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National Institutes of Health, Center for Cancer Research. The costs of publication of this article were defrayed in part by the payment of page charges. This article must therefore be hereby marked "advertisement" in accordance with 18 U.S.C. Section 1734 solely to indicate this fact. S The on-line version of this article available at : jbc ; contains supplemental Table 1 and Figs. 13. 1 A Commissioned Officer in the United States Public Health Service. To whom correspondence should be addressed: NCI, National Institutes of Health, Center for Cancer Research, Medical Oncology Branch, Bldg. 10, Rm. 12N226, 9000 Rockville Pike, Bethesda, MD 20892. Tel.: 301-402-1357; Fax: 301-402-1608; E-mail: tfojo helix.nih.gov.
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The Hypoparathyroidism Association Inc. should NOT be used as a substitute for professional medical and psychological treatment. Any suggestions we may offer in our quarterly newsletter, on our web site, or in any e-mail correspondence should be considered as 'suggestions' only. "Any changes in your current medical treatment you may want to consider should be discussed with your personal physician and should NOT be undertaken without his her concurrence and support to ensure proper medical treatment and follow-up. "Our suggestions and comments are based on our collective experience, both personal and collective. While the suggestions and comments we have offered have been successful for many individuals, we do not mean to imply they will be successful for every individual and under every circumstance. "Proper medical treatment is intended to be a personal matter between the patient and his her own physician. Any suggestions or comments offered are intended to help the patients and their physician s ; determine the best course of action.
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OpenPR ; - THOUSAND OAKS, Kalifornien, USA und GENF, SCHWEIZ 18. Dezember 2002 Amgen Inc. NASDAQ: AMGN ; und Serono S.A. virt-x: SEO und NYSE: SRA ; informierten heute ber den definitiven Abschluss einer Lizenzvereinbarung, derzufolge Serono die Vermarktung des zugelassenen Multiple Sklerose-Prparats und Chemotherapeutikums Novantrone Mitoxantronkonzentrat zur Injektion ; in den Vereinigten Staaten bernehmen wird. Diese Vereinbarung wurde wirksam, nachdem das amerikanische Kartellamt Federal Trade Commission ; die in der entsprechenden Ausfhrungsverordnung Hart-Scott-Rodino Act ; vorgeschriebene Karenzfrist vorzeitig beendet hatte. Novantrone wurde von der amerikanischen Food and Drug Administration FDA ; in den USA zur Behandlung der sekundr-progredienten chronisch ; und der schubfrmig-progredienten MS sowie verschiedener Krebsformen zugelassen. Bei der Substanz handelt es sich um einen Topoisomerase II-Inhibitor, dessen Wirkung auf der Hemmung der DNA-Replikation im Verlauf der Zellteilung beruht. Amgen hatte Novantrone im Rahmen der Akquisition von Immunex Corp. im Juli 2002 erworben. Das Medikament wurde im Oktober 2000 von der FDA fr verschiedene MS-Indikationen und bereits 1987 fr bestimmte Tumorindikationen zugelassen. Die komplette Produktinformation fr Novantrone kann ber die Website novantrone eingesehen werden. Amgen ist ein weltweit ttiges Biotechnologie-Unternehmen, das wichtige Humantherapeutika auf der Grundlage neuer Erkenntnisse in der Zell- und Molekularbiologie erforscht, entwickelt, produziert und vermarktet. Serono ist ein weltweit fhrendes Biotechnologie-Unternehmen. Das Unternehmen hat sechs rekombinante Produkte auf dem Markt: Gonal-F, Luveris, Ovidrel Ovitrelle, Rebif, Serostim und Saizen . Luveris ist in den USA nicht zugelassen. ; This news release contains forward-looking statements that involve significant risks and uncertainties, including those discussed below and more fully described in the Securities and Exchange Commission reports filed by Amgen, including its most recent Form 10-Q. Amgen conducts research in the biotechnology pharmaceutical field where movement from concept to product is uncertain; consequently, there can be no guarantee that any particular product candidate will be successful and become a commercial product. Furthermore, Amgen's research, testing, pricing, marketing and other operations are subject to extensive regulation by domestic and foreign government regulatory authorities. In addition, sales of Amgen's products are affected by reimbursement policies imposed by third party payors, including governments, private insurance plans and managed care providers. These government regulations and reimbursement policies may affect the development, usage and pricing of Amgen's products. In addition, while Amgen routinely obtains patents for its products and technology, the protection offered by Amgen's patents and patent applications may be challenged, invalidated or circumvented by its competitors. Because forward-looking statements involve risks and uncertainties, actual results may differ materially from current results expected by Amgen. Amgen is providing this information as of December 18, 2002 and expressly disclaims any duty to update information contained in this press release. Some of the statements in this press release are forward looking. Such statements are inherently subject to known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements of Serono S.A. and affiliates to be materially different from those expected or anticipated in the forward-looking statements. Forward-looking statements are based on Serono's current expectations and assumptions, which may be affected by a number of factors.
