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We applaud health canada for approving pegasys rbv, said durhane wong-rieger, secretariat, canadian hepatitis c network.
The pressing need for new hepatitis C treatments has spawned a surge of activity in the pharmaceutical industry. Virtually all major drug companies, and a host of small biotech start-ups, have research and development programs aimed at developing new hepatitis C medications. There is potentially a multibillion dollar market for hepatitis C virus HCV ; treatment, providing a strong financial incentive for drug discovery. Yet attempts to develop new medications have been fraught with pitfalls and uncertainty, and many once-promising candidates have failed in clinical trials due to safety concerns or lack of potency. Based on current progress, it appears that major advances in HCV treatment are unlikely to occur until 2010 at the earliest. Yet many people with HCV choose to delay treatment, often on the advice of their doctors, in the hopes that future drug regimens will be better than the current standard of care, pegylated interferon Pegasys and PegIntron ; and ribavirin. The limitations of current treatment are well known, including a host of potential side effects and limited success in eradicating HCV particularly for people coinfected with HIV and for African-Americans ; . But people considering treatment should know that most new hepatitis C drugs will be added on to the current treatment, peginterferon and ribavirin. While it is hoped that these new classes of drugs specifically protease and polymerase inhibitors will increase the success rate of treatment, they will not immediately end the need for peg-interferon and ribavirin, with their well-known side effects.
The agreement also provides the companies with the option to expand the collaboration to develop other novel interferon alpha and beta products specifically tailored for indications outside of HBV and HCV, including oncology, autoimmune diseases, inflammatory diseases, and other infectious diseases such as HIV. Maxygen retains the right to develop such products while Roche may elect to acquire worldwide license and commercialization rights to these product candidates. Maxygen has the option to co-develop in the United States any product to which Roche acquires a license in exchange for profit sharing or an increased royalty rate. Based on the continued successful development of the novel interferon product candidates and the satisfaction of certain contingencies, payments to Maxygen could exceed 0 million plus royalties on product sales. "Roche has a long tradition in successfully developing and commercializing anti-viral drugs, alone or in partnership with other companies. We believe with Pegasys and Copegus we are establishing a new standard of care. Maxygen's portfolio of lead interferon product candidates represents an interesting and novel approach for further improvement in treatment. We are convinced that through our collaboration we will continue to be a clear leader in the treatment of patients suffering from this debilitating disease, " said William M. Burns, Head of Roche's Pharmaceuticals Division. "Maxygen's strategy has always been to partner with world leaders in their respective fields, and with its track record of excellence and an established and strong franchise, Roche is clearly a leader in the development and commercialization of interferon therapies, " said Russell Howard, Ph.D., Chief Executive Officer of Maxygen. "This innovative collaboration is structured to maximize the commercial potential of Maxygen's novel shuffled interferons by enabling their swift development and potential commercialization with a market leader in hepatitis. Importantly, Maxygen retains the right to conduct further discovery and development of novel interferons for additional indications. I particularly excited about Maxygen's option to co-develop these products for hepatitis B and C in the U.S., as this provides substantial potential for longterm value creation for the company.
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The importance of genotype determining the treatment regimen was shown in the newest pegasys combination study presented at the annual meeting of the european association for the study of the liver in april.
An evr rate of 62 percent was achieved in the group of patients who were treated with the induction dose of pegasys with copegus for the first 12 weeks of therapy n 473 and pegfilgrastim.
Researchers say it's the first study to examine how the drug, pegasys peginterferon alfa-2a ; , affects children with chronic hepatitis the virus that causes hepatitis c is the leading cause of liver disease in the it is spread primarily through contact with infected blood and blood products, such as shared or unsterilized needles.
Apr 6, 2007 drug newswire press release ; , the eu approval is based on data from two pivotal clinical trials for pegasys plus copegus and pegvisomant.
