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 'bla'. Sat, 03 Sep 2011 02:48:45 +0100 http://www.medworm.com/index.php?rid=4747883&cid=t_104986_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=4495433&cid=t_104986_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=1837315&cid=t_104986_135_f&fid=35246&url=http%3A%2F%2Faids-write.org%2F%3Fp%3D924 C. diff: The cure for antibiotic abuse Posted by Paul Sax on September 18th, 2008 . . . Human beings love antibiotics — all of us are guilty of this love affair, health care providers and patients alike. (This is a great cartoon!) My first introduction to this phenomenon was during a medicine rotation in medical school, when my esteemed attending obviously had a bad cold. After a particularly noisy round of sneezing (and what was he doing in the hospital, one might wonder), I asked him how he was holding up. He told me the cold was fine, but the nausea from the erythromycin he’d started himself on “just in case” was driving him crazy. But this new “hypervirulent” C. diff has changed the equation, in a way that warnings about antibiotic side effects and risk of resistance nev... aids-write.org blogs http://www.medworm.com/rss/comments.php?id=1837315 Tue, 30 Sep 2008 07:10:07 +0100 1837315 http://www.medworm.com/index.php?rid=1794467&cid=t_104986_135_f&fid=35246&url=http%3A%2F%2Faids-write.org%2F%3Fp%3D903 Iran’s arrest of doctors jeopardizes US program By Farah Stockman boston Globe Staff / September 9, 2008 WASHINGTON - Two celebrated Iranian doctors who participated in a US-funded exchange program have been arrested in Iran and accused of using their global AIDS work to destabilize the Iranian government, according to State Department officials and former students at Harvard’s School of Public Health who are seeking their release. The late June arrests of Harvard alumnus Kamiar Alaei and his brother, Arash - apparently because of their close ties to organizations in the United States - are a setback for State Department officials who are quietly attempting to expand people-to-people exchanges with Iran in a bid to improve relations between the countries. Goli Ameri, assist... aids-write.org blogs http://www.medworm.com/rss/comments.php?id=1794467 Mon, 15 Sep 2008 12:06:01 +0100 1794467 http://www.medworm.com/index.php?rid=1500020&cid=t_104986_135_f&fid=35246&url=http%3A%2F%2Faids-write.org%2F%3Fp%3D839 KENYA: Boy’s suicide reveals gaps in HIV education irin plus news, may 28, 1008 GARISSA, 28 May 2008 (PlusNews) - The recent suicide of a secondary school student in Kenya’s North Eastern Province after he was diagnosed as HIV positive has highlighted the shortage of qualified counsellors in the region, and the urgent need to address the misinformation and stigma attached to the virus. “Serious awareness-raising and counselling of students on HIV is non-existent in schools here; the little information they have is either gathered from public meetings, dramas or media,” said one of the boy’s teachers, who preferred not to be named. In April the student had reportedly visited a voluntary counselling and testing (VCT) centre, manned solely by a junior labor... aids-write.org blogs http://www.medworm.com/rss/comments.php?id=1500020 Fri, 06 Jun 2008 19:03:31 +0100 1500020 http://www.medworm.com/index.php?rid=1500021&cid=t_104986_135_f&fid=35246&url=http%3A%2F%2Faids-write.org%2F%3Fp%3D838 This report does not necessarily reflect the views of the United Nations] (Source: aids-write.org) aids-write.org blogs http://www.medworm.com/rss/comments.php?id=1500021 Fri, 06 Jun 2008 18:51:57 +0100 1500021 http://www.medworm.com/index.php?rid=1454524&cid=t_104986_135_f&fid=35246&url=http%3A%2F%2Faids-write.org%2F%3Fp%3D824 Texas jury concludes saliva of HIV-positive man a ‘deadly weapon’, sentenced to 35 yrs jail Edwin J. Bernard, Friday, May 16, 2008 A 42 year-old HIV-positive man from Texas who spat at a police officer during his 2006 arrest for being drunk and disorderly has been sentenced to 35 years in prison by a Dallas court and must serve at least half of his sentence before being eligible for parole because the jury found that his saliva was a deadly weapon. The case, which was reported by more than 175 news outlets yesterday, has outraged UK HIV organisations, particularly since only three reports – from The New York Times, USA Today and the Mississippi Clarion-Ledger [in an interesting related account of a man allegedly infected by a woman, his wife — rk] – actually mention that H... aids-write.org blogs http://www.medworm.com/rss/comments.php?id=1454524 Mon, 19 May 2008 22:52:32 +0100 1454524 http://www.medworm.com/index.php?rid=1446182&cid=t_104986_135_f&fid=35246&url=http%3A%2F%2Faids-write.org%2F%3Fp%3D818 Hi folks, The May edition of the International Carnival of Pozitivities has been available since May 6th at dropdeadhappy.com. I was in the middle of posting announcements when I received word that my Mom’s health was failing. She passed away the next day and I am just now getting back to posting announcements. Please visit the May, 2008 edition of the ICP and bookmark it so you can take in all of the articles at your leisure. I hope you will leave feedback for the host and the contributors. Our next edition will be posted in June at Black Looks . Until then, peace to you all. Ron Hudson 2sides2ron Poundcake Love The International Carnival of Pozitivities (ICP) (Source: aids-write.org) aids-write.org blogs http://www.medworm.com/rss/comments.php?id=1446182 Thu, 15 May 2008 22:49:23 +0100 1446182 http://www.medworm.com/index.php?rid=1408281&cid=t_104986_135_f&fid=35246&url=http%3A%2F%2Faids-write.org%2F%3Fp%3D788 Angola: HIV/Aids Hinders Implementation of Education Programme Angola Press Agency (Luanda) 22 April 2008 (Luanda, Angola) Angolan deputy minister of Education for Educative Reform, Pinda Simão, said