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 'approvals'. Sat, 03 Sep 2011 02:32:43 +0100 http://www.medworm.com/index.php?rid=4984689&cid=t_195268_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FEygW_voyKzU%2F Rise and shine. Another glorious day is unfolding here on the Pharmalot corporate campus, where we are moving along like a cool breeze. Of course, there is much to be done - phone calls, meetings, reading documents. You name it. And we know you can related. So grab that cup of stimulation - no excuses, please - and pick up your to-do list. Meanwhile, here are some tidbits from around your world. Have a good one… US Court Orders Seizure Of Cipla Pet Drug For Patent Violation (Dow Jones) Lilly Plans 10 Drug In Final-Stage Trials By End Of 2011 (Bloomberg News) Niaspan Prescriptions Fall After Negative Study Results (Dow Jones) Pfizer Signs Deal With Russian Venture Capital Firm For R&D (Associated Press) Forest Files COPD Drug For FDA Approval (Pharma Times) ‘Neurontin Kille... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4984689 Thu, 30 Jun 2011 11:53:38 +0100 4984689 http://www.medworm.com/index.php?rid=4945201&cid=t_195268_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FCwErfhk-Fqs%2F The FDA is often criticized for moving too slowly to approve new drugs, especially those for cancer. But is the agency as slow as some believe? To explore the question, researchers examined 35 oncology meds that were reviewed by the FDA and the European Medicines Agency between 2003 and 2010, and found the median approval time in the US took about half the time spent in Europe. Specifically, the median time for approval for new cancer meds in the US was six months, according to the paper by Friends of Cancer Research, a non-profit think tank that published the results in Health Affairs (read the abstract). However, they did not review initial approvals or supplemental applications, so their analysis did not include prominent secondary uses for drugs already on the market. The FDA approved ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4945201 Thu, 16 Jun 2011 13:50:37 +0100 4945201 http://www.medworm.com/index.php?rid=4911824&cid=t_195268_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FAutTWJ-YZYs%2F Faced with growing challenges in clinical trials, manufacturing and drug safety - among many other issues - the FDA has decided to elevate the Office of Compliance to a so-called Super Office on a par with others in the Center For Drug Evaluation and Research, such as the Office of New Drugs, the Office of Pharmaceutical Science and the Office of Surveillance and Epidemiology. The responsibilities will include ensuring compliance with requirements for good manufacturing practice, good clinical practice, human subject protection, adverse event and drug quality reporting, REMS, drug labeling, drug approval, drug importation, and supply chain integrity, among others, according to a memo from CDER director Janet Woodcock. And the new super compliance office will also have three officewide func... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4911824 Tue, 07 Jun 2011 12:06:07 +0100 4911824 http://www.medworm.com/index.php?rid=4495433&cid=t_195268_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FbbPH3bwPNas%2F The rate at which the FDA approved new molecular entities - including NME’s filed under New Drug Applications (NDAs) and therapeutic biologics filed under Original Biologic License Applications (BLAs) - declined last year from the previous two years, according to new data released by the FDA. As the chart indicates, last year, there were 18 NMEs approved and three biologics, or 21 in total, which is down from 26 in 2009 and 24 in 2008. On the other hand, there were only 18 approvals in total in 2007 and 22 back in 2006. Since 2001, the Center for Drug Evaluation and Research has averaged 22.9 approvals a year, although there is a caveat: biologics were not included during 2001 through 2003. However, new applications are declining. Last year, the FDA received 23, a notable drop from ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4495433 Fri, 18 Feb 2011 14:35:31 +0100 4495433 http://www.medworm.com/index.php?rid=4399663&cid=t_195268_117_f&fid=34696&url=http%3A%2F%2Fwww.straightfromthedoc.com%2F38647165%2Fwill_the_ab_sonic_help_you_improve_your_level_of_fitness.php © theflexbelt.comThere are many ailments that can be improved by doing some exercise. High blood pressure, for example, can be relieved if the cause is excess weight. In general, keeping fit helps maintain a healthy body. There are lots of products advertised to help with toning muscles and strengthening the core of the body, and as a result help with weight loss. One of these is the ab sonic. But does it work? If you are serious about getting healthy, then you need to ... (Source: Straightfromthedoc) Straightfromthedoc blogs http://www.medworm.com/rss/comments.php?id=4399663 Fri, 26 Nov 2010 21:57:32 +0100 4399663 http://www.medworm.com/index.php?rid=3865341&cid=t_195268_117_f&fid=34696&url=http%3A%2F%2Fwww.straightfromthedoc.com%2F50226711%2Fellaa_got_approved_by_the_us_fda.php EllaOneMove Over morning-after pill! Ella™ just got approval from the US FDA for emergency contraception. Ella™ (ulipristal acetate) has been available in Europe for a year before it got to the US market. Ella™ works by inhibiting or delaying ovulation by interfering with the effects of the female hormone progesterone -- which stimulates ovulation. According to the US FDA: "Ella™ successfully prevents pregnancy when taken orally within 120 hours (five days) after a contraceptive failure or unprotected intercourse. It is not intended ... (Source: Straightfromthedoc) Straightfromthedoc blogs http://www.medworm.com/rss/comments.php?id=3865341 Sat, 14 Aug 2010 00:40:19 +0100 3865341 http://www.medworm.com/index.php?rid=3802585&cid=t_195268_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FxRiG_6Xlj5o%2F Here’s a radical idea: Congress should amend the Food, Drug, and Cosmetic Act to allow Americans to use new meds once these are approved by the European Medicines Authority. Why? “Congress’s grant of a regulatory monopoly to the FDA is creating a significant obstacle to Americans’ timely access to new medicines,” according to a new report from the Pacific Research Institute, a conservative think tank. By amending the law, the contention is that regulatory competition would increase, patient choice