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Was generally retarded after 12 days; two of the five rats died, one of liver necrosis at 19 days and the other of both liver necrosis and lung hemorrhage at 33 days. All groups suffered from diarrhea induced by TOCP. Supplementation with 10 ppm arsenic had no influence on the growth-depressing effects of TOCP. In the case of NaaSO4 supplementation, growth was severely de pressed fig. 1 ; and 80% mortality had oc curred by 28 days. Experiment 5. Quail fed the basal diet low in vitamin E and selenium ; without 0.1 % TOCP showed reduced growth by 9 days table 5 ; and between 9 and 17 days, 80% mortality occurred. Similarly, 80 to 1007o mortality exudative diathesis ; occurred in chicks fed an identical diet between 14 and 18 days 12, 27 ; . In the quail, small petechial hemorrhages located in the region of the ventral neck and an terior portion of the breast muscle were observed in some birds postmortem. This form of exudative diathesis has been de scribed in quail 28 ; . An yet unidenti fied antioxidant in Torula yeast 8 ; which has been reported to protect chicks from encephalomalacia 29 ; apparently was ef fective in the quail since no encephaloma lacia was observed. The growth response to addition of both vitamin E and selenium was greater than to vitamin E alone table 5 ; , while mortality was lowest in the groups receiving selenium. Thompson and Scott 30, 31 ; have reported the effective ness of selenium in improving growth and reducing mortality in both chicks and and sorafenib.
Fig. 5 ; . Finally, the apparent recovery may in fact represent a compensated state.'6 with the suspected drug in vitro increase in serum platelet bindable IgG sera tested. The the drug histoniwere and tested did not Table!
NDC 11 Label Name Manufacturer J-Code HCPS 1 HCPS 2 44087000401 SEROSTIM INJ 4MG SERONO J2941 * Q2016 J2941 * 44087000407 SEROSTIM INJ 4MG SERONO J2941 * Q2016 J2941 * 44087000501 SEROSTIM INJ 5MG SERONO J2941 * Q2016 J2941 * 44087000507 SEROSTIM INJ 5MG SERONO J2941 * Q2016 J2941 * 44087000601 SEROSTIM INJ 6MG SERONO J2941 * Q2016 J2941 * 44087000607 SEROSTIM INJ 6MG SERONO J2941 * Q2016 J2941 * * J-Code 2941 covers many other drugs in addition to Serostim. If J-Codes are used, all other drugs must be removed from the search results and soriatane.
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E. C. Zielinski-Gutierrez1, M. Hayden2, M. Fonseca-Ford3, E. Gleckler4; 1 CDC, Fort Collins, CO, 2University of Colorado, Colorado Springs, CO, 3 CDC, San Diego, CA, 4University of New Orleans, New Orleans, LA. Background: Insect repellent use has been advocated to reduce the risk of human infection with West Nile virus and other vector-borne diseases. In a 2004 western US survey, only 28% of Latinos were familiar with "DEET, " vs. 55% overall, and only 17% Latinos had used repellent containing DEET vs. 26% among white respondents. Given large Latino population in areas of WNV transmission and the potential threat to Latin America, appropriate steps for increasing knowledge use of repellent among Latinos are called for. Methods: Existing educational materials promoting repellent use were tested among Latinos on the Baja California California border, and focus groups were conducted to identify barriers to repellent use. Materials using a photonovela format to respond to needs will be presented along with responses from further validation in other border sites. Results: Respondents indicated that existing educational materials did not well explain the problem of WNV, did not distinguish between repellent and insecticide and failed to clarify safety concerns. Barriers included lack of exposure to US-based news regarding WNV, lack of experience using repellent products due to availability, cost and custom, and mosquito coils as a more prevalent strategy for mosquito avoidance in Mexico. Challenges faced by itinerant farmworkers were notable. Such factors will be included in new pictorial-based print materials to allow access to indigenous language speakers who migrate to WNV risk areas for work. Conclusions: Steps such as repellent use are suggested to allow `coexistence' with and prevention of emerging infectious diseases such as WNV. Additional efforts are necessary to reach populations that do not speak the dominant languages or who may have cultural differences. As geographic range of diseases such as WNV expands, prevention strategies must be adapted to suit local ecologies and practices.
