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Synopsis Pharmatimes reports that European competition authorities yesterday fined AstraZeneca about 60 million euros million dollars ; for blocking the market entry of cheaper generic versions of its drug LosecTM omeprazole ; . In its ruling, reached yesterday after a six-year investigation, the Competition Commission said that AstraZeneca had abused its dominant market position between 1993 and 2000 by blocking or delaying market access for generic versions of Losec and preventing parallel imports of the product. The Commission says that the company gave misleading information to several national patent offices in a bid to gain extended patent protection for the drug through supplementary protection certificates. Abuses are said to have occurred in Belgium Denmark, Germany, the Netherlands, Norway and the UK. In addition, the Competition Commission found that AstraZeneca had selectively deregistered certain the marketing authorisations for Losec in Denmark, Norway and Sweden in order to prevent parallel traders selling the product which, at its peak, generated annual sales in excess of .3 billion. AstraZeneca has said that it "fundamentally disagrees" with the findings. The company maintains that it acted in good faith and claims that the case could ultimately have a negative impact on future competitiveness within the pharmaceutical industry. Title Source US report finds drug firms not following up speedy approvals Reuters via Biospace Link!
The sodium dodecyl sulfatepolyacrylamide gel electrophoresis method we used is based on that of Laemmli 29 ; , with slight modifications. Briefly, equal amounts of protein were run on 12% nonreducing gels. Proteins were transferred overnight 4C, 40 V ; onto Hybond-ECL membrane Amersham, Arlington Heights, IL ; in Laemmli buffer 25 mM Tris, 52 mM glycine, pH 8.3 ; , containing 10% methanol. Blots were then blocked for 1 h at room temperature RT ; in PBST 50 mM NaPO4, pH 7.5, 100 mM NaCl, 0.05% Tween-20 ; containing 5% dried milk. This was followed by a 1-h incubation at RT with monoclonal anti-HSP70 antibody Stress Gen, Victoria, BC ; diluted 1: 500 ; in PBST containing 5% milk. After a 15-min wash in PBST, blots were incubated for 1 h at with peroxidase-conjugated secondary antibody diluted 1: 500 ; in PBST containing 5% milk. Blots were then washed for 15 min in PBST, and protein bands were visualized via the ECL-Plus detection system Amersham Life Sciences, Little Chalfont, Buckinghamshire, England ; as per the manufacturer's instructions.
What is Independent Review? Independent Review1 is a process for Providers of TennCare services to resolve their claims payment disputes with TennCare HMOs, BHOs, and Dental Benefits Managers.2 Who are Independent Reviewers? Independent Reviewers are individuals selected by a panel3 to hear disputes between TennCare MCOs and Providers. They fulfill a judge-like role in rendering opinions and directives on claims disputes. Their compensation is not connected to the outcome of the reviews performed. What makes them "Independent"? Independent Reviewers are "independent" because they are selected by an independent panel. They are not selected by the MCO, the Provider, the Tennessee Department of Commerce and Insurance "TDCI" ; or the TennCare Bureau. What kinds of claims can be sent? Only claims that are eligible can be sent to Independent Review. Before a claim is deemed eligible for Independent Review, it must meet the following requirements: To be eligible for Independent Review, a claim must meet ALL of the following: 1. The claim involves a TennCare service, which was provided to a TennCare Enrollee, AND 2. The MCO: a. Partially or totally denied the claim in a written or electronic remittance advice, or b. Subsequently partially or totally denied or recouped a previously allowed claim by a written or electronic notice; or c. Failed to respond by issuing a remittance advice or other appropriate written or electronic notice partially or totally denying the claim within sixty 60 ; calendar days of the MCO's receipt of the claim.
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T-ransient global cere-bral ischemia was produced by temrporarily blocking the bilateral blood supply in the carotid arteries for 5 mmn while continually measuring the temperature of the dura mater and the blood flow of the cerebral cortex. After inducing transient gloal cerebral machernia, the animals were sacrificed and fixed by perfusion of paraformaldehyde solution. The ce-rebrum was enucleated and processed for preparation of paraffin sections. The sections were stained with hematoxylin and eosin. We also processed ce-re-bral tissues for electron microscopy and observed ultrastructural changes sugge-stive of apoptosis. ThAt restults stugge-sted that delayed osuronal death in CAl site after transient global.