would be expanded and lives could be saved for those suffering life-threatening illnesses without any options. What about safeguard? John Graham, who authored the report, writes that the FDA would retain the power to compel drugmakers to label their meds with a warning that ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3802585 Thu, 29 Jul 2010 21:34:57 +0100 3802585 http://www.medworm.com/index.php?rid=3288019&cid=t_195268_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FKQS2-H8vg50%2F In a bid to tout its accomplishments, the FDA is trumpeting a new study showing the agency approved more than 50 new indications for cancer and hematology meds and biologics between July 2005, when the Office of Oncology Drug Products began reviewing marketing applications, and July 2007. And during that stretch, the OCD also reviewed 60 applications for meds to treat all sorts of cancer (see statement). The OCD acted on 58 of the applications, approving 53 new cancer indications. Five were not approved, and two were withdrawn before any regulatory action was taken. The approved applications included indications for 18 new drugs that hadn’t been previously approved and 35 added indications for already approved drugs. Here is the abstract of the study in the Journal of the National Ca... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3288019 Fri, 19 Feb 2010 13:24:33 +0100 3288019 http://www.medworm.com/index.php?rid=3146212&cid=t_195268_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F9lss1R4hDDE%2F The agency approved 26 new meds last year compared with 25 in 2008, a level that hadn’t been reached in five years, according to Dow Jones, which cites a report by Washington Analysis, a research firm. Newly approved meds included Effient, a blood thinner from Lilly and Daiichi Sankyo; Sanofi-Aventis’ Multaq heart pill, and two drugs to treat advanced kidney cancer: GlaxoSmithKline’s Votrient and Novartis’ Afinitor. However, several drugs that had been expected to reach medicine cabinets never made it that far, as the agency delayed some approvals in search of additional info. An example: Amgen’s Prolia, or denosomab, for treating post-menopausal osteoporosis. Ira Loss, a healthcare analyst at Washington Analysis, says the FDA did a decent job approving drugs... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3146212 Wed, 06 Jan 2010 00:04:14 +0100 3146212 http://www.medworm.com/index.php?rid=2662548&cid=t_195268_111_f&fid=36048&url=http%3A%2F%2Ffeeds.b5media.com%2F%7Er%2Fb5media%2FAHeartyLife%2F%7E3%2F0APSdfQFcBQ%2F The FDA in the United States has approved a new medication for the management of type 2 diabetes. Onglyza (saxagliptin) is taken once a day to help normalize blood sugar levels. Currently, management of type 2 diabetes includes a lifestyle component (healthy diet and exercise) as the first part. If lifestyle changes don’t help regulate blood sugar issues or the diabetes is too severe, doctors have a few options for medications. Usually, type 2 diabetes is managed first with oral antihyperglycemics, pills that help the pancreas and insulin work more effectively. The main difference between type 1 diabetes and type 2 diabetes is that with type 1, the pancreas doesn’t produce any insulin. To manage this, people with type 1 diabetes must inject themselves with insulin at least once... A Hearty Life blogs http://www.medworm.com/rss/comments.php?id=2662548 Sun, 02 Aug 2009 11:02:58 +0100 2662548 http://www.medworm.com/index.php?rid=2415517&cid=t_195268_117_f&fid=34696&url=http%3A%2F%2Fwww.straightfromthedoc.com%2F50226711%2Fotc_prevacida_heartburn_medicine_now_fdaapproved.php More than 50 million Americans suffer from frequent heartburn, and nearly half-more than 21 million patients-utilize prescription-only Prevacid® to treat acid-related disorders. The US FDA recently ... (Source: Straightfromthedoc) Straightfromthedoc blogs http://www.medworm.com/rss/comments.php?id=2415517 Fri, 15 May 2009 22:09:53 +0100 2415517 http://www.medworm.com/index.php?rid=2200477&cid=t_195268_117_f&fid=34696&url=http%3A%2F%2Fwww.straightfromthedoc.com%2F50226711%2Fbrain_device_for_severe_ocd_approved_by_the_fda.php Photo courtesy of iStockphoto, Image# 3648499 The US FDA has approved a humanitarian device exemption for the first implantable device that delivers intermittent electrical therapy deep within the... (Source: Straightfromthedoc) Straightfromthedoc blogs http://www.medworm.com/rss/comments.php?id=2200477 Fri, 20 Feb 2009 02:39:09 +0100 2200477 http://www.medworm.com/index.php?rid=2067382&cid=t_195268_117_f&fid=34696&url=http%3A%2F%2Fwww.straightfromthedoc.com%2F50226711%2Fvasovist_first_imaging_agent_to_enhance_scans_of_blood_flow_fdaapproved.php Photo courtesy of iStockphoto, Image# 6980088 Vasovist Injection (gadofosveset trisodium) - the first contrast imaging agent for use in patients undergoing magnetic resonance angiography, or MRA - has... (Source: Straightfromthedoc) Straightfromthedoc blogs http://www.medworm.com/rss/comments.php?id=2067382 Sun, 28 Dec 2008 02:42:51 +0100 2067382 http://www.medworm.com/index.php?rid=1870647&cid=t_195268_117_f&fid=34696&url=http%3A%2F%2Fwww.creative-weblogging%2Faudio%2F%2Fhttp%3A%2F%2Fwww.straightfromthedoc.com%2F50226711%2Flev_pharmas_cinryzea_got_fda_marketing_approval_for_hae.php A rare genetic and life threatening disease, hereditary angioedema (HAE) is an autosomal dominant disorder of C1 inhibitor (C1-INH) deficiency manifested by painless, nonpruritic, nonpitting swelling of the skin. Now, LEV Pharma's Cinryze™ has been given marketing approval for the protection of people with HAE. The product, called Cinryze, is licensed for the prevention of HAE attacks, which can occur spontaneously or during stress, surgery, or infection in patients diagnosed with the disease. Attacks can produce rapid swelling of the hands, feet, limbs, face, intestinal tract or airway. Swelling of the larynx can lead to asphyxiation. Cinryze is a C1-esterase inhibitor product derived from human plasma. This plasma protein regulates clotting and inflammatory reactions that, when... Straightfromthedoc blogs http://www.medworm.com/rss/comments.php?id=1870647 Mon, 13 Oct 2008 08:00:00 +0100 1870647 http://www.medworm.com/index.php?rid=1870667&cid=t_195268_109_f&fid=34750&url=http%3A%2F%2Fpsychcentral.com%2Fblog%2Farchives%2F2008%2F10%2F12%2Fseroquel-xr-gets-additional-approvals%2F Helping to extend Seroquel’s existing reach, AstraZeneca, its maker, has