps that protect human subjects, while maintaining data integrity and compliance with regulations. Despite advance... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=5182320 Thu, 01 Sep 2011 14:50:37 +0100 5182320 http://www.medworm.com/index.php?rid=5181745&cid=t_96265_87_f&fid=36224&url=http%3A%2F%2Ffeeds.wsjonline.com%2F%7Er%2Fwsj%2Fhealth%2Ffeed%2F%7E3%2FyTvDE7iBcpA%2F Tracking Implants: An FDA official said silicone breast implants made by Johnson & Johnson’s Mentor and Allergan will stay on the market, and that the agency will work with the companies to increase participation in post-approval studies, Dow Jones Newswires reports. Companies have struggled to maintain follow-up on the 80,000-plus women originally included in those studies, originally planned to last a decade, with Allergan tracking about 60.5% of them for two years and Mentor following 21% for three years. If more women aren’t tracked, the studies won’t be able to detect possible long-term health issues. Evaluating CPR: Research published in the New England Journal of Medicine suggests that performing CPR for a longer period prior to gauging a patient’s heart rhythms ... WSJ.com: Health Blog blogs http://www.medworm.com/rss/comments.php?id=5181745 Thu, 01 Sep 2011 12:56:23 +0100 5181745 http://www.medworm.com/index.php?rid=5182323&cid=t_96265_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FvMmVEzuXRy0%2F Top of the morning to you. And yet another shiny day is unfolding over the Pharmalot corporate campus, where the short people and the official mascots appear to be snoozing indefinitely. This rare treat gives us more time this morning to brew those mandatory cups of stimulation and poke around for interesting items. So here they are. Meanwhile, we will get back to conducting our own version of R&D. So keep us in mind if you hear something interesting. Have a great day… Sanofi Strikes Deal To Make Generic Lipitor (Reuters) FDA And Drugmakers Agree On 6 Percent PDUFA Fee Hike (Wall Street Journal) XOMA CEO Resigns (Reuters) Baxter Sues Teva To Enforce Propofol Liability (Bloomberg News) Death Rate Rises In Clinical Trials In India (The Tribune) Contract Pharmaceuticals To Lay Off ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=5182323 Thu, 01 Sep 2011 12:08:48 +0100 5182323 http://www.medworm.com/index.php?rid=5181748&cid=t_96265_87_f&fid=36224&url=http%3A%2F%2Ffeeds.wsjonline.com%2F%7Er%2Fwsj%2Fhealth%2Ffeed%2F%7E3%2Fq0z63xpaB8o%2F Linking Financial and Physical Health: New research published by the National Bureau of Economic Research suggests higher foreclosure rates are associated with increased ER visits and hospitalizations for hypertension, diabetes and anxiety among 20- to 49-year-olds in several states, the WSJ reports. It’s unclear whether foreclosure itself is responsible for an increase in stress-related health problems or whether the underlying problem is financial duress or something else, the paper says. Tracking Implants: An FDA advisory panel continues to meet today to figure out how better to conduct safety studies of silicone breast implants, WebMD reports. Companies making the implants had planned to follow 82,000 women with the implants for a decade, but Johnson & Johnson’s Mentor has lo... WSJ.com: Health Blog blogs http://www.medworm.com/rss/comments.php?id=5181748 Wed, 31 Aug 2011 12:58:09 +0100 5181748 http://www.medworm.com/index.php?rid=5182033&cid=t_96265_117_f&fid=37824&url=http%3A%2F%2Fwww.doctorkalitenko.com%2Fblog%2Fdrug-approvals-halt%2F What does it mean when the FDA only approves 21 drugs in one year? Does it mean that the drugs being put before them are so terrible that they refuse to approve them? Maybe it means that they are so riddled with side effects that the FDA can’t possibly say yes. No!     It means that they have hit a wall. Resources have been tapped and there’s nothing new and world-altering that the market really needs. Aside from looking for cures, the drug needs have been exhausted. So, what’s next? Because the truth is that though medication may be exhausted, we are still suffering from the same problems. And if the pharmaceutical companies aren’t going to start moving to finding miracle cures, there has to be another way to make us feel better. The answer is functional medicine. What ... Doctor Kalitenko antiaging blog blogs http://www.medworm.com/rss/comments.php?id=5182033 Tue, 30 Aug 2011 16:46:32 +0100 5182033 http://www.medworm.com/index.php?rid=5182315&cid=t_96265_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2011%2F08%2Fshould-us-government-step-in-to-ease.html (Source: Pharma Marketing Blog) Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=5182315 Tue, 30 Aug 2011 12:20:00 +0100 5182315 http://www.medworm.com/index.php?rid=5174611&cid=t_96265_87_f&fid=39187&url=http%3A%2F%2Fgetbetterhealth.com%2Fcancer-drug-demonstrates-no-survival-benefit-receives-fda-approval%2F2011.08.29 Recently, the FDA announced its approval, upon accelerated review, of a new drug, Adcetris (brentuximab) for patients with Hodgkin’s lymphoma that has relapsed after bone marrow transplant and for some patients with T-cell anaplastic large cell lymphoma (ALCL). This interests me for a lot of reasons, among them that I used to work in the field of lymphoma immunology and spent some time in my life studying molecules like CD30, the protein to which the new antibody binds. First, a mini-primer on the disease and numbers of patients involved: (more…) *This blog post was originally published at Medical Lessons* (Source: Better Health) Better Health blogs http://www.medworm.com/rss/comments.php?id=5174611 Mon, 29 Aug 2011 21:00:19 +0100 5174611 http://www.medworm.com/index.php?rid=5174589&cid=t_96265_87_f&fid=36224&url=http%3A%2F%2Ffeeds.wsjonline.com%2F%7Er%2Fwsj%2Fhealth%2Ffeed%2F%7E3%2F2BbP583QpPw%2F Superior to the Standard: Data from an 18,201-person study show that apixaban, a blood thinner being developed by Bristol-Myers Squibb and Pfizer, reduced the risk of stroke in atrial fibrillation patients by 21% and the risk of death by 11% compared to the standard treatment, warfarin, the WSJ reports. Apixaban also cut the risk of bleeding by 31% compared to warfarin. The drug will be submitted to the FDA for approval this year, the paper says. Bird Flu, Again: The United Nations is warning that a strain of avian flu against which current vaccines may not protect is spreading among birds in China and Vietnam, the Associated Press reports. Meantime, the avian flu virus, officially called H5N1, is now showing up in wild birds in areas that haven’t seen it for many years, thanks to mig... WSJ.com: Health Blog blogs http://www.medworm.com/rss/comments.php?id=5174589 Mon, 29 Aug 2011 12:42:13 +0100 5174589 http://www.medworm.com/index.php?rid=5174618&cid=t_96265_87_f&fid=39187&url=http%3A%2F%2Fgetbetterhealth.com%2Fplastic-surgeon-discusses-safety-and-effectiveness-of-new-anti-wrinkle-product%2F2011.08.28 The FDA has granted a license to the maker of laViv which is said to improve the appearance of smile lines without freezing the muscles of your face. Have you heard of this new drug? Does it work like it claims? Are there any side effects that are worrisome? Source: dailymail.co.uk/femail/article-2028456/New-biological-wrinkle-cure-touted-alternative-Botox-frozen-face.html Maybe. As we have discussed before, FDA approval is not a stamp of approval that a drug is effective. It just means that as far as current studies show, it is not harmful. Some drugs are FDA approved for years until later the FDA reconsiders and removes them from the market. Look at the relatively recent removal of Darvocet from the market after many years of FDA approval. LaViv is an interesting concept. (more…) ... Better Health blogs http://www.medworm.com/rss/comments.php?id=5174618 Sun, 28 Aug 2011 16:35:43 +0100 5174618 http://www.medworm.com/index.php?rid=5169520&cid=t_96265_87_f&fid=36224&url=http%3A%2F%2Ffeeds.wsjonline.com%2F%7Er%2Fwsj%2Fhealth%2Ffeed%2F%7E3%2F2YxfexmzmAo%2F Poison Protection?: Pharmacy-services provider PharMerica said it adopted a poison-pill provision to prevent unwanted takeover bids, Dow Jones Newswires reports. Earlier this week the company rejected a $15-per-share bid from Omnicare, saying it undervalued PharMerica and that regulatory risk was too high. Omnicare said it was still willing to talk with PharMerica about how to “allocate” risk that a deal would run into antitrust hurdles. Cracking Down on Papayas: The FDA has restricted papaya imports from Mexico after inspections showed more than 15%, from a host of different producers, were tainted, Reuters reports. Producers can have the fruit tested by independent labs to show they’re salmonella-free. After five consecutive clean shipments, producers may be exempted from ... WSJ.com: Health Blog blogs http://www.medworm.com/rss/comments.php?id=5169520 Fri, 26 Aug 2011 13:41:02 +0100 5169520 http://www.medworm.com/index.php?rid=5159836&cid=t_96265_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FAhQvJIfu6qE%2F Concerns about conflicts of interests are all the rage these days. The FDA is debating whether to loosen rules over complaints that an insufficient number of experts are available for its advisory committees. And the National Institutes of Health just issued new rules covering academics who receive federal funding for their research and also have ties to industry (see here and here). As it turns out, the US Department of Health & Human Services, which oversees both agencies, has its own problems with conflicts. A new report by the HHS Office of Inspector General found most conflict-of-interest waivers issued two years ago were not documented as recommended in federal ethics regulations and only a minority of waivers were signed and dated by HHS employees receiving them. These waivers... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=5159836 Thu, 25 Aug 2011 15:12:11 +0100 5159836 http://www.medworm.com/index.php?rid=5140304&cid=t_96265_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2011%2F08%2Fvast-majority-of-drug-ads-in-leading.html (Source: Pharma Marketing Blog) Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=5140304 Fri, 19 Aug 2011 10:57:00 +0100 5140304 http://www.medworm.com/index.php?rid=5139676&cid=t_96265_87_f&fid=36224&url=http%3A%2F%2Ffeeds.wsjonline.com%2F%7Er%2Fwsj%2Fhealth%2Ffeed%2F%7E3%2FAME30H7R28I%2F Melanoma Treatment Option: The FDA approved vemurafenib, a treatment from Roche Holding and Daiichi Sankyo aimed at the half of metastatic melanoma patients whose cancer is driven by a specific genetic mutation, the WSJ reports. The treatment, to be sold under the brand name Zelboraf, will be taken for about six months and will cost about $56,400, according to Roche. Back Too Soon: Research published in the American Journal of Obstetrics & Gynecology suggests most physicians are screening women for cervical cancer too frequently, Reuters reports. CDC researchers found that physicians are bringing back women with negative Pap smears and HPV tests are to be re-screened annually, though guidelines from the American Cancer Society and other groups recommend a three-year-wait in between nor... WSJ.com: Health Blog blogs http://www.medworm.com/rss/comments.php?id=5139676 Thu, 18 Aug 2011 12:45:55 +0100 5139676 http://www.medworm.com/index.php?rid=5139678&cid=t_96265_87_f&fid=36224&url=http%3A%2F%2Ffeeds.wsjonline.com%2F%7Er%2Fwsj%2Fhealth%2Ffeed%2F%7E3%2FqCxSoSXzlrc%2F Warning Suit: Cigarette manufacturers filed suit in federal court in an attempt to prevent an FDA requirement for graphic cigarette package warnings from going into effect, the WSJ reports. Lorillard, Reynolds American’s R.J. Reynolds, Imperial Tobacco Group’s Commonwealth Brands and Vector Group’s Liggett claim the proposed changes violate their freedom of speech. Philip Morris’s parent company, Altria, meantime, has supported the law that mandated new labels, the New York Times reports. Screening Recommendation: The U.S. Preventive Services Task Force says there isn’t enough evidence to support regular screening for bladder cancer among healthy people with no symptoms of the disease, Reuters reports. There isn’t enough data to show whether the benefits... WSJ.com: Health Blog blogs http://www.medworm.com/rss/comments.php?id=5139678 Wed, 17 Aug 2011 12:54:41 +0100 5139678 http://www.medworm.com/index.php?rid=5140306&cid=t_96265_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2011%2F08%2Fif-fda-published-social-media.html (Source: Pharma Marketing Blog) Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=5140306 Tue, 16 Aug 2011 18:33:00 +0100 5140306 http://www.medworm.com/index.php?rid=5139680&cid=t_96265_87_f&fid=36224&url=http%3A%2F%2Ffeeds.wsjonline.com%2F%7Er%2Fwsj%2Fhealth%2Ffeed%2F%7E3%2FyiAwAf1m6jo%2F In 2009 the FDA recalled an over-the-counter weight-loss supplement called Pai You Guo because it contained two drugs — sibutramine, the active ingredient in the now-defunct Abbott drug Meridia, and phenolphthalein, an ingredient removed from over-the-counter laxatives after it was pegged as a potential carcinogen. Sibutramine can significantly raise blood pressure and pulse rate and might harm patients with a history of heart problems, the FDA said. Well, the banned supplement never went away, at least in one area of the country, according to a new study. The study, published online in the Journal of General Internal Medicine, looked specifically at the prevalence of Pai You Guo pill and tea use among Brazilian-born women in Massachusetts. Why them? Previous data suggest those women... WSJ.com: Health Blog blogs http://www.medworm.com/rss/comments.php?id=5139680 Tue, 16 Aug 2011 18:30:05 +0100 5139680 http://www.medworm.com/index.php?rid=5130744&cid=t_96265_87_f&fid=39187&url=http%3A%2F%2Fgetbetterhealth.com%2Ffda-approves-ges-newest-ct-scanner%2F2011.08.15 GE Healthcare has received the FDA OK for its Optima CT660 computed tomography (CT) system. The CT660, which is already available in Europe, Latin America and Asia, distinguishes itself by its compact footprint combined with a modular design and low dose imaging. In addition, it is also one of the most energy efficient CT scanners available and has an “environmental design” that eases refurbishment and end-of-life recycling. The scanner itself is scalable from 32 to 128 slices through purchasable options and features automatic table positioning and a color 12-inch integrated gantry display monitor. (more…) *This blog post was originally published at Medgadget* (Source: Better Health) Better Health blogs http://www.medworm.com/rss/comments.php?id=5130744 Mon, 15 Aug 2011 21:05:47 +0100 5130744 http://www.medworm.com/index.php?rid=5130723&cid=t_96265_87_f&fid=36224&url=http%3A%2F%2Ffeeds.wsjonline.com%2F%7Er%2Fwsj%2Fhealth%2Ffeed%2F%7E3%2FxxtIfBchEDw%2F Social media can be a minefield for pharma companies given the FDA’s requirements to keep product information fairly balanced and promote only approved uses of drugs. Until now, Facebook has helped drug companies control the information on their sponsored pages by disabling the comment  function. That’s supposed to end today. As the Washington Post reports, most pharma pages — except those for specific prescription products — will now allow reader input. (The change doesn’t seem to completely be in effect yet.) “What [Facebook says] is that their philosophy is about promoting dialogue, and this wasn’t doing that,” Monique Levy, vice president of research at Manhattan Research, a pharma and health-care market research firm, tells the Health B... WSJ.com: Health Blog blogs http://www.medworm.com/rss/comments.php?id=5130723 Mon, 15 Aug 2011 19:11:39 +0100 5130723 http://www.medworm.com/index.php?rid=5130724&cid=t_96265_87_f&fid=36224&url=http%3A%2F%2Ffeeds.wsjonline.com%2F%7Er%2Fwsj%2Fhealth%2Ffeed%2F%7E3%2FvhZooslpidM%2F Raising Questions: The debate over whether antibiotics should be used less frequently in livestock has been revived by the recent recall of ground turkey tainted by salmonella bacteria that is resistant to many of the drugs, the WSJ reports. Food-safety experts say that routine use of antibiotics in feed as a preventive can promote antibiotic-resistant bacteria and threaten human health, while industry groups counter that the practice reduces animal diseases, promotes growth and keeps meat prices low, the paper says. Crop Inspections: Mushrooms grown about 25 miles away from the Japanese nuclear plant damaged in the March earthquake and tsunami have been found to be contaminated by radiation, Bloomberg News reports. Rice is also a concern, with about half of the country’s crop grown ... WSJ.com: Health Blog blogs http://www.medworm.com/rss/comments.php?id=5130724 Mon, 15 Aug 2011 12:43:25 +0100 5130724 http://www.medworm.com/index.php?rid=5130752&cid=t_96265_87_f&fid=39187&url=http%3A%2F%2Fgetbetterhealth.com%2Fwhy-this-diabetic-isnt-concerned-about-her-insulin-pump-being-hacked%2F2011.08.14 Jay Radcliffe is a fellow type 1 diabetic, and I remember reading his diabetes blog way back in the day, when I first started blogging.  We read and commented on each other’s posts, and we were both part of the blogosphere when the DOC first started to grow.  I knew he was married, had children, and did the day-to-day diabetes stuff that I did. Which is why when I read the mainstream media’s take on his pump-hacking research (this article, Insulin Pumps Vulnerable to Hacking, for example), I reached out to him immediately.  “Can I just tell you that my mother sent me this article about your research?  