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Small mouths with bad teeth" maybe the Taino meant that when they said: "Maize". Home for the Taino? The Bahamas, the Great Antilles, the past. "Small mouths with bad teeth." Modern maize has perfect dentistry. It's yellow, but it's not yellowing. It's not an exact image. I bet in one London allotment the sweet corn has perfect dentistry. But in a good way. It's not an exact image, not exact the tall stalks and long arms of the sweet corn plant, arms with weak elbows, make each human figure its own scarecrow, and thinking about that head of corn again maybe I do think too much, which is the same as not enough about everything else ; it has the qualities of a rubik's cube. Easy! all the squares are the same colour. Almost and humalog.
Recruitment of trainees In order to ensure wide participation of staff in the training, a letter was written to the Heads of all the 32 departments units in the institution to solicit nominations from each. The number of staff was limited to four per department or unit due to funding constraints. The letter of invitation stressed the fact that participation in the program was voluntary. Of the 32 departments units invited to nominate staff, 29 91% ; responded and 3 9% ; did not. In addition, two Non-Governmental Organizations that routinely conduct behavioral and biomedical researchers in Ibadan were invited to nominate staff to participate in the training. Upon receiving names of nominees, a formal letter of invitation was sent to each person providing details about the logistic arrangements for the training. Implementation of the workshops Three rounds of training workshops were conducted between December 2003 and February 2004. Each round, which lasted 21 hours spread over three days, was organized in ways that ensured that the composition of the trainees was multi-disciplinary. The objectives of the workshop were to expose participants to existing international guidelines and regulations on research involving human participants, increase knowledge and application of the principles of research ethics, deepen understanding of the role of investigators and IRBs in ensuring the protection of study participants, and equip participants with knowledge and skills to deal with the ethical challenges they may face in their future research activities. The workshops were facilitated by seven resource persons who had previous training and experience in research ethics. The resource persons used multiple training techniques including lecture, question and answer sessions, and group discussion of case studies. The training had both plenary and group sessions. Participants were divided into small groups to discuss the case studies and feedbacks were provided during plenary sessions thus ensuring indepth discussions of the issues. The workshops were conducted in English, the official language in Nigeria. The training emphasized the importance and universality of the principles of research ethics as described in the Belmont Report; however, the resource persons provided sev.
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NICE produces advice guidance ; for the NHS about preventing, diagnosing and treating different medical conditions. The guidance is written by independent experts including healthcare professionals and people representing patients and carers. They consider all the research on the disease or treatment, talk to people affected by it, and consider the costs involved. Staff working in the NHS are expected to follow this guidance. To find out more about NICE, its work and how it reaches decisions, see nice aboutguidance This leaflet and other versions of the guidance aimed at healthcare professionals are available at nice TA115 You can order printed copies of this leaflet from the NHS Response Line phone 0870 1555 455 and quote reference N1177 and humira.
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To obtain images suitable for precisely estimating the events occurring in pulmonary microvessels, we used a confocal luminescence microscope recently developed in our laboratory.8 The reflected light or fluorescent emission from the sample was imaged onto a high-sensitivity CCD camera with an image intensifier EktaPro Intensified Imager VSG, Kodak ; , which can detect even very low fluorescence signals. By incorporating an excitation wavelength of 488 nm emitted from a low-power air-cooled argon ion laser 532-BSA04; output power, 10 mW V; Omnichrome ; with appropriate fluoresceins, our confocal system enabled us to obtain apparently instantaneous images at 1000 frames s. The final magnifying power of our system reached 968, with a 40 objective, on the video screen. The resulting field of view was 105 m, corresponding roughly to a diameter of a single pulmonary microvessel running beside the terminal bronchiole.21 We registered confocal images at a rate of 250 frames s by means of a high-speed video analysis system EktaPro 1000 Processor, Kodak ; connected to the image-intensified CCD camera EktaPro Intensified Imager VSG, Kodak ; . To determine microvessel diameter and architecture, we added 200 L of 5% FITC-dextran with a molecular weight of 145 000 Sigma ; to the reservoir. Defining the edge of the microvessel of interest as the portion exhibiting a steep change of fluorescence signal, we calculated vessel diameters by processing a confocal video image with a computer-assisted digital imageanalyzing system Quadra 840AV Image 1.58, Apple ; . To discriminate between precapillary arterioles and postcapillary venules, we added a small quantity of erythrocytes stained with FITC Sigma ; to the perfusion medium and measured their flow direction with the confocal luminescence microscope.