received U.S. Food and Drug Administration (FDA) approval to market it as an effective treatment not only for mania associated with bipolar disorder, but also now for depressive episodes in bipolar disorder too. According to the Reuters report on the news: The green light from the Food and Drug Administration makes Seroquel XR the first medication cleared in the United States for the once-daily acute treatment of both depressive and manic episodes associated with bipolar disorder. Seroquel was first approved for the treatment of schizophrenia in 1997 by the FDA, and for manic episodes of bipolar disorder in 2004. The government-funded CATIE trials demonstrated mixed efficacy for Seroquel. Such research has c... World of Psychology blogs http://www.medworm.com/rss/comments.php?id=1870667 Sun, 12 Oct 2008 19:51:50 +0100 1870667 http://www.medworm.com/index.php?rid=1794370&cid=t_195268_117_f&fid=34696&url=http%3A%2F%2Fwww.straightfromthedoc.com%2F50226711%2Fmercks_gardasil_approved_for_new_uses.php 5255912 Photo courtesy of iStockphoto, Image# 5255912 The US FDA has recently approved additional uses for Merck's controversial HPV vaccine Gardasil: prevention of vaginal and vulvar cancer caused by Human Papillomavirus (HPV) types 16 and 18 in girls and women ages 9 to 26. "There is now strong evidence showing that this vaccine can help prevent vulvar and vaginal cancers due to the same viruses for which it also helps protect against cervical cancer," said Jesse L. Goodman, M.D., M.P.H., director of the FDA's Center for Biologics Evaluation and Research. "While vulvar and vaginal cancers are rare, the opportunity to help prevent them is potentially an important additional benefit from immunization against HPV." The FDA originally approved Gardasil in 2006 for girls and women ... Straightfromthedoc blogs http://www.medworm.com/rss/comments.php?id=1794370 Tue, 16 Sep 2008 09:44:43 +0100 1794370 http://www.medworm.com/index.php?rid=1696128&cid=t_195268_117_f&fid=34696&url=http%3A%2F%2Fwww.straightfromthedoc.com%2F50226711%2F20082009_flu_vaccines_approved_by_the_fda.php Photo courtesy of iStockphoto, shannon drawe Earlier this week, the FDA has announced its approved flu vaccines for the 2008-2009 flu season in the United States. Six vaccines approved and their manufacturers are: Afluria by CSL Limited Fluarix by GlaxoSmithKline Biologicals FluLaval by ID Biomedical Corporation of Quebec FluMist by MedImmune Vaccines Inc. Fluvirin by Novartis Vaccines and Diagnostics Limited Fluzone by Sanofi Pasteur Inc. This season's vaccines contain three strains of the influenza virus that disease experts expect to be the most likely cause of the flu in the United States. Each season's vaccines are modified to reflect the virus strains most likely to be circulating. The closer the match between the circulating strains and the strains in the vaccines, the ... Straightfromthedoc blogs http://www.medworm.com/rss/comments.php?id=1696128 Mon, 11 Aug 2008 05:43:01 +0100 1696128 http://www.medworm.com/index.php?rid=1692384&cid=t_195268_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=1692386&cid=t_195268_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F359370999%2F Somehow, you are not surprised, are you? In any event, the FDA has so far approved nine new medicines as of the end of June, putting it on pace to be one of the slowest years for new drug approvals in the last five years, Dow Jones reports. The agency approved 18 “new molecular entities,” which means the active ingredient hadn’t been used before in an FDA-approved therapy, in 2007. The agency could approve a similar amount if its pace continues. The agency approved 22 drugs in 2006. This year’s approvals include Wyeth’s Pristiq, used to treat depression, Cephalon leukemia drug Treanda and UCB’s Cimzia for Crohn’s disease. FDA spokeswoman Sandy Walsh tells Dow Jones the agency may approve more, or fewer, drugs in the second half of the year, but it ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1692386 Fri, 08 Aug 2008 12:01:14 +0100 1692386 http://www.medworm.com/index.php?rid=1683440&cid=t_195268_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F356571056%2F Seems simple, yes? And so a group of Duke University researchers developed a hypothetical model to estimate the expected incremental number of adverse drug events that could be avoided once a drug is widely available. The upshot: “Requiring larger preapproval databases could be a cost-effective means of reducing adverse events in post-approval populations,” they write in Health Affairs. As you may recall, most industry-sponsored clinical trials of new drugs are designed to determine efficacy in order to gain regulatory approval. But the researchers note that detecting adverse drug events is “rarely considered when sample-size calculations are undertaken for clinical trials.” Thus, the statistical power to find side effects is “inherently a by-product” of... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1683440 Tue, 05 Aug 2008 17:39:31 +0100 1683440 http://www.medworm.com/index.php?rid=1668385&cid=t_195268_109_f&fid=34750&url=http%3A%2F%2Fpsychcentral.com%2Fblog%2Farchives%2F2008%2F07%2F30%2Ftreating-bipolar-disorder-in-children%2F A letter to the editor in today’s The Boston Globe by Janet Wozniak suggests that since the U.S. Food and Drug Administration (FDA) approved the use of two atypical antipsychotic medications last year for pediatric bipolar disorder, it is proof the disorder exists: The FDA approvals of Risperdal and Abilify for this purpose not only suggest that at the proper dose, these atypical antipsychotic medications are safe and effective for use as indicated, but affirm that the FDA accepts the validity of pediatric bipolar disorder and the need to treat it. Tortured circular logic notwithstanding, the writer — the director of (surprise, surprise!) the pediatric bipolar disorder program at Mass. General — knows that the FDA is not any kind of scientific arbiter of research into... World of Psychology blogs http://www.medworm.com/rss/comments.php?id=1668385 Wed, 30 Jul 2008 16:30:25 +0100 1668385 http://www.medworm.com/index.php?rid=1581894&cid=t_195268_117_f&fid=34696&url=http%3A%2F%2Fwww.straightfromthedoc.com%2F50226711%2Ffirst_generic_risperdal_risperidone_fdaapproved.php The first generic versions of Risperdal (risperidone) tablets has recently been approved by the FDA. A product of Janssen - Risperdal - is an antipsychotic drug used