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 'approval'. Sat, 03 Sep 2011 01:55:58 +0100 http://www.medworm.com/index.php?rid=5182033&cid=t_123614_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=5174611&cid=t_123614_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=5174618&cid=t_123614_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=5159923&cid=t_123614_180_f&fid=38608&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FLifeDev%2F%7E3%2Fq98fymxte88%2F Social proof is a powerful trigger, and it’s often overlooked by many. If a restaurant waiting list is hours long, odds are there’s a good reason. Why else would people waste time and stand in line if the food wasn’t great? The online version of social proof is a bit more nuanced. There are tons of ways to attract and showcase proof that people actually appreciate your stuff. And the larger the number, the better. These could be numbers of…. likes stumbles number of comments votes +1′s fans favorites saves shares forwards subscribers followers retweets clips views thumbs up sales stars watches All of these combine to show the visitor how great other people think your stuff is. But here’s the kicker: You can’t collect social proof without actuall... LifeDev blogs http://www.medworm.com/rss/comments.php?id=5159923 Mon, 22 Aug 2011 13:16:01 +0100 5159923 http://www.medworm.com/index.php?rid=5130744&cid=t_123614_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=5130752&cid=t_123614_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=5096204&cid=t_123614_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=5050880&cid=t_123614_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=5028220&cid=t_123614_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=4992990&cid=t_123614_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=4984687&cid=t_123614_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=4984690&cid=t_123614_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_123614_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=4853216&cid=t_123614_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=4747883&cid=t_123614_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FjVn9aALfCCc%2F Here is yet another possible indication that the FDA is getting still tougher with its approval process. A review of so-called refuse-to-file letters - in which the agency refuses to file an application for approval review - finds that these missives are no longer being received by only the small, most inexperienced biotechs. Rather, a growing number are going to big pharma. Among big drugmakers receiving an RTF in the last two years were Pfizer, Novartis, Roche and Merck, as well as Gilead Sciences, one of the largest biotechs, according to Leerink Swann analyst Howard Liang. In fact, all but one was issued in the past eight months. And prior to that, none of the 17 RTFs sent since 1998 that he identified was issued to a top-tier biopharma, he writes in an investor note. What might this ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4747883 Mon, 25 Apr 2011 13:01:45 +0100 4747883 http://www.medworm.com/index.php?rid=4724268&cid=t_123614_151_f&fid=35818&url=http%3A%2F%2Frecoveryissexy.com%2Fresolve-to-be-thyself%2F Resolve to be thyself; and know that who finds himself, loses his misery.–Matthew ArnoldIn recovery from alcoholism, addiction and ACOA our need for approval compels us to try to look good – no matter what’s going on. We imagine that somehow everything will be okay as long as it looks okay. Our hearts may be breaking from fear, disillusionment, and rejection, real or imagined, but we keep smiling so that no one will guess. Why do we do this to ourselves? Is it so hard to turn to a friend and say, “Hey, I’m hurting. I’ve been having a bad time and I need help”? Would the earth tremble if we said it right out, just like that?We’re not likely to get what we don’t ask for.  Instead of denying that our knees are shaking, our hands are sweat... Recovery Is Sexy.com blogs http://www.medworm.com/rss/comments.php?id=4724268 Mon, 18 Apr 2011 16:21:00 +0100 4724268 http://www.medworm.com/index.php?rid=4704954&cid=t_123614_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FNe6vaqZAGEo%2F Despite weeks of haggling, Roche and the FDA remain unable to agree on the questions that must be addressed during the upcoming June hearing that will be held to decide whether the agency will proceed with plans to remove the metastatic breast cancer indication for the Avastin. The two sides are so far apart, in fact, that each one has submitted separate documents summarizing their differing views of the key questions to be addressed. Some quick background: The FDA decided to yank the breast cancer indication after results of four clinical studies showed that Avastin does not prolong overall survival in breast cancer patients or provide a sufficient benefit in slowing disease progression to outweigh significant risks. These include severe high blood pressure; bleeding and hemorrhage; devel... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4704954 Tue, 12 Apr 2011 16:31:32 +0100 4704954 http://www.medworm.com/index.php?rid=4693505&cid=t_123614_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F1ht08wD4WlQ%2F The run-up to what will be a closely watched FDA meeting this coming June to review the Avastin cancer med is prompting some interesting behind-the-scenes sparring between the agency and Roche. To wit, in a recent letter to different FDA officials, Covington & Burling attorney Michael Labson, who represents Roche’s Genentech unit, accused the FDA Oncologic Drugs Advisory Committee of bias. Why? In his view - and obviously, the view of the drugmaker - there are concerns about “objectivity and fairness.” To underscore this contention, Labson writes in his March 10 missive that nearly all members of the committee last July voted to withdraw FDA approval for the metastatic breast cancer indication for Avastin (back story). And since then, various committee members were q... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4693505 Fri, 08 Apr 2011 13:26:24 +0100 4693505 http://www.medworm.com/index.php?rid=4642994&cid=t_123614_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FCNw4FaSlyn0%2F To prompt drugmakers to follow through more quickly on post-marketing studies required as part of the controversial acceleted approval program, several FDA officials suggest the agency make use of an existing provision of a 2007 law - issuing fines of up to $10 million. And the FDA may also require post-marketing studies get under way before expedited approval is granted, according to agency officials who floated the possibilities in a new article in the Journal of the National Cancer Institute. The tougher approach for oncology meds is being considered in the wake of considerable handwringing after two episodes last year that questioned the veracity of the FDA accelerated approval program. Last June, Pfizer withdrew a drug used to treat acute myeloid leukemia, or AML, after a study found... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4642994 Mon, 28 Mar 2011 15:46:53 +0100 4642994 http://www.medworm.com/index.php?rid=4610887&cid=t_123614_117_f&fid=37824&url=http%3A%2F%2Fwww.doctorkalitenko.com%2Fblog%2Finept-trials-tainted-studies-living-disease-waiting-cure%2F According to statistics, 1500 people die every day in the United States from cancer. Shocking statistic? Sure. But how long have these people lived with the disease, how long did they know about it? What kind of treatment did they receive? What kind of treatment could they have received if it was not held up in one study after another? A recent article in the Wall Street Journal highlighted perhaps the most amazing point (1) How long will someone have to wait for a drug to be approved? How many treatments are there that are being held up by inefficient trials while you or a loved one are dying of cancer. Here’s where a holistic doctor like myself just doesn’t understand. Why should we trust clinical studies? Well, there are years and years of various testing done before a product is ap... Doctor Kalitenko antiaging blog blogs http://www.medworm.com/rss/comments.php?id=4610887 Fri, 18 Mar 2011 22:38:31 +0100 4610887 http://www.medworm.com/index.php?rid=4482973&cid=t_123614_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fgx4rI8ShUso%2F File this under Catch 22. A study released this week found that only a fraction of the devices recalled by the FDA had been approved under the more stringent pre-market approval, or PMA process, which requires clinical tests and inspections. The PMA is usually reserved for higher risk devices, as opposed to the less stringent 510K standard for other devices. The findings were bleak: Of 113 devices recalled between 2005 and 2009, only 21 had been approved through PMA, while 80 were cleared by the 510K process (the remaining eight were exempt from FDA review). The upshot: most devices that were recalled for life-threatening or very serious problems were originally cleared by the lower standard, suggesting a “reform” of the review process is needed. However, the findings, which we... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4482973 Tue, 15 Feb 2011 17:04:18 +0100 4482973 http://www.medworm.com/index.php?rid=4455482&cid=t_123614_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FuEu4Ajq_SyY%2F In 2005, AstraZeneca ran into a problem with its Iressa cancer drug, which had been approved two years earlier to treat non-small cell lung cancer as part of the FDA accelerated approval program. This meant the drugmaker was required to conduct so-called confirmatory studies, but the follow-up failed to show a survival benefit and Iressa was withdrawn, except for patients already being treated. In fact, this turned out to be the first of five instances in which such follow-up trials flopped and a drug was subsequently yanked or new restrictions were imposed. This was a distinction that, no doubt, AstraZeneca would like to forget. Of course, the drugmaker was not helped after receiving reports of serious illness and deaths due to a lung disease associated with the med in Japan. However, con... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4455482 Wed, 09 Feb 2011 22:11:48 +0100 4455482 http://www.medworm.com/index.php?rid=4455484&cid=t_123614_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FmsXo3RF7Rpo%2F For much of the past year, the FDA accelerated approval program has come under withering scrutiny. Last June, Pfizer withdrew a drug used to treat acute myeloid leukemia, or AML, after a study found a lack of clinical benefit and an unexpected number of deaths. But the study didn’t get under way until four years after approval was granted in 2000 (back story). More recently, the FDA decided the breast-cancer indication for Roche’s Avastin should be withdrawn after studies found patients on the med and chemotherpay didn’t survive longer than those given chemo alone. And Avastin patients suffered more serious side effects. The decision amounted to an about-face, having endorsed the indication in 2008 under accelerated approval (look here). And so the FDA’s Oncologic Drugs... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4455484 Wed, 09 Feb 2011 14:06:27 +0100 4455484 http://www.medworm.com/index.php?rid=4322692&cid=t_123614_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FZwTtD0ctKmk%2F The debate over the breast cancer indication for Avastin was one of the more highly charged issues last year. After clinical studies revealed the Roche med did not prolong overall survival and caused serious side effects, an FDA panel recommended withdrawing approval. To the applause of some consumer advocates (see here), the agency last month took that step, even though many breast cancer patients urged the FDA to preserve an option they say worked for some people (look at this). After deciding to unravel the indication, however, the FDA was criticized by Republicans for using cost as a reason - the treatment carries a price tag of about $80,000 a year - amid growing concern that healthcare rationing is becoming an issue for regulators. Now, however, Richard Pazdur, who heads the FDA&#821... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4322692 Fri, 07 Jan 2011 14:37:39 +0100 4322692 http://www.medworm.com/index.php?rid=4277834&cid=t_123614_87_f&fid=39187&url=http%3A%2F%2Fgetbetterhealth.com%2Favastin-the-fdas-disappointing-decision%2F2010.12.21 “With this disappointing decision, the FDA has chosen to place itself between patients and their doctors by rationing access to a life-extending drug. . . We can’t allow this government takeover of health care to continue any longer.” That quote, courtesy of this morning’s [Dec 17th] Washington Post, incensed me to such a degree that I am writing this blog despite the two deadlines I have today. The speaker is Sen. David Vitter (R-La). The “disappointing decision” he refers to: The FDA’s decision to remove the breast cancer indication for Avastin (bevacizumab). I wrote about this earlier, and you can read the post here, but that was before yesterday’s [Dec 16th] decision. I’m not going to comment here on the benefits or risks of Avasti... Better Health blogs http://www.medworm.com/rss/comments.php?id=4277834 Tue, 21 Dec 2010 16:00:00 +0100 4277834 http://www.medworm.com/index.php?rid=4266266&cid=t_123614_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FBvkC4XWP9nc%2F After months of anticipation, the FDA has started the process of removing the breast cancer indication for Roche’s Avastin med, dealing a huge setback to the drugmaker. The decision comes after months of intense debate over the merits of such a move and is estimated to cost Roche about $1 billion in annual sales. Roche plans to appeal in hopes of being granted a hearing. The European Medicines Agency, meanwhile, is not taking the same step. In explaining their decision, FDA officials cited the results of four clinical studies and determined the data indicate Avastin does not prolong overall survival in breast cancer patients or provide a sufficient benefit in slowing disease progression to outweigh significant risks. These include severe high blood pressure; bleeding and hemorrhage; ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4266266 Thu, 16 Dec 2010 16:48:27 +0100 4266266 http://www.medworm.com/index.php?rid=4200737&cid=t_123614_151_f&fid=35818&url=http%3A%2F%2Frecoveryissexy.com%2Fneurosis-alcoholism-codependency-and-recovery-2%2F Dr Karen Horney saw neurosis as continuous with normal life.Specifically, she saw neurosis as an attempt to make life bearable, as a way of “interpersonal control and coping.” This is, of course, what we all strive to do on a day-to-day basis, only most of us seem to be doing alright, while the neurotic seems to be sinking fast.In her clinical experience, she discerned ten particular patterns of neurotic needs. They are based on things that we all need, but they have become distorted in several ways by the difficulties of some people’s lives.Let’s take the first need, for affection and approval, as an example (see below).We all need affection, so what makes such a need neurotic? First, in the neurotic the need is unrealistic, unreasonable, indiscriminate. For exampl... Recovery Is Sexy.com blogs http://www.medworm.com/rss/comments.php?id=4200737 Tue, 23 Nov 2010 15:36:01 +0100 4200737 http://www.medworm.com/index.php?rid=3969184&cid=t_123614_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F7rGeUjUn5rM%2F Last month, an FDA advisory committee voted 12 to 1 to recommend the agency withdraw approval for the multi-billion-dollar Avastin cancer drug to be used to treat breast cancer. The move came after two recently released studies - which were undertaken as a condition of approval - found that patients given Avastin and chemotherapy didn’t survive longer than those given chemo alone. And Avastin patients also suffered more serious side effects. Two years ago, an FDA panel voted against approval (see here), but the agency endorsed treatment for breast cancer anyway. And later this week, the FDA is expected to decide again what to do about the breast cancer indication for the drug, which is already approved to treat colon, lung and brain cancer. The impending decision is sparking heated debat... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3969184 Tue, 14 Sep 2010 13:32:32 +0100 3969184 http://www.medworm.com/index.php?rid=3915285&cid=t_123614_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FJhu1W0Nq_XU%2F In a surprising move, the FDA late last week issued a Refuse to File letter to Roche’s Genentech unit for its T-DM1 biologic, which is being developed to treat women who have advanced breast cancer, test positive for the HER2 protein and hadn’t responded - or stopped responding - to other meds, including Roche’s Herceptin. The decision is a blow after the drugmaker trumpeted T-DM1 as an important salve - not only for women - but also as a way to extend its breast cancer franchise. The agency action came as a surprise, because the FDA explained not all treatment choices had been included in the single-arm, Phase II trial that was used as the basis for the Genentech application (see here). It was only last month that Genentech filed its application, noting T-DM1 shrank tumo... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3915285 Mon, 30 Aug 2010 14:26:39 +0100 3915285 http://www.medworm.com/index.php?rid=3915289&cid=t_123614_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fhuv0ECHQp-M%2F The drugmaker recently discussed cutbacks at a management meeting and the number of jobs being considered for elimination are expected to be in the thousands, and come not only from sales and marketing, but also research and development and pharma administration, according to the Swiss newspaper, Sonntag. “This will not only concern a few hundred people but many more. And the job cuts will not be made in one single country but on a worldwide scale,” the paper quoted one source, who also indicated the announcement will be made this week, although a Roche spokesperson tells Reuters that no decision will be made that soon. “We are always working to improve productivity and will continue to do so. But it is too early to speculate on potential job cuts,” Reuters reports... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3915289 Mon, 30 Aug 2010 12:15:24 +0100 3915289 http://www.medworm.com/index.php?rid=3885343&cid=t_123614_87_f&fid=39187&url=http%3A%2F%2Fgetbetterhealth.com%2Favastin-for-breast-cancer-will-the-fda-revoke-it%2F2010.08.19 Time to get back up on my soap box. Next month the FDA is supposed to consider taking the unique, first-time-ever step of revoking a drug’s indication not because it’s dangerous, but because it doesn’t work well enough to offset its risks. Never mind that it costs about $8,000 a month. The drug is Avastin (bevacizumab), a targeted monoclonal antibody that prevents tumors from creating and maintaining their own blood supply, a process called angiogenesis. Without oxygen and nutrients from blood, tumors can’t keep growing. Avastin is the world’s best-selling cancer drug, approved for use with chemotherapy to treat lung cancer and metastatic colorectal and breast cancer. It is also being investigated (and, likely, being prescribed off label) for numerous other c... Better Health blogs http://www.medworm.com/rss/comments.php?id=3885343 Thu, 19 Aug 2010 20:00:00 +0100 3885343 http://www.medworm.com/index.php?rid=3872519&cid=t_123614_87_f&fid=36050&url=http%3A%2F%2Fblisstree.com%2Flive%2Fdo-you-trust-the-fda-drug-approval-process-questionable-says-time-magazine%2F We rely on the FDA to safety check medications before they hit the market, but a revealing article from TIME Magazine about the diabetes drug Avandia has us wondering if the FDA – and the drugs they approve – are really so trustworthy. The article discusses the case of Avandia, which was approved by the FDA despite studies that showed a 43% increase in heart attacks. What’s really disturbing about the story is the fact that drug companies like GSK, the makers of Avandia, have a closer relationship to the FDA than we’d like. In Avandia’s case, GSK actually met with the FDA to convince them that the research suggesting heightened risk of heart attack was inconclusive, and that their drug should stay on the market. In all, the article made us realize that huge, multi-bil... Breastfeeding 1-2-3 blogs http://www.medworm.com/rss/comments.php?id=3872519 Mon, 16 Aug 2010 18:29:54 +0100 3872519 http://www.medworm.com/index.php?rid=3772462&cid=t_123614_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FLzIE6gpetxY%2F An FDA advisory committee dealt a huge setback to Roche by voting 12 to 1 to recommend the agency withdraw approval for the multibillion-dollar Avastin cancer drug to be used to treat breast cancer. Avastin should generate $6.5 billion in sales this year, with about $1.2 billion coming breast cancer usage, according to Sanford Bernstein analyst Tim Anderson. Unless, of course, the agency revokes the breast cancer indication. Avastin, by the way, is the first med to fight cancer by blocking the growth of blood vessels that feed tumors, a process called angiogenesis. It targets a chemical signal known as vascular endothelial growth factor, or VEGF. The med is also approved for brain, lung and colon tumors, and costs about $50,000 a year. The panel vote may raise further questions about the F... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3772462 Tue, 20 Jul 2010 22:08:48 +0100 3772462 http://www.medworm.com/index.php?rid=3772467&cid=t_123614_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FcFuL0NnhnWQ%2F Two years ago, the FDA approved Avastin to combat breast cancer, even though an advisory panel determined that risks such as high blood pressure and death outweighed the benefit of slowing the spread of tumors. The agency, however, acted under its accelerated approval program and the move pumped up sales of a Roche drug that is also used to treat brain, lung and colon tumors. Now, though, Avastin is on trial again. Another FDA panel today will decide whether use of the $50,000-a-year med should be continued, expanded, or halted after two studies - which were undertaken as a condition of approval - found patients given Avastin and chemotherpay didn’t survive longer than those given chemo alone. And Avastin patients also suffered more serious side effects. This is the second time in re... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3772467 Tue, 20 Jul 2010 14:02:57 +0100 3772467 http://www.medworm.com/index.php?rid=3687359&cid=t_123614_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FQ8SscvbYqOI%2F The decision to withdraw Mylotarg, a drug used to treat acute myeloid leukemia, or AML, is more significant for the FDA than for Pfizer, which garnered about $100 million in worldwide sales from the medicine. That’s because the drug was approved in 2000 as part of the accelerated approval process. As the FDA explained when announcing the withdrawal: “This program allows the agency to approve a drug to treat serious diseases with an unmet medical need based on a surrogate endpoint – a laboratory measurement or a physical sign used as a substitute for a clinically meaningful endpoint that directly measures how a patient feels, functions, or survives.” The program was an outgrowth of criticism that the agency wasn’t moving fast enough to approve new drugs, especially... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3687359 Tue, 22 Jun 2010 12:03:13 +0100 3687359 http://www.medworm.com/index.php?rid=3592407&cid=t_123614_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FI4fZsyYZdHM%2F Most Americans believe the FDA takes too long to approve new drugs and devices, and that confidence in safety reviews is slipping, according to a new poll. Meanwhile, most say drugmakers do a good job of providing risk and safety info, as well as product awareness, but don’t listen very well to patient concerns. Many Americans also have no clue whether clinical trials are handled responsibly. Specifically, 72 percent are very confident or confident in the FDA’s safety review system, down from 74 percent in 2007. And 41 percent say the FDA approval process takes too long. However, Americans are more evenly divided about risk: 52 percent say the FDA should move more quickly to get new treatments to patients, even if it means there may be risks, while 48 percent believe the FDA sh... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3592407 Mon, 24 May 2010 13:19:03 +0100 3592407 http://www.medworm.com/index.php?rid=3533799&cid=t_123614_87_f&fid=36050&url=http%3A%2F%2Fblisstree.com%2Flive%2F177144%2F Happy birthday in advance to the pill! (It turns 50 this weekend.) Not only did the birth control pill revolutionize women’s sexuality, but it also meant major changes for F.D.A.’s regulation practices, according to today’s New York Times. Post from: BlissTree (Source: Breastfeeding 1-2-3) Breastfeeding 1-2-3 blogs http://www.medworm.com/rss/comments.php?id=3533799 Wed, 05 May 2010 03:21:26 +0100 3533799 http://www.medworm.com/index.php?rid=3511586&cid=t_123614_109_f&fid=34750&url=http%3A%2F%2Fpsychcentral.com%2Fblog%2Farchives%2F2010%2F04%2F28%2Fastrazeneca-settles-case-for-520-million%2F AstraZeneca agreed to a $520 million dollar settlement with the U.S. Department of Justice and a consortium of state Medicaid agencies without admitting any wrongdoing in its marketing of the atypical antipsychotic drug, Seroquel. “AstraZeneca paid kickbacks to doctors as part of an illegal scheme to market drugs for unapproved uses,” Kathleen Sebelius, secretary of health and human services, said at the event in Washington. She said the company promoted drugs for unapproved uses by children, the elderly, veterans and prisoners. Glenn Engelmann, AstraZeneca’s U.S. general counsel, released a statement saying the company denies the allegations but settled the investigation with the payment. The government said the company also paid for ghostwritten journal articles, and marketed the... World of Psychology blogs http://www.medworm.com/rss/comments.php?id=3511586 Wed, 28 Apr 2010 14:25:06 +0100 3511586 http://www.medworm.com/index.php?rid=3502831&cid=t_123614_109_f&fid=34750&url=http%3A%2F%2Fpsychcentral.com%2Fblog%2Farchives%2F2010%2F04%2F25%2Fultrawellness-or-ultra-hype-antidepressant-as-demagogue%2F Mark Hyman, MD, is a “practicing physician and pioneer in functional medicine,” according to his bio on the Huffington Post where he recently penned the nonsensical, “Why Antidepressants Don’t Work for Treating Depression.” I say “nonsensical” because this article is based upon a study that came out 3 years ago, so writing this article to educate the public seems not to be its primary purpose. Exhibiting sound reasoning and logic also doesn’t seem apparent in this article, since generally a scientist or doctor would not dismiss an entire class of medications — antidepressants — based upon a single study. Or when there are many different types of antidepressants and sub-classes — SSRIs, tricyclics, MAOIs, SRNIs, etc. The stud... World of Psychology blogs http://www.medworm.com/rss/comments.php?id=3502831 Sun, 25 Apr 2010 15:45:16 +0100 3502831 http://www.medworm.com/index.php?rid=3432860&cid=t_123614_87_f&fid=36438&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FCato-at-liberty%2F%7E3%2FpmQzhYsuTBI%2F By John SamplesThe CBS News Poll reports that President Obama’s approval rating has dropped to its lowest point (of that poll) of 44 percent. Also, his work on the health care law might be a contributing factor. Onlly 34 percent approved of his performance on health care while 55 percent disapproved. At the end of March 1994, Bill Clinton enjoyed a 51 percent approval rating. Two caveats: First, other factors besides presidential approval affect the outcomes of mid-term congressional elections. Second, Clinton’s approval rating dropped like a stone in September and October of 1994. He ended up in the mid-40s by election day. In other words, Clinton ended up where Obama is now. Obama’s approval rating could rise between now and November. (Source: Cato-at-liberty) Cato-at-liberty blogs http://www.medworm.com/rss/comments.php?id=3432860 Fri, 02 Apr 2010 14:45:58 +0100 3432860 http://www.medworm.com/index.php?rid=3424820&cid=t_123614_87_f&fid=36050&url=http%3A%2F%2Fblisstree.com%2Flive%2Fshould-we-be-drugging-our-kids%2F When seven-year-old foster child Gabriel Myers hanged himself by a shower cord last year, all eyes turned to psychiatrist Dr. Sohail Punjwani, who had been treating the boy. The doctor had prescribed several powerful mental health drugs to Myers – some of which aren’t approved for use by kids, and had been linked to suicide among children. Image: istockphoto Every day, more and more youngsters around the country are being diagnosed with ADHD, depression, anxiety, autism, and other emotional disorders. Some parents and doctors jump to the conclusion that every hyper kid has ADHD, or that every sad child suffers from depression and needs medication. Somewhat surprising is the fact that the FDA has officially approved only one antidepressant drug for the treatment of depression in chi... Breastfeeding 1-2-3 blogs http://www.medworm.com/rss/comments.php?id=3424820 Tue, 30 Mar 2010 21:30:31 +0100 3424820 http://www.medworm.com/index.php?rid=3322441&cid=t_123614_111_f&fid=36048&url=http%3A%2F%2Ffeeds.b5media.com%2F%7Er%2Fb5media%2FAHeartyLife%2F%7E3%2FXA8UpFST0cs%2F Prescribing medications can be tricky for some physicians, depending on what their patient  has, how they want to treat it, and what is available for prescription. And, it’s particularly difficult if the condition they are trying to treat is either not responding to the traditional treatments or there really isn’t anything yet that has been developed for it. This is where off-label prescribing comes in. The FDA When the FDA approves a medication, it approves it for one or more specific conditions. It okays the dosage ranges, the frequency it can or should be taken, how long it can or should be taken and who should or shouldn’t take it. They base their decision on multiple trials and studies, where they should be given accurate information on how patients responded to wh... A Hearty Life blogs http://www.medworm.com/rss/comments.php?id=3322441 Mon, 01 Mar 2010 21:38:12 +0100 3322441 http://www.medworm.com/index.php?rid=3318671&cid=t_123614_151_f&fid=35818&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FRecoveryIsSexycom%2F%7E3%2FP8hSX8c_pXA%2F Dr Karen Horney saw neurosis as continuous with normal life. Specifically, she saw neurosis as an attempt to make life bearable, as a way of “interpersonal control and coping.” This is, of course, what we all strive to do on a day-to-day basis, only most of us seem to be doing alright, while the neurotic seems to be sinking fast. In her clinical experience, she discerned ten particular patterns of neurotic needs. They are based on things that we all need, but they have become distorted in several ways by the difficulties of some people’s lives. Let’s take the first need, for affection and approval, as an example (see below). We all need affection, so what makes such a need neurotic? First, in the neurotic the need is unrealistic, unreasonable, indiscriminate. For ex... Recovery Is Sexy.com blogs http://www.medworm.com/rss/comments.php?id=3318671 Sun, 28 Feb 2010 16:57:00 +0100 3318671 http://www.medworm.com/index.php?rid=3149315&cid=t_123614_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2010%2F01%2Fjapanese-cloth-company-trumps-merck.html With regard to new drug approvals in 2009, "Pfizer and Merck were among the big names that struck out for the year," says Peter Landers over at the WSJ Health Blog. Companies that did NOT strike out were four Japanese companies, including Teijin, a major textile maker!I was inspired by this story to create this cartoon:A note about Godzilla (from wikipedia):Godzilla is one of the most recognizable symbols of Japanese popular culture worldwide and remains an important facet of Japanese films, embodying the kaiju subset of the tokusatsu genre. He has been considered a filmographic metaphor for the United States, as well as an allegory of nuclear weapons in general. The earlier Godzilla films, especially the original Godzilla, portrayed Godzilla as a frightening, nuclear monster. Godzilla rep... Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=3149315 Thu, 07 Jan 2010 13:02:00 +0100 3149315 http://www.medworm.com/index.php?rid=3123400&cid=t_123614_109_f&fid=34750&url=http%3A%2F%2Fpsychcentral.com%2Fblog%2Farchives%2F2009%2F12%2F27%2Fstanding-up-for-yourself-from-a-recovering-people-pleaser%2F I think some people grow up believing in their heart and soul that they are loved and accepted and so therefore don’t have to depend so much on other people to give them their daily dose of attaboys, the approval ratings that determine if they’ll be able to function properly throughout the day. Me? I know, in my adult, neo-cortex, sophisticated part of my brain that I am loved. But the reptilian, immature brat part of my brain does most of the thinking in my noggin. So this girl is petrified of not being liked, of doing anything that might hurt somebody’s feelings, of the slightest confrontation, because whenever she raised a concern in the past, the reprimand for challenging Person A was far more painful than the reason she raised her voice to begin with. I learned that ... World of Psychology blogs http://www.medworm.com/rss/comments.php?id=3123400 Sun, 27 Dec 2009 13:20:17 +0100 3123400 http://www.medworm.com/index.php?rid=2899002&cid=t_123614_109_f&fid=34750&url=http%3A%2F%2Fpsychcentral.com%2Fblog%2Farchives%2F2009%2F10%2F16%2Ffriday-flashback-for-october-16-2009%2F This articles note the tripling of Ritalin prescriptions over 5 years (1990-1995), and not surprisingly, prescriptions for ADHD medications have grown exponentially since then. Is ADHD a serious problem in children? Absolutely. But can it be too-quickly diagnosed without a thorough mental health evaluation of the child? Yes, even today. 