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Found the Java code which uses such proxies, without the permission of their owners, to connect to the sites that HMS harvests. The offending source code was written by Rob DiMarco, Tim McCune, and Jason Franklin. This deplorable activity by HMS has serious legal, moral, and professional implications. First, the legal. I not a lawyer, but I can read the plain English of the Pennsylvania Consolidated Statutes, and it is clear to me that hijacking the computers of random people is a crime in Pennsylvania. Under PSC 3933, every instance every single instance of hijacking an open proxy is a misdemeanor of the first degree. HMS is committing these misdemeanors by the tens of thousands, under explicit management direction, and in accord with corporate strategy. One petty theft may draw little attention; but tens of thousands of petty thefts, all made by one company, at explicit management direction, and in accord with company strategy, might well lead to unpleasant legal consequences. Even a small fine is painful when multiplied by a hundred thousand. HMS thus makes itself an attractive target for prosecution by a state's attorney who wants to show himself tough on corporate crime. HMS could be a stand-in for the spammers who commit the same crimes. HMS's legal exposure is not limited to Pennsylvania. A number of the sites that HMS harvests are run by governments of other states who would be incensed at the disrespect HMS has shown them. For example, Washington State site tried to block HMS from harvesting. HMS persisted, evading block after block; the harvester personnel treated it like a game. It can only be an understatement to observe that accessing state government computers in blatant disregard for their acceptable use policies is not legally sound. Worse, Montana's web server actually crashed as a result of HMS harvesting it. Once you go beyond access into crashing, you're way into felony territory. In my opinion, if HMS continues its current practices, some state's attorney is eventually going to take an unpleasant interest. If they got together, they might even decide that HMS would make a press-friendly, high-visibility test case. Spammers are usually hard to find. HMS is not. And it doesn't end with state law. Federal courts have held that web spiders must obey the established ROBOTS.TXT mechanism by which web site owners limit automated access, and that a failure to obey ROBOTS.TXT constitutes trespass. None of HMS's harvesting source code even mentions the ROBOTS file, let alone obeys it. This is no mere theoretical problem. In 2001, Bidder's Edge paid an undisclosed amount to settle eBay's suit for trespass based on failure to obey ROBOTS.TXT. Similarly, Verio was enjoined by a federal district court from harvesting WHOIS information from domain registrar Register based on Verio's deliberate violations of Register 's terms of service. HMS harvesting code pays no attention whatsoever to ROBOTS.TXT. Yet at least one of the authors of the harvesting system did know about it, since the "RequestDistribution.txt" document in the harvester source code actually contains a reference to the W3C standard for ROBOTS.TXT. HMS can't even plead ignorance, not that it would get very far. And ignoring ROBOTS.TXT is not just a criminal matter, it's also a civil cause of action. Legality and Morality of Harvesting Operations April 19, 2005 2 and hydralazine.
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Chicago's own Lookingglass Theater's METAMORPHOSES for Best Play, Best Director Mary Zimmerman ; and Best Scenic Design Daniel Ostling MAMMA MIA! for Best Musical, Best Book and Leading Actress in a Musical Louise Pitre and SWEET SMELL OF SUCCESS for Best Musical, Best Book, Best Score, Leading Actor in a Musical John Lithgow ; and Featured Actor in a Musical Brian D'Arcy James ; . Our most sincere thanks to Laura Matalon and TMG The Marketing Group, Amy Jacobs and Nina Lannan Associates, and Wayne Wolfe and Barlow Hartman Public Relations for involving HMS in these wonderful endeavors. All three shows are still running on Broadway, so check them out next time you're in New York.