1. Why did I get this Notice? You were mailed this notice based on a request we received from you or from someone on your behalf. This Notice explains: What the lawsuit and Proposed Settlement are about. What the lawsuit claim and what the Serono Defendants say about the claims. Who is affected by the Proposed Settlement. Who represents the Class in the lawsuit. What your legal rights and choices are. How to file a claim. How and by when you need to act. 2. What is the lawsuit about? Serostim is a drug approved by the FDA to treat HIV AIDS patients with wasting or cachexia. The lawsuits claim, among other things, that the Serono Defendants encouraged physicians to prescribe Serostim: a ; based on diagnostic criteria that were not approved by the FDA, and b ; for purposes other than those indicated. The lawsuits also claim that the Serono's Defendants' conduct caused physicians to prescribe the drug, and caused consumers and third-party payors to pay for the drug, under circumstances and for purposes for which it was not indicated. 3. What do the Serono Defendants say about the lawsuits? The Serono Defendants deny all of these claims and any liability. The Serono Defendants have many defenses to these claims, and have entered into the Proposed Settlement solely to avoid the further expense, inconvenience, burden, and uncertainty of these lawsuits. 4. Why is this a class action? The Court has found that class action treatment is the superior method for the fair and efficient settling of this litigation. In a class action lawsuit, one or more people called "class representatives" sue on behalf of people who have similar claims. The people together are a "class" or "class members." A court must determine if it will allow a lawsuit to proceed as a class action. If it does, a trial of the claims then decides the lawsuit for everyone in the class, or the Parties may settle without a trial. The Parties in this case have agreed to, and the Court has preliminarily approved, the 4 and sparfloxacin.
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Injection. All animals were killed 4 hr after I23I-MIBG injection. Right and left ventricles were separated, weighed and their I23I activity was counted. Counting technique, corrections and units were similar to those used in 123I-MIBG uptake quantification. Myocardial Blood Row Quantification Nine normoxic and six 5-day hypoxic rats were used for myocardial blood flow quantification. Animals were injected in the tail vein with 15 u-Ciof 201T1.They were killed 10 min after 201T1 injection by intraperitoneal injection of sodium pentobarbital. Left and right ventricles were separated, weighed and counted in a well counter KONTRON 2000, Paris, France ; . Ventricular activity was counted for 1 min, using peak-energy setting at 70 keV 20% window ; . Corrections were used for radioactive decay and counter efficiency. The unit used was % kg dose g"1. Plasma Catecholamine Concentration Six of the normoxic and six of the 5-day hypoxic rats were selected. Two milliliters of blood were drawn from the aorta immediately before the death of the animals. Samples were centrifugated 3000 rpm for 10 min ; . The supernatant was collected and stored at " 80C asma norepinephrine and epinephrine concentration were measured by HPLC method adapted from Anton and Sagro 16 ; , using an ESA plasma catecholamine kit ESA, Bedford, MA ; . Statistical Analysis Values are mean values s.d., except when otherwise indicated. Statistical analysis was performed using paired and unpaired Student's t-tests. Differences were considered to be statistically significant at p 0.05. RESULTS Five-Day Hypoxia and lodine-123-MIBG Uptake Five-day hypoxic rats had lower global cardiac 123I-MIBG than normoxic rats 0.188% 0.029% kg dose g"1 versus 0.253% 0.036% kg dose g"1, p 0.001 Fig. 1 ; . Myocardial 123I-MIBG uptake was not significantly differ ent between left and right ventricle in hypoxic rats Table 1 ; . After 5 days of hypoxia, I23I-MIBG uptake decreased by 37% in the right ventricle and 20% in the left ventricle. This contrasted with the results observed in normoxic rats where right ventricular I23I-MIBG uptake was greater than left ven tricular uptake p 0.001 ; . In the other sampled organs, 123I-MIBG uptake was lower than in the heart and did not change between the two conditions Fig. 1 ; . Secondary Cardiac Hypertrophy and Cardiac lodine-123-MIBG Uptake Since myocardial hypertrophy may alter MIBG cardiac uptake # ; , the additional role of hypertrophy was evaluated by studying rats before and after the appearance of hypertrophy. No ventricular hypertrophy was detected after 5 days of hypoxia Table 2 ; . A biventricular hypertrophy was found after 7 days of hypoxia. However, only right ventricular weight increase reached statistical significance at this time. Left ven tricular weight increase also reached statistical significance after 21 days of hypoxia. However, the percentage of right ventricular weight increase + 48% ; still remained greatly superior to the left ventricular weight increase + 16% ; . Seven-day and 21-day hypoxic rats had significantly de creased cardiac I23I-MIBG uptake compared to normoxic ani mals Table 1 ; . However, there was no significant difference in cardiac MIBG uptake between rats submitted to different durations of hypoxia 5, 7, 21 days.
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