5 Years Ago on Psych Central A Patient’s Suicide, a Psychiatrist’s Pain Five years ago we highlighted this story from The New York Times, where a psychiatrist describes his first experience with one of his patients committing suicide. While not for the feint of heart, it remains a poignant story worth reading. FDA Orders Strong Antidepressant Warnings The first black box warnings hit antidepressant medications 5 years ago, and despite warnin... World of Psychology blogs http://www.medworm.com/rss/comments.php?id=2899002 Fri, 16 Oct 2009 10:03:19 +0100 2899002 http://www.medworm.com/index.php?rid=2834387&cid=t_123614_131_f&fid=34989&url=http%3A%2F%2Ffeeds.b5media.com%2F%7Er%2Fb5media%2FGeneticsHealth%2F%7E3%2Fi_yQInvwMsY%2F This latest FDA approval would bring relief to more than 7.5 million Americans who suffer from a chronic skin disorder called PSORIASIS, which look like red, thick, scaly patches on the skin. Psoriatic patches, which are usually itchy and painful, are inflamed areas where excessive layers of cells had built up on the skin. And now, after extensive and extended testing, the FDA has approved ustekinumab (Stelara) for moderate to severe plaque psoriasis. (See amazing before-and-after photos!) Psoriasis is an auto-immune disease, which means a faulty immune system mistakenly attacks the skin and joints, treating the body like an invader and releasing chemicals that otherwise fight infections and foreign substances. As bad as it already looks, psoriasis affects more than the skin. The dis... Genetics and Health blogs http://www.medworm.com/rss/comments.php?id=2834387 Sat, 26 Sep 2009 03:56:00 +0100 2834387 http://www.medworm.com/index.php?rid=2715918&cid=t_123614_87_f&fid=36438&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FCato-at-liberty%2F%7E3%2F9XBQ3cnpM3g%2F Last week, the governor of Arizona signed H.B. 2426, which bars the state from implementing the “enhanced” drivers license (EDL) program. If the federal REAL ID revival bill (PASS ID) becomes law, it will give congressional approval to EDLs, which up to now have been simply a creation of the federal security and state driver licensing bureaucracies. As governor of Arizona, the current Secretary of Homeland Security signed a memorandum of understanding with the DHS to implement EDLs, and she backs PASS ID even though she signed an anti-REAL ID bill as governor. As I said before, Secretary Napolitano seems to be taking the national ID tar baby in a loving embrace. (Source: Cato-at-liberty) Cato-at-liberty blogs http://www.medworm.com/rss/comments.php?id=2715918 Wed, 19 Aug 2009 19:04:05 +0100 2715918 http://www.medworm.com/index.php?rid=2447732&cid=t_123614_111_f&fid=36048&url=http%3A%2F%2Ffeeds.b5media.com%2F%7Er%2Fb5media%2FAHeartyLife%2F%7E3%2FhJrmYWlhs2Q%2F Lamictal XR (lamotrigine) Extended Release Tablets have been approved by the US FDA for prescription to people, aged 13 or older, who have partial onset seizures. The original version of Lamictal has been available since the mid-1990s. Instead of trying to explain how it works, here is a video of a pharmacist explaining what Lamictal is. Just click on the TV screen: The newly approved extended version, Lamictal XR, limits the number of pills a person must take in a day - some people take several. The fewer medications a person has to take, the lower the chance of mistakes and the higher the chance of the person taking all medications as they should be taken. ~~~~ Image: iStock Share and Enjoy: Post from: Blisstree FDA Approves Extended Epilepsy Medication (Sourc... A Hearty Life blogs http://www.medworm.com/rss/comments.php?id=2447732 Mon, 01 Jun 2009 14:49:23 +0100 2447732 http://www.medworm.com/index.php?rid=2441695&cid=t_123614_109_f&fid=34750&url=http%3A%2F%2Fpsychcentral.com%2Fblog%2Farchives%2F2009%2F05%2F24%2Fwhat-if-ray-sandford-were-your-brother%2F Forced treatment is not a new topic here on World of Psychology, nor is this the first time we’ve discussed the unusual case of Ray Sandford. What did Mr. Sandford do wrong? Nothing. He’s simply mentally ill, the medications and prior treatments over his lifetime have failed him, and his legal guardian is a social service agency in Minnesota. The convergence of those three characteristics means he was a prime candidate — in the court’s eyes — for ECT treatment. The only problem? He opposes his electroconvulsive therapy (ECT). And despite experts’ insistence that Mr. Sandford is not competent to make such decisions for himself, his case has galvanized the “mad pride” movement and those who opposed any type of forced treatment. Last week, Minne... World of Psychology blogs http://www.medworm.com/rss/comments.php?id=2441695 Sun, 24 May 2009 23:04:05 +0100 2441695 http://www.medworm.com/index.php?rid=2398856&cid=t_123614_111_f&fid=36048&url=http%3A%2F%2Ffeeds.b5media.com%2F%7Er%2Fb5media%2FAHeartyLife%2F%7E3%2FvKNFgNsDr2I%2F The United States FDA has granted marketing approval to a new drug to help treat schizophrenia. Called Fanapt (iloperidone), the medication is intended to treat adults with schizophrenia while in the acute phases. It isn’t yet known how long they should be kept on the medication once the acute phases is over, but researchers agree that if the patient is responding, continuing with the treatment is encouraged. According to a company press release , “The approval was supported by two placebo-controlled Phase III clinical studies comparing Fanapt(TM) to placebo and active control in patients with schizophrenia, as well as safety data from more than 3,000 patients.” Schizophrenia is a fairly common mental illness, estimated to strike one out of every 100 people in North Amer... A Hearty Life blogs http://www.medworm.com/rss/comments.php?id=2398856 Sat, 09 May 2009 15:02:46 +0100 2398856 http://www.medworm.com/index.php?rid=2398818&cid=t_123614_109_f&fid=34750&url=http%3A%2F%2Fpsychcentral.com%2Fblog%2Farchives%2F2009%2F05%2F07%2Fsurprise-approval-of-fanapt-makes-stock-go-wild%2F Shares of Vanda Pharmaceuticals, the makers of Fanapt (iloperidone), surged today after the U.S. Food and Drug Administration sprang a surprise drug approval for Fanapt for schizophrenia late yesterday. In afternoon trading today, the stock hit $10.00 a share, over 8 times what the stock was trading just a day earlier. It fell back to trading around $7.54 - $7.95 range at this time. The drug has a better safety profile in clinical trials than other atypical antipsychotics, which some analysts believe will help boost prescriptions when it goes on the market this summer. Of course, the safety profile may be overly optimistic, as it was for other atypical antipsychotics before they hit the market and reality set in (e.g., use on a more diverse population). Certainly the company could’ve... World of Psychology blogs http://www.medworm.com/rss/comments.php?id=2398818 Thu, 07 May 2009 19:58:34 +0100 2398818 http://www.medworm.com/index.php?rid=2389931&cid=t_123614_109_f&fid=34750&url=http%3A%2F%2Fpsychcentral.com%2Fblog%2Farchives%2F2009%2F05%2F06%2Fthe-problem-with-phase-iii-clinical-trials%2F Phase III clinical trials are the final phase of research needed before a drug receives U.S. Food and Drug Administration (FDA) approval. Two fairly large-scale studies are needed and they need to show the drug is both safe and effective on the subjects tested. There’s been a long-standing problem with such clinical studies, however, one that the FDA has long been aware of but powerless to fix. They are purposely designed to employ stringent inclusion and exclusion criteria that may exclude a substantial portion of the population. In other words, the people the drugs are studied on are not representative of the people that will actually be receiving the drugs once approved. In other words, Phase III clinical studies are stacked in favor of finding positive results for the medicatio... World of Psychology blogs http://www.medworm.com/rss/comments.php?id=2389931 Wed, 06 May 2009 09:06:31 +0100 2389931 http://www.medworm.com/index.php?rid=2348546&cid=t_123614_109_f&fid=34750&url=http%3A%2F%2Fpsychcentral.com%2Fblog%2Farchives%2F2009%2F04%2F15%2Fwith-fda-change-ect-may-go-the-way-of-the-dinosaur%2F Last week, the U.S. Food and Drug Administration (FDA) finally decided to start taking action to close a loophole that’s been around nearly as long as the agency itself. Last Wednesday it said that it would require safety and efficacy data from manufacturers of medical devices in 25 different categories. This data is equivalent to the types of data the FDA currently requires for medical devices and drugs — data that shows the device is both safe and effective in use for a prescribed disorder. One of those 25 categories is electroconvulsive therapy (ECT) machines. Yes, you heard right. For decades, the most notorious of all psychiatric treatments available has never met any type of rigorous FDA approval for their use. How can this be? In the case of electroconvulsive therapy ma... World of Psychology blogs http://www.medworm.com/rss/comments.php?id=2348546 Wed, 15 Apr 2009 22:51:52 +0100 2348546 http://www.medworm.com/index.php?rid=2290611&cid=t_123614_117_f&fid=36026&url=http%3A%2F%2Fwww.everydayhealth.com%2Fblog%2Fzimney-health-and-medical-news-you-can-use%2Flexapro-celexa-and-depression%2F Last week’s FDA approval of Lexapro to treat depression in adolescents 12-17 years old got me to thinking both about bureaucratic nonsense and corporate shenanigans. That’s because, in a classic case of bureaucratitis, the FDA approval came just weeks after Justice Department prosecutors, following a 5-year investigation, accused Forest Laboratories of illegally marketing Lexapro for use in these very same children. Of course, such actions are not mutually exclusive because, in fact, it would have been illegal for Forest to promote the use of Lexapro in kids prior to such an FDA approval, but, really, when one arm of the government says it’s now fully convinced of Lexapro’s efficacy in children doesn’t it seem a bit odd that another arm would be spending so mu... Dr. Z's Medical Report blogs http://www.medworm.com/rss/comments.php?id=2290611 Wed, 25 Mar 2009 21:42:16 +0100 2290611 http://www.medworm.com/index.php?rid=2287239&cid=t_123614_109_f&fid=34750&url=http%3A%2F%2Fpsychcentral.com%2Fblog%2Farchives%2F2009%2F03%2F18%2Fcongress-aims-to-combat-%25e2%2580%2598nature-deficit-disorder%25e2%2580%2599%2F Midweek Mental Greening Despite my thoughts about how some technological advances can help boost your mental health, ideally I think it’s best for people to spend as much time outdoors as possible. New friend requests, message alerts, and the hum of a computer can’t hold a candle to fresh air, sunlight, and the smell of newly cut grass. Is this why, after it won in the House but failed to pass overall last year, the “No Child Left Inside Act” is getting ready to be reintroduced to the House and Senate? Perhaps. That, and the idea (or fact, depending on who you’re talking to) that America’s children are becoming increasingly detached from the outside (i.e. natural) world – they’re coming close to or already suffering from “Nature-Deficit Disorder” – according to a rec... World of Psychology blogs http://www.medworm.com/rss/comments.php?id=2287239 Wed, 18 Mar 2009 14:56:52 +0100 2287239 http://www.medworm.com/index.php?rid=2052861&cid=t_123614_134_f&fid=35137&url=http%3A%2F%2Fdiabetesupdate.blogspot.com%2F2008%2F12%2Fwhat-id-like-to-see-change-at-fda.html The FDA announced some changes in how it will approve drugs for Type 2 diabetes which have sparked controversy in the diabetes community. Unlike many, I believe this is good news, not bad. A fellow diabetes activist asked me what I would like to see changed in the FDA and I wrote him a reply which I am sharing with you here.The most important thing I'd like to see change at the FDA is going to happen without our needing to submit petitions: restoring science as a criteria for drug approval. The Bush FDA was notorious for the way that decisions were made based on financial connections of FDA staff to drug makers and their religious beliefs. But beyond that I think the following are most important:1. End "direct to consumer" drug advertisements. These are well-known to be full of lies, but i... Diabetes Update blogs http://www.medworm.com/rss/comments.php?id=2052861 Fri, 19 Dec 2008 13:59:00 +0100 2052861 http://www.medworm.com/index.php?rid=1860605&cid=t_123614_136_f&fid=37846&url=http%3A%2F%2Fhealthinfoispower.wordpress.com%2F2008%2F10%2F08%2Ffda-issues-a-warning-letter-to-labcorp-regarding-the-illegal-marketing-of-the-ovasure%25e2%2584%25a2-test%2F On September 29, 2008, the U.S. Food and Drug Administration (FDA) Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD), Center for Devices and Radiological Health, issued a warning letter (FDA Warning Letter) to the Chief Executive Officer of the Laboratory Corporation of America (LabCorp) regarding the illegal marketing of the OvaSure™ ovarian cancer [...] (Source: Libby's H*O*P*E*) Libby's H*O*P*E* blogs http://www.medworm.com/rss/comments.php?id=1860605 Wed, 08 Oct 2008 19:39:45 +0100 1860605 http://www.medworm.com/index.php?rid=1692384&cid=t_123614_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F359504449%2F Americans are likely to be exposed to unacceptable side effects of FDA-approved drugs because of flaws in the way new drugs are tested and marketed, according to research presented earlier this week at the annual meeting of the American Sociological Association. “Drug disasters are literally built into the current system of drug testing and approvals in the United States,” says Donald Light, a sociologist and a professor of comparative health policy at the University of Medicine and Dentistry of New Jersey, who gave the talk. “Recent changes in the system have only increased the proportion of new drugs with serious risks.” Systematic reviews indicate that one in seven new drugs is superior to existing drugs, but two in every seven new drugs result in side effects se... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1692384 Fri, 08 Aug 2008 15:19:48 +0100 1692384 http://www.medworm.com/index.php?rid=1664276&cid=t_123614_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2008%2F07%2Fpraise-for-lyrica-ad-is-this-joke.html Occasionally, I use humor to make important points about pharmaceutical marketing. Sometimes, however, the humor is lost on my readers, who miss the humor entirely, believe I am being disrespectful, think I am "snarky," or do not think I am humorous at all!Take for example, my recent posts about Lyrica direct-to-consumer (DTC) ads, the most recent one being "Lyrica Lightens Up, DTCwise." In that post I praised -- yes, PRAISED! -- a new Lyrica DTC ad for its upbeat portrayal of women as opposed to previous Lyrica ads that showed women in a bad light (ie, battered).In that post, I suggested the Pfizer ad people must have been reading my blog and as a result changed the image of women in the Lyrica ads accordingly.I was joking, of course! No pharma ad agency would read my blog much less liste... Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=1664276 Tue, 29 Jul 2008 12:19:00 +0100 1664276 http://www.medworm.com/index.php?rid=2510712&cid=t_123614_97_f&fid=35050&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmaGazette%2F%7E3%2F3Cq56JChK_0%2Ftopamax_gets_6_month_pediatric_exclusivity_extension.html The U.S. Food and Drug Administration has granted a six month pediatric exclusivity to Ortho-McNeil-Janssen Pharmaceuticals for its drug Topamax for use in patients aged 1 to 24 months with partial onset seizures.The extension does not give the drug FDA approval but instead allows the pharmaceutical 6 months to continue to investigate the use of Topamax on this specific segment of patients.Currently Topamax is approved for use with patients 10 years of age and older with partial onset seizures or generalized tonic-clonic seizures. It is also indicated in adults for the treatment of migraine headaches.Recent research may have found a link between the use of Topamax and birth defects and recently, along with other epilepsy drugs, narrowly escaped being required to have a black box warni... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=2510712 Fri, 25 Jul 2008 17:00:16 +0100 2510712 http://www.medworm.com/index.php?rid=1626037&cid=t_123614_107_f&fid=36585&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FHighlightHEALTH%2F%7E3%2F336132424%2F This study therefore suggest that social approval bias might well be a substantial problem in the interpretation of nutritional intervention effects that are dependent on education and awareness to affect behavior change. The magnitude of this bias is similar to the intervention effects reported in many studies evaluating changes in fruit and vegetable intake (ranging from 0.93 to 1.25 servings per day). Thus, a major challenge facing nutritional intervention researchers is assessing true behavioral change based on self-reports from reporting bias. This doesn’t mean that health questionnaires are useless. Rather, it means that many people simply aren’t being entirely truthful when it comes to how many fruits and vegetables they eat. The authors suggest that, in large dietary i... Highlight HEALTH blogs http://www.medworm.com/rss/comments.php?id=1626037 Tue, 15 Jul 2008 14:30:18 +0100 1626037 http://www.medworm.com/index.php?rid=1622216&cid=t_123614_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F335215369%2Ffda_changes_drug_application_process.html The U.S. Food and Drug Administration announced that it has revised its method of communicating that a drug cannot be approved as submitted to pharmaceutcial companies.Previously the FDA's Center for Drug Evaluation and Research (CDER) issued "approvable" or "non-approval" letters when a drug application was not approved. The new approval process will consist only of a "complete response" letter at the end of the review process to inform the drug company of the agency's decision."These new regulations will help the FDA adopt a more consistent and neutral way of conveying information to a company when we cannot approve a drug application in its present form," said Janet Woodcock, M.D., director of the agency's Center for Drug Evaluati... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=1622216 Mon, 14 Jul 2008 17:00:32 +0100 1622216 http://www.medworm.com/index.php?rid=1564171&cid=t_123614_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F325191337%2F An FDA advisory committee voted 14 to 2 that all new diabetes drugs should undergo longer studies to ensure cardiovascular risks aren’t increased, a move that is expected to cost drugmakers untold millions of dollars to conduct additional clinical trials, the Associated Press reports. The recommendation comes less than a year after the FDA was criticized for its handling of heart risks connected with Glaxo’s widely used Avandia diabetes pill, which was approved in 1999. The agency, however, didn’t add a warning about potential heart risks until last November, the AP notes. The majority of the panel said drugmakers could begin safety testing, which is expected to take between five and seven years to complete, before they submit drugs to the FDA and finish the studies after... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1564171 Wed, 02 Jul 2008 21:03:14 +0100 1564171 http://www.medworm.com/index.php?rid=1556385&cid=t_123614_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F323640511%2Fgsk_answers_fda_on_cervarix.html GlaxoSmithKline (NYSE:GSK) announced that it has submitted its response to the U.S. Food and Drug Administration to questions the agency had in response to GSK's drug application for Cervarix.Cervarix, a vaccine for the prevention of cervical cancer, one of the largest drug hopes in Glaxo's pipeline has already been approved in 67 countries but the FDA issued a "Complete Response" letter in December 2008 requiring the company answer questions."Study 008 is a key study that will be completing later this year, andwe expect the final results will strengthen the U.S. label forCERVARIX(R)," said Barbara Howe, M.D., Vice President and Director, NorthAmerican Vaccine Development, GlaxoSmithKline. "We continue to havepositive and productive disc... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=1556385 Mon, 30 Jun 2008 19:00:46 +0100 1556385 http://www.medworm.com/index.php?rid=1543340&cid=t_123614_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F319965579%2Ffda_approves_combo_vaccine_kinrix_for_kids.html The U.S. Food and Drug Administration has approved GlaxoSmithKline's combination booster vaccine, Kinrix.Kinrix protects children between 4 and 6 years old against diphtheria, pertussis, polio and tetanus and is approved for children who previously received GSK's Infanrix, which covers diptheria, tetanus and pertussis and who received Pediarix. Pediarix is a combination vaccine that covers DPT, hepatitis B and polio."Children 4 to 6 years-old can receive five or more vaccinations in a single visit, which can be stressful for parents and vaccinators," said William P. Hitchcock, M.D., Assistant Clinical Professor of Pediatrics, University of California, San Diego School of Medicine. "By reducing the number of shots given in one visit, combination vaccines like Kinrix m... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=1543340 Wed, 25 Jun 2008 19:00:43 +0100 1543340 http://www.medworm.com/index.php?rid=1543341&cid=t_123614_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F319955555%2Ffda_delays_prasugrel_approval.html Eli Lilly & Co and Daiichi Sankyo announced the U.S. Food and Drug Administration had extended the period of review by three months for their anti-clotting drug, Prasugrel.Prasugrel received priority review status from the FDA in February based on studies that showed Prasugrel has better results than Plavix but carried a higher risk of bleeding in some patients."We remain confident in our prasugrel submission package," said Jennifer Stotka, vice president for global regulatory affairs at Lilly.Daiichi and Lilly confirmed plans to start a Phase III clinical trial this month that will compare the results of prasugrel against Plavix in patients with acute coronary syndromes. The trials will consisted of 10,000 patients at over 800 hospitals.The FDA is expected to act on the... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=1543341 Wed, 25 Jun 2008 18:00:38 +0100 1543341 http://www.medworm.com/index.php?rid=1543343&cid=t_123614_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F319775023%2Fgardasil_gets_fda_non-approval_for_expanded_use.html Merck & Co. (NYSE:MRK) announced that the U.S. Food and Drug Administration did not approve the company's application to expand the use of Gardasil to include women between the ages of 27 and 45.Gardasil, a cervical cancer vaccine, was previously approved by the FDA in 2006 for women between the ages of 9 and 27 and the non-acceptance of the expanded use does not affect that approval. (Source: PharmaGazette) PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=1543343 Wed, 25 Jun 2008 15:00:12 +0100 1543343 http://www.medworm.com/index.php?rid=1543344&cid=t_123614_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F319116896%2Ffda_approves_cymbalta_for_fibr.html Eli Lilly & Co. (NYSE:LLY) announced that it has received U.S. Food and Drug Administration approval for Cymbalta for the management of fibromyalgia, a chronic pain disorder.Cymbalta (duloxetine HCl) is the first serotonin-norepinephrine reuptake inhibitor that has proven effective in the treatment of pain associated with fibromyalgia. The new approved indication becomes the fourth FDA approved use of the drug.  Cymbalta has been previously approved for management of diabetic peripheral neuropathic pain (DPNP), the treatment of major depressive disorder and generalized anxiety disorder. (Source: PharmaGazette) PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=1543344 Tue, 24 Jun 2008 18:00:45 +0100 1543344 http://www.medworm.com/index.php?rid=1543346&cid=t_123614_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F319036633%2Favodart_fda_approved_for_symptomatic_enlarged_prostate.html The U.S. Food and Drug Administration has approved GlaxoSmithKline(NYSE:GSK) Avodart in combination with tamsulosin for the treatment of symptomatic enlarged prostate.Enlarged prostate is a disease that affects 50% of men over the age of 50 and 90% of men over the age of 80. The disease causes changes in urinary habits and over time the prostate can continue to enlarge and the bladder can loses its ability to empty itself. (Source: PharmaGazette) PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=1543346 Tue, 24 Jun 2008 15:00:19 +0100 1543346 http://www.medworm.com/index.php?rid=1497502&cid=t_123614_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F305317831%2Fhumira_remicade_and_enbrel_under_fda_review_for_cancer_link.html   The U.S. Food and Drug Administration announced that it is investigating whether a group of arthritis drugs increase the risk of pediatric cancer. The group of drugs include Abbott Laboratories' Humira, Schering-Plough's Remicade and Enbrel by Amgen and Wyeth.The FDA stated that it has received 30 reports of children and young adults developing cancer while taking the arthritis medications. The reports were received to the FDA's Adverse Event Reporting System over a 10 year period. Children with arthritis, and sometimes Crohn's disease, are prescribed these drugs to block a chemical that causes inflammation. (Source: PharmaGazette) PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=1497502 Thu, 05 Jun 2008 13:00:36 +0100 1497502 http://www.medworm.com/index.php?rid=1480736&cid=t_123614_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F301431509%2Fyesterday_i_brought_you_an.html Yesterday I brought you an article about a new experimental drug from GlaxoSmithKline called Promacta. Its purpose is to lower bleeding in patients with rare blood disorders but the U.S. Food and Drug Administration released a report stating that the agency had found that the drug did not, yes i repeat, NOT, significantly lower bleeding.The next step was to submit all data to a panel of outside advisors who would vote on whether they had found that the drug fell within acceptable parameters.Today it was announced, by the FDA, that the panel voted unanimously in favor of Promacta. It was noted, however, that long-term data has not been provided but that results from two six-week studies showed significant benefit. Long term benefit data is expected by year end. The FDA has until J... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=1480736 Fri, 30 May 2008 17:00:40 +0100 1480736 http://www.medworm.com/index.php?rid=1478027&cid=t_123614_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F300764496%2Fwyeth_receieves_approvable_let.html Wyeth Pharmaceuticals announced that it has received and approvable letter from the U.S. Food and Drug Administration for its first-in-class antibiotic drug Tygacil. Tygacil (tigecycline) is indicated for the treatment of adult patients with community-acquired pneumonia (CAP).Prior to granting approval the the FDA has request that Wyeth submit additional analyses supporting the safety and efficacy of the drug. The FDA also required that benefit/risk analysis be submitted for any potential liver toxicity."We believe the data from our current clinical development program support TYGACIL as a potential therapeutic option for patients with CAP," says Gary L. Stiles, M.D., Executive Vice President, Chief Medical Officer, Wyeth Pharmaceuticals. "Wyeth is committed to working with ... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=1478027 Thu, 29 May 2008 19:00:31 +0100 1478027 http://www.medworm.com/index.php?rid=1478029&cid=t_123614_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F300748888%2Fpromacta_fails_to_control_blee.html The U.S. Food and Drug Administration announced that it found that Promacta does not significantly lower bleeding in patients with rare blood disorders.FDA reviewers stated that upon review of company studies that Promacta, an experimental drug from GlaxoSmithKline, was not found to help control the severity and frequency of bleeding as purported by the company. Of the two studies submitted by GlaxoSmithKline, neither showed a significant difference between patients receiving Promacta and those that received a placebo.GlaxoSmithKline had applied for a New Drug Application for Promacta (eltrombopag olamine) with the FDA in December of 2007 and had released previous reports that the drug had decreased bleeding in previous trials.The drug was intended to treat idiopathic thrombocyto... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=1478029 Thu, 29 May 2008 17:00:35 +0100 1478029 http://www.medworm.com/index.php?rid=1466099&cid=t_123614_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F296646640%2Fwyeth_gets_fda_approvable_letter_for_bazedoxifene.html Wyeth Pharmaceutucals announced that it has received an Approvable Letter from the U.S. Food and Drug Administration for bazedoxifene, a selective estrogen receptor modulator (SERM), for the prevention of postmenopausal osteoporosis. Gary Stiles, M.D., Executive Vice President and Chief Medical Officer, Wyeth Pharmaceuticals stated: "We will work closely with the FDA to address the items noted in the letter and are moving forward with plans to seek an additional indication for the treatment of postmenopausal osteoporosis for bazedoxifene later this year. We remain confident that bazedoxifene has the potential to become an important option for the millions of postmenopausal women who are at risk for developing an osteoporotic fracture."The approvable letter states that prior to th... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=1466099 Fri, 23 May 2008 15:00:15 +0100 1466099 http://www.medworm.com/index.php?rid=1409765&cid=t_123614_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F280779831%2Famitiza_fda_approved_for_ibsc.html The U.S. Food and Drug Administration has confirmed that lubiprostone, brand name Amitiza, has been approved as the only prescription drug therapy FDA approved treatment for Irritable Bowel Syndrome with Constipation (IBS-C) in women over 18."For some people IBS can be quite disabling, making it difficult for them to fully participate in everyday activities," said Julie Beitz, M.D., director of the Office of Drug Evaluation III, Center for Drug Evaluation and Research, FDA. "This drug represents an important step in helping to provide medical relief from their symptoms."IBS symptoms include cramping, abdominal pain, bloating, constipation and diarrhea and the illness seems to affect 2x the number of woman as men.The safety and efficacy studies of Amitiza ... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=1409765 Tue, 29 Apr 2008 19:00:45 +0100 1409765 http://www.medworm.com/index.php?rid=1402141&cid=t_123614_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F278464653%2Fcimzia_approved_by_fda_to_trea.html The U.S Food and Drug Administration has approved Cimzia (certolizumab pegol) for the treatment of moderate to serve Crohn's disease in adults who have not responded to other therapies."Crohn's is a debilitating disease that disrupts the quality of life for its sufferers," said Julie Beitz, M.D., director of the Office of Drug Evaluation III for the FDA's Center for Drug Evaluation and Research. "This drug works to reduce the signs and symptoms of Crohn's, but it also carries risks that will require patients on it to be closely monitored by their physicians or other health care professionals."Cimzia is to be given, by injection, every two weeks for the first 3 injections and once the medication's benefit has been established patients are to receive t... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=1402141 Sat, 26 Apr 2008 21:00:49 +0100 1402141 http://www.medworm.com/index.php?rid=1401383&cid=t_123614_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F278439764%2Frelistor_fda_approved_for_opio.html The U.S. Food and Drug Administration announced on Thursday that it has approved Relistor (methylnaltrexone bromide) for use with patients who are receiving opioids to treat pain in late-stage, advanced illnesses to help restore bowel function.According to the FDA news release opioids can "interfere with normal bowel elimination function by relaxing the intestinal smooth muscles and preventing them from contracting and pushing out waste products." Relistor blocks opioids from entering the smooth muscles of the intestine and allows the blowels to function normally.“This new drug will be helpful to patients who experience severe constipation associated with the continuous use of morphine or other opioids, which are an important part of care for patients with late-stage, advan... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=1401383 Sat, 26 Apr 2008 20:00:33 +0100 1401383 http://www.medworm.com/index.php?rid=1396459&cid=t_123614_117_f&fid=36026&url=http%3A%2F%2Fblog.healthtalk.com%2Fzimney%2Fcimzia-approved-for-crohns-disease%2F The FDA has granted approval of Cimzia (certolizumab pegol) as the fourth biologic agent for the treatment of Crohn’s disease. Cimzia, like Remicade (infliximab) and Humira (adalimumab), is an antibody that blocks the action of TNF (tumor necrosis factor), a pro-inflammatory chemical known to play a central role in causing the pathology of a variety of inflammatory disorders including Crohn’s, ulcerative colitis, rheumatoid arthritis and psoriasis. Tysabri (natalizumab), the fourth biologic for Crohn’s, is also an antibody, but it works by blocking the action of certain types of white blood cells that are involved in the inflammatory process. Cimzia received approval for treating adults with moderate to severe Crohn’s disease who have not responded to conventional therapies. Al... Dr. Z's Medical Report blogs http://www.medworm.com/rss/comments.php?id=1396459 Thu, 24 Apr 2008 18:28:04 +0100 1396459 http://www.medworm.com/index.php?rid=1352103&cid=t_123614_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F264203408%2Frotarix_gets_fda_approval.html The U.S. Food and Drug Administration has approved Rotarix, the oral vaccine for the prevention of rotavirus, for children between the ages of 6 to 24 weeks.Rotavirus is an infection that causes gastroenteritis, vomiting and diarrhea, which causes approximately 55,000 to 70,000 cases of hospitalization and 20 to 60 deaths in the U.S. every year. The vaccine is a liquid which is given orally to children in a two-dose series protects against the G1, G3, G4 and G9 strains of rotavirus gastroenteritis.The FDA estimates that without the vaccine almost every child in the U.S. would be infected at least once by the age of 5."This vaccine provides another option to combat and reduce a potentially severe illness that affects so many children," said Jesse L. Goodman, M.D., M.P.H., dir... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=1352103 Fri, 04 Apr 2008 20:00:02 +0100 1352103 http://www.medworm.com/index.php?rid=1327525&cid=t_123614_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F257942669%2Ftreanda_gets_fda_approval_for.html The U.S. Food and Drug Administration has approved Treanda (bebdanustine hydrocloride) for patients with the slow growing blood and bone marrow cancer chronic lymphocytic leukemia (CLL).The drug, marketed by Cephalon, is a chemotherapy drug that has shown to slow the progression of the disease will be available as an alternative treatment option as of April.A randomized study of 301 patients found that 59% of those taking Treanda had their cancer significantly reduced compared to 26% of those taking Leukeran (chlorombucil), a drug commonly used to treat CLL.Researchers believe that Treanda works by disrupting cell division and damaging DNA in tumor cells leading to cell death.Cephalon has also applied to the FDA for approval of Treanda for the treatment of non-Hodgkin lymphoma in pati... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=1327525 Tue, 25 Mar 2008 20:00:53 +0100 1327525 http://www.medworm.com/index.php?rid=1286275&cid=t_123614_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F247575942%2Ffda_warns_on_unapproved_and_mi.html The U.S. Food and Drug Administration issued Warning Letters to six U.S companies for marketing unapproved and misbranded drug that are being sold over the internet claiming to prevent and treat sexually transmitted diseases.The products are sold as Tetrasil, Genisil, Aviralex, OXi-MED, Imulux, Beta-mannan, Micronutrient, Qina, and SlicPlus and some claim to have "FDA Approval" or claim to be more effective that standard medication. (Source: PharmaGazette) PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=1286275 Fri, 07 Mar 2008 18:00:27 +0100 1286275 http://www.medworm.com/index.php?rid=1245115&cid=t_123614_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F238238499%2Fsanofiaventis_xyzal_tablets_ge.html sanofi-aventis (EPA:SAN) and UBC announced that the U.S. Food and Drug Administration has approved a New Drug Application (NDA) for Xyzal (levocetirizine dihydrochloride) 0.5 mg/ml oral solution.Xyzal is an oral antihistamine, available only by prescription, for the relief of symptoms associated with indoor and outdoor allergies and is also indicated for the treatment of chronic idiopathic urticaria.The tablet form of Xyzal received FDA approval in May, 2007 and both the tablet and oral formulations are now approved for use in adults and children over the age of 6."The oral solution of Xyzal provides a welcome alternative for those patients who have difficulty swallowing or who prefer liquid medication," said Michael S. Blaiss, MD, Clinical Professor of Paediatrics and Medic... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=1245115 Wed, 20 Feb 2008 15:00:06 +0100 1245115 http://www.medworm.com/index.php?rid=1238153&cid=t_123614_109_f&fid=34750&url=http%3A%2F%2Fpsychcentral.com%2Fblog%2Farchives%2F2008%2F02%2F17%2Ffda-to-drug-companies-off-label-use-ok%2F Doctors have always been able to prescribe whatever drug they want, for whatever they want. However, drug companies have only been allowed to advertise and market drugs that have been FDA-approved for specific uses or disorders. That means that generally an antidepressant drug can only be marketed and advertised for depression. If a company wants to market and advertise its drug for other uses, it has to go back to the U.S. Food and Drug Administration (FDA) and file additional applications, with a wealth of supporting research to support those uses. Unless the research is strong and the market is potentially lucrative, many pharmaceutical companies choose to limit the amount of additional uses they seek FDA approval for. Any use of a drug that hasn’t gained FDA approval is conside... World of Psychology blogs http://www.medworm.com/rss/comments.php?id=1238153 Mon, 18 Feb 2008 01:36:13 +0100 1238153 http://www.medworm.com/index.php?rid=1216524&cid=t_123614_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F231210557%2Fteva_gets_fda_approval_for_gen.html Teva Pharmaceuticals USA has received U.S. Food and Drug Administration approval to manufacture generic Fosamax.Alendronate sodium tablets are indicated for the treatment of osteoporosis, a condition that causes thinning and weakening of the bones.Approved dosages will be available in three once-daily dosages of 5 milligrams, 10 milligrams and 40 milligrams and the two once weekly dosages of 35 milligrams and 70 milligrams."The FDA works to assure the safety and efficacy of generic drugs through a rigorous scientific and regulatory process," said Gary J. Buehler, R.Ph, director of the FDA's Office of Generic Drugs. "These approvals will provide generic options for patients who take Fosamax for their osteoporosis."Generic manufacturers must show that a generic drug h... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=1216524 Thu, 07 Feb 2008 20:00:35 +0100 1216524 http://www.medworm.com/index.php?rid=1212094&cid=t_123614_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F230434278%2Froches_xeloda_gets_ec_approval.html The European Commission has approved Roche's oral chemotherapy Xeloda for treatment of metastatic colorectal cancer in combination with any chemotherapy with or without Avastin.The approval of the new indication will allow more patients that have colorectal cancer that has spread to be able to take advantage of the treatment. Pivotal studies demonstrated that Xeloda tablets provided patients with a more flexible treatment that delivered the same survival rates as previously standard chemotherapy treatments. Other studies have shown Xeloda to be more effective than other standard therapies."Colorectal cancer is a devastating disease and treatment options for patients have been limited," said Professor Jim Cassidy, Cancer Research UK Professor of Oncology and Chair of Medical O... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=1212094 Wed, 06 Feb 2008 17:00:44 +0100 1212094 http://www.medworm.com/index.php?rid=1207467&cid=t_123614_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F229807116%2Ffda_grants_priority_review_for_multiple_myeloma_drug_velcade.html Millennium Pharmaceuticals (NASDAQ:MLNM) announced that its multiple myeloma (MM) drug Velcade has been granted priority review by the U.S. Food and Drug Administration. Millenium is looking for a new indication to allow newly diagnosed MM patients to be treated with Velcade.Data submitted to the FDA for the supplemental New Drug Application (sNDA) included data from the phase III VISTA study which was a large, international clinical trial that compared Velcade to traditional treatment. Velcade is already the market leader for MM patients that have attempted at least one prior therapy."Priority review designation puts us on track for a potential label expansion decision by June 20," said Nancy Simonian, M.D., chief medical officer, Millennium. "The rapid action by the F... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=1207467 Tue, 05 Feb 2008 18:00:07 +0100 1207467 http://www.medworm.com/index.php?rid=1207469&cid=t_123614_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F229712151%2Fasmanex_twisthaler_from_scheri.html Schering-Plough Corp (NYSE:SGP) announced that the U.S. Food and Drug Administration has approved its once-a-day asthma corticosteroid inhaler for children. The inhaled steroid for the prevention of asthma attacks can be used with children as young as 4.Asmanex Twisthaler received FDA approval two years ago as a maintenance treatment to prevent flare-ups in adults and children over the age of 12. The dosage for children under 12 is roughly half the adult dosage of 220 micrograms. While other asthma product exisit for young children all must be taken more often throughout the day.The unique aspect of the Twisthaler is that it does not have a propellant like other inhalers. It is activated as the patients inserts the inhaler into their mouth and inhales. A counter on the product keeps track ... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=1207469 Tue, 05 Feb 2008 16:00:20 +0100 1207469 http://www.medworm.com/index.php?rid=1185818&cid=t_123614_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F225444014%2Fastellas_mycamine_gets_additional_indication_fda_approval.html The U.S. Food and Drug Administration has approved Astella Pharma Inc's Supplemental New Drug Application (sNDA) for use of Mycamine in the treatment of patients with Candidemia, Acute Disseminate Candidiasis, Candida Peritonitis and Abscesses.Mycamine, an injectable treatment, is part of the echinocandins class of antifungal agents and was approved for use in 2005 for patients with esophageal candidiasis. It is the only approved treatment for the prophylaxis of Candida infections in patients that are undergoing hematopoietic stem cell transplantation."The FDA's approval of this sNDA further confirms the safety and efficacy profile of MYCAMINE and its importance in the treatment of candidemia and other Candida infections," said Yoshihiko Hatanaka, President and Chief Exec... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=1185818 Tue, 29 Jan 2008 17:00:42 +0100 1185818 http://www.medworm.com/index.php?rid=1169789&cid=t_123614_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F221177993%2Ffda_approves_new_version_of_te.html Tekturna, a high blood pressure medication that was previously approved last March by the U.S. Food and Drug Administration, has received new approval for its combined form of hypertension medication and diuretic.Hydrochlorothiazide, a compound that inhibits the kidneys ability to retain water, has been added to Tekturna's high blood pressure medication aliskiren. Aliskiren is a direct renin inhibitor (DRI) which targets renin an enzyme responsible for hypertension. Tekturna HCT is available in tablet form and is intended for use by patients that have been unsuccessful in controlling their high blood pressure with a single drug. Novartis expects the medication to be available in early February.Side effects of this new hypertension/water pill can include dizziness, c... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=1169789 Tue, 22 Jan 2008 17:00:32 +0100 1169789 http://www.medworm.com/index.php?rid=1169790&cid=t_123614_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F221163390%2Fabbottt_gets_fda_approval_for_humira_for_plaque_psoriasis.html Abbott Laboratories (NYSE:ABT) announced that it has received the fifth indication for its drug Humira. The new indication gives the company U.S. Food and Drug Administration approval to market Humira as a treatment for moderate to severe psoriasis."The approval of HUMIRA for psoriasis is welcome news for people living with this challenging, lifelong disease," said Pam Field, acting president and CEO, National Psoriasis Foundation. "We are pleased to let people with plaque psoriasis know they now have a new treatment option available to them."Psoriasis is an autoimmune disease that is characterized by skin lesions that can be painful and itchy. It is estimated that 125 million people worldwide suffer from psoriasis which can lead to poor self-image and isolation to... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=1169790 Tue, 22 Jan 2008 16:00:17 +0100 1169790 http://www.medworm.com/index.php?rid=1166418&cid=t_123614_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F220604911%2Fwelchol_receives_fda_approval.html Daiichi Sankyo Inc. announced that it has received U.S. Food and Drug Administration approval for its drug Welchol that improves glycemic control when combined with metformin, sulfonylureas or insulin in patients with Type 2 diabetes.Welchol becomes the only FDA approved medication that reduces both glucose levels and low density lipoprotien cholesterol levels (LDL-C). The American Diabetes Association estimates that 40% of patients with Type 2 diabetes also have increased levels of LDL-C and Welchol affords the opportunity to treat both conditions with one medication."We are excited by the opportunity to help more patients with chronic conditions reach their recommended health goals," said Joseph P. Pieroni, President and CEO of Daiichi Sankyo, Inc. "This approval represent... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=1166418 Mon, 21 Jan 2008 20:00:26 +0100 1166418 http://www.medworm.com/index.php?rid=1166420&cid=t_123614_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F220481777%2Fbirth_control_patch_gets_updat.html The Ortho Evra Contraceptive Transdermal (skin) Patch now has additional changes to its label. The U.S. Food and Drug Administration approved the changes as a result of a new epidemiology study that stated the users of the patch were at a higher risk for developing serious blood clots, known as venous thromboembolism (VTE) than women using birth control pills."For women that choose to use contraceptives, it is important that they thoroughly discuss with their health care providers the risks and benefits involved," said Janet Woodcock, M.D., the FDA's deputy commissioner for scientific and medical programs, chief medical officer, and acting director of the Center for Drug Evaluation and Research. "This is an example of FDA working in tandem with the drug manufacturer to k... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=1166420 Mon, 21 Jan 2008 16:00:52 +0100 1166420 http://www.medworm.com/index.php?rid=1166421&cid=t_123614_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F220473495%2Fetravine_gets_fda_approval_for.html Tibotec Pharmaceuticals, a division of Ortho Biotech Products, announced that its drug Etravine has received U.S. Food and Drug Administration approval for the treatment of HIV infection in patients who have not responded to other antiretroviral treatments.The tablets sold under the name Intelence consist of a non-nucleoside reverse transcriptase inhibitor (NNRTI) that helps to block an enzyme that the HIV virus requires to multiply. The FDA approved it for use in combination with other HIV medications.Etravine was given a priority review, status given to medications that treat life threatening conditions. The FDA stated that the drug can reduce the amount of HIV in the blood and increase white blood cells that are needed to fight off other infections."This is another s... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=1166421 Mon, 21 Jan 2008 15:00:53 +0100 1166421 http://www.medworm.com/index.php?rid=1155901&cid=t_123614_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F217683235%2Ftysabri_gets_fda_approval_for.html Biogen Idec Inc. and Elan Corp's Tysabri received U.S. Food and Drug Administration approval to be used in patients with moderate to severe Crohn's disease when standard drug treatments are ineffective.Tysabri was previously FDA approved for the treatment of Multiple Sclerosis but was removed from market in 2005 after three patients using it developed the nervous disorder multifocal leukoencephalopathy (PML). Under restricted distribution the drug was allowed back on the market the following year and Biogen reports that 12,000 MS patients use it with no further reports of the fatal disorder.Crohn's disease patients will have to enroll in a similar distribution program to receive Tysabri. The program consists of educational information regarding the drug'... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=1155901 Wed, 16 Jan 2008 14:00:41 +0100 1155901 http://www.medworm.com/index.php?rid=1139828&cid=t_123614_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F213935760%2Feli_lilly_and_co_gets_fda_appr.html Eli Lilly & Co. (NYSE:LLY) announced that the U.S. Food and Drug Administration has approved two low-dose forms of Cialis for use on a daily basis.Cialis, an anti-impotence drug, will now be available in 2.5 milligram and 5 milligram doses and will allow men more flexibility in the timing of sexual activity."In clinical trials, when taken without restrictions on the timing of sexual activity, Cialis for once daily use improved erectile function over the course of therapy," Lilly said in a release.The low-dose formulations have already been available in parts of Europe but the company warns that even the new reduced dosage makes the medication inappropriate for heart patients who take nitrates. The combination of sildenafil citrate (Viagra), tadalafil (Cialis) or vardenaf... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=1139828 Wed, 09 Jan 2008 16:00:26 +0100 1139828 http://www.medworm.com/index.php?rid=1133907&cid=t_123614_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F212773704%2Fbystolic_gets_fda_approval_for.html Forest Laboratories Inc. (NYSE: FRX) and Mylan Inc. (NYSE: MYL) announced that the U.S. Food and Drug Administration has approved the novel beta blocker Bystolic for the treatment of high blood pressure.Bystolic is a once a day drug that can be used alone or in combination with other hypertension medications in the treatment of high blood pressure. An extensive clinical trial that involved more than 2000 patients, Bystolic showed significant decreases in sitting diastolic and systolic blood pressure. The medication was found to be well tolerated with low incidence of normal beta blocker side effects.Howard Solomon, Chairman and Chief Executive of Forest, commented: "We, along with our partner Mylan, are pleased to have received final Food and Drug Administration marketing approval for... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=1133907 Mon, 07 Jan 2008 17:00:11 +0100 1133907 http://www.medworm.com/index.php?rid=1108699&cid=t_123614_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F203612407%2Ftentative_fda_approval_for_gen_1.html The U.S Food and Drug Administration has announced that it has issued tentative approval for a generic version of Viread (tenofovir disoproxil fumarate). Viread is a drug that is used in combination with other antriretroviral agents in the treamtent of HIV."Tentative approval" means that the product meets all FDA manufacturing standards and safety and efficacy requirements but that existing patents or marketing exclusivity prevents final approval in the U.S at this time.“The fight to save lives with high-quality anti-retroviral treatment is of significant importance to FDA,” said Gary Buehler, director of FDA’s Office of Generic Drugs. “Our scientists have been working diligently to make safe and effective treatments for AIDS available as quickly as possib... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=1108699 Thu, 20 Dec 2007 19:00:53 +0100 1108699 http://www.medworm.com/index.php?rid=1103497&cid=t_123614_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F202250891%2Fforest_labs_and_mylans_bystoli.html Forest Laboratories Inc. (NYSE:FRX) and Mylan Inc.(NYSE:MYL) have received U.S. Food and Drug Administration approval for their beta blocker Bystolic.Bystolic, indicated for the treatment of hypertension, is a one daily medication that can be used in conjunction with other high blood pressure drugs or alone. The drug is a beta blocker which is one of the most prescribed classes of drug in the U.S. In several clinical trials Bystolic showed significant decreases in sitting diastolic and systolic blood pressure in a group of patients that included 26 percent black, 54 percent male, 19 percent elderly and 8 percent diabetic."Bystolic is the newest beta blocker approved for the treatment of hypertension in the U.S. and should prove useful due to its efficacy in a broad range of patie... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=1103497 Tue, 18 Dec 2007 15:00:43 +0100 1103497 http://www.medworm.com/index.php?rid=1100156&cid=t_123614_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F201732157%2Fglaxosmithkline_receives_fda_complete_response_letter_for_cervarix.html GlaxoSmithKline announced that it received a FDA complete response letter with regards to its application for new drug status for Cervarix, a cervical cancer vaccine. A complete response letter is issued when the FDA has completed review of the file but still has unanswered questions prior to final approval."We have already started addressing the questions and will be engaged in discussions with the FDA to finalize our responses," said Barbara Howe, M.D., Vice President and Director, North American Vaccine Development, GlaxoSmithKline. "Our discussions with the agency continue to be positive and constructive, and we are working diligently to resolve any outstanding questions to bring CERVARIX(R) to the U.S. market."Cervarix, one of the largest drug hopes in Gl... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=1100156 Mon, 17 Dec 2007 16:00:45 +0100 1100156 http://www.medworm.com/index.php?rid=1096192&cid=t_123614_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F200474290%2Fmylan_pharmaceuticals_incs_lam_1.html U.S. Food and Drug Administration today issued tentative approval for Mylan Pharmaceuticals Inc’s Lamotrigine tablets. Lamotrigine is the generic version of GlaxoSmithKline's Lamictal tablets which is an anticonvulsant drug used to treat partial seizures associated with epilepsy. It is also used as a mood stabilizer and was the first drug since lithium granted FDA approval for the maintenance treatment of bipolar type I disorder. It was granted FDA approval for the treatment of epilepsy in 1994 and bipolar I disorder in 2003. Black box warnings include Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis. More common side effects include headaches, dizziness, insomnia, acne, vivid dreams, body aches, fatigue, memory and cognitive problems, irritability, changes in libido, naus... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=1096192 Thu, 13 Dec 2007 20:00:54 +0100 1096192 http://www.medworm.com/index.php?rid=1084250&cid=t_123614_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F198190914%2Ffda_decision_regarding_nexium_and_omeprazole_no_cardiac_risk.html Final assessment of two small, long-term, open studies on patients with gastro-esphogeal reflux disease (GERD) comparing anti-reflux surgery with either Nexium or omeprazole was announced by the U.S. Food and Drug Administration. The FDA concluded that "long-term use of these drugs is not likely to be associated with an increased risk of heart problems. FDA recommends that health care providers continue to prescribe, and patients continue to use, these products as described in the labeling for the two drugs."AstraZeneca, manufacturer of Nexium, agreed with the FDA's findings and further agreed that the overall risk/benefit profiles of omeprazole and Nexium remain unchanged and continues to be confident in the safety of both drugs.AstraZeneca's tradenames for ome... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=1084250 Mon, 10 Dec 2007 16:00:44 +0100 1084250 http://www.medworm.com/index.php?rid=1074988&cid=t_123614_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F196385852%2Fcommitte_votes_to_approve_tetr.html A U.S. Food and Drug Administration advisory committee voted unanimously to recommend approval of tetrabenzine for chorea associated with Huntington disease (HD). If approved it would be the first drug in the U.S. approved for the treatment of chorea. The FDA is not required to follow the suggestions of its advisory committees, however, approval usually follows such a recommendation."The advisory committee's support of tetrabenazine represents an important advancement for Huntington disease patients, caregivers, advocates and physicians who treat this devastating disease," said George F. Horner III, president and chief executive officer of Prestwick. "We are committed to continuing to work with the FDA to secure full approval of tetrabenazine."Huntington disease is ... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=1074988 Thu, 06 Dec 2007 20:00:47 +0100 1074988 http://www.medworm.com/index.php?rid=1067792&cid=t_123614_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F194600524%2Fdiovan_gets_fda_approval_for_t.html The U.S. Food and Drug Administration has approved Diovan (valsartan) for use on children between the ages of six and sixteen following a priority review. Diovan is an angiotensin receptor blocker (ARB). The drug has already been previously approved for use by adults suffering from high blood pressure.It is believe that nearly 5% of children and adolescents suffer from high blood pressure. Novartis Pharmaceuticals, the manufacturer of Diovan, claims that studies showed no difference in adverse affects on children than were previously reported for adults. Those side effects can include: headache and dizziness or more seriously hypotension and kidney problems."Novartis believes it is important to provide physicians with treatment options such as Diovan which are effective in treati... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=1067792 Mon, 03 Dec 2007 20:00:38 +0100 1067792 http://www.medworm.com/index.php?rid=1062889&cid=t_123614_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F193074550%2Fcymbalta_gets_fda_approval_as.html The U.S. Food and Drug Administration has approved Cymbalta (duloxetine HCl) for the maintenance treatment of major depressive disorder (MDD) in adults according to the drug manufacturer, Eli Lilly and Company (NYSE:LLY).The efficacy and safety of Cymbalta, as a maintenance treatment, was established in a double-blind, placebo-controlled clinical trial involving 533 patients with major depression. After 12 weeks, 278 patients met the criteria to continue in the trial and were randomly assigned Cymbalta or a placebo for the next six months. Those taking Cymbalta had a statistically longer period of time between relapses."Relapse, the re-emergence of depressive symptoms after a successful treatment of depression, is a significant clinical concern," says Doug Williamson, M.D., ... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=1062889 Fri, 30 Nov 2007 16:00:59 +0100 1062889 http://www.medworm.com/index.php?rid=1054848&cid=t_123614_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F191462750%2Ffda_drug_approval_news.html Vanada Pharmaceuticals has announced that its drug, iloperidone, has been accepted for U.S. Food and Drug Administration New Drug Application (NDA). Iloperidone is an investigational atypical antipsychotic for the treatment of schizophrenia.In other FDA news, Watson Pharmaceuticals Inc announced that it received final approval on its ANDA for Oxycodone Hydrochloride and Ibuprofen tablets in the 5/400 mg strengths. Waston's product is the generic equivalent of Forest Laboratories Inc.'s Combunox which is used for the short term (no more than 7 days) treatment of acute, moderate to severe pain.The FDA has accepted filing of a NDA for Schering-Plough's asenapine, a fast-dissolving, sub-lingual tablet for schizophrenia and acute mania associated with Bipolar I Disorder. To dat... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=1054848 Tue, 27 Nov 2007 20:00:38 +0100 1054848 http://www.medworm.com/index.php?rid=1054849&cid=t_123614_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F191438299%2Finomax_by_ikaria_approved_in_australia.html Ikaria Holdings Inc's subsidiary INO Therapeutics LLC announced today that it has received approval from Australia's Therapeutic Goods Administration (TGA) for INOmax (nitric oxide) for inhalation. INOmax stated that it had received Orphan Drug status, a process by which medical products for rare illnesses are approved, which it has already received in the U.S. Europe, Canada, Singapore and several Latin American countries.INOmax is indicated for the treatment of near and full-term newborns suffering from hypoxic respiratory failure (HRF), a life-threatening condition that prevents babies' lungs from delivering sufficient oxygen to their bodies."As we broaden the reach of INOmax to new continents, we are expanding our ability to advance critical care around the globe,&quot... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=1054849 Tue, 27 Nov 2007 19:00:19 +0100 1054849 http://www.medworm.com/index.php?rid=1047610&cid=t_123614_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F189406329%2Ffda_approves_abilify_as_add-on_for_major_depression.html Earlier this month the U.S Food and Drug Administration approved Abilify for the treatment of schizophrenia in teens and have now expanded that approval to include patients with major depressive disorder.Approved in 2002 for schizophrenia in adults and for adults suffering from bipolar manic episodes, Bristol-Myers Squibb states that Abilify is the first drug approved as an adjunctive treatment for major depressive disorder for patients needing more than just antidepressants."The approval of this new add-on treatment option is critical for adults suffering from depression who cannot find sufficient relief for their symptoms with antidepressants alone," commented Madhukar Trivedi, M.D., of the University of Texas Southwestern Medical School in Dallas.Supplemental approva... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=1047610 Fri, 23 Nov 2007 15:00:13 +0100 1047610 http://www.medworm.com/index.php?rid=1036940&cid=t_123614_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F187316051%2Fbayer_and_onyx_nexavar_fda_approved_for_liver_cancer.html Bayer HealthCare Pharmaceuticals and Onyx Pharmaceuticals, Inc. (Nasdaq: ONXX) have received U.S. Food and Drug Administration supplemental New Drug approval for Nexavar (sorafenib).Nexavar is the first FDA approved drug indicated for the treatment of patients with liver cancer (unresectable hepatocellular carcinoma - HCC). It is an oral anticancer and has shown significant overall survival in patients since it was first used in 2005."The approval of Nexavar in liver cancer marks the second time in two years that this novel kinase inhibitor has been granted FDA approval on a Priority Review basis, making it rapidly available to patients who previously had limited treatment options," said Arthur Higgins, chairman of the Executive Committee of Bayer HealthCare. "This mile... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=1036940 Mon, 19 Nov 2007 18:30:35 +0100 1036940 http://www.medworm.com/index.php?rid=1035616&cid=t_123614_122_f&fid=35055&url=http%3A%2F%2Fsarasotaneurology.com%2F2007%2F11%2F19%2Fseizures-medication-treatment-offers-hope-for-a-normal-lifestyle%2F Seizures are the manifestation of uncontrolled electrical activity in the brain. Affected individuals show clinical symptoms of seizures with twitching or jerking of one side or their entire body. With this they can make gasping noises, turn blue in the face, bite their tongue or lose control of their bladder. These symptoms are charateristic of a grand mal seizure. During an epileptic attacks, the person is not responsive or aware of what is going on around them. Fortunately there is excellent treatment available to control seizures and in many cases, keep patients seizure free. It is estimated that there are 2-3 million individuals in the United States who suffer from recurrent seizures (epilepsy.) Many of these people are neurologically intact with the cause of their seizures being unkn... Sarasota Neurology blogs http://www.medworm.com/rss/comments.php?id=1035616 Mon, 19 Nov 2007 11:32:22 +0100 1035616 http://www.medworm.com/index.php?rid=1032967&cid=t_123614_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F185969732%2Ffda_approves_astrazenecas_sero.html The U.S Food and Drug Administration has approved AstraZeneca (NYSE:AZN)Seroquel XR for maintenance treatment of schizophrenia in adult patients. Seroquel XR was previously approved for the treatment of acute schizophrenia in May of this year. According to PRNewsIn the clinical trial supporting this approval, patients with schizophrenia who were treated with SEROQUEL XR experienced a significantly longer time to relapse, compared with patients receiving placebo. Patients receiving SEROQUEL XR demonstrated an 84% reduction in the relative risk of relapse (hazard ratio 0.16; p<0.0001). Results showed the estimated risk of relapse after six months was 14.3% in the SEROQUEL XR group versus 68.2% in the placebo group (p<0.0001). Differences in relapse rate between active treatment an... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=1032967 Fri, 16 Nov 2007 20:00:46 +0100 1032967 http://www.medworm.com/index.php?rid=1021309&cid=t_123614_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F183646737%2Ffda_approval_for_nonprescripti.html Zyrtec-D (cetirizine HCl 5 mg and pseudoephedrine HCl 120 mg), an allergy drug, has been approved for nonprescription use in adults and children over the age of 12 by the U.S. Food and Drug Administration.Previously approved by the FDA in 2001 as a prescription drug, Zyrtec-D is now available without a prescription. It is indicated for the relief of symptoms due to hay fever or other upper respiratory allergies like runny nose, sneezing, itchy andwatery eyes, itching of nose or throat and nasal congestion. It also reduces the swelling of nasal passages for the relief of sinus congestion and pressure.National Institute of Allergy and Infectious Diseases estimates that 50 million Amaericans suffer from hay fever and allergies every year and is the sixth leading cause of chronic disease.&quot... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=1021309 Mon, 12 Nov 2007 16:30:45 +0100 1021309 http://www.medworm.com/index.php?rid=1021310&cid=t_123614_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F183625480%2Fclogged_arteries_take_crestor.html AstraZeneca plc (NYSE:AZN) has received U.S. Food and Drug Administration approval to sell its cholesterol drug, Crestor, to also treat clogged arteries. Crestor will now be available to treat atherosclerosis in addition to being used as to lower cholesterol. It is the first widely used statin to receive this new approval.AstraZeneca has been conducting a large number of clinical trials to prove that it is superior to other statins. "This new indication gives Crestor an important differentiator from competitors in the cholesterol-lowering marketplace," AstraZeneca said in a statement.The new FDA approval is expected to give Crestor a leg up over competitors in the cholesterol lowering market like Lipitor from Pfizer Inc."FDA today approved Crestor as adjunctive therapy to di... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=1021310 Mon, 12 Nov 2007 15:30:06 +0100 1021310 http://www.medworm.com/index.php?rid=1012381&cid=t_123614_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F181193627%2Fatir_from_kiadis_pharma_gets_o.html The U.S. Food and Drug Administration has granted orphan drug status to Kiadis Pharma for its lead drug ATIR.ATIR is currently in Phase I/II clinical studies as a therapy for immune reconstitution and prevention of Graft vs Host Disease (GvHD) following allogenic bone marrow transplantation. The drug is expected to go into Phase III trials in 2008."This is an important strategic milestone in the development of ATIR as a novel approach which may enable a safe and potentially life-saving mismatched bone marrow transplantation as a treatment option for end-stage blood cancer patients" said Dr. Manja Bouman, Chief Executive Officer of Kiadis Pharma.GvHD is one of the biggest concerns during any bone marrow transplant. It is a condition where the donor's immune cells and attack th... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=1012381 Wed, 07 Nov 2007 16:30:38 +0100 1012381 http://www.medworm.com/index.php?rid=1009446&cid=t_123614_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F180742700%2Fabilify_fda_approved_for_teens.html Bristol-Myers Squibb (NYSE:BMY) announced that the U.S Food and Drug Administration has approved its drug Abilify for teens aged 13 - 17 that have been diagnosed with schizophrenia.Abilify (aripiprazole) is an antipsychotic drug that was first approved by the FDA at the end of 2002 for adults with schizophrenia and since that time Bristol-Myers says that more than 12.5 million US prescriptions for the drug have been written."We are extremely pleased that ABILIFY, the first available dopamine partial agonist, is approved for the treatment of pediatric patients (13 to 17 years of age) suffering from schizophrenia," said Tatsuo Higuchi, President and Representative Director, Otsuka Pharmaceutical Co., Ltd. "ABILIFY® (aripiprazole) offers an effective new option to help... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=1009446 Tue, 06 Nov 2007 20:30:44 +0100 1009446 http://www.medworm.com/index.php?rid=1003705&cid=t_123614_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F180045114%2F As Bob prepares to leave the ceo job on Jan. 1 and become chairman for an unspecified period of time, he’s using his final weeks to sound off quite sharply about the FDA, which has caused Wyeth unending aggravation this year by refusing to approve some of its drugs. In an interview with The Financial Times, Bob say the FDA “is establishing monopolies” by denying drug approvals. He’s concerned that FDA assessments now include whether a drug can work better than an existing product, instead of allowing the market to determine what it wants. Specifically, he says the FDA was blocking new drugs after their efficacy was compared to those already on the market. This is, he claims, beyond the FDA’s mandate and could prompt legal action. Whether he is about to sue isn... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1003705 Mon, 05 Nov 2007 13:42:24 +0100 1003705 http://www.medworm.com/index.php?rid=1001033&cid=t_123614_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F178819114%2Fthe_us_food_and_drug.html The U.S. Food and Drug Administration has accepted Indevus Pharmaceuticals Inc.'s (NASDAQ:IDEV)  New Drug Application (NDA) for Nebido. The NDA was submitted August 28, 2007 and the target action date for the drug is June 27, 2008. Nebido is a long-acting testosterone injection for the treatment of hypogonadism. The NDA contained data from six clinical trials of over 3,000 injections as well as data from 260,000 injections worldwide. Hypogonadism is a medical condition in which there is an absence or reduction of testosterone in the testes. Reduced testosterone levels can lead to decreased sexual desire, muscle loss and weakness and the increased risk of osteoporosis. It is estimated that four to five million men in the U.S. suffer from hypogonadism and less than 10% are rece... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=1001033 Fri, 02 Nov 2007 17:15:44 +0100 1001033 http://www.medworm.com/index.php?rid=995006&cid=t_123614_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F177853452%2Fcombigan_eye_drop_for_galucoma_fda_approved.html The U.S. Food and Drug Administration has approved Combigan by Allergan Inc.(NYSE:AGN) for the treatment of glaucoma. It is a prescription eye drop that reduces elevated intraocular pressure (IOP) using an alpha adrenergic receptor agonist with a beta adrenergic inhibitor."COMBIGAN(TM) ophthalmic solution is a medication that provides well documented safety and efficacy for patients with inadequately controlled IOP," said Scott Whitcup, M.D., Allergan's Executive Vice President, Research and Development. "The development of COMBIGAN(TM), which has included five key clinical studies, underscores Allergan's commitment to provide new treatment options for patients with glaucoma." Glaucoma is a group of eye diseases that are characterized by damage to the optic... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=995006 Wed, 31 Oct 2007 20:00:46 +0100 995006 http://www.medworm.com/index.php?rid=991867&cid=t_123614_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F177259353%2Fadams_respitory_therapeutics_gets_approval_letter_for_mucinex_with_codeine.html The U.S Food and Drug Administration has issued a letter of approval regarding the New Drug Application for Adams Respitory Therapeutics Inc's (NASDAQ:ARXT) Mucinex with Codeine.Mucinex with Codeine is to be used in the prescription treatment of cough associated with the common cold, inhaled irritants and stable chronic bronchitis.The FDA stated that it had it had completed its review of the medication and that it was approvable however prekiminary labeling comments are required in addition to more data on the use of the product with food."An approvable letter for Mucinex with Codeine is a positive step in the FDA review process," said COO Robert D. Casale. "As a next step, we intend to seek a meeting with the agency in order to agree on an approach. We wi... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=991867 Tue, 30 Oct 2007 17:15:31 +0100 991867 http://www.medworm.com/index.php?rid=991869&cid=t_123614_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F177201169%2Fnovartis_ag_gets_fda_approval_1.html Novartis AG (NYSE:NVS) has received U.S. Food and Drug Administration approval for Tasigna.Tasigna is indicated for use in chronic myeloid leukemia for patients that no longer respond to Glivec(Gleevec in the US). It was developed as a next-generation targeted therapy for adult patients with chronic or accelerated phase Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) with intolerance and/or resistance to Gleevec.Both Tasigna and Gleevec were designed to inhibit the production of cells containing the Philadelphia chromosome by inhibiting the Bcr-Abl protein which is recognized as the key cause of the proliferation of white blood cells that characterizes Ph+CML."These exciting data demonstrate that Tasigna has the potential to offer a compelling new treatment ... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=991869 Tue, 30 Oct 2007 15:15:12 +0100 991869 http://www.medworm.com/index.php?rid=988451&cid=t_123614_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F176777581%2Ftentative_approval_for_valsart.html Ranbaxy Pharmaceuticals announced that it has received tentative approval to manufacture and market Valsartan Tablets in 40 mg, 80 mg, 160 mg and 320 mg strengths.Valsartan is the generic version of Diovan, a Novartis drug, and is used in the treatment of high blood pressure. I tcan be used alone or in combination with other anti-hypertensive medications. It is also indicated for the treatment of heart failure."We are pleased to receive tentative approval for Valsartan Tablets. We believe, we are first to file a substantially complete ANDA and will stand to gain from the 180 day exclusivity available to the first filer. These product formulations have been developed organically within Ranbaxy and will further expand our product portfolio of affordable generic alternatives," said ... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=988451 Mon, 29 Oct 2007 18:15:13 +0100 988451 http://www.medworm.com/index.php?rid=979218&cid=t_123614_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F174962703%2Fsanofiaventis_receives_warning.html The FDA sent a warning letter to Sanofi's CEO Gregory Irace accusing the company of knowingly having submitted clinical data had "multiple and significant violations of FDA regulations… that affected the integrity of data submitted".After the FDA required more information on Ketek following fears that it could cause liver damage, data obtained as part of a postmarketing study by Pharmaceutical Product Development was submitted on behalf of Aventis prior to its merge with Sanofi-Synthelabo.At the heart of the matter is Dr Anne Kirkman-Campbell who in 2004 was convicted of fraud regarding patient enrollment and fake consent forms during the Ketek study. The issue also raised concerns in Congress and a former Pharmaceutical Product Development employee testified that... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=979218 Thu, 25 Oct 2007 18:15:14 +0100 979218 http://www.medworm.com/index.php?rid=976396&cid=t_123614_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F174474669%2Fwyeth_applies_to_fda_approval_for_new_drug_tygacil.html Wyeth Pharmaceutical (NYSE:WYE) announced that the FDA has accepted the filing of Tygacil (tigecycline) for new drug approval. Tygacil is a first-in-class antibiotic for the treatment of patients with community acquired pneumonia.The next step is for the FDA to review the application and either approve or disapprove the request. It may also request additional data or take other actions."CAP is a serious respiratory disease that affects millions of Americans," says Gary L. Stiles, M.D., Executive Vice President, Chief Medical Officer, Wyeth Pharmaceuticals. "The acceptance of this sNDA is an important event as it brings Wyeth closer to providing physicians with a new option for the treatment of CAP."The submission included data from two clinical studies of 846 ... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=976396 Wed, 24 Oct 2007 19:15:28 +0100 976396 http://www.medworm.com/index.php?rid=972759&cid=t_123614_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F173940137%2Fnovartis_ag_gets_fda_approval.html The U.S Food and Drug Administration has given approval to Novartis AG (NYSE:NVS) for Voltaren Gel, a non-steriodal anti-inflammatory (NSAID) medication for osteoarthritic pain.The gel can be applied directly to joints, such as knees, hands, elbows, to relieve the pain assosciated with osteoarthritic pain. Osteoarthritis is a chronic condition in which the cartilage of the joints deteriorates. "Voltaren Gel represents an important clinical milestone - it is the first prescription topical treatment in the US shown to relieve osteoarthritis pain and to clinically prove efficacy in treating both the knees and hands," said Jorge Insuasty, MD, Senior Vice President, Research and Development, Novartis Consumer Health, Inc. "Patients now have the option to effectivel... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=972759 Tue, 23 Oct 2007 19:15:11 +0100 972759 http://www.medworm.com/index.php?rid=972762&cid=t_123614_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F173837388%2Fsun_pharmaceutical_industries_gets_fda_approval_to_market_generic_exelon.html Sun Pharmaceutical Industries (BOM:524715) announced that it has received U.S. Food and Drug Administration final approval to market the generic version of Exelon capsules.Exelon (rivastgmine tartrate) is a pharmaceutical drug manufactured by Novartis that helps slow down the progress of Alzheimer's disease and for mild to moderate Parkinson's disease dementia.Alzheimer's disease is a progressive, degenerative disease that causes changes in the brain. A type of dementia, it affects a person's memory, mood and behavior. Most commonly affecting people over the age of 65, its cause is unknown but plaques form in the brain causing a disruption in the flow of information between neurons. Exelon is a cholinesterase inhibitor that works by increasing the amount of a... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=972762 Tue, 23 Oct 2007 15:15:27 +0100 972762 http://www.medworm.com/index.php?rid=970104&cid=t_123614_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F173458404%2Ffda_expands_age_range_for_mena.html The bacterial meningitis vaccine, Menactra has been now been approved for use on people between the ages of 2 and 10 years. The FDA has previously approved Menactra, in 2005, for people between the ages of 11 and 55. Meningitis is an inflammation of the lining that surrounds the spinal cord and brain and can result in death or permanent injury to the brain and nervous system. An estimated 2,600 people in the U.S. contract meningitis annually and about 10% die.“Approving Menactra for younger children offers another option for health care providers and parents. Now there are two vaccines available for children between 2 and 10 years of age who may be at increased risk of meningitis,” said Jesse L. Goodman, M.D., M.P.H., director of FDA's Center for Biologics Evaluation a... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=970104 Mon, 22 Oct 2007 21:30:38 +0100 970104 http://www.medworm.com/index.php?rid=968377&cid=t_123614_122_f&fid=35055&url=http%3A%2F%2Fsarasotaneurology.com%2F2007%2F10%2F22%2Fstroke-prevention-a-better-way-of-stroke-treatment%2F The objective is to have a total cholesterol less than 180, good cholesterol (HDL) of greater than 50 and bad cholesterol (LDL) less than 100. A recent study published in the journal Stroke reported that discontinuing statin therapy in the year after a stroke is associated with a significant increase in the risk for death, even in the absence of heart disease. Medications are not the only treatment for stroke prevention. Smoking is associated with a 2-3 times greater risk of stroke and bleeding in the brain. Smoking also contributes to the accelerated development of heart disease, emphysema and peripheral artery disease. Chantix is a new medication that received FDA approval to help stop smoking. Exercise is important in maintaining overall body conditioning and weight control. This in tur... Sarasota Neurology blogs http://www.medworm.com/rss/comments.php?id=968377 Mon, 22 Oct 2007 11:15:34 +0100 968377 http://www.medworm.com/index.php?rid=964604&cid=t_123614_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F172205606%2Ffda_approves_doribax.html Doribax, an intravenous infusion that has been shown to be affective against several strains of bacteria, has been approved by the U. S. Food and Drug Administration.The doripenem injection is indicated for the treatment of complicated urinary tract infections and intra-abdominal infections. “This is a significant new drug in the treatment of hospitalized patients with serious bacterial infections,” said Janet Woodcock, M.D., FDA’s deputy commissioner for scientific and medical programs, chief medical officer and acting director, Center for Drug Evaluation and Research.In multi-center studies, doripenem has a cure rate comparable to the currently used medication levofloxacin. Common adverse reactions were headache, nausea, diahhrea, rash and plebitis. Should an allerigic ... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=964604 Fri, 19 Oct 2007 19:15:01 +0100 964604 http://www.medworm.com/index.php?rid=958915&cid=t_123614_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F171239793%2Fixempra_by_bristol-myers_squibb_approved_by_fda_for_breast_cancer_.html Ixempra, a new chemotherapy drug from Bristol-Myers Squibb (NYSE:BMY), has been approved for sale by the U.S. Federal Drug Administration and is expected to be available for sale within the next few days.Ixempra, a new class of drugs called epothilones, is a stand alone treatment for women with advanced breast cancer that has not responded to other anthracyclines or taxanes."We now have an important new option for patients with metastatic breast cancer who have rapidly progressed through currently approved chemotherapies," Dr. Linda Vahdat, a cancer expert at New York-Presbyterian Hospital/Weill Cornell Medical Center, said in a Bristol-Myers statement.Patients who took Ixempra with Xeloda, in clinical trials, had tumors that either shrank or did not grow for an average... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=958915 Wed, 17 Oct 2007 19:30:34 +0100 958915 http://www.medworm.com/index.php?rid=956131&cid=t_123614_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F170721317%2Fglaxosmithkline_gets_fda_appro.html The FDA approved GlaxoSmithKline's (NYSE:GSK) oral Hycamtin (topotcan) for the treatment of relapsed small cell lung cancer. The capsules are indicated for patients who had a complete or partial response to chemotherapy and who are at least 45 days from the end of their treatment."The approval of HYCAMTIN capsules is particularly important forpatients with relapsed small cell lung cancer as they now have an effective treatment option that has been shown to provide a survival benefit and can be conveniently taken at home," said Debasish Roychowdhury, M.D., Vice President, Global Clinical Development, Oncology Medicine Development Center, GSK.Small Cell Lung Cancer (SCLC) is caused by uncontrollable growth of cancer cells on the bronchi and tends to spread to the rest of the bo... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=956131 Tue, 16 Oct 2007 17:45:20 +0100 956131 http://www.medworm.com/index.php?rid=948591&cid=t_123614_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F169476649%2Fmerck_cos_aids_pills_approved_by_fda.html The FDA has approved Merck & Co.'s (NYSE:MRK)newest AIDS option, Isentress and the company said that the pill should be available to the public within the next two weeks.Three different enzymes are used by the AIDS virus to reproduce and infect cells and numerous drugs are available that attack two of those enzymes, protease and reverse transcriptase. Isentress is the first in a new class of medication that blocks the third called integrase. When Isentress (raltegravir) is added to the drug "cocktail", it can lower the amount of HIV in the blood and thus help immune cells rebound. Inhibiting integrase from allowing HIV DNA insertion into human DNA blocks the ability of the virus to replicate and infect new cells.The FDA approved the use of Isentress for use of patien... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=948591 Sat, 13 Oct 2007 19:36:22 +0100 948591 http://www.medworm.com/index.php?rid=941865&cid=t_123614_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F167996160%2Fglenmark_pharmaceuticals_limited_receives_fda_approval_to_market_generic_version_of_trileptal_.html Glenmark Pharmaceuticals Limited (NSE:GLENMARK)has received final U.S. Food and Drug Administration approval to market generic Trileptal (Oxcarbazepine) tablets.Trileptal is currently manufactured by Roxane Laboratories Inc (Google Finance), Glenmark Pharmaceuticals Ltd. and Sun Pharmaceutical Industries Limited (BOM:524715) in three strength (150 mg, 300 mg and 600 mg) and is used alone or in combination with other drugs in the treatment of partial epileptic seizures in adults and children over the age of 4.Trileptal was the 74th best selling brand name medication in 2005 according to Drug Topics."FDA requires generic drugs to have the same quality, strength, purity and stability as brand-name drugs," said Gary J. Buehler, director of FDA's Office of Generic Drugs.... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=941865 Wed, 10 Oct 2007 17:00:36 +0100 941865 http://www.medworm.com/index.php?rid=938781&cid=t_123614_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F167504668%2Fteva_pharmaceutical_industries.html Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced that it has received final FDA approval for its Abbreviated New Drug Application for the generic version of Actonel.Actonel, a Procter & Gamble Company (NYSE:PG) product, is used in the treatment and prevention of postmenopausal and glucocorticoid-induced osteoporosis and for the treatment of Paget's disease.Teva is currently in patent litigation concerning the generic version of Actonel. A trial was held in November 2006 but no decision has been rendered. As part of the litigation Teva agreed to give a 30 day notice to Procter and Gamble prior to any launch of the product. Notice has not yet been given.Teva has been awarded 180 days marketing exclusivity for being the first company to file an Abbreviated New Dr... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=938781 Tue, 09 Oct 2007 17:00:03 +0100 938781 http://www.medworm.com/index.php?rid=935294&cid=t_123614_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F166978293%2Feuropean_approval_for_novatis.html Novartis AG (NYSE:NVS) has received European approval for its drug Aclasta for postmenopausal osteoporosis. The treatment is taken once a year and has been shown to reduce fractures normally affected by osteoporosis such as spine, wrists and hips. Belonging to a drug family called bisphosphonates, it has long been used to treat the osteoporosis which affects over 94 million people in the E.U. and U.S.Aclasta is given as an annual 15 minute, to fight osteoporosis, which is a symptom of aging. The bones start to become less dense, later in life, and that increases the risk of fracture. Typically women suffer from it more than men. Aclasta, marketed as Reclast in the U.S. has already received FDA approval."Aclasta is highly effective at reducing fractures and can be given once-... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=935294 Mon, 08 Oct 2007 15:00:17 +0100 935294 http://www.medworm.com/index.php?rid=931166&cid=t_123614_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F165859967%2Faptivus_tipranavir_gets_full_fda_approval.html Boehringer Ingelheim Pharmaceuticals Inc. announced that it has received full approval from the FDA for Aptivus. It had already received accelerated approval in June of 2005. Full approval was granted on data from a 48-week analysis of the Phase 3 clinic studies."Data show that APTIVUS/r may provide treatment-experienced HIV patients with an effective treatment option through nearly one year of therapy. Furthermore, longer-term safety data are now available for physician and patient consideration," said Dr. Daniel Kuritzkes, associate professor of medicine, Harvard Medical School; director of AIDS research, Brigham and Women's Hospital, Boston, MA.Aptivus has already been approved in Argentina, Australia, Canada, Switzerland, Mexico, Iceland, Taiwan and the European Unio... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=931166 Fri, 05 Oct 2007 21:00:17 +0100 931166 http://www.medworm.com/index.php?rid=931168&cid=t_123614_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F165814298%2Ftentative_fda_approval_for_tev.html Teva Pharmaceutical Industries Ltd. (NASDAQ:TEVA) announced that it has received tentative approve for its generic version of Valtrex. Manufactured by GlaxoKleinSmith, the patent for Valtrex expires in December and final approval for the generic version is expected at that time. Mylan Laboratories Inc. (NYSE:MYL) has also received tentative FDA approval for generic Valtrex. Valtrex is used in the treatment of herpes zoster (shingles), genital herpes and herpes labialis (cold sores). Total sales of Valtrex were about $1.3 billion last year.   (Source: PharmaGazette) PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=931168 Fri, 05 Oct 2007 19:00:02 +0100 931168 http://www.medworm.com/index.php?rid=931169&cid=t_123614_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F165789583%2Ftentative_fda_approval_for_gen.html Caraco Pharmaceuticals (AMEX:CPD)  announced today that they have received tentative approval to market their generic version of Zyrtec Chewable, Cetirizine HCl Chewable. They are expecting final approval prior to the expiration of the patent in December of this year.Cetirizine HCl Chewable is used for the relief of nasal symptoms of seasonal allergies and is the bioequivalent of Pfizer Inc's Zyrtec Chewable which has U.S. sales of $75 million from June 2006 to June 2007.Daniel H. Movens, Caraco's Chief Executive Officer, said, "We are extremely pleased to receive this tentative approval and look forward to the expiration date of the patent on December 25, 2007, which will allow Caraco to market the product. We feel that Cetirizine HCl Chewable complements our previo... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=931169 Fri, 05 Oct 2007 18:00:49 +0100 931169 http://www.medworm.com/index.php?rid=928093&cid=t_123614_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F165270801%2F The agency notes that generics are cheaper as it announces GIVE - the Generic Initiative for Value and Efficiency - as a way to move the approval process along. Although the FDA approved or tentatively approved 682 generics in fiscal year 2007, or 30 percent more than the previous year, FDA commish Andy von Eschenbach wants to pick up the pace. And he’s going to hire more people to get it done. (Read more here). Faced with a backlog of 1,300 applications, up from about 800 about a year ago, the FDA is revising the review order for certain drug applications. For example, the agency says first generic products, for which there are no blocking patents or exclusivity protections on the reference listed drug, are identified at the time of submission for expedited review. This will mean th... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=928093 Thu, 04 Oct 2007 15:57:32 +0100 928093 http://www.medworm.com/index.php?rid=925341&cid=t_123614_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F164772674%2Ffda_approves_evista_raloxifene_1.html The FDA has approved Raloxifene as a treatment to reduce breast cancer risk in menopausal women. Raloxifene, under the brand name Evista, has previously been approved for postmenopausal women with osteoporosis but is now available to women with high risk for invasive breast cancer. Based on clinical studies of postmenopausal women over a 10 year period of time, raloxifene "provides an important new option for women at heightened risk of breast cancer," said Dr. Steven Galson, director of the FDA's Center for Drug Evaluation and Research. (Source: PharmaGazette) PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=925341 Wed, 03 Oct 2007 17:30:40 +0100 925341 http://www.medworm.com/index.php?rid=918931&cid=t_123614_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F164163860%2Ffda_approves_lamisil_for_scalp.html The FDA has approved the use of Lamisil Oral Granules in the treatment of scalp ringworm, tinea capitis, in children over the age of 4."Tinea capitis is a persistent infection that is hard to treat, and one that causes children embarrassment," said Steven Galson, M.D., M.P.H., director of FDA's Center for Drug Evaluation and Research. "A parent's ability to sprinkle it on the food of a child, who may not like to take medicine, should go a long way to helping ensure the infection is properly treated and to limiting its spread." Lamisil is a Novartis Pharmaceuticals product. The company was approached by the FDA for a formulation that would appeal to children. Novartis developed the granules which can be sprinkled on food.  (Source: PharmaGazette) PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=918931 Mon, 01 Oct 2007 22:15:14 +0100 918931 http://www.medworm.com/index.php?rid=918020&cid=t_123614_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F163819243%2Ftaxotere_gets_fda_approval_to.html Sanofi-Aventis (EPA:SAN) has announced that the FDA has approved Taxotere™  for use in cancer patients with carcinoma of the head and neck prior to chemotherapy or surgery.A clinical trial found that patients receiving a combination of Taxotere-based therapy (TPF) and cisplatin and 5-flurouracil (PF) has a 30% lower risk of death than those receiving PR alone. Patients treated with TPF has an average overall survival of 70.6 months as compared to 30.1 months for those getting PF.Clinical investigator Marshall Posner, MD, Medical Director of the Head and Neck Oncology Program at Dana-Farber Cancer Institute in Boston stated "The approval of Taxotere to be given in combination with other standard chemotherapy as the first step in a therapeutic sequence followed by c... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=918020 Mon, 01 Oct 2007 17:00:27 +0100 918020 http://www.medworm.com/index.php?rid=911902&cid=t_123614_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F162637594%2Fethicon_endo-surgery_inc_gets_fda_approval_for_realize_gastric_band.html The FDA issue approval on Ethicon Endo-Surgery Inc. Realize™ Gastric Band. Realize™ Adjustable Gastric Band is a surgical implant for weight reduction in obesity related health conditions. In a 3 year study of 276 patients, those using the Realize(TM) Band saw an average of 42.8 percent weight loss. Thirty-five percent hose who completed the trial had a 50% more loss of weight while 10.5% lost 75% or more in excess body weight. Ed Phillips, MD, FACS, principal investigator in the REALIZE Band clinical trial and Director of the Center for Minimally Invasive and Bariatric Surgery at Cedars-Sinai Medical Center in Los Angeles said "This procedure, combined with the proper support system and a commitment to dietary and lifestyle changes after surgery helped these pat... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=911902 Fri, 28 Sep 2007 21:10:41 +0100 911902 http://www.medworm.com/index.php?rid=911904&cid=t_123614_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F162491739%2Funapproved_hydrocodone_products_marketing_stopped_by_fda.html The FDA announced that it will take enforcement action against companies who manfucture unapproved prescription drug products that contain hydrocodone.Hydrocodone, one of the strongest pain relief and cough suppressants, can result in breathing problems or cardiac arrest when used improperly. Manufacturing and distribution of unapproved hydrocodone products to children under the age of 6 must end by October 31, 2007. Marketing of other unapproved hydrocodone products must cease being produced by December 31, 2007 and must cease to be shipped by March 31, 2008. The FDA warns that legal action could be taken against those who do not comply by failing to meet the deadlines. (Source: PharmaGazette) PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=911904 Fri, 28 Sep 2007 16:10:33 +0100 911904 http://www.medworm.com/index.php?rid=908617&cid=t_123614_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F162097534%2Fdaiichi_sankyo_inc_gets_fda_ap.html Daiichi Sankyo Co. (TYO:4568) announced today that it has received FDA approval for AZOR.AZOR, amlodipine and olmesartan medoxomil, is used in the treatment of hypertension also referred to as high blood pressure. A once daily pill that is a combination of calcium channel blocker and angiotensin receptor blocker."AZOR with its established efficacy and favorable side effect profile provides twocomplementary mechanisms of action to lower blood pressure. It will givephysicians a new treatment option for patients whose blood pressure remainstoo high on currently prescribed medications" stated Michael A. Weber, MD, Professor of Medicine, State University of New York, Downstate College of Medicine.Hypertension is estimated to affect as many as one in three Americans. It is estimated th... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=908617 Thu, 27 Sep 2007 18:30:17 +0100 908617 http://www.medworm.com/index.php?rid=906104&cid=t_123614_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F161585989%2Ffda_approval_for_watson_pharma.html Watson Pharmaceuticals announced that it has received final FDA approval for its generic drug, Accuneb. Accuneb is an alubterol sulfate inhalation solution, the generic equivalent of Dey, L.P.’s AccuNeb Inhalation Solution, is used for relief of bronchospam in patients between the ages of 2 and 12 with asthma.Watson has secured a six month market exclusivity from the date of commercial launch which Watson plans to do immediately.Watson Pharmaceuticals Inc. is headquartered in Corona, CA. It is a leading specialty pharmaceutical company that develops, manufactures markets and sells brand and generic drugs. (Source: PharmaGazette) PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=906104 Wed, 26 Sep 2007 16:00:29 +0100 906104 http://www.medworm.com/index.php?rid=896075&cid=t_123614_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F160671176%2Fpfizer_aids_drug_celsentri_get.html Pfizer Inc. has announced that it has received European Commission approval for its AIDS drug Celsentri. The drig, generically known as Maraviroc is the first in a class of oral HIV medicine in more than 10 years.Celsentri, discovered and developed by Pfizer UK blocks viral entry of the HIV virus into the white blood cells. IT will be made available to HIV patients in the EU in combination with other antiretroviral medications. Maraviroc prevents the virus from entering white blood cells by blocking its main entry route, the CCR5 co-receptor rather than fighting HIV inside the white blood cells.Maraviroc, known as Selzentry in the United States, was approved by the U.S. Food and Drug Administration (FDA) on August 6, 2007 and is currently available in the U.S. [Source: Gay Wired]... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=896075 Mon, 24 Sep 2007 17:30:11 +0100 896075 http://www.medworm.com/index.php?rid=891626&cid=t_123614_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F159571523%2Fincreased_dosage_of_norditropi_1.html Novo Nordisk A/S announced that it has received approval for its drug, Norditropin, from the FDA. Norditropin is for use on children with Turner's Sydrome. Turner's Syndrome is a rare chromosomal condition that is caused by a complete or partial lack of the X chromosome in girls. Short stature is the most common feature of Turner's and Norditropin targets this. Results from a clinical trial found that 80% of patients receiving a higher than previously approved dosage reach normal adult height."Turner syndrome is a rare chromosomal disorder of females characterizedby short stature and the lack of sexual development at puberty. Amongaffected females, physical features may include a short neck with a webbedappearance, heart defects, kidney abnormalities and various other... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=891626 Fri, 21 Sep 2007 19:00:35 +0100 891626 http://www.medworm.com/index.php?rid=886292&cid=t_123614_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F159005866%2Ffda_approves_flumist_for_child_1.html MedImmune Inc. announced that the FDA has now approved FluMist™ for use in children as young as 24 months. The expansion in age now allows for FluMist™ to be used on people from ages 2 - 59. FluMIst(TM) is an Intranasal Influenza Virus Vaccine that is approved for immunization against influenza A and B. A study of over 4,000 children between the ages of two and five saw a 54% decrease in cases of the flu in children who received FluMIst™ as opposed to those that received a traditional flu shot. FluMist differs from the traditional flu shot in that it consists of live, weakened viruses that help stimulate an immune response to influenza. Pedro Piedra, M.D., professor, Department of Molecular Virology and Microbiology, and Pediatrics, Baylor College of Medicine said &q... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=886292 Thu, 20 Sep 2007 13:56:37 +0100 886292 http://www.medworm.com/index.php?rid=885396&cid=t_123614_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F158640946%2Ftraumacure_inc_woundstat_1.html TraumaCure Inc. received news that the FDA has cleared its product, WoundStat™, after only six weeks of review.WoundStat™, a lightweight, pre-mixed dressing compound, has been scientifically proven to control high pressure bleeding in moderate to severe wounds.  "The FDA's speedy approval of WoundStat means that we can get it more quickly into the hands of those who need it most today -- our war fighters in harm's way around the world." said Devinder S. Bawa, chief executive officer of TraumaCure, the developer of WoundStat. "The products effectiveness is particularly important with core body wounds that a tourniquet can't reach. We believe that WoundStat has the potential to provide the military with another important tool to minimize ... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=885396 Wed, 19 Sep 2007 18:24:26 +0100 885396