Tuesday in Luanda that Hiv/Aids constitutes an obstacle to the implementation of the “Education for All” programme designed to eradicate illiteracy until 2015. The government official said so while speaking during a talk on “Challenges to Education for All in Angola”, as part of the International Week on Education for All (EFT). According to Pinda Simão, many teachers who were attending training programmes or already trained in educational reform, died as a result of Hiv/Aids, which led to the recruitment and training of new ones, thus delaying the education proces... aids-write.org blogs http://www.medworm.com/rss/comments.php?id=1408281 Wed, 30 Apr 2008 03:08:56 +0100 1408281 http://www.medworm.com/index.php?rid=1367959&cid=t_104986_135_f&fid=35246&url=http%3A%2F%2Faids-write.org%2F%3Fp%3D769 The state of ADAP by Bob Roehr april 10, 2008 bay area reporter Despite the rosy report, the road ahead for ADAP is likely to have potholes. Two demographic factors are at work. Estimates are that at least a quarter of those infected with HIV do not know it. The Centers for Disease Control and Prevention is rolling out programs to increase testing so that more people learn their status, and that will increase the demand for services, including ADAP. Most Americans get their health insurance through the workplace. Rising unemployment means that more will [be] losing that coverage and will be seeking help through government programs. And, the deteriorating economy means less tax revenue for state and the federal governments, crimping expenditures even further.” Read more in Bay A... aids-write.org blogs http://www.medworm.com/rss/comments.php?id=1367959 Sat, 12 Apr 2008 01:58:34 +0100 1367959 http://www.medworm.com/index.php?rid=795157&cid=t_104986_135_f&fid=35246&url=http%3A%2F%2Faids-write.org%2F%3Fp%3D652 Public Health & Education | Many High-Risk Older Black Women Are Uninterested in Receiving HIV Tests, Study Finds [Aug 09, 2007] Few women older than age 50, particularly black women, find it necessary to undergo testing for HIV even though many of the women have a moderate- to high-risk of exposure, according to a study published in the Journal of Women’s Health, United Press International reports. The study, led by Aletha Akers of the University of Pittsburgh School of Medicine, involved 514 Atlanta, Ga., women ages 50 to 95 during an 11-month period in 2001 and 2002. The women completed a 68-item questionnaire about their attitudes regarding lifetime HIV infection risk and interest in being tested for HIV. Most of the women said they were not currently sexually active ... aids-write.org blogs http://www.medworm.com/rss/comments.php?id=795157 Mon, 13 Aug 2007 02:12:06 +0100 795157 http://www.medworm.com/index.php?rid=534292&cid=t_104986_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F107932642%2Fcsl_biotherapies_submitted_bla.html CSL Biotherapies is one of the world’s leading manufacturers of influenza vaccine. The company would like to penetrate the American market and so has recently submitted a Biologics License Application (BLA) to the USFDA, seeking approval of its influenza vaccine for immunization of individuals aged 18 years and above, which when approved will be made into both a single-dose, thimerosal-free, pre-filled syringe and in multi-dose vials. According to Paul Perreault, Executive Vice President of CSL Biotherapies Worldwide Commercial Operations: "Our parent company, CSL Limited, has supplied safe and effective influenza vaccine for more than 40 years. By extending our influenza vaccine franchise into more geographies, including the U.S., our goal is to help address a large and growing... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=534292 Tue, 10 Apr 2007 10:09:58 +0100 534292 http://www.medworm.com/index.php?rid=515920&cid=t_104986_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F105921151%2Fgsk_submitted_bla_to_usfda_for.html GlaxoSmithKline (NYSE:GSK) has recently submitted a Biologics License Application (BLA) for CERVARIX® (human papillomavirus vaccine, AS04 adjuvant-adsorbed) to the USFDA. CERVARIX® is GSK’s candidate vaccine for cervical cancer, which when approved will be indicated for the prevention of cervical cancer and precancerous lesions associated with the most common cancer-causing human papillomavirus (HPV) types. The GSK cervical cancer candidate vaccine is formulated with a proprietary adjuvant system called AS04, containing aluminum hydroxide and monophosphoryl lipid A (MPL®). Published data have shown that the GSK cervical cancer candidate vaccine formulated with AS04 provides a stronger and longer lasting immune response compared to the same GSK vaccine composition formulat... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=515920 Mon, 02 Apr 2007 04:02:27 +0100 515920 http://www.medworm.com/index.php?rid=486705&cid=t_104986_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F102147897%2Flev_pharmaceuticals_c1esterase.html Currently without a USFDA-approved acute therapy in the United States, Hereditary Angioedema (HAE) or hereditary C1-inhibitor deficiency is a rare and life-threatening inflammatory condition characterized by recurrent attacks of inflammation affecting the extremities (the hands and feet), the face, the urogenital tract, the abdomen, and the larynx. This genetic disorder is caused by a deficiency of the plasma protein C1-INH.While there is no current approved therapy for HAE in the U.S., C1-INH is the treatment of choice for HAE in Europe for more than 30 years. Lev Pharmaceuticals, Inc. (OTC: LEVP) – maker of the C1-esterase inhibitor (C1-INH) – believes that replacement therapy with C1-INH will benefit the estimated 10,000 people with HAE in the United States. Now, Lev Pharmac... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=486705 Fri, 16 Mar 2007 12:36:47 +0100 486705