Kadoch JJK, Frydman NNF, Castelo Branco AAC, Ld Bataille Franchin RRF and Frydman RRF 2003 ; IVF-ET using naturally-selected dominant follicles for poor prognosis patients: a hypothesis. Fertil Steril 80 Suppl 3 ; , P-199. Kolibianakis E, Zikopoulos K, Camus M, Tournaye H, Van Steirteghem A and Devroey P 2004 ; Modified natural cycle for IVF does not offer a realistic chance of parenthood in poor responders with high day 3 FSH levels, as a last resort prior to oocyte donation. Hum Reprod 19, 25452549. Lukassen HGM, Kremer JAM, Lindeman EJM, Braat DDM and Wetzels AMM 2003 ; A pilot study of the efficacy of intracytoplasmic sperm injection in a natural cycle. Fertil Steril 79, 231232. Meldrum DR, Rivier J, Garzo G, Wisot A, Stubbs C and Hamilton F 1994 ; Successful pregnancies with unstimulated cycle oocyte donation using an antagonist of gonadotropin-releasing hormone. Fertil Steril 61, 556557. Nargund G, Waterstone J, Bland JM, Philips Z, Parsons J and Campbell S 2001 ; Cumulative conception and live birth rates in natural unstimulated ; IVF cycles. Hum Reprod 16, 259262. Omland AK, Fedorcsk P, Storeng R, Dale PO, byholm T and Tanbo T 2001 ; Natural cycle IVF in unexplained, endometriosis-associated and tubal factor infertility. Hum Reprod 16, 25872592. Paulson RJ, Sauer MV and Lobo RA 1994 ; Addition of a gonadotropin releasing hormone GnRH ; antagonist and exogenous gonadotropins to unstimulated in vitro fertilization IVF ; cycles: physiologic observations and preliminary experience. J Assist Reprod Genet 11, 2832. Pelinck MJ, Hoek A, Simons AHM and Heineman MJ 2002 ; Efficacy of natural cycle IVF: a review of the literature. Hum Reprod Update 8, 129139. Pelinck MJ, Vogel NEA, Hoek A, Arts EGJM, Simons AHM and Heineman MJ 2005 ; Minimal stimulation IVF with late follicular phase administration of the GnRH antagonist cetrorelix and concomitant substitution with recombinant FSH: a pilot study. Hum Reprod 20, 642648. Ramsewak SS, Kumar A, Welsby R, Mowforth A, Lenton EA and Cooke ID 1990 ; Is analgesia required for transvaginal single-follicle aspiration in in vitro fertilization? A double-blind study. J In Vitro Fert Embryo Transf 7, 103106. Rongires-Bertrand C, Olivennes F, Righini C, Fanchin R, Taeb J, Hamamah S, Bouchard P and Frydman R 1999 ; Revival of the natural cycles in in-vitro fertilization with the use of a new gonadotrophin-releasing hormone antagonist Cetrorelix ; : a pilot study with minimal stimulation. Hum Reprod 14, 683688. Takeuchi S, Minoura H, Shibahara T, Shen X, Futamura N and Toyoda N 2000 ; In vitro fertilization and intracytoplasmic sperm injection for couples with unexplained infertility after failed direct intraperitoneal insemination. J Assist Reprod Genet 17 9 ; , 515520. Tan SL, Waterstone J, Wren M and Parsons J 1992 ; A prospective randomized study comparing aspiration only with aspiration and flushing for transvaginal ultrasound-directed oocyte recovery. Fertil Steril 58, 356360. Ubaldi F, Rienzi L, Baroni E, Ferrero S, Iacobelli M, Minasi M, Martinez F and Greco E 2003 ; GnRH antagonist and natural ICSI cycle in poor responder patients. Hum Reprod 18 Suppl 1 ; , P-327. Van Royen E, Mangelschots K, De Neuborg D, Valkenburg M, Van de Meerssche M, Ryckaert G, Eestermans W and Gerris J 1999 ; Characterisation of a top quality embryo, a step towards single-embryo transfer. Hum Reprod 14, 23452349. Vogel NEA, Pelinck MJ, Arts EGJM, Hoek A, Simons AHM and Heineman MJ 2003 ; Effectiveness of the modified natural cycle ICSI: results of a pilot study. Fertil Steril 80 Suppl 3 ; , P-7. Weghofer A, Margreiter M, Bassim S, Sevelda U, Beilhack E and Feichtinger W 2004 ; Minimal stimulation using recombinant follicle-stimulating hormone and a gonadotropin-releasing hormone antagonist in women of advanced age. Fertil Steril 81, 10021006. Zhioua F, Zhioua A, Chaker A, M'Solly S and Meriah S 2004 ; Efficacy of intracytoplasmic sperm injection in a natural cycle with GnRH antagonists. Hum Reprod 19 Suppl 1 ; , P-299.