for the treatment of schizophrenia, bipolar disorder, and other psychiatric conditions. "This generic drug approval is another example of the FDA's efforts to increase access to safe and effective generic drugs as soon as the law permits," said Gary Buehler, director of the FDA's Office of Generic Drugs in the Center for Drug Evaluation and Research. Varying strengths of risperidone tablets, manufactured by TEVA Pharmaceuticals USA, have been approved. Read more from FDA News. [Photo Credit] See full article. Related Entries: Generic Allegra from Mylan Laboratories - 13 April 2006 Bipolar Disorder - 10 M... Straightfromthedoc blogs http://www.medworm.com/rss/comments.php?id=1581894 Sun, 06 Jul 2008 03:48:00 +0100 1581894 http://www.medworm.com/index.php?rid=1575644&cid=t_195268_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F325735091%2F A Harvard University professor defended research suggesting the FDA was too hasty in approving drug, which the agency has criticized as mistaken, The Wall Street Journal writes. The professor, Daniel Carpenter, acknowledged that the FDA had identified mistakes in his study, which was published by the New England Journal of Medicine in March. But he said that the FDA’s own records also had errors, and that after he made necessary corrections, his original finding still held: Drugs the FDA has approved soon before a regulatory deadline have been more likely to develop severe safety problems later on, the paper continues. Between 1993 and 2005, the 88 drugs approved near the FDA’s deadline had a 15 percent chance of being flagged for severe safety problems, either a Black Box warn... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1575644 Thu, 03 Jul 2008 11:57:03 +0100 1575644 http://www.medworm.com/index.php?rid=1556512&cid=t_195268_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F323189744%2F So what else is new? In yet another round-up that discusses the slow rate of approvals compared with the number of FDA warnings, rejections and delays, The Wall Street Journal gathers some recent developments to re-examine the issue once again. Last year, the FDA approved 19 new meds, the fewest in 24 years, and announced about 75 new or revised Black Box warnings, which was twice the number in 2004. The number of approvable letters, which postpone FDA decisions pending more data, increased by 40 percent last year, according to Sagient Research, the paper writes. Meanwhile, pharma grouses the European Medicines Agency has approved several drugs that haven’t passed muster with the FDA, including Galvus, Prexige and Acomplia. The FDA has delayed approval of Glaxo’s HPV vaccine, ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1556512 Mon, 30 Jun 2008 11:42:48 +0100 1556512 http://www.medworm.com/index.php?rid=1543930&cid=t_195268_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F319749054%2F The 35 new drug application approvals by the FDA through May exactly match 2005 and 2006 approval levels and reflect 40 percent year-over-year growth from 25 at the same time last year, writes James Kumpel of Friedman Billings Ramsey, in an investor note this morning. But, he adds, “looks can be deceiving.” “Fully 40 percent of the NDA approvals constitute new manufacturers for existing compounds, approvals of drugs that had already been marketed, or new formulations of existing compounds. Aside from those approvals, the comparison would have been 21 year-to-date in 2008 versus 16 in the comparable year-ago period.” Meanwhile, the number of new molecular entities, or NMEs, approved are still “moribund,” as he puts it. Year-to-date totals amount to just f... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1543930 Wed, 25 Jun 2008 14:30:03 +0100 1543930 http://www.medworm.com/index.php?rid=1531167&cid=t_195268_117_f&fid=34696&url=http%3A%2F%2Fwww.straightfromthedoc.com%2F50226711%2Fneurx_dps_ra4_respiratory_stimulation_system_fdaapproved.php An implantable electronic device that stimulates the diaphragm and allows certain spinal cord injury patients to breathe for at least four hours a day without a mechanical ventilator - NeuRx DPS RA/4 Respiratory Stimulation System - has been approved by the US FDA. Patients with severe spinal cord injuries who cannot control their diaphragms often need mechanical ventilation to help them breathe. This usually requires a full-time connection to a ventilation machine. The NeuRx DPS RA/4 uses four electrodes implanted in the muscle of the diaphragm to electronically stimulate contraction; this stimulation allows the patient to inhale. The FDA approved the distribution of this device under a Humanitarian Device Exemption, an approval process for devices intended to treat or diagnose condi... Straightfromthedoc blogs http://www.medworm.com/rss/comments.php?id=1531167 Thu, 19 Jun 2008 12:28:27 +0100 1531167 http://www.medworm.com/index.php?rid=1480738&cid=t_195268_87_f&fid=35052&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FWomensBioethicsBlog%2F%7E3%2F301250640%2Fopening-black-box.html As reported in a news blurb that nearly escaped my attention because the major newspapers and websites either failed to report it or buried it deep, the US Food and Drug Administration (FDA) is... [[ This is a content summary only. Visit my website for full links, other content, and more! ]] (Source: Women's Bioethics Blog) Women's Bioethics Blog blogs http://www.medworm.com/rss/comments.php?id=1480738 Fri, 30 May 2008 13:02:56 +0100 1480738 http://www.medworm.com/index.php?rid=1463736&cid=t_195268_117_f&fid=34696&url=http%3A%2F%2Fwww.straightfromthedoc.com%2F50226711%2Fenterega_alvimopan_fdaapproved_for_postsurgery_bowel_function.php The FDA has recently approved Entereg® (Alvimopan) for help to restore bowel function after surgery. Entereg® (Alvimopan) is a first-in-class small molecule, peripherally-acting mu opioid receptor (PAM-OR) antagonist designed to block the adverse side effects of opioid analgesics on the GI tract without blocking their beneficial analgesic effects. Entereg® (Alvimopan) is a product of Adolor Corporation in collaboration with GlaxoSmithKline. Following major abdominal surgery, some patients develop a condition known as postoperative ileus (POI). POI is a disorder that causes temporary impairment of the gastrointestinal (GI) tract's motility, or the ability of the intestines to push out waste products (not a complete blockage of the GI tract), following surgery. POI can be a