Do you have time to talk?” Jay was out in Las Vegas this morning, attending the Black Hat security conference, but he and I had a chance to hash it out over the ph... Better Health blogs http://www.medworm.com/rss/comments.php?id=5130752 Sun, 14 Aug 2011 14:00:57 +0100 5130752 http://www.medworm.com/index.php?rid=5125923&cid=t_96265_136_f&fid=37846&url=http%3A%2F%2Fhealthinfoispower.wordpress.com%2F2011%2F08%2F12%2Ffda-approves-clinical-protocol-for-additional-phase-1-study-of-tkm-plk1-in-primary-liver-cancer-or-liver-metastases%2F The U.S. Food and Drug Administration approves the clinical protocol for an additional Phase 1 study of TKM-PLK1 in patients with either primary liver cancer or liver metastases associated with select cancers including ovarian. RNA Interference Nucleic acids are molecules that carry genetic information and include DNA (deoxyribonucleic acid) and RNA (ribonucleic acid). Together these [...] (Source: Libby's H*O*P*E*) Libby's H*O*P*E* blogs http://www.medworm.com/rss/comments.php?id=5125923 Fri, 12 Aug 2011 19:03:27 +0100 5125923 http://www.medworm.com/index.php?rid=5118994&cid=t_96265_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FX-4k_OX50Ks%2F Top of the morning to you. And what a morning it is. A lovely sun is shining overhead and a cool breeze is wafting through the Pharmalot corporate campus. This calls for a celebratory cup of stimulation. Nonetheless, meetings and deadlines loom. So let us all get started. A few interesting items can be found below. Meanwhile, if you hear of anything interesting, drop us a line. Have a great day, everyone… FDA OKs Gilead And J&J Once-Daily HIV Pill (Reuters) Pfizer Pays First Compensation To Nigerian Trovan Victims (BBC) Vioxx Lawyers Get More Fees After Filing Objections (Bloomberg News) Pfizer To Shed 130 Jobs And Close Former King Plant (TriCities) FDA Sets Review Deadline For Amylin Diabetes Drug (Reuters) FDA Questions Adventrx Trial Run By CRO In Argentina (Outsourcing Phar... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=5118994 Thu, 11 Aug 2011 11:53:50 +0100 5118994 http://www.medworm.com/index.php?rid=5118649&cid=t_96265_87_f&fid=39187&url=http%3A%2F%2Fgetbetterhealth.com%2Fantibiotic-resistant-glue-ear-and-a-potential-new-treatment%2F2011.08.10 Glue ear is the layman’s term for thick mucoid effusion of the middle ear, usually due to chronic ear infections. The fluid itself is like maple syrup and usually treated with ear tube placement followed by suctioning as much of the fluid out as possible. However, given there is always some residual present, antibiotic ear drops with steroids is often prescribed. Unfortunately, these patients are at higher risk of requiring repeated sets of tubes after the body spits them out. Why? (more…) *This blog post was originally published at Fauquier ENT Blog* (Source: Better Health) Better Health blogs http://www.medworm.com/rss/comments.php?id=5118649 Wed, 10 Aug 2011 12:00:00 +0100 5118649 http://www.medworm.com/index.php?rid=5107893&cid=t_96265_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FXpncqmok5No%2F Rise and shine. Another day is on the way. And it looks to be a sunny one here on the Pharmalot corporate campus, where we are brewing a delicious cup of mandatory stimulation. Our flavor today is Southern Pecan. Please join us. After all, there is much to do as meetings and deadlines beckon. You know the score, so time to dig in. Meanwhile, here are some tidbits. Have a great day and let us know if you hear of something interesting… FDA Approval Of Roche Melanoma Drug May Come Early (Reuters) Pfizer Sends Israeli Sniffing Dogs To Finland (The Jerusalem Post) Revlimid Side Effects Linked To Protein In Study (Reuters) Valeant Pharma Eyes Medicis For Another Acquisition (Pharma Times) Merck And J&J Sit On Piles Of Cash (The Star-Ledger of New Jersey) Lexicon Tumor Drug Shows Posit... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=5107893 Tue, 09 Aug 2011 12:06:27 +0100 5107893 http://www.medworm.com/index.php?rid=5107457&cid=t_96265_87_f&fid=34765&url=http%3A%2F%2Fhcrenewal.blogspot.com%2F2011%2F08%2Fretreat-back-to-regulatory-capture-us.html After some brave words about transparency, integrity and all that, US government officials seem to be running back to the arms of the health care corporate CEOs.Weakening FDA Conflict of Interest RulesAs reported by Reuters,U.S. lawmakers likely will change the criteria for advisers reviewing new medicines next year because of complaints that the rules meant to prevent conflicts of interest make it harder to find real experts.Congressional lawmakers may require the Food and Drug Administration to relax the rules that bar advisers from reviewing a drug if they have even indirect financial ties to related manufacturers, as part of an FDA funding bill.This was not purely an initiative of legislators, but was egged on by a top FDA administratorThe agency often must delay panel meetings while i... Health Care Renewal blogs http://www.medworm.com/rss/comments.php?id=5107457 Mon, 08 Aug 2011 17:13:00 +0100 5107457 http://www.medworm.com/index.php?rid=5103336&cid=t_96265_87_f&fid=39187&url=http%3A%2F%2Fgetbetterhealth.com%2Fhealth-care-attorney-discusses-the-use-of-disclaimers-on-facebook-pages%2F2011.08.06 This is the third part of a three part post addressing the legal concerns of social networking in the health care arena. In part one, legal expert David Harlow, Esq., Health Care Attorney and Consultant at The Harlow Group, LLC in Boston, answered questions regarding “The Legal Implications for Doctors, Nurses and Hospitals Engaging in Social Media?” In part two, Mr. Harlow answered questions related to the Pharma industry;  “Legal Concerns: What Steps can Pharma Take to Engage in Social Media?” The third part addresses a question from a follower on Facebook about the use of disclaimers. Q:  Barbara: A Healthin30 reader on Facebook writes:  “I’m looking for a good disclaimer to put on a couple of medical practices’ Facebook pages. The AMA social media guidelines aren’t h... Better Health blogs http://www.medworm.com/rss/comments.php?id=5103336 Sat, 06 Aug 2011 21:00:47 +0100 5103336 http://www.medworm.com/index.php?rid=5140251&cid=t_96265_147_f&fid=39273&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FePharmaSummit%2F%7E3%2FGWlmCgeYYoE%2Fpharma-companies-facing-challenge-with.html August 15 is the day all companies on Facebook are required to have open discussion forums on their Facebook pages.  Pharma companies view this as a problem because they will be required to have open commenting on their Facebook walls. BrandChannel.com recently looked back at the recent hacking that too place at Pfizer's Facebook page.  On July 19, Pfizer was recently surprised by the Script Kiddies, who were responsible for hacking into their fan page and posting a series of messages that commented negatively on the brand, then openly claimed responsibility for doing so.  Even though this took place, the author points out that Pfizer is one of the digital companies who is taking a hands-on approach to managing their digital presence.  They're... ePharma Summit blogs http://www.medworm.com/rss/comments.php?id=5140251 Fri, 05 Aug 2011 17:08:00 +0100 5140251 http://www.medworm.com/index.php?rid=5097083&cid=t_96265_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FNigM4gh7KXI%2F And so, another working week is about to come to an end. Not a moment too soon, yes? This is, of course, our signal to daydream about weekend plans. Our modest agenda includes golfing with our shortest of short people, catching up on some reading and taking at least one cozy nap. And you? How about a day at the beach? A night out with someone special? Or perhaps a shopping trip to stimulate what is left of the economy? Whatever you do, be safe and enjoy. Meanwhile, here is an assortment of tidbits. See you soon… Pharma Collaborations Are On The Rise (Nature Reviews Drug Discovery) Payers Will Want More Biosimilar Data Than FDA (Pharma Times) Cost Of Medicare Part D Drug Plan Is Dropping (The Los Angeles Times) Takeda And Amylin Pull The Plug On Obesity Drug (Bloomberg News) NICE Reje... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=5097083 Fri, 05 Aug 2011 12:08:49 +0100 5097083 http://www.medworm.com/index.php?rid=5096204&cid=t_96265_87_f&fid=39187&url=http%3A%2F%2Fgetbetterhealth.com%2Fthe-perspective-of-the-clinical-trial-that-you-need-to-know%2F2011.08.04 There are big companies like Quintiles that run clinical trials around the world. There are local clinics that specialize in clinical trials and make a lot of money at it. There are, of course, pharmaceutical companies and device manufacturers who depend upon the results to gain marketing approval for new products. People in all those groups know a lot about trials. But the perspective that counts is the view from you and me – patients. Most of us do not enroll in clinical trials. We don’t want to get too up close and personal with anything “experimental.” And often our doctors never tell us about available trials anyway since it can be a lot of paperwork for them. Given that most people don’t enroll in trials and new science is delayed because of it and also because most people ... Better Health blogs http://www.medworm.com/rss/comments.php?id=5096204 Thu, 04 Aug 2011 18:00:38 +0100 5096204 http://www.medworm.com/index.php?rid=5096574&cid=t_96265_113_f&fid=39278&url=http%3A%2F%2Fblogsite.mdbuyline.com%2F%3Fp%3D320 I came across a poll indicating that hospitals plan on increasing their technology spending by up to 37% over the next five years.  This is great news considering the 8% drop in 2009.  But, who is buying what? It’s an interesting discussion considering so much has happened in the last couple of years.   One of the advantages of my position at MD Buyline is that I can see in real time who is buying what and when.  I did some trending and found ultrasound (up 22%), cath labs (up 17%) endoscopy/laparoscopy (up 16%), and nuclear med (14%) technologies will see the most growth.  IT also appears to be growing (12% growth) but not as strong as it did in the last six months.  I also found it interesting that high-end technologies, such as MRI, will see growth (3 to 4%) but not like we hav... MD Buyline blogs http://www.medworm.com/rss/comments.php?id=5096574 Thu, 04 Aug 2011 15:32:22 +0100 5096574 http://www.medworm.com/index.php?rid=5097093&cid=t_96265_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FB_rma9edmls%2F Last week, FDA commish Margaret Hamburg told a congressional committee that the agency may loosen conflict of interest rules that were enacted in 2008, because finding qualified experts to serve on advisory committees has become increasingly difficult (back story here). Her remarks parroted a point made three months ago by Janet Woodcock, who heads the FDA’s Center for Drug Evaluation and Research, who has been pushing to relax the rules, which include barring participation for any individual who has potentially conflicting financial interests totaling more than $50,000 ( you can read more here). Last year, the agency tweaked its procedures for granting waivers (see this). The effort by FDA officials to roll back the rules, which were passed after an arduous campaign to promote greater ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=5097093 Thu, 04 Aug 2011 14:37:45 +0100 5097093 http://www.medworm.com/index.php?rid=5096152&cid=t_96265_87_f&fid=36224&url=http%3A%2F%2Ffeeds.wsjonline.com%2F%7Er%2Fwsj%2Fhealth%2Ffeed%2F%7E3%2FdRsNb5vcuh4%2F Some 17,000 scorpion stings were reported to U.S. poison-control centers in 2009, with about 11,000 recorded each year in Arizona alone. So residents of the Grand Canyon State will likely be particularly happy to learn that the FDA has just approved the first treatment for stings by the most common type of scorpion found in the U.S., the Centruroides scorpion, also known as the bark scorpion. They’re found in the Southwest. The product, Anascorp, is an injection made from the plasma of horses immunized with scorpion venom (and vaccinated against diseases that might hurt humans). Anascorp is made by a Mexican company and is licensed to Rare Diseases Therapeutics, of Franklin, Tenn. It will be distributed by a subsidiary of Medco Health Solutions. The FDA said while scorpion stings are... WSJ.com: Health Blog blogs http://www.medworm.com/rss/comments.php?id=5096152 Thu, 04 Aug 2011 13:25:03 +0100 5096152 http://www.medworm.com/index.php?rid=5096153&cid=t_96265_87_f&fid=36224&url=http%3A%2F%2Ffeeds.wsjonline.com%2F%7Er%2Fwsj%2Fhealth%2Ffeed%2F%7E3%2FNS7lvS4dblo%2F Reviewing Infuse Data: Medtronic will give Yale University $2.5 million to supervise two independent reviews of clinical trial and other data on the company’s controversial spinal-fusion product Infuse Bone Graft, the WSJ reports. In June, a paper published in the Spine Journal raised questions about clinical trials of Infuse, including a failure to report some complications. Infection Rates: Data from the Centers for Disease Control and Prevention show that some 50,000 Americans become infected each year with HIV, a number that has changed little in a decade and that is prompting discussion about whether government prevention programs are working, the New York Times reports. More infections are being seen in young gay black men, while the number of infections of children by their HI... WSJ.com: Health Blog blogs http://www.medworm.com/rss/comments.php?id=5096153 Thu, 04 Aug 2011 12:39:54 +0100 5096153 http://www.medworm.com/index.php?rid=5107649&cid=t_96265_113_f&fid=34634&url=http%3A%2F%2Fwww.emrandhipaa.com%2Femr-and-hipaa%2F2011%2F08%2F03%2Feprescribing-controlled-substances%2F Back on September 13, 2009 I wrote a post titled, “FDA Approves Pilot Electronic Prescribing of Controlled Substances.” I’d link to the post, but unfortunately the news got sent to me prematurely and so I had to take the post down. It was unfortunate, since there was and still is a lot of interest in being able to ePrescribe controlled substances. In fact, I’d say that not being able to prescribe controlled substances electronically is the current Achilles heal of ePrescribing. Fast forward to the recent announcement that DrFirst’s announcement of the Nationwide Launch of their ePrescribing Controlled Substances product. Their latest ePrescribing product for controlled substances is called EPCS Gold and is fully certified to meet the prescription processing re... EMR and HIPAA blogs http://www.medworm.com/rss/comments.php?id=5107649 Wed, 03 Aug 2011 19:33:22 +0100 5107649 http://www.medworm.com/index.php?rid=5097076&cid=t_96265_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2011%2F08%2Ffda-intern-quest-for-social-media.html (Source: Pharma Marketing Blog) Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=5097076 Wed, 03 Aug 2011 12:02:00 +0100 5097076 http://www.medworm.com/index.php?rid=5096211&cid=t_96265_87_f&fid=39261&url=http%3A%2F%2Fvactruth.com%2F2011%2F08%2F02%2Ftime-to-say-enough%2F There comes a time in everyone’s consciousness and life when one realizes that too many things are going off beam and that life is becoming more problematic day by day, especially now when it comes to our health, which probably is our most valued personal possession, and which seems to be undermined in various and sundry ways and fashions. Let’s examine some of the medical ‘fashions’ for starters, since most healthcare consumers think that those professionals wearing white coats topped with stethoscopes really know what they are talking about.  White Coats and Cigarettes First, and foremost, I’d like to remind everyone that MDs were proud to recommend Camels cigarettes as the brand most doctors preferred and smoked. Don’t believe me; check out this advertisement http://www.y... vactruth.com blogs http://www.medworm.com/rss/comments.php?id=5096211 Tue, 02 Aug 2011 13:14:44 +0100 5096211 http://www.medworm.com/index.php?rid=5086135&cid=t_96265_87_f&fid=36224&url=http%3A%2F%2Ffeeds.wsjonline.com%2F%7Er%2Fwsj%2Fhealth%2Ffeed%2F%7E3%2Fz44fo_4SYfo%2F Developing new drugs is a tricky business. Teva Pharmaceutical Industries and Active Biotech got a tough reminder of that today; shares in the companies fell after they said their experimental multiple-sclerosis drug, laquinimod, missed the main goal of a major study. The drug — one of a clutch of new oral treatments being developed for MS — failed to significantly reduce the number of relapses when compared to a sugar pill. Teva still plans to file for regulatory approval early next year, saying that an adjusted analysis demonstrates laquinimod’s effectiveness, according to Dow Jones Newswires. “Since this is predefined and it is the right thing to do scientifically, we believe the FDA will accept that, but of course we cannot predict the FDA response,” Rivka... WSJ.com: Health Blog blogs http://www.medworm.com/rss/comments.php?id=5086135 Mon, 01 Aug 2011 18:58:54 +0100 5086135 http://www.medworm.com/index.php?rid=5086557&cid=t_96265_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F9bdN0mPFRfU%2F Last week, the FDA announced that any clinical tests conducted between April 2005 and June 2010 by a contract research organization called Cetero Research may have to be reevaluated because two FDA inspections and an outside audit found falsified data and manipulated samples. In explaining its move, the agency maintained there were “significant instances” of misconduct. The agency says Cetero failed to conduct an adequate internal investigation to determine the extent and impact of the violations, and did not take sufficient steps to assure data integrity during those five years. And so drugmakers must check their databases for trials that were used to support New Drug Applications and Abbreviated New Drug Applications - and may have to repeat or confirm results (back story). For its ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=5086557 Mon, 01 Aug 2011 13:30:19 +0100 5086557 http://www.medworm.com/index.php?rid=5086560&cid=t_96265_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FfEJZC4F4xVU%2F Good morning, everyone. Hope you had a nice weekend. Now, of course, the routine resumes, although this is often a slow time of year. Nonetheless, there is much to be done here in the official Pharmalot c-suite, where we are catching up on interesting documents and conversations. And of course, we are brewing that mandatory cup of stimulation and invite you to join us. Meanwhile, here are a few tidbits from around the world. Hope your day goes well and you accomplish much… Teva’s Copaxone Successor Fails In Latest Clinical Trial (Bloomberg News) Pfizer Says FDA Delays Prevnar Review For Three Months (Bloomberg News) Cuba Sentences Pharma Execs For Corruption (Associated Press) Japan’s Shionogi Acquires C&O Pharmaceutical Tech (ChannelNewsAsia) New FDA Commish Asks Co... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=5086560 Mon, 01 Aug 2011 12:00:25 +0100 5086560 http://www.medworm.com/index.php?rid=5078028&cid=t_96265_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FeXH08oXg61s%2F As if Merck does not have enough problems with vaccine production, the drugmaker apparently distributed charred bits of plastic shrink wrap in vials of various vaccines - including Gardasil for preventing HPV infection, Varivax for chicken pox, Pneumovax for pneumococcal disease, Zostavax for shingles and MMR II for measles, mumps and rubella, according to Dow Jones. In 2008, the FDA issued a warning letter about manufacturing problems at Merck’s West Point, Pa., plant (read here). Since then, FDA inspection reports have cited more problems: the presence of metal particles in certain products, cracks in vaccine vials and delays in Merck’s reporting adverse event from products made at the plant to the FDA, Dow Jones writes. The drugmaker maintains most problems have been resolve... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=5078028 Fri, 29 Jul 2011 18:09:05 +0100 5078028 http://www.medworm.com/index.php?rid=5077646&cid=t_96265_87_f&fid=36224&url=http%3A%2F%2Ffeeds.wsjonline.com%2F%7Er%2Fwsj%2Fhealth%2Ffeed%2F%7E3%2FT11jkuMcbRE%2F Medical-device regulation is a tricky balancing act. Consumer advocates say the current process doesn’t ensure the safety and efficacy of devices on the market, while the device industry says the FDA’s process is inefficient and expensive and keeps products from reaching patients in need. Today, as the WSJ reports, the Institute of Medicine weighed in with its own much-anticipated report on device regulation. Notably, an 11-member committee recommends scrapping entirely the streamlined approval pathway known as 510(k), under which a device such as a joint replacement or heart defibrillator can be approved more quickly, without studies in humans, if it’s considered “substantially equivalent” to devices already on the market. A major flaw in the process, the rep... WSJ.com: Health Blog blogs http://www.medworm.com/rss/comments.php?id=5077646 Fri, 29 Jul 2011 15:38:57 +0100 5077646 http://www.medworm.com/index.php?rid=5078034&cid=t_96265_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FpESdhESRxXI%2F And so, another working week is drawing to a close. This is, of course, our signal to daydream about weekend plans. We have not yet finalized our agenda, but we do hope to catch up on some reading and spend time with our short people. We may even tidy up the Pharmalot corporate campus. And you? Anything special in the offing? A day at the beach? A night at the movies? Maybe a dinner with someone special? Or if you have a high pain threshold, you could track the children in Washington DC as they jeopardize the economy. Whatever your pleasure, have a great time, but be safe. See you soon… Pfizer Wins Prempro Case In West Virginia (Bloomberg News) Nevada Wins Right To Continue Hormone Replacement Lawsuit (Las Vegas Sun) Sanofi Won’t Make Genzyme Milestone Payment (The Boston Globe... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=5078034 Fri, 29 Jul 2011 12:10:06 +0100 5078034 http://www.medworm.com/index.php?rid=5077688&cid=t_96265_87_f&fid=39187&url=http%3A%2F%2Fgetbetterhealth.com%2Fcan-pharmacogenomic-tests-help-to-improve-public-health%2F2011.07.29 Adverse drug events are a serious public health problem. Consider the following facts: an estimated 82% of American adults take at least one medication and 29% take five or more; 700,000 emergency department visits and 120,000 hospitalizations are due to adverse drug events annually; $3.5 billion is spent on extra medical costs of adverse drug events annually; at least 40% of costs associated with adverse drug events occurring outside hospitals can be prevented. How can genomics help? Pharmacogenomics is the study of genetic variation as a factor in drug response, affecting both safety and effectiveness. The intended applications of pharmacogenomics research include identifying responders and non-responders to medications, avoiding adverse events, optimizing drug dose and avoiding unnece... Better Health blogs http://www.medworm.com/rss/comments.php?id=5077688 Fri, 29 Jul 2011 12:00:10 +0100 5077688 http://www.medworm.com/index.php?rid=5140255&cid=t_96265_147_f&fid=39273&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FePharmaSummit%2F%7E3%2FWttWPWuaV6o%2Fepharma-west-regulation-and-innovation.html What does Pharma Want form DDMAC? Peter Pitts, President, Center for Medicine in the Public Interest The only way to credibly engage with influencers is to have critical information for them to say. What Pharma has to say must be to the public's benefit. This train of thought is lacking in health care. Pharma does not realize their own network value. Their goal should be to advance the public health, which can be done through active lively and regular participation. Pitts suggests that it’s not the responsible thing to not participate in social media, because that is where the public is. It’s not comfortable for people because it’s not a pay world, it’s a play world. Social Media’s Golden rule is Transparency. If you don’t challenge the [Social Media] path at all, no one will... ePharma Summit blogs http://www.medworm.com/rss/comments.php?id=5140255 Wed, 27 Jul 2011 19:23:00 +0100 5140255 http://www.medworm.com/index.php?rid=5069824&cid=t_96265_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F5ktd4wPgYzs%2F Valeant Pharmaceuticals has been on an acquisition spree, but perhaps the Canadian drugmaker may want to conduct a bit more due diligence before its next purchase. One of its recent deals was for Sanitas, which is based in Lithuania and controls Jelfa, another drugmaker based in Poland and that actually produces much of the Sanitas portfolio (read this). Valeant is paying about $455 million in cash (see here and here). However, a July 14 warning letter issued by the FDA to Jelfa notes that the Polish drugmaker has some basic problems with quality control. During an October 2010 inspection, the FDA found Jelfa did not thoroughly investigate the failure of a batch or any of its components to meet specifications, which the agency called an unacceptable practice. The FDA then offered a tutoria... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=5069824 Tue, 26 Jul 2011 15:35:11 +0100 5069824 http://www.medworm.com/index.php?rid=5069826&cid=t_96265_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F51VWUJEh5j8%2F Earlier this month, the National Comprehensive Cancer Network, a non-profit group of oncologists whose guidance is closely followed by leading treatment centers, voted overwhelmingly in favor of maintaining its recommendation that Avastin should be used to treat breast cancer. The vote came shortly after an FDA panel voted 6-to-0 to revoke the breast cancer indication for Avastin. The endorsement is important because oncologists will likely continue to use Avastin even if FDA commish Margaret Hamburg rescinds the breast cancer indication. Roche and its Genentech unit had appealed a decision last December by the agency to pull the indication for their best-selling med after new studies showed Avastin does not prolong overall survival in breast cancer patients or provide a sufficient benefi... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=5069826 Tue, 26 Jul 2011 13:24:27 +0100 5069826 http://www.medworm.com/index.php?rid=5063176&cid=t_96265_4_f&fid=38622&url=http%3A%2F%2Ffdatransparencyblog.fda.gov%2F2011%2F07%2F26%2Fcheck-it-out-newly-redesigned-fda-track-dashboard-pages%2F FDA’s performance management system, FDA-TRACK, allows the public to follow the agency’s progress on a range of measures (see April 7 blog  post). We redesigned FDA-TRACK!  It has been a little over one year since the launch of the FDA-TRACK website.  After collecting web traffic data during this time, we decided to make some changes to the dashboard pages in hopes of improving your experience.  The changes include: Cleaner look-and-feel; Charts and options to overlay related measures; XML downloads; and “FDA-TRACK Indices” by program area, for easier access navigation to specific content. Check out these before and after shots: Before: After: Please visit any of the FDA-TRACK dashboard pages to see these changes. (Source: FDA Transparency Blog) FDA Transparency Blog blogs http://www.medworm.com/rss/comments.php?id=5063176 Tue, 26 Jul 2011 12:10:21 +0100 5063176 http://www.medworm.com/index.php?rid=5062501&cid=t_96265_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FBxxWwaHNRcQ%2F Hello, everyone. How was your weekend? We apologize for the delay this morning but the Pharmalot corporate campus was without juice, so we have had to switch to our Red Alert mode. We trust you understand. To cope, we are downing unusually large cups of stimulation. Meanwhile, here are some tidbits. And the usual flow of interesting items will soon appear. Have a great day… Bayer’s Xarelto Bloodthinner Matched Warfarin In Safety Study (Bloomberg News) FDA Rejects J&J’s Simponi For Additional Use (Associated Press) Prescription Drug Prices To Plunge As Patents Expire (Associated Press) Medicis CEO In The Spotlight After Deaths At His Mansion (Los Angeles Times) Express Scripts Deal With Medco Could Pressure Pharma (Dow Jones) Lupin And Medicis Sign R&D Agreement ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=5062501 Mon, 25 Jul 2011 13:48:52 +0100 5062501 http://www.medworm.com/index.php?rid=5062246&cid=t_96265_87_f&fid=39187&url=http%3A%2F%2Fgetbetterhealth.com%2Fhow-effective-are-antidepressants%2F2011.07.24 Antidepressant drugs have been getting a bad rap in the media. I’ll just give 3 examples: On the Today show, prominent medical expert Tom Cruise told us Brooke Shields shouldn’t have taken these drugs for her postpartum depression. In Natural News, “Health Ranger” Mike Adams accused pharmaceutical companies and the FDA of covering up negative information about antidepressants, saying it would be considered criminal activity in any other industry. And an article in Newsweek said  “Studies suggest that the popular drugs are no more effective than a placebo. In fact, they may be worse.” Yet psychiatrists are convinced that antidepressants work and are still routinely prescribing them for their patients. Is it all a Big Pharma plot? Who ya gonna believe? Inquiring minds want ... Better Health blogs http://www.medworm.com/rss/comments.php?id=5062246 Sun, 24 Jul 2011 16:00:36 +0100 5062246 http://www.medworm.com/index.php?rid=5057722&cid=t_96265_87_f&fid=39187&url=http%3A%2F%2Fgetbetterhealth.com%2Fthe-new-details-about-the-fda-regulation-of-mhealth-apps%2F2011.07.23 Since the beginning of this year, there have been clues that the FDA will be heading toward clarification of the complex regulatory issues posed by mobile health devices and software. We have previously reported on testimony and public comments by Dr. Jeffrey Shuren, director of the  FDA’s Center for Devices and Radiological Health (CDRH) alluding to coming guidelines. Today, the FDA finally released a detailed draft guidance of how it intends to regulate this rapidly exploding sector of mobile medical devices and software. This is what the Emergo group, regulatory compliance consultants, has gleaned from today’s FDA press release: (more…) *This blog post was originally published at iMedicalApps* (Source: Better Health) Better Health blogs http://www.medworm.com/rss/comments.php?id=5057722 Sat, 23 Jul 2011 16:00:04 +0100 5057722 http://www.medworm.com/index.php?rid=5050791&cid=t_96265_113_f&fid=34621&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FHealthcareGuy%2F%7E3%2Fx-LpDDL2QwY%2F The FDA released the (currently non-binding) “Draft Guidance for Industry and  Food and Drug Administration Staff on Mobile Medical Applications” earlier this week. I knew many of my clients and readers would be asking about the ramifications of this new guidance so I read the document as soon as it came out. In general I was impressed by the FDA’s balanced approach to patient safety and their desire not to stifle competition; overall I thought they were not looking to overreach their purview and I think they succeeded (except for the part on clinical decision support, discussed further below). Unlike many regulations that come out of DC, this guidance document is quite readable by us mere mortals: it’s written in plain English  and not legal-speak so I recommend picking ... The Healthcare IT Guy blogs http://www.medworm.com/rss/comments.php?id=5050791 Fri, 22 Jul 2011 01:50:04 +0100 5050791 http://www.medworm.com/index.php?rid=5050577&cid=t_96265_87_f&fid=39187&url=http%3A%2F%2Fgetbetterhealth.com%2Fresearch-investigates-a-percutaneous-option-for-aortic-valve-replacement%2F2011.07.21 To ensure rational and responsible dissemination of this new technology (transcatheter aortic valve replacement [TAVR]), government, industry and medicine will need to work in harmony.” - David R. Holmes, Jr., MD, FACC President, American College of Cardiology Today, Edwards Lifesciences’ will request pre-market approval of its SAPIEN Transcatheter Heart Valve from the FDA’s Circulatory Systems Devices Panel of the Medical Devices Advisory Committee. And for the first time, the groundwork for our complicated new era of health care rationing will be exposed. To win an expensive technology on behalf of patients these days, there will have to be “harmony” between doctors and their professional organizations and government regulators. If not, patients lose. At issue is a... Better Health blogs http://www.medworm.com/rss/comments.php?id=5050577 Thu, 21 Jul 2011 18:00:00 +0100 5050577 http://www.medworm.com/index.php?rid=5051242&cid=t_96265_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fbj1UlOgA4Ic%2F Although France and Germany suspended use of the Actos diabetes pill, the European Medicines Agency has decided to take a more conservative approach and today recommended that Takeda Pharmaceuticals simply place new warnings about possible links to bladder cancer. In reaching its decision, the EMA’s Committee for Medicinal Products for Human Use, or CHMP, decided that there are some patients who cannot be adequately treated by other drugs and who will benefit from continued treatment with Actos. “The CHMP agreed that it was not possible to further restrict the current indications of pioglitazone,” according to the EMA statement. Last week, the Agence Francaise de Securite Sanitaire des Produits de Sante (AFSSAPS) asked Takeda to withdraw Actos and based its decision by AF... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=5051242 Thu, 21 Jul 2011 17:22:47 +0100 5051242 http://www.medworm.com/index.php?rid=5051025&cid=t_96265_131_f&fid=35008&url=http%3A%2F%2Fscienceroll.com%2F2011%2F07%2F21%2Fmobile-apps-regulated-by-fda%2F FDA has published an announcement about regulations regarding medical mobile applications. The agency’s draft guidance defines a small subset of mobile medical apps that impact or may impact the performance or functionality of currently regulated medical devices. This subset includes mobile medical apps that: a. are used as an accessory to medical device already regulated by the FDA (For example, an application that allows a health care professional to make a specific diagnosis by viewing a medical image from a picture archiving and communication system (PACS) on a smartphone or a mobile tablet); or b. transform a mobile communications device into a regulated medical device by using attachments, sensors or other devices (For example, an application that turns a smartphone into an ECG mac... ScienceRoll blogs http://www.medworm.com/rss/comments.php?id=5051025 Thu, 21 Jul 2011 14:13:37 +0100 5051025 http://www.medworm.com/index.php?rid=5050583&cid=t_96265_87_f&fid=39187&url=http%3A%2F%2Fgetbetterhealth.com%2Fwhy-doctors-should-participate-in-the-debt-ceiling-debate%2F2011.07.20 Joe Scarborough reminds us that the divisions in American government are hardly new, paraphrasing Benjamin Franklin’s observation that “When you assemble a number of men, to have the advantage of their joint wisdom, you inevitably assemble . . . all their prejudices, their passions, their errors of opinion, their local interests, and their selfish views. From such an assembly can a perfect production be expected?” (This comes from a September 17, 1787 speech by Mr. Franklin to urge ratification of the U.S. Constitution, read on his behalf because he was too ill to deliver it in person. The Constitution was ratified the same day.) I suppose we should be encouraged that Congress’s prejudices, passions, errors of opinion, local interests and selfish views are as American as apple pie,... Better Health blogs http://www.medworm.com/rss/comments.php?id=5050583 Wed, 20 Jul 2011 16:00:00 +0100 5050583 http://www.medworm.com/index.php?rid=5051232&cid=t_96265_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2011%2F07%2Ffda-issues-long-awaited-guidance-for.html (Source: Pharma Marketing Blog) Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=5051232 Wed, 20 Jul 2011 12:38:00 +0100 5051232 http://www.medworm.com/index.php?rid=5050517&cid=t_96265_87_f&fid=36224&url=http%3A%2F%2Ffeeds.wsjonline.com%2F%7Er%2Fwsj%2Fhealth%2Ffeed%2F%7E3%2FCDh_46bNdEU%2F Drug Vote: An FDA advisory panel voted 9-6 against approving dapagliflozin, a new type of diabetes drug from Bristol-Myers Squibb and AstraZeneca, saying more information is needed on possible risks including breast and bladder cancers, the WSJ reports. Some panel members, however, said teasing out those possible safety problems would be best accomplished not by requiring more studies before approval, but by using post-marketing studies and patient registries. The FDA often, but not always, follows the advice of its outside panels. VC Dollars: Venture-capital investors invested $1.24 billion in biotech companies during the second quarter, 46% more than in the first quarter, Bloomberg News reports, citing a report from the National Venture Capital Association and PricewaterhouseCoopers. Mea... WSJ.com: Health Blog blogs http://www.medworm.com/rss/comments.php?id=5050517 Wed, 20 Jul 2011 12:25:51 +0100 5050517 http://www.medworm.com/index.php?rid=5050880&cid=t_96265_117_f&fid=37824&url=http%3A%2F%2Fwww.doctorkalitenko.com%2Fblog%2Ffda-decide-fate-cancer-drug-holds-life-hands%2F Back and forth goes the FDA when it comes to a decision regarding Avastin, the breast cancer treatment drug. The drug itself has an interesting history and relationship with the FDA. Back in 2004, Avastin received approval by the FDA. In 2007, the FDA suddenly pulled the approval, by a 5-4 vote. But only several months later re-granted the drug accelerated approval. Over the next couple of years it became a staple for women fighting breast cancer. Until last month, when the FDA announced it was questioning some of the studies done by the company and pulled approval once again. But what about the women who have been on it all these years? The debate is heated and not anywhere close to over yet. A study says it adds five months to your life, but now evidence says it actually marginally help... Doctor Kalitenko antiaging blog blogs http://www.medworm.com/rss/comments.php?id=5050880 Tue, 19 Jul 2011 17:27:55 +0100 5050880 http://www.medworm.com/index.php?rid=5028127&cid=t_96265_87_f&fid=36224&url=http%3A%2F%2Ffeeds.wsjonline.com%2F%7Er%2Fwsj%2Fhealth%2Ffeed%2F%7E3%2FrdrSs832HaA%2F Thumbs-Up, Conditionally: An FDA advisory panel unanimously recommended the accelerated approval of brentuximab vodotin, an experimental lymphoma drug that Seattle Genetics wants to market under the brand name Adcetris, the WSJ reports. Accelerated approval requires further studies to be conducted after the drug is on the market; Seattle Genetics would prefer regular approval, which isn’t conditional. The FDA often, but not always, follows the advice of its outside committees. Fewer Butts: A report published by the CDC finds that Time Warner, Comcast and the Walt Disney Co. cut the number of tobacco scenes in movies rated G, PG or PG-13 by 96% between 2005 and 2010, the Associated Press reports. Those companies had established policies to reduce the prevalence of tobacco in their fil... WSJ.com: Health Blog blogs http://www.medworm.com/rss/comments.php?id=5028127 Fri, 15 Jul 2011 13:06:21 +0100 5028127 http://www.medworm.com/index.php?rid=5029208&cid=t_96265_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FxS7A0T_xTzA%2F Hired someone new and exciting? Promoted a rising star? Finally solved that hard-to-fill spot? Share the news with us and we’ll share with it others. That’s right. Send us your announcements and we’ll find a home for them. Don’t be shy. Everyone wants to know who is coming and going, especially with all the layoffs. Despite the downsizing, there is movement. Here are some of the latest changes. Recognize anyone? And here is our regular feature. Send us a photo and we will spotlight a different person each week. This time around, we note that Sangamo BioSciences hired Geoffrey Nichol as executive vp for research and development. From 2002 to 2010, he was senior vp of product development at Medarex, which is now part of Bristol-Myers Squibb, and before that, he held various senior ma... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=5029208 Fri, 15 Jul 2011 12:53:56 +0100 5029208 http://www.medworm.com/index.php?rid=5028517&cid=t_96265_111_f&fid=39123&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2Fnursingcomments%2Ftdtc%2F%7E3%2FTIy93UnlV6M%2F I was doing some research on clinical trials and it is much more complex than I dreamed!  First of all, any new treatment must go through numerous stages of testing before its benefits and risks can completely be known.  New treatments are discovered in the laboratory and it can take many years of research before they are given to patients.  Why?  Because it is essential to identify that the new treatment is actually better than what is already available.  These research studies are also called clinical trials.  If a treatment has definite potential in the final stages of development, then research is carried out in patients with the particular type of illness that the treatment aims to help.  Furthermore, I always believed that clinical trials were only regarding drugs, and that is... Nursing Comments blogs http://www.medworm.com/rss/comments.php?id=5028517 Thu, 14 Jul 2011 15:37:10 +0100 5028517 http://www.medworm.com/index.php?rid=5029212&cid=t_96265_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F48ruNb0tqKc%2F Six months after reviewing her operations, FDA commish Margaret Hamburg has made good on reorganizing the workload and responsibilities by hiring an outsider as a deputy commish and promoting an agency stalwart to a different deputy commish slot. The overhaul was also undertaken at the time that former deputy commish Josh Sharfstein - a close Hamburg ally - departed from the agency after less than two years on the job (see here). And so, former Dartmouth University Medical School Dean Stephen Spielberg was named to the newly created position of deputy commissioner for medical products and tobacco, while Deborah Autor, an attorney who now is director of the Center for Drug Evaluation & Research, to deputy commish for global regulatory operations and policy. “The structure of the ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=5029212 Thu, 14 Jul 2011 14:06:08 +0100 5029212 http://www.medworm.com/index.php?rid=5028130&cid=t_96265_87_f&fid=36224&url=http%3A%2F%2Ffeeds.wsjonline.com%2F%7Er%2Fwsj%2Fhealth%2Ffeed%2F%7E3%2FUWutRQPKQBI%2F Chip-Factory Cancer Cases: Samsung Electronics Co. says a report by consulting firm Environ International found no link between cancer in six workers and the chemicals they were exposed to at a semiconductor manufacturing facility, the WSJ reports. Previous reports by South Korea’s occupational health and safety agency have also found no link. But Samsung workers and others have said there were far more leukemia and lymphoma cases among chip-factory workers. Data from the latest study are not being immediately released. Reconsidering Risk: The FDA warned that when used to prevent pelvic organ prolapse, surgical mesh carries a higher risk of adverse effects like pain, bleeding and infection, without necessarily providing additional benefit over traditional surgical stitches, the Assoc... WSJ.com: Health Blog blogs http://www.medworm.com/rss/comments.php?id=5028130 Thu, 14 Jul 2011 12:43:45 +0100 5028130 http://www.medworm.com/index.php?rid=5028220&cid=t_96265_87_f&fid=39187&url=http%3A%2F%2Fgetbetterhealth.com%2Fmeta-analyses-and-a-capricious-drug-approval-process-the-actos-and-avandia-stories%2F2011.07.13 Both Germany and France have now suspended the marketing of Actos (pioglitazone) due to concerns of a link between Actos and bladder cancer. Though we have known about bladder cancer concerns for some time, these recent concerns about the bladder cancer link stem from a recent report analyzing the FDA’s Adverse Event Reporting System (AERS), which found that 93 cases of cancer were recorded between 2004 and 2009 in patients treated with antidiabetic drugs, of which 31 patients were treated with pioglitazone, representing a statistically significant increased risk of bladder cancer (ROR 4.30, 95% confidence interval, 2.82-6.52; P less than 0.0001). Interestingly, the FDA announced that it was going to look into the link between Actos and bladder cancer only a few days before it made i... Better Health blogs http://www.medworm.com/rss/comments.php?id=5028220 Wed, 13 Jul 2011 19:00:00 +0100 5028220 http://www.medworm.com/index.php?rid=5029204&cid=t_96265_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2011%2F07%2Ffda-is-monitoring-this-blog-and-perhaps.html (Source: Pharma Marketing Blog) Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=5029204 Fri, 08 Jul 2011 17:56:00 +0100 5029204 http://www.medworm.com/index.php?rid=5008657&cid=t_96265_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FzvMEtESvnWs%2F File this under ‘Only In Your Dreams.’ To promote its Zolfresh sleeping pill in India, Abbott Laboratories has embarked on an advertising campaign that is being harshly criticized for using unproven data and old-fashioned fear in the guise of educating consumers about insomnia. Moreover, critics say the ads may prompt some people to buy potentially harmful pills that are not really needed, Reuters writes in an interesting expose. To wit, a newspaper ad featuring an attractive Bollywood actress warns that “Hard Work Never Kills. Lack of Sleep Can.” The message then says that “Research shows that sleeping less than 6 hours at night leads to (a) 48 percent increase in developing or dying from heart disease.” But the research cited only demonstrates an assoc... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=5008657 Fri, 08 Jul 2011 17:12:36 +0100 5008657 http://www.medworm.com/index.php?rid=5140270&cid=t_96265_147_f&fid=39273&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FePharmaSummit%2F%7E3%2FIFO3oOfLaRU%2Fare-you-ready-for-impending-guidelines.html Are you prepared for the regulatory changes coming the digital marketing universe? Thomas Abrams, Director of DDMAC and previous speaker at the ePharma Summit has recently announced that they are closing in on regulation for social media. The digital marketing universe could change dramatically in the coming weeks and we've got the tools to help you adapt. ePharma Summit West brings together the best speakers from around the country to discuss the most important topics in digital marketing including mobile trends, best practices, patient engagement, sales force integration, physician interaction and of course regulatory. We give you all of this while providing you with hours of networking to meet new contacts and discuss the future of the industry. Download the brochure here. In additio... ePharma Summit blogs http://www.medworm.com/rss/comments.php?id=5140270 Fri, 08 Jul 2011 13:56:00 +0100 5140270 http://www.medworm.com/index.php?rid=5008120&cid=t_96265_87_f&fid=36224&url=http%3A%2F%2Ffeeds.wsjonline.com%2F%7Er%2Fwsj%2Fhealth%2Ffeed%2F%7E3%2F2KlBS-xNuZs%2F Hip Suits: Artificial hips made by Johnson & Johnson’s DePuy Orthopaedics unit are the subject of about 1,000 lawsuits claiming J&J knew about problems with some of the metal-on-metal joint replacements before it ceased their production in 2009, the WSJ reports. A Wells Fargo analyst says J&J stands to lose more than $1 billion in liability and other costs; J&J says it boosted its product-liability reserves by $570 million last year and has also set aside $280 million to cover medical costs of people who received the joints and experienced problems. Last year the company recalled the joints that remained on the market. Privacy Penalty: UCLA is paying $865,000 and will tighten its internal controls as part of an agreement settling federal allegations that unauthorized ... WSJ.com: Health Blog blogs http://www.medworm.com/rss/comments.php?id=5008120 Fri, 08 Jul 2011 12:36:28 +0100 5008120 http://www.medworm.com/index.php?rid=5008662&cid=t_96265_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fjg8EpAu81jA%2F And so, another working week will soon draw to a close. As always, this is the signal to daydream about weekend plans. Our agenda calls for a dip in the pool, a little yardwork, hanging with assorted short people and catching up on some interesting R&D. What about you? Is a day at the beach in order? Or a drive in the country? Maybe catching up on some sleep or thinking big thoughts? Whatever you do, have a good time and be safe. Meanwhile, here are some tidbits. See you soon… Bayer Loses European Patent For Yasmin (Reuters) PETA Proposes Procter & Gamble Stop Animal Testing (Dayton Business Journal) Republicans Complain FDA Review Procedures Slow Innovation (Bloomberg News) Bydureon Diabetes Med Passed The Test In Heart Trial (Reuters) FDA Bans Imports From Dr. Reddy&#8217... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=5008662 Fri, 08 Jul 2011 12:04:58 +0100 5008662 http://www.medworm.com/index.php?rid=5008654&cid=t_96265_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2011%2F07%2Ffk-fda-drug-industry-should-issue-self.html (Source: Pharma Marketing Blog) Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=5008654 Thu, 07 Jul 2011 13:54:00 +0100 5008654 http://www.medworm.com/index.php?rid=5008129&cid=t_96265_87_f&fid=36224&url=http%3A%2F%2Ffeeds.wsjonline.com%2F%7Er%2Fwsj%2Fhealth%2Ffeed%2F%7E3%2Fu18c7VOxgNE%2F A new paper offers a possible road map for getting more drugs approved to treat rare diseases. One key recommendation: improving access to the FDA’s accelerated approval pathway, originally developed to quickly get treatments to patients with life-threatening diseases. The paper, written by Brigitta Miyamoto and Emil Kakkis of the Kakkis EveryLife Foundation and published today in the Orphanet Journal of Rare Diseases, says the FDA should offer specific guidelines on how companies seeking to develop drugs for rare diseases can better utilize accelerated approval. Kakkis helped develop and guide the approval process for three treatments for rare diseases at BioMarin Pharmaceutical, where he served as chief medical officer. He’s now CEO and president of Ultragenyx Pharmaceutical, whic... WSJ.com: Health Blog blogs http://www.medworm.com/rss/comments.php?id=5008129 Wed, 06 Jul 2011 12:29:27 +0100 5008129 http://www.medworm.com/index.php?rid=5008655&cid=t_96265_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2011%2F07%2Fcitizens-petition-filed-with-fda-likely.html (Source: Pharma Marketing Blog) Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=5008655 Wed, 06 Jul 2011 10:57:00 +0100 5008655 http://www.medworm.com/index.php?rid=4997523&cid=t_96265_87_f&fid=39187&url=http%3A%2F%2Fgetbetterhealth.com%2Fthe-bottom-line-on-new-fda-sunscreen-guidelines%2F2011.07.03 Life is really simple, but we insist on making it complicated. -Confucius This is certainly true of sunscreens. “Broad spectrum, UVA, UVB, avobenzone, oxybenzone, parsol, sensitive skin, titanium dioxide, SPF 15, 30, 45, 50, 55, 60, 70, 75, 100, 100+, waterproof, sweatproof, spray, cream, lotion, antioxidant…” We spend about $700 million in sunscreens every year, and many people don’t have a clue as to what’s good or bad, or a waste of money. The Food and Drug Administration has been meaning to help you out with this problem for a while now. Actually for over 30 years (who says nothing gets done in government?). The F.D.A. has made a final decision on sunscreen labels. They’ve sought to make labels simple and accurate to help you choose the right one: 1. The sunscreen must pro... Better Health blogs http://www.medworm.com/rss/comments.php?id=4997523 Sun, 03 Jul 2011 21:00:40 +0100 4997523 http://www.medworm.com/index.php?rid=4992990&cid=t_96265_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FLVsy771S9hA%2F The FDA may want to yank the breast cancer indication for Avastin, but the Centers for Medicare & Medicaid Services will continue to provide coverage, even if treatment amounts to off-label usage. “As long as doctors continue to prescribe it, we will continue to pay, even for an off-label use, until and unless some time in the future we decide to change our coverage policy. We have no such thing underway at this time,” a CMS spokesman tells us. “We often pay for off-label use of drugs, but not always.” The move will, no doubt, cheer many breast cancer patients and their loved ones, who feared the FDA would soon put Avastin out of reach (look here), now that an agency advisory panel unanimously voted - once again - to rescind the indication. The vote came earlie... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4992990 Fri, 01 Jul 2011 16:36:13 +0100 4992990 http://www.medworm.com/index.php?rid=4992996&cid=t_96265_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FIKpuqSGxcXI%2F Good morning, everyone. And how are you today? Another beautiful morning is rising over the Pharmalot corporate campus. However, we will be rolling in the sidewalks early as we prepare for a long weekend on this side of the pond. Our modest agenda includes a dip in the pool, hanging with the short people, catching up on some research (with thanks to our sources) and one of our favorite sports - hunting for mice. What about you? Anything special planned? Maybe a ride in the country, a barbecue in the backyard or how about a day at the beach? This will be Independence Day, after all, so perhaps this is a good time to think of suggestions for trimming the national debt. The symbolism is heavy, yes? Whatever you do, have a great time and be safe. See you soon… Glaxo Kicks Off Sale Of OTC... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4992996 Fri, 01 Jul 2011 11:50:16 +0100 4992996 http://www.medworm.com/index.php?rid=4984685&cid=t_96265_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FfPQN1FrNG4Y%2F In the ongoing war between device makers and the FDA, the Minnesota Congressional delegation has sent a terse letter to the agency over what they maintain is a slow-as-molasses approval process. This comes less than three months after a Congressional hearing in which FDA procedures were hotly debated and included testimony from patients who claimed tougher agency reviews would have prevented injuries. At issue is the simmering tension between the agency, which embraces a get-tough policy on safety matters while lamenting a lack of sufficient funding, and an industry that wants to grow its bottom line but is also under a microscope - largely thanks to the ongoing Medtronic scandal over repudiated research and unseemly ties to physicians. However, the Minnesota pols - a group that includes ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4984685 Thu, 30 Jun 2011 16:46:08 +0100 4984685 http://www.medworm.com/index.php?rid=4984687&cid=t_96265_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F8Pxx2sLGKGM%2F After months of controversy, an FDA advisory panel yesterday voted unanimously to uphold an earlier agency decision to yank the breast cancer indication for Avastin, a widely used sold by Roche and its Genentech unit (see this). The run-up to the two-day meeting was highly contentious as the drugmaker accused the FDA panel of bias, there were behind-the-scenes debates over potential conflicts of interest among expert speakers, and patients and their families organized protests - online and in person. Clearly, more was at stake than the fate of a best-selling med, which remains available for treating other cancers. The hearing was also a referendum of sorts on the veracity of the FDA accelerated approval program and, by extension, the agency itself. We asked Daniel Carpenter, the Allie S. F... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4984687 Thu, 30 Jun 2011 12:45:07 +0100 4984687 http://www.medworm.com/index.php?rid=4984413&cid=t_96265_87_f&fid=36224&url=http%3A%2F%2Ffeeds.wsjonline.com%2F%7Er%2Fwsj%2Fhealth%2Ffeed%2F%7E3%2FNYfw_VMWbrM%2F Avastin Vote: An FDA appeals panel made up of outside experts voted 6-0 to recommend the agency remove Avastin’s approval for breast cancer, the WSJ reports. Panel members said studies showed the Roche drug provided no meaningful benefit to patients while raising the risk for serious side effects. The ultimate decision on the drug’s breast-cancer indication rests with FDA head Margaret Hamburg. Regardless of what she decides, the drug will remain on the market since it’s approved for other cancers. Focus on Fenugreek: The search for the culprit in the E. coli outbreak in Germany and, most recently, France, has focused on fenugreek seeds from Egypt, the New York Times reports. Sprouts from contaminated seeds are “implicated in both outbreaks,” according to a Eu... WSJ.com: Health Blog blogs http://www.medworm.com/rss/comments.php?id=4984413 Thu, 30 Jun 2011 12:42:44 +0100 4984413 http://www.medworm.com/index.php?rid=4984690&cid=t_96265_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FnPwCL76CH9s%2F Concluding a rare, two-day hearing, an FDA panel has voted 6-to-0 to revoke the breast cancer indication for Avastin, dealing a huge blow to Roche and its Genentech unit, which now stand to lose an estimated $1 billion in annual sales. The drugmaker had appealed a decision last December by the agency to yank the indication, prompting a heated debate over the veracity of the FDA accelerated approval program. A final decision, however, rests with FDA commish Margaret Hamburg. Meanwhile, the FDA and Roche’s Genentech unit will provide additional written submissions by July 28, and the docket will remain open for public comment until then (see this). At the conclusion of the meeting, some patients were particularly vocal. “What do you want us to take!? We have nothing else!” shouted ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4984690 Wed, 29 Jun 2011 20:07:35 +0100 4984690 http://www.medworm.com/index.php?rid=4984560&cid=t_96265_117_f&fid=37824&url=http%3A%2F%2Fwww.doctorkalitenko.com%2Fblog%2Flupus-drug-approved-cost%2F It was just recently announced that Benlysta, a lupus drug, was approved by the FDA, making it the first lupus drug approved by the group in 50 years. But out of this approval, we noted something shocking. A statement issued by the FDA. “In approving the drug, the agency said the findings suggested but didn’t definitively show that some patients had a reduced likelihood of severe flare-ups, a painful characteristic of the disease.” as per the Washington Post. (1)(2)(3) What this means is that this drug is not really effective.  Otherwise why would FDA say that it did not definitely show benefits? As a matter of fact the FDA held up the approval for some time because it wasn’t clear about the benefits of the drug. The next question is: if it is not clear about benefits, th... Doctor Kalitenko antiaging blog blogs http://www.medworm.com/rss/comments.php?id=4984560 Wed, 29 Jun 2011 17:15:35 +0100 4984560 http://www.medworm.com/index.php?rid=4976205&cid=t_96265_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FtVU0kTPjSIk%2F With concerns about social media front and center, drugmakers can clearly use some guidance when it comes to creating a product web site. Then again, a degree of common sense should already be in place, yes? Cephalon, however, committed a few avoidable blunders with a web site for Trisenox, which was approved to treat acute promyelocytic leukemia. An FDA warning letter dated June 21 notes that in the healthcare professional website for Trisenox, Cephalon overstated the case for its drug in big, bold letters in a prominent location at the top of the web pages. The agency found the claims misleading, “because they suggest that Trisenox is approved to treat patients with any kind of relapsed or refractory APL when this is not the case.” There are, in fact, some important limitati... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4976205 Tue, 28 Jun 2011 12:02:47 +0100 4976205 http://www.medworm.com/index.php?rid=4975819&cid=t_96265_87_f&fid=36224&url=http%3A%2F%2Ffeeds.wsjonline.com%2F%7Er%2Fwsj%2Fhealth%2Ffeed%2F%7E3%2Fvra3c12TJyY%2F No Hearing: The Supreme Court yesterday rejected an appeal from insurers and other payers who said they paid too much for Eli Lilly’s antipsychotic drug Zyprexa because the drug company misrepresented the benefits of the medication, the WSJ reports. A lower court had ruled that there wasn’t a sufficient link between the high prices and Lilly’s marketing practices; the Supreme Court won’t hear a challenge to that ruling. Hospice Questions: There are concerns that commercial hospices are seeking out patients with better prognoses in an attempt to boost income, Kaiser Health News and the New York Times report. The inspector general of HHS is looking at “unusual patterns of hospice stays,” while whistleblower lawsuits have alleged efforts to keep patients in... WSJ.com: Health Blog blogs http://www.medworm.com/rss/comments.php?id=4975819 Tue, 28 Jun 2011 10:57:19 +0100 4975819 http://www.medworm.com/index.php?rid=4975822&cid=t_96265_87_f&fid=36224&url=http%3A%2F%2Ffeeds.wsjonline.com%2F%7Er%2Fwsj%2Fhealth%2Ffeed%2F%7E3%2FheOl2vQ08lE%2F Avastin Arguments: At an FDA appeals hearing tomorrow and Wednesday, Roche’s Genentech unit will argue that the conditional approval for its drug Avastin to be used against breast cancer shouldn’t be pulled, despite evidence showing it doesn’t help patients live any longer and carries the risk of serious side effects, the WSJ reports. FDA head Margaret Hamburg will ultimately make the decision about the drug, which is already approved for use in other cancers. Sprouts, Again: The deadly E. coli strain implicated in the German outbreak that killed 43 people has now popped up in France, though authorities say it appears to be an isolated instance, the New York Times reports. Once again, the illness is linked to sprouts; seven people were in the hospital as of Sunday, the NY... WSJ.com: Health Blog blogs http://www.medworm.com/rss/comments.php?id=4975822 Mon, 27 Jun 2011 12:34:33 +0100 4975822 http://www.medworm.com/index.php?rid=4968489&cid=t_96265_87_f&fid=39187&url=http%3A%2F%2Fgetbetterhealth.com%2Ffda-approved-drugs-are-not-always-effective-the-benefits-of-alternative-medicine%2F2011.06.25 On Saturday, while thousands of Boston Bruins fans gathered at Government Center to celebrate the team’s recent Stanley Cup victory, a hundred or so true die-hards met a few blocks away at a Massachusetts General Hospital conference to talk about complementary and alternative medicine for psychiatric disorders. While I hated to miss the Bruins parade, I’m glad I attended the MGH conference. I’ve always been a bit of a skeptic about so-called natural therapies for one simple reason: they don’t have to go through the same rigorous testing in clinical trials that medications do. At the same time, I realize that FDA-approved drugs don’t work for everyone. One in three adults with major depression, for example, can’t completely improve their mood and other symptoms even after trying... Better Health blogs http://www.medworm.com/rss/comments.php?id=4968489 Sat, 25 Jun 2011 21:00:31 +0100 4968489 http://www.medworm.com/index.php?rid=4968448&cid=t_96265_87_f&fid=36224&url=http%3A%2F%2Ffeeds.wsjonline.com%2F%7Er%2Fwsj%2Fhealth%2Ffeed%2F%7E3%2FyZrEdU9ywW8%2F Weight-loss drug development is not for the faint of heart. Three companies — Orexigen, Arena and Vivus — had promising candidates before the FDA last year. All walked away empty-handed. Orexigen said earlier this month it was suspending U.S. development of its own candidate, Contrave, because the bar set by the FDA was impossible to clear. Arena and Vivus are pushing ahead to provide the agency with the information it has requested. Ken Fujioka thinks the current state of affairs is a shame. He’s a diabetologist and internal medicine specialist who directs the Center for Weight Management at the Scripps Clinic-Del Mar. (He’s also conducted clinical research with “multiple companies” working on obesity drugs.) In an op-ed that ran in the Washington Post ... WSJ.com: Health Blog blogs http://www.medworm.com/rss/comments.php?id=4968448 Fri, 24 Jun 2011 19:45:54 +0100 4968448 http://www.medworm.com/index.php?rid=4968421&cid=t_96265_86_f&fid=34445&url=http%3A%2F%2Fwomenshealthnews.wordpress.com%2F2011%2F06%2F24%2Fthe-fdas-new-report-on-silicone-breast-implant-safety%2F Did you know that women who get silicone breast implants should “assume that you will need additional surgeries,” and should get follow-up MRIs every couple of years? Over at Our Bodies Our Blog, I have summary of this and other information from the FDA’s new report on the safety of silicone breast implants, along with links to the agency’s additional resources on the topic, such as things to consider before getting implants, questions to ask your surgeon if you’re thinking of getting them, and more information on complications and adverse outcomes. Filed under: Body Image & Eating Disorders, Boobs, Government (Source: Women's Health News) Women's Health News blogs http://www.medworm.com/rss/comments.php?id=4968421 Fri, 24 Jun 2011 12:42:25 +0100 4968421 http://www.medworm.com/index.php?rid=4968909&cid=t_96265_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FVPghfLkLLqc%2F Good morning, everyone. Another working week is about to draw to a close and already, we are daydreaming about weekend plans. Our modest agenda includes catching up on some reading, tending to the official Pharmalot grounds and spending time with our short people. And you? Now that summer is here, perhaps a drive to the beach is in order. Or curling up with a good e-book. Of course, one can always take that proverbial walk in the park. Whatever you fancy, have a great time and see you soon… Patent Overhaul Bill Clears US Senate (Reuters) America’s Vanishing Science Jobs (The New York Post) EMA Delays Decision On Actos To July (Reuters) FDA Inspects New Ranbaxy Plant In India (The Economic Times) Commonly Used Drugs Raise Risk Of Death In The Elderly (Reuters) Pfizer To Keep 350... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4968909 Fri, 24 Jun 2011 11:56:33 +0100 4968909 http://www.medworm.com/index.php?rid=4968553&cid=t_96265_106_f&fid=36682&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FSutureForALiving%2F%7E3%2F1a2yYKT2U04%2Ffda-updates-safety-data-for-silicone.html Yesterday, the FDA published this press release:  FDA provides updated safety data on silicone gel-filled breast implants In November 2006, the FDA approved silicone gel-filled breast implants for breast augmentation in women over age 22 and for breast reconstruction in all women.  This latest report includes preliminary safety data from post-approval studies conducted by each of the two breast implant manufacturers (Allergan and Mentor), a summary and analysis of adverse events received over the years by the FDA, and a comprehensive review and analysis of recent scientific publications that discuss the safety and effectiveness of silicone gel-filled breast implants. Based on the report, women should know: Breast implants are not lifetime devices. The longer a woman has silic... Suture for a Living blogs http://www.medworm.com/rss/comments.php?id=4968553 Thu, 23 Jun 2011 17:01:00 +0100 4968553 http://www.medworm.com/index.php?rid=4960328&cid=t_96265_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FBKp9JbQ2S5I%2F Good morning, everyone. How are you today? Getting ready for those meetings and deadlines? We relate. There is much to do here on the Pharmalot corporate campus - reading, writing, chasing down interesting people. To prepare, we are brewing that reliable cup of stimulation - our flavor today is Rain Forest Nut. Feel free to join us. And to get things started, here are some tidbits. Have a good one and stay in touch… Bristol And Astra Diabetes Pill Faces Safety Hurdles (Bloomberg News) Biotechs Want Faster Drug Approvals (Boston Globe) Lilly CEO Blames Tax Laws And Immigration For Slower Innovation (Bloomberg News) Glaxo Ordered To Give Plaintiff Lists To United Health (Legal Intelligencer) Too Many UK Patients Are Prescribed Risky Drugs (Pharma Times) Abbott Labs Plant Closure Delaye... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4960328 Thu, 23 Jun 2011 11:54:26 +0100 4960328 http://www.medworm.com/index.php?rid=4960015&cid=t_96265_87_f&fid=36224&url=http%3A%2F%2Ffeeds.wsjonline.com%2F%7Er%2Fwsj%2Fhealth%2Ffeed%2F%7E3%2FbJ66k7H6Mak%2F Drug Vote: An FDA advisory panel voted not to recommend approval of Novartis’s Ilaris for gout pain, though it did say the drug is effective, the WSJ reports. Safety concerns, specifically the risk of serious infections, gave committee members pause, but several said it might be possible for the drug to be approved with restrictions, the paper says. The FDA often but not always follows the advice of its outside panels. Diabetes Risk?: A JAMA study of previously published research suggests high doses of cholesterol-reducing statin drugs may slightly increase the risk of developing type 2 diabetes, the New York Times reports. Experts tell the paper that statins still have a net benefit given that they can help cut the risk of heart attack and stroke, but that more study is needed on th... WSJ.com: Health Blog blogs http://www.medworm.com/rss/comments.php?id=4960015 Wed, 22 Jun 2011 13:04:45 +0100 4960015 http://www.medworm.com/index.php?rid=4953359&cid=t_96265_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FVV5N71KRqKg%2F The FDA hearing officer who is presiding over the upcoming Avastin review has rejected a request from her agency colleagues to require all outside scientific experts who speak at the meeting to disclose financial ties to Roche’s Genentech unit or rival manufacturers. The June 17 request had been made by FDA lawyers in the name of greater transparency. The two-day event, which begins June 28, stems from an unprecedented decision last year by the FDA to yank the breast cancer indication for the best-selling Avastin cancer med. That came after results of four clinical studies showed the drug does not prolong overall survival in breast cancer patients or provide a sufficient benefit in slowing disease progression to outweigh significant risks (see here). In response, Roche appealed the d... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4953359 Tue, 21 Jun 2011 18:10:01 +0100 4953359 http://www.medworm.com/index.php?rid=4953360&cid=t_96265_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FJ_ALGGujptA%2F If at first you don’t succeed, try, try again? Last year at this time, the FDA chastised CSL, a big maker of flu vaccines based in Australia, for flunking an inspection that found several manufacturing deficiencies and, in addition to demanding a summary of corrective actions, agency officials took the unusual step of demanding a meeting with senior execs to review their plan (back story). Apparently, such meetings have absolutely no impact. The FDA has just issued a warning letter as a follow up to a March 2011 inspection, which generated a 483 report showing that CSL has no idea how to properly conduct an investigation to determine why fevers and convulsions were reported after children were given its products. Just the same, the FDA wants another meeting. But how bad was the effo... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4953360 Tue, 21 Jun 2011 14:09:08 +0100 4953360 http://www.medworm.com/index.php?rid=4952779&cid=t_96265_87_f&fid=36224&url=http%3A%2F%2Ffeeds.wsjonline.com%2F%7Er%2Fwsj%2Fhealth%2Ffeed%2F%7E3%2FGNph6_C3V1A%2F Last fall the FDA proposed a host of new cigarette labels; today the agency announced its final selections, as the Wall Street Journal reports. While some of the nine new labels — including the one to the right — offer graphic depictions of the consequences of smoking, others focus on the impact secondhand smoke can have on other people, such as unborn fetuses, kids and nonsmoking relatives. One label notes that “quitting smoking now greatly reduces serious risks to your health.” The larger, more explicit warnings were required by a 2009 law that also banned candy- and fruit-flavored cigarettes and descriptions of cigarettes as “low-tar” and “light.” When we talked last fall to Jonathan Whiteson, medical director of NYU Langone Medical Center... WSJ.com: Health Blog blogs http://www.medworm.com/rss/comments.php?id=4952779 Tue, 21 Jun 2011 13:48:00 +0100 4952779 http://www.medworm.com/index.php?rid=4952780&cid=t_96265_87_f&fid=36224&url=http%3A%2F%2Ffeeds.wsjonline.com%2F%7Er%2Fwsj%2Fhealth%2Ffeed%2F%7E3%2FZhYZYUgMMGU%2F Medical Cases: The Supreme Court will hear an appeal from the Mayo Clinic challenging two Prometheus Laboratories patents for a diagnostic test determining drug dosages for certain autoimmune diseases, the WSJ reports. Mayo says Prometheus is trying to patent medical observations of a natural phenomenon; the company says its patents “describe concrete and improved methods of treating seriously ill patients.” Separately, the court said it wouldn’t consider an appeal by Pfizer’s Wyeth unit of a $58 million judgment in favor of three women who claimed Wyeth’s hormone-replacement drugs caused their breast cancer, the WSJ reports. Auditing Recalls: An audit of the FDA’s procedures for removing contaminated imported foods from U.S. shelves found the agency did... WSJ.com: Health Blog blogs http://www.medworm.com/rss/comments.php?id=4952780 Tue, 21 Jun 2011 12:55:34 +0100 4952780 http://www.medworm.com/index.php?rid=4953364&cid=t_96265_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fxf82daLCbCo%2F And now, a study confirms what many people probably already knew - those brief summaries about drug side effects, contraindications and effectiveness that appear in print advertisements can be hard to fathom. Or to put it another way, “the traditional method of conveying information in the brief summary is neither the most comprehensible nor the most preferred by consumers.” That’s the conclusion reached by a study in Medical Decision Making. The researchers asked 300 consumers who were in shopping malls and, at one time, had been told they overweight and told they needed to lose more than 15 pounds were qualified. About half were female. These people were shown four different brief summary formats as alternatives to the existing approach that usually has two pages in a p... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4953364 Mon, 20 Jun 2011 19:08:47 +0100 4953364 http://www.medworm.com/index.php?rid=4952782&cid=t_96265_87_f&fid=36224&url=http%3A%2F%2Ffeeds.wsjonline.com%2F%7Er%2Fwsj%2Fhealth%2Ffeed%2F%7E3%2FOM9kp_wLMG0%2F Border and port inspections alone aren’t sufficient to make sure the imported food and drugs consumed by U.S. residents are safe. That’s the word from the FDA, which today laid out a plan to monitor the rising tide of goods from abroad. It includes planned partnerships with counterpart regulators in other countries and better data-sharing between those regulators. The scope and scale of food and drug imports has increased dramatically, growing to 24 million shipments to the U.S. this year from 6 million shipments a decade ago, the report says. Imports of FDA-regulated products are growing at an estimated 15% annual rate. The agency has stepped up overseas inspections — there are now three FDA locations in China, for example — formed some alliances with other regulat... WSJ.com: Health Blog blogs http://www.medworm.com/rss/comments.php?id=4952782 Mon, 20 Jun 2011 18:34:59 +0100 4952782 http://www.medworm.com/index.php?rid=4953368&cid=t_96265_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FmZtV5T1ccqk%2F Beset by an inability to thoroughly monitor pharmaceutical ingredients and production around the world, the FDA has declared a new ‘global strategy’ to cope with the fast-paced industry changes that are straining its resources. And in issuing a 37-page report on the topic, the agency says the step reflects a lack of “resources to adequately keep pace with the pressures of globalization.” To illustrate the point, the FDA says that imports of pharmaceutical products have grown rapidly, at approximately 13 percent annually over the past seven years and accounted for more than 350,000 import lines in 2009. This volume accounted for approximately 30 percent by value of pharma products used annually. And the rise in imports has contributed to a growing trade deficit in ph... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4953368 Mon, 20 Jun 2011 14:25:44 +0100 4953368 http://www.medworm.com/index.php?rid=4952783&cid=t_96265_87_f&fid=36224&url=http%3A%2F%2Ffeeds.wsjonline.com%2F%7Er%2Fwsj%2Fhealth%2Ffeed%2F%7E3%2FfHUKuGPZ8jE%2F Waivers to End: After Sept. 22, employers won’t be able to apply for a waiver of the health-care overhaul law’s $750,000 minimum annual-benefit payout requirement, the WSJ reports. Health-benefit providers can be exempted from the requirement if it would mean a significant premium boost or benefits reduction; those receiving waivers so far have mostly been employers offering so-called mini-med, or limited-benefit, plans, the paper says. Not So Harmless: A study published in Pediatrics finds that an average of 23 kids drown each year in portable pools, in some cases in only a few inches of water, USA Today reports. According to the Consumer Product Safety Commission, about 11% of all pool drownings among kids under five occur in portable pools. Parents need to supervise kids jus... WSJ.com: Health Blog blogs http://www.medworm.com/rss/comments.php?id=4952783 Mon, 20 Jun 2011 10:56:28 +0100 4952783 http://www.medworm.com/index.php?rid=4945129&cid=t_96265_147_f&fid=39266&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FCreationInteractive%2F%7E3%2FtfIIu6iuEZE%2F No one wants to be wrong; ever. As much as there are trendy business mantras such as ‘Fail Fast’ which apparently encourage failure (as long as you learn quickly), it somehow just doesn’t translate to the world of a pharmaceutical company. In fact, ‘fail-fast’ is really an engineering concept that is most often considered in a research and development phase, long before a product reaches the general public where it might affect reputation. To be fair, any kind of ‘failure’ in the world of pharmaceutical companies can potentially result in a significant loss in some form or another which could include shareholder value, customer confidence, or general credibility, not to mention individual careers. Consequently, we are risk-averse. Rightly so. As much as no individual wants to... Creation Interactive blogs http://www.medworm.com/rss/comments.php?id=4945129 Fri, 17 Jun 2011 17:00:35 +0100 4945129 http://www.medworm.com/index.php?rid=4952787&cid=t_96265_87_f&fid=36224&url=http%3A%2F%2Ffeeds.wsjonline.com%2F%7Er%2Fwsj%2Fhealth%2Ffeed%2F%7E3%2Fff5Ff0xfAp4%2F Heart Risk?: The FDA says that people who already have cardiovascular disease may see their chances of a heart attack rise if they take Pfizer’s Chantix smoking-cessation drug, the WSJ reports. The agency based its warning on a trial of 700 heart-disease patients, and says it will update the product’s label and medication guide. Pfizer notes there are big heart benefits to be gained by quitting smoking. No Change: The Centers for Medicare and Medicaid Services will leave the issue of reimbursement for Amgen’s Aranesp and Epogen and Johnson & Johnson’s Procrit up to regional contractors rather than making a so-called national coverage determination, Bloomberg News reports. An analyst says the decision on the anemia drugs will remove an “overhang” on A... WSJ.com: Health Blog blogs http://www.medworm.com/rss/comments.php?id=4952787 Fri, 17 Jun 2011 12:51:52 +0100 4952787 http://www.medworm.com/index.php?rid=4945197&cid=t_96265_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F6lF6tGbTdbE%2F And so, another working week is about to draw to a close. This is, of course, our signal to daydream about weekend plans. For now, we intend to do some reading, catch up with our short people and promenade with the official Pharmalot mascots. And you? Anything special? Perhaps a drive in the country? A chance to meet with friends? Or maybe balance your checkbook and show the indebted nations how it’s done? Whatever your fancy, have a great time. Oh, and say ‘hi’ to Dad… FDA Reviewers Say Novartis Gout Drug Data Is Complicated (Reuters) Roche Faces Significant Hurdles For Avastin Breast Cancer Indication (Financial Times) UK Officials Say Pfizer Doing ‘Too Little’ As Plant Closes (BBC) FDA Approves Expanded Use Of Celgene Lymphoma Drug (Reuters) AstraZene... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4945197 Fri, 17 Jun 2011 12:15:14 +0100 4945197 http://www.medworm.com/index.php?rid=4934159&cid=t_96265_87_f&fid=39187&url=http%3A%2F%2Fgetbetterhealth.com%2Fwhat-to-expect-from-the-new-sunscreen-labels%2F2011.06.16 Yesterday, the U.S. Food and Drug Administration released the new rules regarding labeling of sunscreen.  The goal is to make it easier for the average person to chose a sunscreen. The new labels will not be in place until next summer, so you need to be aware. When the new labels are in place, NO sunscreen will be allowed to be labeled as a SUNBLOCK or as WATERPROOF. Under the new labeling rules Products that have SPF values between 2 and 14 may be labeled as Broad Spectrum if they pass the required test. Only products that are labeled both as Broad Spectrum with SPF values of 15 or higher may state that they reduce the risk of skin cancer and early skin aging, when used as directed. A warning statement will be required on any product that is not Broad Spectrum, or that is Broad Spect... Better Health blogs http://www.medworm.com/rss/comments.php?id=4934159 Thu, 16 Jun 2011 16:00:00 +0100 4934159 http://www.medworm.com/index.php?rid=4945200&cid=t_96265_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FCbqgDgPCnaw%2F In a highly unusual move, a Wall Street fund manager has filed a citizen’s petition with the FDA in an effort to prevent a small drugmaker from having its imaging agent reviewed. Why take such a step? The investor readily acknowledges that he holds a short position in the stock which, of course, means that he is betting the value of the shares will drop. The petition was filed by Martin Shkreli of MSMB Capital Management, who believes the FDA should decline to review a pair of Phase III clinical trials that were conducted by Neoprobe due to what he calls “severe deficiencies and flaws” (you can read the petition here). The move comes just as Neoprobe plans to submit an approval application for its Lymphoseek imaging agent with the FDA. Filing a citizen’s petition is... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4945200 Thu, 16 Jun 2011 15:25:38 +0100 4945200 http://www.medworm.com/index.php?rid=4945201&cid=t_96265_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FCwErfhk-Fqs%2F The FDA is often criticized for moving too slowly to approve new drugs, especially those for cancer. But is the agency as slow as some believe? To explore the question, researchers examined 35 oncology meds that were reviewed by the FDA and the European Medicines Agency between 2003 and 2010, and found the median approval time in the US took about half the time spent in Europe. Specifically, the median time for approval for new cancer meds in the US was six months, according to the paper by Friends of Cancer Research, a non-profit think tank that published the results in Health Affairs (read the abstract). However, they did not review initial approvals or supplemental applications, so their analysis did not include prominent secondary uses for drugs already on the market. The FDA approved ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4945201 Thu, 16 Jun 2011 13:50:37 +0100 4945201 http://www.medworm.com/index.php?rid=4934088&cid=t_96265_87_f&fid=36224&url=http%3A%2F%2Ffeeds.wsjonline.com%2F%7Er%2Fwsj%2Fhealth%2Ffeed%2F%7E3%2FbhK_6xJKL3o%2F Label Change: The FDA is warning that people using Takeda Pharmaceuticals’ diabetes drug Actos at higher cumulative doses and for longer periods of time may be at a higher risk of bladder cancer, the WSJ reports. The product’s label and medication guide will be updated to reflect the possible risk after interim study results suggested no overall link with cancer — but signs of an association amongst the heavier users. Takeda is sponsoring the study, which runs through 2012, and says that it remains committed to the drug. Eyeing Approval: In other FDA-related news, agency reviewers said VEGF Trap-Eye, Regeneron’s experimental drug for a form of macular degeneration is effective and doesn’t raise any major safety worries, the WSJ reports. Studies sponsored by th... WSJ.com: Health Blog blogs http://www.medworm.com/rss/comments.php?id=4934088 Thu, 16 Jun 2011 12:37:07 +0100 4934088 http://www.medworm.com/index.php?rid=4934163&cid=t_96265_87_f&fid=39187&url=http%3A%2F%2Fgetbetterhealth.com%2Fthe-right-to-bear-salt-is-sodium-restriction-warranted-for-the-general-population%2F2011.06.15 Q. What is the difference between a public health expert and Il Duce? A. Mussolini was not nearly as arrogant as a public health expert. In prior posts, DrRich related how two major publc health efforts over the past few decades – the effort to put all of us on low-fat diets, and the effort to reduce everyone’s cholesterol levels – have amounted to massive experiments, based upon insufficiently-tested assumptions and surmises and hypotheses which the experts arrogantly (and incorrectly) determined to be fact, and which were conducted upon the entire American population without its knowledge or consent. These public health experiments cost billions of dollars, needlessly transformed large swatches of American industry, and (at least in the case of low-fat diets) likely produced signif... Better Health blogs http://www.medworm.com/rss/comments.php?id=4934163 Wed, 15 Jun 2011 19:00:25 +0100 4934163 http://www.medworm.com/index.php?rid=4945188&cid=t_96265_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2011%2F06%2Ftwelve-steps-of-pharma-social-marketers.html Welcome to Pharma Social Marketers Anonymous (PSMA)! You are among friends.Soon, you will take important steps on the path to overcoming your fear of social media. The first step is to admit you are powerless over social media and that your online life has become unmanageable.Are you ready to take ALL 12 steps toward recovery?Here are the Twelve Steps of Pharma Social Marketers Anonymous:I admitted I was powerless over social media—that my online life had become unmanageable.I came to believe that a Power greater than myself – innovative outside digital ad agencies – could restore me to sanity.I made a decision to turn my will and my online projects over to the care of the first social media agency that walked through my door and impressed me with their knowledge and experience,... Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=4945188 Wed, 15 Jun 2011 17:09:00 +0100 4945188 http://www.medworm.com/index.php?rid=4934110&cid=t_96265_87_f&fid=36438&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FCato-at-liberty%2F%7E3%2FPghU4WPAWks%2F By Walter OlsonAs readers may know, I’ve been beating the drum for a while on the increasingly dangerous shortages that doctors are encountering in the availability of common, off-patent drugs used in hospital and clinical settings, including drugs that are important in chemotherapy, anesthesia, and infection control. Among the reasons for the shortages: the Food and Drug Administration has toughened its regulation of pharmaceutical makers in ways that lead to manufacturing line shutdowns and withdrawals from production. John Goodman has a must-read blog post at Health Affairs Blog on the mounting crisis, amplified by a post by George Mason economist Alex Tabarrok at Marginal Revolution, getting into further specifics. In particular: • 246 drugs are now considered to be in shortage... Cato-at-liberty blogs http://www.medworm.com/rss/comments.php?id=4934110 Wed, 15 Jun 2011 16:43:06 +0100 4934110 http://www.medworm.com/index.php?rid=4934276&cid=t_96265_106_f&fid=36682&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FSutureForALiving%2F%7E3%2FuGyLoGQiFyQ%2Fnew-fda-sunscreen-labeling.html Yesterday, the U.S. Food and Drug Administration released the new rules regarding labeling of sunscreen.  