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Louis md consult ; - swiss drugs group roche's pegasys, a once-weekly injection, has received us food and drug administration approval as a stand-alone therapy for adults with chronic hepatitis the approval of pegasys peginterferon alfa-2a ; as a stand-alone therapy had been widely expected and pemetrexed.
DRUGS COVERED UNDER THE MEDICARE REPLACEMENT DRUG DEMONSTRATION Demonstration Covered Indication Drug Biological--Compound Name Brand Name ; Rheumatoid Arthritis Adalimumab Humira ; Anakinra Kineret ; Etanercept Enbrel ; Psoriatic Arthritis Etanercept Enbrel ; Multiple Sclerosis Glatiramer acetate Copaxone ; Interferon beta 1a Rebif, Avonex ; Interferon beta 1b Betaseron ; Post Menopausal Osteoporosis Calcitonin nasal Miacalcin nasal ; patient must be homebound ; Risedronate Actonel ; Pulmonary Hypertension Bosentan Tracleer ; Secondary Hyperparathyroidism Doxercalciferol Hectoral ; Paget's Disease Alendronate Fosamax ; Risedronate Actonel ; Hepatitis C Pegylated interferon alfa-2a Pegasys ; Pegylated interferon alfa-2b PEG-Intron ; CMV Retinitis Valcyte Valganciclovir ; Acromegaly Pegvisomant Somavert ; Anti-Cancer Cutaneous T-cell Lymphoma Bexarotene Targretin ; Non-small cell lung cancer Gefitinib Iressa ; Epithelial ovarian cancer Altretamine Hexalen ; Chronic Myelogenous Leukemia Imatinib Mesylate Gleevec ; GI Stromal Tumor Imatinib Mesylate Gleevec ; Multiple Myeloma Thalidomide Thalomid ; Breast Cancer Hormonal therapy Stage 2-4 only Anastrozole Arimidex ; Exemestane Aromasin ; Letrozole Femara ; Tamoxifen Nolvadex ; Toremifene Fareston ; Prophylactic agent to reduce Mesna Mesnex ; ifosfamide-induced hemorrhagic cystitis Beneficiary cost sharing under this demonstration is the same as it will be under the Medicare Part D drug benefit that will be implemented in 2006. Although some
Roche announced today that the U.S. Food and Drug Administration FDA ; has approved Pegasys peginterferon alfa-2a ; for the treatment of adults with chronic hepatitis C who have compensated liver disease and have not previously been treated with interferon alpha. Patients in whom efficacy was demonstrated included patients with compensated cirrhosis. Pegasys is a pegylated interferon that remains active in the bloodstream longer and at a more constant level than interferon alpha. Currently, 2.7 million Americans are chronically infected with hepatitis C. "The approval of Pegasys is an important milestone for the hepatitis C patients in the United States who are waiting for treatment, " said George B. Abercrombie, President and Chief Executive Officer, Hoffmann-La Roche Inc. "Roche has supported Pegasys with the most extensive development program ever undertaken for a hepatitis C treatment. The result is that patients and physicians have an important new option for treatment." Pegasys was granted approval based on the results of three pivotal Phase III clinical trials that demonstrated it is an effective treatment for patients with chronic hepatitis C, including cirrhotic patients with compensated liver disease, versus treatment with Roferon-A interferon alfa-2a ; . Two of these pivotal trials were published in The New England Journal of Medicine. The sustained virological response rate in the Pegasys treated patients was as high as 38 percent in the overall population versus 19 percent in the interferon alfa-2a group. The sustained virological response in patients with cirrhosis treated with Pegasys was as high as 30 percent versus 8 percent in the interferon alfa2a group. Higher sustained virological response results were also found in patients with genotype 1, on Pegasys treatment 23 percent ; versus interferon alfa-2a 6 percent ; , the most common type in the U.S. and most difficult to treat. Sustained virological response was defined as undetectable serum hepatitis C RNA levels post-treatment on or after study week 68 ; . Clinical trials of Pegasys have shown that patients can determine at 12 weeks if they are unlikely to attain a sustained virological response with Pegasys. Pegasys investigator, Donald Jensen, MD, director of Hepatology at Rush-Presbyterian-St. Luke's Medical Center, Chicago said, "With Pegasys, we can determine at week 12 of therapy those patients who are unlikely to achieve a sustained virological response to treatment. This reduces the cost and burden of taking therapy for patients who are unlikely to respond to therapy. This may help patients adhere to therapy that can be difficult on them, particularly during the first few months and pemoline.