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Vaccines are no more or less likely to be involved in medication errors than other drugs. Nevertheless, it is helpful to consider this group of medicinal products in isolation, especially in light of the consequences of immunological reactions to a medication error. From the disciplines of engineering and aerospace research, medication error experts have borrowed the term "failure mode and effects" and have created an analysis system FMEA ; . This technique recognizes the inevitability of human error and encourages the development of systems to anticipate, prevent and recover from human error. The goal of FMEA is to identify mistakes that could happen before they happen, and determine whether the consequences of such errors are tolerable or intolerable. When FMEA indicates that an error would be intolerable, "safety layers" are added to the procedures involved. The more layers or error traps that are added, the safer the system -- albeit cumbersome -- and the less likely it will be for the patient to suffer injury 1 ; . By planning ahead, health professionals can strengthen their error-detection system and minimize the potential for error, or at least its consequences. The following is a summary and discussion of some reports of errors involving vaccines, as well as anecdotal reports known to the authors 2 ; . By agreement with the United States Pharmacopeia, the Institute for Safe Medication Practices ISMP ; is notified of all voluntary reports submitted by practitioners to the USP's Medication Errors Reporting Programme. The ISMP also reviews medication error reports submitted to the US Food & Drug Administration MedWatch programme. A standard approach to classifying errors is to create categories such as: wrong patient, wrong drug, wrong dose. However, this method does little to pinpoint where improvements in the delivery system can be made. Instead, we suggest classifying errors according to severity 3 ; . This helps concentrate qualityimprovement efforts where risks are greatest. It will also help identify where: the system failed to catch the error, and how this affected the patient; the system worked and stopped the error before it affected the patient; and the system identified an uncorrected risk, which can be defined as "someone will be harmed if a change is not made". Next, the component of the system that failed must be categorized 4 ; . A single incident can involve multiple failures of a system. The following illustrative examples serve to show how this works. Most are actual cases; others are accidents that could happen. 1. Paediatric-strength diphtheria-tetanus toxoids DT ; have been confused with adult-strength tetanus-diphtheria toxoids Td ; because of the similarity in label wording and print-type styles and because official titles of the products are so similar. This error can be averted through clearer labelling. 2. An obsolete colloquial term for rubella in the United States is German measles. The wrong vaccine has been given when health workers confuse vaccines against measles and German measles. Alternative terms for the two are no better: rubeola and rubella. In this case, use of the words measles and rubella should be encouraged and use of the other terms should be actively discouraged. This can be achieved through training and the cooperation of industry and regulatory authorties. 3. Several sound-alike or look-alike names involve vaccines: varicella and vaccinia; hepatitis A and hepatitis B; Haemophilus influenzae type B HiB.
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Includes: Anastomosis, bladder with cloacal deformity ; Reapproximation, bladder halves cloacal deformity ; Repair, bladder exstrophy Excludes: Augmentation cystoplasty to increase size of existing bladder see 1.PM.79. ; Bladder resection with concomitant reconstruction see 1.PM.90. ; Correction, bladder exstrophy [externalized] see 1.SY.84. ; Cystectomy, radical with concomitant reconstruction see 1.PM.92. ; Non- continent urinary diversion see 1.PG.77. ; Code Also: Any concomitant colostomy for cloacal exstrophy see 1.NM.77. ; Any concomitant pelvic [innominate] osteotomy see 1.SQ.80. ; Any concomitant repair of omphalocele for staged repair of cloacal exstrophy see 1.SY.84 and hms.
Discussion Recombinant glucocerebrosidase containing glycans with terminal mannose residues can be produced using either non-mammalian expression systems or mammalian expression systems in which the normal intracellular remodeling to complex carbohydrate structures has been blocked. These expression systems could potentially improve mannose receptor targeting of GCase due to larger oligomannose chains and or simplify production by eliminating the need for carbohydrate remodeling. To determine what effect these different glycan structures might have on the properties of the enzyme, multiple expression systems were employed to produce forms of GCase containing primarily oligomannose, ranging in size from Man2 to Man9. The different forms of GCase were shown to be comparable in enzymatic activity but also demonstrated surprisingly little difference in their targeting behavior. Uptake by macrophages in vitro was similar for all of the forms that were evaluated as was intracellular half-life. There was also no significant difference seen in vivo between the form with the largest oligomannose chains kGCase containing primarily Man9 ; and Cerezyme. Rather than enhancing affinity for mannose receptor, increasing the number of terminal mannose residues appeared to have the opposite effect, with the baculovirus GCase containing some Man2 ; having the highest affinity and the kGCase with Man9 ; having the lowest affinity. Interestingly, despite its higher affinity for mannose receptor, baculovirus GCase was taken up somewhat less well by macrophages. It is likely that the smaller Man2 structures present in this form lead to less efficient internalization by the mannose receptor on these cells. Addition of short, linear mannose chains to GCase has been shown to provide little improvement in delivery to Kupffer cells relative to GCase containing complex carbohydrate chains Brady et al., 1994 and hydromorphone.
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