The goal is to make it easier for the average person to chose a sunscreen.  The new labels will not be in place until next summer, so you need to be aware. When the new labels are in place, NO sunscreen will be allowed to be labeled as a SUNBLOCK or as WATERPROOF.   Under the new labeling rules Products that have SPF values between 2 and 14 may be labeled as Broad Spectrum if they pass the required test. Only products that are labeled both as Broad Spectrum with SPF values of 15 or higher may state that they reduce the risk of skin cancer and early skin aging, when used as directed. A warning statement will be required on any product that is not Broa... Suture for a Living blogs http://www.medworm.com/rss/comments.php?id=4934276 Wed, 15 Jun 2011 11:15:00 +0100 4934276 http://www.medworm.com/index.php?rid=4934093&cid=t_96265_87_f&fid=36224&url=http%3A%2F%2Ffeeds.wsjonline.com%2F%7Er%2Fwsj%2Fhealth%2Ffeed%2F%7E3%2Fpvkf-nNAJAA%2F The FDA’s much-anticipated new sunscreen rules are out, nearly four years after the agency originally proposed changes. Though we’re all used to picking a sunscreen on the basis of its sun protection factor (SPF), that number refers only to UVB rays, which cause burning and skin cancer. The longer-wavelength UVA rays can wreak their own damage, though, including playing a role in premature aging and contributing to skin cancer. (Here’s how the Skin Cancer Foundation explains the types of radiation.) The FDA is now requiring sunscreens to indicate whether they protect against UVA rays, too. If you see “Broad Spectrum SPF” on the label, that means the product has cleared the agency’s bar for protecting against both types of ultraviolet radiation. And the S... WSJ.com: Health Blog blogs http://www.medworm.com/rss/comments.php?id=4934093 Tue, 14 Jun 2011 16:17:27 +0100 4934093 http://www.medworm.com/index.php?rid=4945192&cid=t_96265_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2011%2F06%2Fmajority-of-bad-ad-complaints-submitted.html According to a Bad Ad Program 2010-2011 Year End Report just issued by the FDA (see here), the program is a success despite the fact that ONLY 125 complaints were deemed worthy of "comprehensive review." The remaining 203 Bad Ad complaints were presumably filed away in DDMAC's circular file. Those 125 complaints worthy enough for review lead to 5 enforcement actions.The agency "does not view the total number of reports, or number of enforcement actions taken as the primary measures for program success," said FDA in the report. "Instead, FDA’s most important measure of success for this program is the heightened sense of awareness of misleading promotion among HCPs throughout the health care community and the likely useful deterrent this awareness has on drug promoters who might run afoul ... Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=4945192 Mon, 13 Jun 2011 18:18:00 +0100 4945192 http://www.medworm.com/index.php?rid=4921751&cid=t_96265_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FSl0FiwryeeY%2F An Illinois jury has awarded $625,000 to the estate of a man who was given a dosage of the heparin blood thinner that contained a contaminated ingredient, The Chicago Tribune writes. The verdict is the first against Baxter International and its supplier, Scientific Protein Laboratories, among hundreds of such lawsuits. Three years ago, the FDA determined the heparin contained fake ingredients from China. The heparin scandal, you may recall, focused a harsh light on the pharmaceutical supply chain, notably poorly supervised manufacturing in China and the inability of the FDA to perform sufficient oversight. The episode led to Congressional hearings and significant pressure on the agency to upgrade its supervision (see here, here and here). Attorneys for the estate of Steven Johansen of Oak ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4921751 Fri, 10 Jun 2011 12:41:17 +0100 4921751 http://www.medworm.com/index.php?rid=4921753&cid=t_96265_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FPIwO-IEL5xE%2F And so another working week will soon draw to a close. This is, of course, our signal to dream about weekend doings. Our modest agenda includes spending time with Mrs. Pharmalot and the short people, catching up on our own version of R&D - a never-ending quest - and maybe taking a nap. And you? Perhaps there will be time for a walk in the park? A moment with someone special? Or seize the moment and make plans to enter the Republican presidential primary? Whatever you do, have a great time. See you soon… Bristol-Myers Resolves Problems At Puerto Rico Plant (Dow Jones) Japan Does Not Plan To Recall Actos (Reuters) Germany Joins France In Suspending Actos (Reuters) FDA Links Some Prostate Drugs To Cancer Risk (Associated Press) Sanofi CEO Tells Canada To Upgrade Patent Protection (... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4921753 Fri, 10 Jun 2011 12:02:18 +0100 4921753 http://www.medworm.com/index.php?rid=4921379&cid=t_96265_87_f&fid=36224&url=http%3A%2F%2Ffeeds.wsjonline.com%2F%7Er%2Fwsj%2Fhealth%2Ffeed%2F%7E3%2FG-ljtAmqcGk%2F Lower Dose: The FDA says the 80-mg dose of Merck’s cholesterol drug Zocor, also known as simvastatin, shouldn’t be prescribed for new patients or those taking certain other drugs because of an increased risk of muscle problems, the WSJ reports. Simvastatin, available as a generic and also a component of Merck’s Vytorin and Abbott’s Simcor, is most frequently prescribed in 20- or 40-mg doses, the paper says. Uniquely Positioned?: Blue Shield of California’s move to cap profits may not easily be duplicated by other health insurers, Kaiser Health News reports. The company’s not-for-profit status means it’s not answerable to shareholders, and it has healthy reserves and higher-than-average margins. Other nonprofits may offer some form of policyholder r... WSJ.com: Health Blog blogs http://www.medworm.com/rss/comments.php?id=4921379 Thu, 09 Jun 2011 11:27:02 +0100 4921379 http://www.medworm.com/index.php?rid=4911815&cid=t_96265_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FgRHackJWG0U%2F Pfizer is voluntarily suspending US sales of its Roxarsone product, which has been used as a chicken-feed additive by poultry farmers for nearly 70 years, after a recent FDA study of 100 broiler chickens found inorganic arsenic, a known carcingoen, at higher levels in the livers of chicken that were given the med compared with untreated chickens. Roxarsone contains organic arsenic, which is a less toxic form of arsenic, but this can transform into inorganic arsenic, according to the FDA which, by the way, maintains levels detected were very low and continuing to eat chicken does not pose a health risk. However, chronic exposure is known to cause cancer and has been linked to heart disease, diabetes and declining brain function. Organic arsenic is added to the feed of most roasters grown in... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4911815 Wed, 08 Jun 2011 18:58:08 +0100 4911815 http://www.medworm.com/index.php?rid=4911824&cid=t_96265_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FAutTWJ-YZYs%2F Faced with growing challenges in clinical trials, manufacturing and drug safety - among many other issues - the FDA has decided to elevate the Office of Compliance to a so-called Super Office on a par with others in the Center For Drug Evaluation and Research, such as the Office of New Drugs, the Office of Pharmaceutical Science and the Office of Surveillance and Epidemiology. The responsibilities will include ensuring compliance with requirements for good manufacturing practice, good clinical practice, human subject protection, adverse event and drug quality reporting, REMS, drug labeling, drug approval, drug importation, and supply chain integrity, among others, according to a memo from CDER director Janet Woodcock. And the new super compliance office will also have three officewide func... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4911824 Tue, 07 Jun 2011 12:06:07 +0100 4911824 http://www.medworm.com/index.php?rid=4902416&cid=t_96265_87_f&fid=39187&url=http%3A%2F%2Fdrlindagalloway.files.wordpress.com%2F2011%2F06%2Fbookjpg.jpg Of the 4 million babies born in the U.S. each year, approximately 12.3 percent of them will be premature and 3.56 percent will occur before 34 weeks. Premature birth is one of the leading causes of severe handicaps and has an annual cost of approximately $26 billion dollars. Although risk factors for preterm labor have been identified, there is still no cure. As stated in a previous blog post, when the cervix becomes weak (a condition called cervical insufficiency), the patient is at risk for second trimester miscarriages and preterm labor. Also, if a patient has a previous history of premature birth then she needs her cervix measured in a future pregnancy.  If her cervix is short and measures between 16 mm and 25 mm before 23 weeks, she is at risk for premature labor and delivery. The re... Better Health blogs http://www.medworm.com/rss/comments.php?id=4902416 Mon, 06 Jun 2011 21:00:23 +0100 4902416 http://www.medworm.com/index.php?rid=4893379&cid=t_96265_87_f&fid=36224&url=http%3A%2F%2Ffeeds.wsjonline.com%2F%7Er%2Fwsj%2Fhealth%2Ffeed%2F%7E3%2Fg2JDR4uZ71w%2F What does it take to get an obesity drug approved by the FDA? In the case of Orexigen’s Contrave, a lot. Namely, a trial of between 60,000 and 100,000 patients showing that the drug — rejected by the FDA in February — doesn’t raise the risk of heart attack or stroke, the company says. As Dow Jones Newswires reports, Orexigen has suspended its U.S. development of Contrave, saying that a trial of that scale is neither feasible nor necessary. The company had proposed a trial of something closer to 12,000-15,000 patients, with an interim analysis in early 2013. But Orexigen says the FDA rejected that proposal as inadequate. Nor would it approve the drug, in the meantime, for people with a lower risk of heart problems, Orexigen says. (Previous studies have suggested a li... WSJ.com: Health Blog blogs http://www.medworm.com/rss/comments.php?id=4893379 Fri, 03 Jun 2011 17:34:05 +0100 4893379 http://www.medworm.com/index.php?rid=4893913&cid=t_96265_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FZzoVYKju9hA%2F Four months after receiving a complete response letter from the FDA for its Contrave diet pill, Orexigen Therapeutics has now put further development on hold after receiving an “unprecedented” request for a pre-approval clinical trial that the aspiring drug developer believes “would generate significantly more information than is necessary or feasible.” As a result, Orexigen plans an appeal this month. At issue are concerns over cardiovascular risks that prompted the FDA to request a randomized, double-blind, placebo-controlled trial. In fact, the FDA told Orexigen execs that the agency plans to hold an advisory committee meeting early next year to assess cardiovascular issues with diet drugs, in general. This is only the latest indication the FDA is raising a high ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4893913 Fri, 03 Jun 2011 13:28:00 +0100 4893913 http://www.medworm.com/index.php?rid=4893910&cid=t_96265_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2011%2F06%2Ffirst-fda-social-media-guidance-to.html Yesterday, my post "FDA Drops Social Media from Its 2011 Guidance Agenda" (here) created quite a stir on Twitter. We had a good discussion of this on last nights #socpharm chat.All the hubbub revolved around the fact that FDA's 2011 guidance agenda did NOT include "Promotion of Prescription Drug Products Using Social Media Tools", which WAS on the 2010 Agenda. What IS included in the 2011 agenda, however, is "Responding to Unsolicited Requests for Prescription Drug and Medical Device Information, Including Those Encountered on the Internet."I didn't understand what "Responding to Unsolicited Requests" had to do with social media and technically, FDA's 2011 guidance agenda does NOT mention social media, hence the title of my blog post.Jean-Ah Kang, Special Assistant to Tom Abrams at DDMAC, ... Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=4893910 Thu, 02 Jun 2011 14:07:00 +0100 4893910 http://www.medworm.com/index.php?rid=4893891&cid=t_96265_147_f&fid=39273&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FePharmaSummit%2F%7E3%2Ft7wH1M2yXiY%2Fmedical-apps-have-fda-regulation-on-way.html Medical apps are slated to get FDA guidance later this year through the Center for Devices and Radiological Health. The majority of apps being used by the medical world today are information based and are therefore not required to be FDA approved, but next generation apps will be instrumental in the diagnosis and treatment of patients, making it more important to regulate them. According to American Medical News, the FDA has recently indicated that it will begin to regulate these, and could provide a guidance later this year. The Center for Devices and Radiological Health will be the ones regulating and issuing guidance for these apps. Some companies have gone ahead and applied for approval on an ad hoc basis, but it is likely that this will get tougher to do in the coming year. ePharma... ePharma Summit blogs http://www.medworm.com/rss/comments.php?id=4893891 Wed, 01 Jun 2011 16:29:00 +0100 4893891 http://www.medworm.com/index.php?rid=4893389&cid=t_96265_87_f&fid=36224&url=http%3A%2F%2Ffeeds.wsjonline.com%2F%7Er%2Fwsj%2Fhealth%2Ffeed%2F%7E3%2FrHtSGemKBrE%2F Melanoma Focus: Two of the as-yet unreleased studies to be highlighted at the upcoming annual meeting of the American Society of Clinical Oncology will deal with melanoma drugs — one from Bristol-Myers Squibb and another from Roche and Daiichi Sankyo, Dow Jones Newswires reports. The study of Bristol-Myers’ Yervoy, which was approved by the FDA in March for late-stage disease, will look at how it performs in newly diagnosed melanoma patients who are also on chemotherapy. Willing to Pay: Novartis will pay as much as $3 billion for the right acquisitions in veterinary medicine, consumer health, generic drugs, biotech or diagnostics, Bloomberg News reports, citing an interview with CEO Joe Jimenez. He wouldn’t comment, however, on analyst speculation that the pharma giant wo... WSJ.com: Health Blog blogs http://www.medworm.com/rss/comments.php?id=4893389 Wed, 01 Jun 2011 12:46:14 +0100 4893389 http://www.medworm.com/index.php?rid=4893911&cid=t_96265_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2011%2F06%2Ffda-drops-social-media-from-its-2011.html I just downloaded the "Guidance Agenda: New & Revised Draft Guidances CDER is Planning to Publish During Calendar Year 2011" from the FDA site (find it here). Missing from this agenda is "Promotion of Prescription Drug Products Using Social Media Tools", which WAS on the 2010 Agenda (see here).However, included in the 2011 agenda under the Advertising Category is "Responding to Unsolicited Requests for Prescription Drug and Medical Device Information, Including Those Encountered on the Internet." Is this supposed to be the promised guidance we've all been waiting for? "Responding to unsolicited requests" is NOT a social media issue nor was it one of the questions FDA asked at the November 2009, public hearing (see all the questions here).I don't know who/what to believe. In February, 2... Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=4893911 Wed, 01 Jun 2011 12:37:00 +0100 4893911 http://www.medworm.com/index.php?rid=4883903&cid=t_96265_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FL2T8dkrEaLw%2F One month after a pair of studies found that women taking birth control pills containing a hormone called drospirenone are more likely to develop blood clots than those who take an older oral contraceptive, the FDA has decided to review the evidence. But since other studies have not reported the same risk, the agency is not taking any additional action at this time. The most widely known oral contraceptives containing this hormone are the Yaz and Yasmin pills sold by Bayer. You may recall that one study reviewed insurance data for US women aged 15 to 44 who took a contraceptive pill containing either drospirenone or levonorgestrel after January 2002, and compared 186 women who had had a blood clot with 681 who had not. Those taking newers pill had a 2.3 times greater risk for a blood clot... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4883903 Tue, 31 May 2011 22:12:39 +0100 4883903 http://www.medworm.com/index.php?rid=4872477&cid=t_96265_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FgXmYGKYgYhk%2F A study run by the National Institutes of Health was ended 18 months early after finding that adding Niaspan to a statin in people with heart disease did not reduce the risk of cardiovascular events, including heart attacks and strokes. Moreover, Niaspan may have boosted the risk of ischemic events, raising questions about the benefit of raising HDL, or so-called good cholesterol, to fight heart disease. The 3,414-person study, which added the Abbott Laboratories pill to Merck’s Zocor, found the combination was linked to stroke in 1.6 percent of patients, compared with 0.7 percent among those given a placebo. The combo failed to reduce heart attacks, heart-related hospitalizations and the need for procedures to reduce chest pain and restore strong blood flow to the heart. “The... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4872477 Thu, 26 May 2011 16:07:59 +0100 4872477 http://www.medworm.com/index.php?rid=4872096&cid=t_96265_87_f&fid=39187&url=http%3A%2F%2Fgetbetterhealth.com%2Fchantix-lawsuits-the-next-greatest-get-rich-quick-scheme-for-smokers%2F2011.05.26 Chantix lawsuits here we come.  I’ve been prescribing Chantix and helping fill out forms for free Chantix for my patients for several years now.  Chantix is one medicine used to help get patients to quit smoking right now.  In fact, I even had a case presentation of a woman I warned to quit smoking for good or face a lifetime of being cross eyed. Does Chantix help to quit smoking? Yes it does.  It helps to take the cravings away in folks who use it.  If you smoke, you should want to quit, based on my discussions with a tobacco farming insider.  If nothing has helped, Chantix might be your last hope.  As a hospitalist, I always offer Chantix therapy as part of my smoking lecture (that I bill out as smoking cessation CPT 99406 or 99407) With the average cost of cigarettes... Better Health blogs http://www.medworm.com/rss/comments.php?id=4872096 Thu, 26 May 2011 16:00:00 +0100 4872096 http://www.medworm.com/index.php?rid=4872478&cid=t_96265_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FNiLoxnKRUDE%2F The Duke University researcher who consulted for Sanofi at the same he implored the FDA not to approve a med from a rival drugmaker is now being investigated for failing to disclose his financial ties. Last March, thrombosis expert Victor Tapson wrote the agency to argue that generic versions of Lovenox may not be as safe as the brand-name med, but he did not mention his relationship to Sanofi. His work on behalf of Sanofi was disclosed yesterday in a US Senate Finance Committee report that detailed how Sanofi also engaged two medical societies to encourage the FDA to delay approval of a rival med the drugmaker feared would undercut its blockbuster Lovenox bloodthinner. Sanofi paid more than $5 million to the two medical societies, including $260,600 to Duke’s Tapson (back story). And no... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4872478 Thu, 26 May 2011 14:46:08 +0100 4872478 http://www.medworm.com/index.php?rid=4872098&cid=t_96265_87_f&fid=39187&url=http%3A%2F%2Fgetbetterhealth.com%2Fdo-you-know-how-to-recognize-deadly-bacterial-meningitis%2F2011.05.26 One of the most feared infectious diseases for outdoor travelers—particularly children and young adults—meningitis caused by the bacterium Neisseria meningitidis (meningococcus). The infection can appear in outbreaks, most commonly abroad, particularly in sub-Saharan Africa and China. The infection is spread in the respiratory secretions of humans. The disease appears in many forms, the most common of which are meningitis, pneumonia, and disseminated bacterial infection. The typical presentation of meningitis is fever, headache, and a stiff neck. If the cause is meningococcus, the victim may develop a skin rash, which consists of red dots or bumps, or a flat, more patchy dark red discoloration. If the dark red dots begin to enlarge and coalesce into large purplish bruise-like... Better Health blogs http://www.medworm.com/rss/comments.php?id=4872098 Thu, 26 May 2011 11:00:00 +0100 4872098 http://www.medworm.com/index.php?rid=4862920&cid=t_96265_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FwIP6GVupYbw%2F Sanofi contributed more than $5 million to two medical groups and a Duke University researcher that encouraged the FDA to delay approval of a medicine the drugmaker feared would undercut its blockbuster Lovenox bloodthinner, according to a US Senate Finance Committee report released this morning. The Society of Hospital Medicine, the North American Thrombosis Forum and Duke University thrombosis expert Victor Tapson wrote to the FDA to argue that generic versions of Lovenox may not be as safe as Lovenox, but the letters did not mention any ties to Sanofi, according to the Senate findings, which were first reported by The Wall Street Journal. Just the same, the FDA last summer approved a generic from Momenta Pharmaceuticals and Sandoz, the Novartis generics unit (back story here and here).... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4862920 Wed, 25 May 2011 12:55:52 +0100 4862920 http://www.medworm.com/index.php?rid=4862922&cid=t_96265_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FWOR8kB8UEnM%2F In response to regulatory demands and mounting litigation, drugmakers have puffed up their product labeling to the point where the verbiage occupies numerous pages and contains a laundry list of possible side effects. Yet all these warnings have a down side, because they may undermine patient adherence and overwhelm docs as they try to find suitable treatments, according to a new study. In fact, the study found that the list of potential side effects averaged 70 per drug, and the 200 most widely prescribed meds averaged 105 possible adverse events, leading to what the researchers labeled (pun intended) overwarning. The study, which analyzed 5,602 labels and was published in The Archives of Internal Medicine, even found one label listing 525 possible side effects. “The idea that lab... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4862922 Wed, 25 May 2011 12:03:18 +0100 4862922 http://www.medworm.com/index.php?rid=4862918&cid=t_96265_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2011%2F05%2Fsanofis-strategic-use-ie-bribery-of.html In a report titled "Sanofi's Strategic Use of Third Parties to Influence the FDA," the Senate Finance Committee said Sanofi SA "contributed more than $5 million to two medical groups and a medical researcher that encouraged U.S. regulators to delay approval" of the generic version of Levenox, a bloodthinner that had global sales exceeding $4 billion in 2009.According a WSJ article (see "Sanofi Pays Doctors to Dis Generic Version of Lovenox"), "between 2007 and 2010, the company contributed more than $2.6 million to the Society of Hospital Medicine; more than $2.3 million to the North American Thrombosis Foundation, which studies blood clots; and more than $260,000" to Dr. Victor Tapson, thrombosis specialist and faculty member in the Pulmonary, Allergy and Critical Care Medicine division o... Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=4862918 Wed, 25 May 2011 11:04:00 +0100 4862918 http://www.medworm.com/index.php?rid=4862498&cid=t_96265_87_f&fid=36224&url=http%3A%2F%2Ffeeds.wsjonline.com%2F%7Er%2Fwsj%2Fhealth%2Ffeed%2F%7E3%2FdEjfxIxCcbc%2F Vertex Pharmaceuticals CEO Matt Emmens came by Health Blog HQ today to chat about yesterday’s FDA approval of the hepatitis C drug Incivek and what’s up next for the company. As for that approval, he told us and our WSJ and Dow Jones Newswires colleagues that the first prescriptions were coming in within an hour or so of the announcement. About 100,000 patients have been waiting for the drug, he says, and millions more  — both those who are diagnosed and those unknowingly carrying the virus — are eligible for it. (Here’s the DJN story.) As has been much discussed, Vertex and Merck will be rolling out new hep C drugs — Merck’s Victrelis was approved last week — at the same time. Emmens says there’s plenty of room for both drugs in the m... WSJ.com: Health Blog blogs http://www.medworm.com/rss/comments.php?id=4862498 Tue, 24 May 2011 21:08:17 +0100 4862498 http://www.medworm.com/index.php?rid=4862926&cid=t_96265_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fq283udIKjWI%2F In another effort to shed light on untoward relationships, the FDA has just issued a draft guidance on financial conflicts of interest for clinical investigators and the drugmakers that enlist their assistance. The document is designed to revise a 10-year set of rules and address an issue that has grown increasingly contentious in recent years. “During the intervening years, interest has grown in the public disclosure of industry financial arrangements with physicians,” the agency writes. The “FDA is striving to achieve a proper balance between transparency and the right to privacy of clinical investigators with respect to their financial arrangements as expressed in the agency’s protection of privacy regulation.” The guidance would require any drugmaker to submit... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4862926 Tue, 24 May 2011 15:43:46 +0100 4862926 http://www.medworm.com/index.php?rid=4862928&cid=t_96265_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FYbxeh9RwSNI%2F While the FDA continues to ponder rules for social media, Facebook is now changing its own rules and will no longer allow drugmakers to disable comments posted on newly created pages. And existing pages will no longer be able to do so as of August 15, according to InTouch Solutions. The move reportedly came by way of email last week: “As you know, Facebook Pages are a free product for organizations, public figures, businesses, and brands to express themselves and have an authentic, engaging, two-way dialog with people on Facebook…We think these policy changes support consistency for the Facebook Pages product and encourage an authentic dialogue between people and businesses on Facebook.” The social media gorilla goes on to acknowledge the changes may cause pharma to &#82... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4862928 Tue, 24 May 2011 13:19:52 +0100 4862928 http://www.medworm.com/index.php?rid=4862501&cid=t_96265_87_f&fid=36224&url=http%3A%2F%2Ffeeds.wsjonline.com%2F%7Er%2Fwsj%2Fhealth%2Ffeed%2F%7E3%2FzsD7Il1kI1Y%2F Hep C Drugs: Incivek, the hepatitis C drug from Vertex Pharmaceuticals and Johnson & Johnson, won FDA approval, setting up a marketing battle with Merck’s new drug Victrelis, which was approved a week ago, the WSJ reports. Both drugs are added to existing therapies and will be expensive; a course of Victrelis will cost between $26,400 and $48,400, and 12 weeks of Incivek will cost $49,200, the paper says. Paper vs. Paper: Two seemingly conflicting studies have been published on the subject of serotonin levels and bone density, with one research group finding that blocking serotonin production in the guts of mice can help stave off osteoporosis and another group finding no connection, the New York Times reports. The question is important because if there is a causal relationship, ... WSJ.com: Health Blog blogs http://www.medworm.com/rss/comments.php?id=4862501 Tue, 24 May 2011 12:31:12 +0100 4862501 http://www.medworm.com/index.php?rid=4853217&cid=t_96265_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FZdvfQlG4ejw%2F The ‘phantom recall’ scandal last year in which Johnson & Johnson hired contractors to yank over-the-counter meds such as Motrin from store shelves rather than conduct a proper recall prompted congressional hearings and contributed to a consent decree, among many other things. And during one hearing, the FDA agreed to review procedures that allowed the health care giant to, essentially, circumvent agency oversight (back stories here, here and here). Now, though, Darrell Issa, who chairs the House Committee on Oversight and Government Reform, which held those hearings, has written FDA commish Margaret Hamburg to say the agency has failed to take “promised and necessary corrective actions at its San Juan office.” And he complains that he encountered “great ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4853217 Mon, 23 May 2011 18:19:57 +0100 4853217 http://www.medworm.com/index.php?rid=4852836&cid=t_96265_87_f&fid=36224&url=http%3A%2F%2Ffeeds.wsjonline.com%2F%7Er%2Fwsj%2Fhealth%2Ffeed%2F%7E3%2F0aDeuXe8Ntc%2F In his latest print column and blog post, the WSJ’s Numbers Guy digs into the debate over Eli Lilly’s test to detect in live patients the presence of beta-amyloid plaques associated with Alzheimer’s disease. The test involves injecting a radioactive substance called florbetapir F 18, or Amyvid, followed by a PET scan. But as the Numbers Guy points out, reading this and other imaging studies is not always as straightforward as you might think. In the Amyvid study, physicians who read the scans gave them a numerical score pegged to the level of amyloid detected. But researchers reported “the median, the middle number when a group of figures are put in numerical order. In this case, that amounted to discarding the high and low scores on each patient’s brain scans... WSJ.com: Health Blog blogs http://www.medworm.com/rss/comments.php?id=4852836 Mon, 23 May 2011 15:35:47 +0100 4852836 http://www.medworm.com/index.php?rid=4853219&cid=t_96265_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F0YpF1gE-5K8%2F Could data mining medical literature uncover side effects before they cause serious harm to patients? A new study maintains the effort could effectively complement existing methods, such as combing through the FDA’s Adverse Events Reporting database, because prior research suggests that up to 98 percent of searches are irrelevant to side effects and may skew results toward false positive links. To prove the point, two researchers from the Rank think tank developed an algorithm to sift through the PubMed literature and searched for mentions of least one of 38 drugs and 55 side effects. From there, they determined the relevance of the articles and forecast expected rates of adverse events. They would up analyzing 9,133 articles published between 1949 and September 2009, plus others tha... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4853219 Mon, 23 May 2011 14:18:21 +0100 4853219 http://www.medworm.com/index.php?rid=4852837&cid=t_96265_87_f&fid=36224&url=http%3A%2F%2Ffeeds.wsjonline.com%2F%7Er%2Fwsj%2Fhealth%2Ffeed%2F%7E3%2FNDlWsDrkqts%2F New HIV Drug Option: The FDA approved Johnson & Johnson’s HIV drug rilpivirine, which will be marketed as Edurant and used in combination with other drugs in previously untreated patients infected by the virus, Dow Jones Newswires reports. The drug blocks replication of HIV. Waiting Lists: Meantime, tight-budgeted states are trimming programs that assist low-income HIV patients to purchase antiretroviral and other drugs, Kaiser Health News and the Washington Post report. At least 8,300 people are now on state waiting lists for assistance, KHN says. Google Warned?: Regulators and others warned Google that many of its online drugstore advertisers were breaking laws against prescribing without a doctor’s prescription, selling fake drugs and improperly selling controlled substa... WSJ.com: Health Blog blogs http://www.medworm.com/rss/comments.php?id=4852837 Mon, 23 May 2011 12:52:23 +0100 4852837 http://www.medworm.com/index.php?rid=4853216&cid=t_96265_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2011%2F05%2Ffda-doj-google-conspiracy-theory-part-2.html Last week, I suggested that the FDA’s infamous 14 warning letters sent to major pharma companies regarding violative search engine ads may have been a "shot across Googles bow," intended to force Google to halt its acceptance of ads from "illegal" online pharmacies (see "How FDA, in Cahoots with DOJ, Brought Google Down").Many people did not take my "conspiracy theory" seriously. Some pooh-poohed my suggestion that the FDA was involved. One commenter to my blog said "OMG... what a stretch...I'm sure they are laughing at you at FDA."It turns out that the FDA WAS INVOLVED in the criminal investigation of Google by the Department of Justice (DOJ).Today, the Wall Street Journal reports that "as part of the criminal investigation, undercover agents for the Food and Drug Administration contact... Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=4853216 Sat, 21 May 2011 12:47:00 +0100 4853216 http://www.medworm.com/index.php?rid=4848152&cid=t_96265_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FIJJqdimReMk%2F Two years after the FDA warned Apotex about severe manufacturing problems at one of its plants, the agency has issued a so-called close out letter that, essentially, gives the drugmaker a green light to resume shipments to the US. However, the FDA notice did not mention problems cited with another plant that were noted in a separate warning letter issued to Apotex last year (read the close out letter). The move may largely end a difficult episode for had been one of the biggest providers of generic drugs to the US. A June 2009 warning letter detailed numerous lapses, notably failing to fully investigate why batches of various products did not meet specifications. Three months later, the FDA issued an import alert for all meds made at this facility and the other plant, which was the subject... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4848152 Fri, 20 May 2011 11:43:34 +0100 4848152 http://www.medworm.com/index.php?rid=4848154&cid=t_96265_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FkTurjNnKuyc%2F And so another working week will soon draw to a close. This is, of course, our signal to daydream about weekend plans. Our modest agenda includes yardwork, hanging with assorted short people and another installment in the ‘Let’s-see-them-before-they-die‘ concert series. And you? Anything special in the pipeline? How about curling up with a good e-book? Or a dinner with a favorite someone? Or maybe just a walk in the park? Whatever you do, have a great time and be safe. See you soon… FDA Approves J&J HIV Med For Combo Use (Reuters) EU OKs Bloodthinner From Pfizer And Bristol (Associated Press) EMA Approves Glaxo And Human Genome’s Benlysta For Lupus (Reuters) Pfizer Truck Robbed On Way To CVS (Securing Pharma) AstraZeneca To Eliminate 135 Jobs In Massachus... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4848154 Fri, 20 May 2011 11:39:57 +0100 4848154