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 'drug approval'. Sat, 03 Sep 2011 02:17:47 +0100 http://www.medworm.com/index.php?rid=5028220&cid=t_105881_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=4747883&cid=t_105881_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=4277834&cid=t_105881_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=3885343&cid=t_105881_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_105881_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=3592407&cid=t_105881_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=3149315&cid=t_105881_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=2398818&cid=t_105881_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=2052861&cid=t_105881_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=735516&cid=t_105881_87_f&fid=34867&url=http%3A%2F%2Fwww.thediabetesblog.com%2F2007%2F07%2F15%2Fhouse-passes-bill-on-drug-safety-senate-version-kinder-to-drugm%2F Filed under: Type 1, Type 2, Adult Onset, Drugs, Daily NewsComplaints of the Food and Drug Administration (FDA) abound lately, especially after the Vioxx and Avandia scares. In response to criticism of FDA's handling of serious side effects emerging after problem drugs hit the market, the U.S. House of Representatives voted last Wednesday to give the agency more power over drugmakers. Passing 403-16, the legislation allows the FDA to require post-approval studies of new prescription drugs or order additional warnings. Drugmakers don't always listen, so the new law allows the FDA to levy heavier fines. $50 million for companies failng to follow FDA directives, and a potential $250,000 fine for misleading/false consumer advertising. I am always amazed when the television voiceover speedily r... The Diabetes Blog blogs http://www.medworm.com/rss/comments.php?id=735516 Sun, 15 Jul 2007 04:00:00 +0100 735516 http://www.medworm.com/index.php?rid=676284&cid=t_105881_134_f&fid=35137&url=http%3A%2F%2Fdiabetesupdate.blogspot.com%2F2007%2F06%2Favandiaactos-problems-well-known-in.html I just did a search of the alt.support.diabetes newsgroup to see when, exactly, I became aware of the significant problems with Avandia and Actos that just made the medical news this month.It was in 2003.Here are the side effects I posted about along with the date of the posting and the thread title in case you want to look up the old messages yourself. All postings were made under the username "Jenny." The posted text is in italics.1. Heart Failure:Posted on a.s.d. on Oct 24, 2003. Thread name: Metformin & Glyburide should I change meds?:Actos and Avandia (a similar drug) have their own problems--notably a tendency to cause weight gain and worsen heart failure. Also, they have not been on the market long enough for us to really know what their long term effects might be. They are related ... Diabetes Update blogs http://www.medworm.com/rss/comments.php?id=676284 Thu, 07 Jun 2007 16:26:00 +0100 676284 http://www.medworm.com/index.php?rid=623516&cid=t_105881_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2007%2F05%2Fmyth-1-high-us-drug-prices-guarantee-us.html The drug industry often defends higher drug prices in the U.S. by claiming that it guarantees Americans "first shot" at new drugs.Bob Ehrlich at DTC Perspectives stated as much in his e-mail commentary today:"As far as high pricing goes, here is where it can get quite complex. Drug companies need someone to pay high retail prices, because so many countries have price controls. There is not really a palatable explanation to the American public on why drug prices are higher in the U.S. market. The truth is that someone needs to make drug sales profitable and unfortunately it is the American public that is hit with the tab. The benefit is more drug research and a market inspired guarantee that Americans will get first shot at newer drugs. We certainly will appreciate that when a pandemic hits... Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=623516 Fri, 18 May 2007 11:16:00 +0100 623516 http://www.medworm.com/index.php?rid=587923&cid=t_105881_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2007%2F05%2Fyummi-its-zimulti.html According to the Acomplia Report, "It's now official. If diet drug Acomplia (rimonabant) is ultimately approved for sale in the United States, the prescription diet pill will go on the U.S. market not as Acomplia but as Zimulti."While this is bad news for the Acomplia Report, which will have to change it's name, I guess, and is perhaps a mild setback for Sanofi-Aventis, which plans to market the diabetes drug in the US, it is definitely good news for bloggers like the jokers over at the Wall Street Journal Health Blog who quipped "To us, the new name seems to promise a mysterious Italian delicacy — 'We'd like the Zimulti with clams, please" (see "What’s in a Name? Too Much for Acomplia").The WSJ guys think Zimulti is a good name for an Italian main course, whereas I think it's a great ... Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=587923 Thu, 03 May 2007 16:34:00 +0100 587923 http://www.medworm.com/index.php?rid=490127&cid=t_105881_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2007%2F03%2Ffda-advisor-rule-loophole.html (Source: Pharma Marketing Blog) Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=490127 Thu, 22 Mar 2007 14:00:00 +0100 490127