by-pr... Straightfromthedoc blogs http://www.medworm.com/rss/comments.php?id=1463736 Fri, 23 May 2008 09:42:37 +0100 1463736 http://www.medworm.com/index.php?rid=1433728&cid=t_195268_117_f&fid=34696&url=http%3A%2F%2Fwww.straightfromthedoc.com%2F50226711%2Ffirst_generic_ropinirole_approved_by_the_fda.php Requip (ropinirole hydrochloride) tablets - product of GlaxoSmithKline (GSK) - are for the treatment of moderate to severe Restless Legs Syndrome (RLS). © Brymo From the NINDS-NIH: Restless legs syndrome (RLS) is a neurological disorder characterized by unpleasant sensations in the legs and an uncontrollable urge to move when at rest in an effort to relieve these feelings. RLS sensations are often described by people as burning, creeping, tugging, or like insects crawling inside the legs. Often called paresthesias (abnormal sensations) or dysesthesias (unpleasant abnormal sensations), the sensations range in severity from uncomfortable to irritating to painful. Now the FDA has approved the generic versions of Requip - Ropinirole Hydrochloride. The said generics approved are from the ... Straightfromthedoc blogs http://www.medworm.com/rss/comments.php?id=1433728 Sat, 10 May 2008 06:12:29 +0100 1433728 http://www.medworm.com/index.php?rid=1396200&cid=t_195268_117_f&fid=34696&url=http%3A%2F%2Fwww.straightfromthedoc.com%2F50226711%2Fucbs_cimzia_fdaapproved_for_chrons_disease.php With no cure and still of unknown cause - Crohn's disease - is a chronic, inflammatory bowel disease that affects more than 1 million men and women worldwide. Chron's disease can cause diarrhea, fever, rectal bleeding, malnutrition, narrowing of the intestinal tract, obstructions, abscesses, cramping, and abdominal pain. Now, the US FDA has approved Cimzia (certolizumab pegol) for the treatment of adults with moderate to severe Crohn's disease who have not responded to conventional 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&#3... Straightfromthedoc blogs http://www.medworm.com/rss/comments.php?id=1396200 Thu, 24 Apr 2008 08:00:00 +0100 1396200 http://www.medworm.com/index.php?rid=1352015&cid=t_195268_117_f&fid=34696&url=http%3A%2F%2Fwww.straightfromthedoc.com%2F50226711%2Frotaviruscaused_gastroenteritis_vaccine_rotarix_approved_by_us_fda.php Rotarix - the second oral U.S. licensed vaccine for the prevention of rotavirus (an infection that causes gastroenteritis (vomiting and diarrhea) in infants and children) - has been approved by the US FDA. There are many different strains of rotavirus. The vaccine protects against rotavirus gastroenteritis caused by the G1, G3, G4, and G9 strains. "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., director of FDA's Center for Biologics Evaluation and Research. During studies involving more than 24,000 infants, Rotarix was effective in preventing both severe and mild cases of rotavirus-caused gastroenteritis during the first two years of life. The most common adverse reactions re... Straightfromthedoc blogs http://www.medworm.com/rss/comments.php?id=1352015 Fri, 04 Apr 2008 15:15:12 +0100 1352015 http://www.medworm.com/index.php?rid=1315351&cid=t_195268_117_f&fid=34696&url=http%3A%2F%2Fwww.straightfromthedoc.com%2F50226711%2Ffibrin_sealant_artiss_fdaapproved_for_burn_patients.php A new medical adhesive - a fibrin sealant - called Artiss for use in attaching skin grafts onto burn patients, has just been approved by the US FDA. Fibrin sealants are tissue adhesives that contain the proteins fibrinogen and thrombin, which are essential in the clotting of blood. Artiss (Fibrin Sealant, VH S/D 4) differs from other fibrin sealants in that it contains a lower concentration of thrombin. This lower concentration allows surgeons more time to position skin grafts over burns before the graft begins to adhere to the skin. Artiss also contains aprotinin, a synthetic protein that delays the break down of blood clots. "The approval of Artiss can help surgeons using a fibrin sealant to fine tune graft placement on burn sites," said Jesse L. Goodman M.D., M.P.H., director of FDA&... Straightfromthedoc blogs http://www.medworm.com/rss/comments.php?id=1315351 Thu, 20 Mar 2008 02:47:44 +0100 1315351 http://www.medworm.com/index.php?rid=1279425&cid=t_195268_117_f&fid=34696&url=http%3A%2F%2Fwww.straightfromthedoc.com%2F50226711%2Fnexium_fdaapproved_for_pediatric_gerd.php Last week, the FDA has approved Nexium (esomeprazole magnesium) for short-term use in children ages 1-11 years for the treatment of gastroesophageal reflux disease (GERD). The agency approved Nexium in two forms, a delayed-release capsule and liquid form. Nexium is approved in 10 milligrams (mg) or 20 mg daily for children 1-11 years old compared to 20 mg or 40 mg recommended for pediatric patients 12 to 17 years of age. "This approval provides important information for appropriate dosing for children ages 1-11 years with GERD," said Julie Beitz, M.D., director of the FDA's Office of Drug Evaluation III in the Center for Drug Evaluation and Research. "Children prescribed this drug should be monitored by their physicians for any adverse drug reactions." Nexium is part of a class of d... Straightfromthedoc blogs http://www.medworm.com/rss/comments.php?id=1279425 Wed, 05 Mar 2008 05:03:33 +0100 1279425 http://www.medworm.com/index.php?rid=1265117&cid=t_195268_117_f&fid=34696&url=http%3A%2F%2Fwww.straightfromthedoc.com%2F50226711%2Farcalyst_new_orphan_drug_fdaapproved_for_treatment_of_rare_inflammatory_syndromes.php The FDA has just approved a new orphan drug for the treatment of rare inflammatory syndromes. The said dug - Arcalyst - is the first treatment for an extremely rare condition known as Cryopyrin-Associated Periodic Syndrome or CAPS. Arcalyst (rilonacept, an Interleukin-1 blocker) is now approved for the long term treatment of two Cryopyrin-Associated Periodic Syndromes (CAPS) disorders: Familial Cold Auto-Inflammatory Syndrome (FCAS) and Muckle-Wells Syndrome (MWS). Symptoms of both of these disorders include inflammation such as joint pain, rash or skin lesions, fever and chills, eye redness or pain, and fatigue in both children and adults; however MWS is associated with more severe inflammation and may include hearing loss or deafness. In addition, some MWS patients may also be af... Straightfromthedoc blogs http://www.medworm.com/rss/comments.php?id=1265117 Thu, 28 Feb 2008 16:47:06 +0100 1265117 http://www.medworm.com/index.php?rid=1165301&cid=t_195268_117_f&fid=34696&url=http%3A%2F%2Fwww.straightfromthedoc.com%2F50226711%2Fabbotts_humirar_adalimumab_fdaapproved_for_moderate_to_severe_chronic_plaque_psoriasis.php The US FDA has recently approved the marketing of Abbott's HUMIRA(R) (adalimumab) as a treatment for adult patients with moderate to severe chronic plaque psoriasis. Plaque psoriasis is an autoimmune disease characterized by skin lesions that are sometimes painful and itchy. HUMIRA has been approved for the treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. HUMIRA should only be administered to patients who will be closely monitored and have regular follow-up visits with a physician. The approval is based on two pivotal trials, REVEAL and CHAMPION, showing that nearly 3 in 4 patients achieved 75 percent clearance or better at week 16 ... Straightfromthedoc blogs http://www.medworm.com/rss/comments.php?id=1165301 Mon, 21 Jan 2008 08:00:00 +0100 1165301 http://www.medworm.com/index.php?rid=1150649&cid=t_195268_117_f&fid=34696&url=http%3A%2F%2Fwww.straightfromthedoc.com%2F50226711%2Ftysabri_natalizumab_fdaapproved_for_moderatetosevere_crohns_disease.php (Source: Straightfromthedoc) Straightfromthedoc blogs http://www.medworm.com/rss/comments.php?id=1150649 Tue, 15 Jan 2008 09:01:06 +0100 1150649 http://www.medworm.com/index.php?rid=1137222&cid=t_195268_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F213128370%2F The FDA approved 19 new drugs last year, the fewest in 24 years. The number of new meds, including those made with novel chemical ingredients and using biotechnology, was three less than in 2006, Bloomberg News reports. Last year’s approvals were tallied by analyst Ira Loss, but the FDA declined to confirm the numbers. Drugmakers complain the FDA raised standards for approvals in the wake of safety concerns, an assertion the agency denies. But pharma shifted its emphasis to tinkering with existing drugs and finding other diseases these could be used to treat, instead of developing new meds, says Ken Kaitin, director of the Tufts University Center for the Study of Drug Development. “They got away from their core mission, which was to bring new medicines and new treatments to m... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1137222 Tue, 08 Jan 2008 11:42:05 +0100 1137222 http://www.medworm.com/index.php?rid=1132685&cid=t_195268_117_f&fid=34696&url=http%3A%2F%2Fwww.straightfromthedoc.com%2F50226711%2Fxtag_respiratory_viral_panel_fdacleared_for_marketing.php The FDA has recently cleared for marketing, the very first test that can simultaneously detect and identify 12 specific respiratory viruses in one sample. The said test, called the xTAG Respiratory Viral Panel (RVP) - (RVP) is a diagnostic test for the detection of multiple viral strains and subtypes designed to allow better decision-making in patient management and to limit the spread of infection. Influenza A is the most severe form of influenza for humans, and has been the cause of major epidemics. The new panel is also the first test for human metapneumovirus (hMPV), newly identified in 2001. The xTAG Respiratory Viral Panel amplifies viral genetic material found in secretions taken from the back of the throat in patients with possible respiratory tract infections. In the test, sp... Straightfromthedoc blogs http://www.medworm.com/rss/comments.php?id=1132685 Mon, 07 Jan 2008 08:00:00 +0100 1132685 http://www.medworm.com/index.php?rid=1131203&cid=t_195268_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F211364959%2F A quiet end to a short week. We apologize for the interruption in service, but we were attending a meeting that required a bit of travel. Now, however, we have returned to lasso a few items that have come to our attention in our absence. Meanwhile, we hope you enjoy the weekend. Our own to-do list includes shuttling about with one or more of the short people. See you shortly… As threatened, Lilly and its Japanese partner, Daiichi Sankyo, have asked the FDA to approve the prasugrel blood clot buster. The drugmakers submitted data from several clinical trials, including one that compared the drug to Plavix. The overall results demonstrated that for every 1,000 patients treated with prasugrel as compared with Plavix, there were 22 fewer patients with heart attacks, but, major bleeding o... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1131203 Sat, 05 Jan 2008 01:59:16 +0100 1131203 http://www.medworm.com/index.php?rid=1121700&cid=t_195268_117_f&fid=34696&url=http%3A%2F%2Fwww.straightfromthedoc.com%2F50226711%2Fvoluvena_approved_by_the_fda_for_treatment_of_serious_blood_volume_loss_postsurgery.php The FDA has recently approved Voluven® for the treatment of serious blood volume loss following surgery. Significant blood losses can cause a rapid drop in the volume of red blood cells and plasma circulating through the body. This can lead to shock, which is potentially fatal. Blood volume expanders are commonly administered to quickly restore some of the lost volume so that remaining red blood cells can continue to deliver needed oxygen to the body's tissues. Severe loss of blood volume can happen during or after surgery. In both cases, loss of blood volume is dangerous. Voluven® is an intravenous solution that prevents and treats a dangerous loss of blood volume. Voluven contains a synthetic starch that does not dissolve in water. It is made by linking individual starch ... Straightfromthedoc blogs http://www.medworm.com/rss/comments.php?id=1121700 Sat, 29 Dec 2007 18:00:00 +0100 1121700 http://www.medworm.com/index.php?rid=1106972&cid=t_195268_117_f&fid=34696&url=http%3A%2F%2Fwww.straightfromthedoc.com%2F50226711%2Fkuvana_sapropterin_dihydrochloride_fdaapproved_for_phenylketonuria_pku.php Phenylketonuria (PKU) is a rare genetic disorder that causes mental retardation, smaller brain size, delayed speech and other neurological problems. If diabetes is characterized by the body not being able to metabolize sugar thereby resulting in high levels of glucose in the blood, PKU is characterized as the body not being able to metabolize phenylalanine (Phe), thereby resulting to high levels of Phe in the blood. PKU is a genetic disorder in which the enzyme phenylalanine hydroxylase (PAH), which helps our bodies break down phenylalanine (Phe), an amino acid found in foods, does not function properly. The result is high levels of phenylalanine in the blood. High levels of Phe are toxic to the brain and can lead to mental retardation, behavioral abnormalities, seizures, an inabilit... Straightfromthedoc blogs http://www.medworm.com/rss/comments.php?id=1106972 Thu, 20 Dec 2007 03:53:22 +0100 1106972 http://www.medworm.com/index.php?rid=1037736&cid=t_195268_117_f&fid=34696&url=http%3A%2F%2Fwww.straightfromthedoc.com%2F50226711%2Fnexavara_sorafenib_fdaapproved_for_inoperable_hepatocellular_carcinoma.php Originally approved in 2005 for the treatment of patients with advanced renal cell carcinoma (a form of kidney cancer) - Nexavar® (sorafenib) has recently been approved by the FDA for use in patients with a form of liver cancer known as hepatocellular carcinoma -- when the cancer is inoperable. According to Robert Justice, M.D., director of FDA's division of drug oncology products: "In a randomized clinical trial, the group of patients with inoperable hepatocellular carcinoma who received Nexavar survived 2.8 months longer than the group of patients who didn't receive the drug. This is an important new treatment option for patients who are fighting this very difficult form of cancer." Manufactured by Bayer HealthCare AG (Leverkusen, Germany) for Bayer Pharmaceuticals Corporation (West... Straightfromthedoc blogs http://www.medworm.com/rss/comments.php?id=1037736 Tue, 20 Nov 2007 13:24:58 +0100 1037736 http://www.medworm.com/index.php?rid=1028330&cid=t_195268_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F185211785%2F New drug approvals by the FDA have fallen further behind last year’s levels, with just 59 NDA approvals through October, down 29 percent year-over-year from last year’s 83, and 13 percent below the 10-year average of 68 NDAs, writes Jim Kumpel, an analyst at Friedman Billings Ramsey, in an investor note this morning. More importantly, the 14 new molecular entity (NME) approvals through October represent an 18 percent drop year-over-year and is 22 percent below the 10-year average of 18 NMEs. That said, the four NME approvals in October represent the high water mark for NMEs in 2007, although that’s still down 20 percent from the prior October, he notes. Biologics approvals have fallen off a cliff in 2007, he adds, with just one year so far this year, compared with four at... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1028330 Thu, 15 Nov 2007 13:24:24 +0100 1028330 http://www.medworm.com/index.php?rid=1015909&cid=t_195268_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F182166702%2F Remember how more and more execs are carping about the agency? They blame the FDA for becoming too conservative in the wake of the Vioxx controversy and, as a result, fewer drugs are gaining approval. For instance, this is from Fred Hassan, the Schering-Plough ceo: “It just indicates to you that when bureaucrats come under pressure, they tend to choose the path of asking for more data, as opposed to approving the drug.” Wyeth’s Bob Essner recently fumed: “If you’re the first company to get approved in a certain area and competitors can’t get on the market, the FDA is now establishing monopolies. And that’s certainly not their mandate.” And this is what Dan Vasella at Novartis had to say: “The discussion on what this drug brings over and above what’s on the mark... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1015909 Fri, 09 Nov 2007 12:48:30 +0100 1015909 http://www.medworm.com/index.php?rid=993133&cid=t_195268_117_f&fid=34696&url=http%3A%2F%2Fwww.straightfromthedoc.com%2F50226711%2Ftasigna_nilotinib_fdaapproved_for_philadelphia_chromosome_positive_cml.php Novartis Pharma's Tasigna (nilotinib) has recently been approved by the US FDA for the treatment of Philadelphia chromosome positive chronic myeloid leukemia (CML) in adult patients whose disease has progressed on or who cannot tolerate other therapies that included imatinib (Gleevec). FDA's approval of Tasigna includes a black box warning for possible life-threatening heart problems that may lead to an irregular heartbeat and possible sudden death. The effectiveness of Tasigna is based on response rates observed in an ongoing clinical trial. Responses are associated with normalization of blood counts and bone marrow examinations. Further follow-up of patients is needed to determine how long these responses will last. The abnormal chromosome called the Philadelphia chromosom... Straightfromthedoc blogs http://www.medworm.com/rss/comments.php?id=993133 Wed, 31 Oct 2007 06:41:34 +0100 993133 http://www.medworm.com/index.php?rid=974176&cid=t_195268_117_f&fid=34696&url=http%3A%2F%2Fwww.straightfromthedoc.com%2F50226711%2Fnew_fdaapproved_label_of_ed_drugs_contains_risk_of_hearing_loss.php Revisions of the labeling of ED drugs (Cialis, Levitra and Viagra) that includes the potential risk of sudden hearing loss have already been approved by the FDA. The said approval will also apply for the drug Revatio (also a member of this drug class known as phosphodiesterase type 5 (PDE5) inhibitors) even though Revatio is used to treat pulmonary arterial hypertension (PAH) - a serious medical condition in which continuous high blood pressure in arteries of the lungs weakens the heart muscle (often leading to right heart failure and death). Erectile dysfunction (ED) drugs will noe display more prominently the potential risk of sudden hearing loss, and to guide consumers on what to do if they experience sudden problems with their hearing. Patients taking Cialis, Levitra, or Viagra wh... Straightfromthedoc blogs http://www.medworm.com/rss/comments.php?id=974176 Wed, 24 Oct 2007 12:11:27 +0100 974176 http://www.medworm.com/index.php?rid=971389&cid=t_195268_117_f&fid=34696&url=http%3A%2F%2Fwww.straightfromthedoc.com%2F50226711%2Fnew_bristolmeyers_squibbs_new_anticancer_treatment_ixempra_fdaapproved.php A new anti-cancer treatment distributed by Bristol-Meyers Squibb Company (Princeton, New Jersey) -Ixempra (ixabepilone) - has recently been approved by the US FDA for use use in patients with metastatic or locally advanced breast cancer who have not responded to certain other cancer drugs. The approval of Ixempra includes the following: for use in combination with another cancer drug (capecitabine) in patients who no longer benefit from two other chemotherapy treatments: including an anthracycline (such as doxorubicin or epirubicin) and a taxane (such as paclitaxel or docetaxel)for use alone in patients who no longer benefit from an anthracycline, a taxane and capecitabine Administered by intravenous infusion, Ixempra has been shown to bind to cancer cell microtubules but with some sid... Straightfromthedoc blogs http://www.medworm.com/rss/comments.php?id=971389 Tue, 23 Oct 2007 07:29:53 +0100 971389 http://www.medworm.com/index.php?rid=934114&cid=t_195268_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F166920740%2F And can we blame it on Bush? During the first 81 months of the Bush administration, drug approvals have significantly lagged the averages logged under the Clinton administration, Jim Kumpel, an analyst at Friedman Billings Ramsey, writes in an investor note this morning. Under Bush, the FDA has averaged 80.7 new drug application and 20.6 new molecular entity approvals per year. During the Clinton era, there were annual averages of 92.1 NDA and 32.4 NME approvals. So far, this year is shaping up terribly. New drug approvals by the FDA have plunged from last year, with just 51 NDA approvals through September, down 25 percent year-over year from 68 in 2006 and 13 percent below the 10-year average of 59, Kumpel notes. More importantly, the 10 NME approvals through September represent a 17 perc... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=934114 Mon, 08 Oct 2007 11:45:34 +0100 934114 http://www.medworm.com/index.php?rid=915032&cid=t_195268_117_f&fid=34696&url=http%3A%2F%2Fwww.straightfromthedoc.com%2F50226711%2Flamisil_fdaapproved_for_pediatric_treatment_of_scalp_ringworm.php We know Lamisil Tablets as a treatment for nail fungus infection (onychomycosis) whose generic versions have been approved by the FDA in July of this year. Now, the FDA has just approved Lamisil Oral Granules for the treatment of tinea... Continue. (Source: Straightfromthedoc) Straightfromthedoc blogs http://www.medworm.com/rss/comments.php?id=915032 Sun, 30 Sep 2007 11:19:44 +0100 915032 http://www.medworm.com/index.php?rid=886233&cid=t_195268_117_f&fid=34696&url=http%3A%2F%2Fwww.straightfromthedoc.com%2F50226711%2Fnasal_influenza_vaccine_flumista_now_fdaapproved_for_children_ages_25.php Previously the nasal influenza vaccine Flumist® is limited to healthy children aged 5 and older and adults up to 49 years of age. Now, it has been recently approved by the US FDA to include children aged 2-5. According to... Continue. (Source: Straightfromthedoc) Straightfromthedoc blogs http://www.medworm.com/rss/comments.php?id=886233 Thu, 20 Sep 2007 12:00:00 +0100 886233 http://www.medworm.com/index.php?rid=874921&cid=t_195268_117_f&fid=34696&url=http%3A%2F%2Fwww.straightfromthedoc.com%2F50226711%2Fosteoporosis_drug_evista_fdaapproved_for_risk_reduction_of_invasive_breast_cancer.php A product of Eli Lilly - Evista (raloxifene hydrochloride) was previously indicated for the treatment of osteoporosis in postmenopausal women. Now, the FDA has recently approved the second indication of Evista: reducing the risk of invasive breast cancer in postmenopausal... Continue. (Source: Straightfromthedoc) Straightfromthedoc blogs http://www.medworm.com/rss/comments.php?id=874921 Sun, 16 Sep 2007 09:29:27 +0100 874921 http://www.medworm.com/index.php?rid=856748&cid=t_195268_117_f&fid=34696&url=http%3A%2F%2Fwww.straightfromthedoc.com%2F50226711%2Ffirst_generic_versions_of_corega_fdaapproved.php Coreg™ - a product of GlaxoSmithKline - is a widely used FDA-approved medication for the treatment of high blood pressure, mild to severe chronic heart failure and left ventricular dysfunction following a heart attack. Now, the FDA has recently approved... Continue. (Source: Straightfromthedoc) Straightfromthedoc blogs http://www.medworm.com/rss/comments.php?id=856748 Mon, 10 Sep 2007 13:16:52 +0100 856748 http://www.medworm.com/index.php?rid=837433&cid=t_195268_117_f&fid=34696&url=http%3A%2F%2Fwww.straightfromthedoc.com%2F50226711%2Fsomatuline_depot_lanreotide_acetate_injection_fdaapproved_for_treatment_of_acromegaly.php [photo credit: faqs.org] Acromegaly is a a rare and potentially life threatening disease in adults caused by abnormal secretion of growth hormone (GH), commonly from a benign tumor located in the pituitary gland located in the brain. Just recently, the... Continue. (Source: Straightfromthedoc) Straightfromthedoc blogs http://www.medworm.com/rss/comments.php?id=837433 Mon, 03 Sep 2007 08:00:00 +0100 837433 http://www.medworm.com/index.php?rid=827983&cid=t_195268_117_f&fid=34696&url=http%3A%2F%2Fwww.straightfromthedoc.com%2F50226711%2Fevithrom_human_thrombin_fdaapproved_for_topical_use_in_surgery.php Evithrom (human thrombin) - manufactured by Omrix Biopharmaceuticals, Ltd. and will be distributed by Johnson & Johnson Wound Management (a division of Ethicon, Inc.) - is the first human thrombin approved since 1954 and the only product currently licensed. Evithrom... Continue. (Source: Straightfromthedoc) Straightfromthedoc blogs http://www.medworm.com/rss/comments.php?id=827983 Wed, 29 Aug 2007 08:00:00 +0100 827983 http://www.medworm.com/index.php?rid=801644&cid=t_195268_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F144427013%2F What’s wrong with the FDA? Are safety concerns emphasized at the expense of needed therapies? Are drugs approved too quickly or not fast enough? And whatever your view, who’s to blame? A recent segment on CNBC’s Squawkbox tries to sort it out with help from Joel Sendek, a Lazard Capital Markets managing director and biotech analyst, and Paul Brown, a consumer healthcare advociate with the Public Interest Research Group. Click on this link to watch the video. Share / E-mail (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=801644 Wed, 15 Aug 2007 15:09:09 +0100 801644 http://www.medworm.com/index.php?rid=800175&cid=t_195268_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F144376937%2F Blame it on Bush? There were just 38 NDA approvals through July, down 31 percent year-over-year from last year’s 55 and 16 percent below the 10-year average of 45, writes Jim Kumpel, a healthcare analyst at Friedman Billings Ramsey, in an investor note this morning. And the 7 new molecular entities approved through July is down 30 percent year-over-year, marking a 10-year low and 50 percent below July 2004. He points out that, during the first 79 months of the Bush administration, drug approvals have significantly lagged the averages logged under the Clinton administration. Under Bush, the FDA has averaged 80.8 NDA and 20.7 NME approvals per year, both down from the Clinton era’s average of 92.1 NDA and 32.4 NME approvals annually. It’s also true that, other than Mark McC... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=800175 Wed, 15 Aug 2007 12:50:00 +0100 800175