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Arbor Research Collaborative for Health, Ann Arbor, MI, USA, 2Institution for Veterans Medicine, Uppsala Universitet, Uppsala, Sweden, 3Department of Nephrology, Showa University School of Medicine, Tokyo, Japan, 4Department of Internal Medicine, Sashima Redcross Hospital, Tochigi, Japan, 5Amgen, Inc., Thousand Oaks, CA, USA, 6 Division of Nephrology, Kidney Epidemiology and Cost Center, University of Michigan, Ann Arbor, MI, USA, 7 Division of Nephrology, Humber River Regional Hospital and University of Toronto, Weston, ON, Canada and 8 Veterans Administration Medical Center, Ann Arbor, MI, USA.
PEGASYS components must be restarted so that the changes you made to the network configuration file take effect. As there are several components that need restarting, it is most effective to simply restart the PEGASYS workstations. Before restarting your workstation, consider configuring it to start the core PEGASYS components automatically and penicillamine.
Hepsera is a registered trademark of Gilead Sciences, Inc. Hepsera Tablets are indicated for the treatment of CHB in adults with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases ALT or AST ; or histologically active disease. Baraclude is a trademark of Bristol-Myers Squibb Company. Baraclude is indicated for the treatment of CHB virus infection in adults with evidence of active viral replication and either evidence of persistent elevations in serum ALT or AST or histologically active disease. Pegasys is a registered trademark of Roche Laboratories Inc. Pegasys is indicated for the treatment of adult patients with HBeAg positive and HBeAg negative chronic hepatitis B who have compensated liver disease and evidence of viral replication and liver inflammation.
Royal Health Care Builds Streamlined Child Health Plus Premium Billing Process The Challenge New York State moved to a new transactional processing system, called CHP KIDS, for its Child Health Plus program. Plans were required to create new interfaces with New York State to send transactions for payment of premiums. The Royal Health Care Solution Child Health Plus is a New York State program for uninsured children who do not qualify for Medicaid. Royal has several clients in New York who participate in the Child Health Program. The State pays Plans on a capitated basis for each enrollee. New York State devised a new system called KIDS to track enrollment, collect necessary demographic and qualifying information, and issue payment to Plans. This comprehensive new system requires health plans to submit transactions such as an additions, changes, disenrollments, and recertifications to the State along with associated data. The State edits these transactions and provides remittances that accept or deny the requests. Royal Health Care integrated these requirements into the PEGASYS enrollment and billing systems to create streamlined business processes for its clients. First, logic was created to define key strokes and actions within the PEGASYS enrollment system as specific transaction types. Then PEGASYS was modified to produce extract files with these transactions for delivery to the State. Edits were built into the extract process to produce accurate files and error reports for data scrubbing. These files produce accounts receivable records at the member level. Next, a process was created to read State remittance files back into PEGASYS to match premium receipts to receivables. In addition, acceptance and denial codes were transferred into the core system so that reconciliation reports could be generated. On-line reporting via the PEGASYS user friendly RAC LST module allows users to design custom reports for member corrections and follow-up. On-line capabilities and new screens allow users to view remittance file history and member transaction history. By understanding the new KIDS transaction system and integrating it within existing PEGASYS functionality, Royal was able to create a central repository for Child Health Plus enrollment, billing, and reconciliation, and allowed its clients to meet State regulatory mandates and pennyroyal.
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As most military taxpayers are aware, Soldiers can exclude from gross income certain military pay received during a month the Soldier served in a combat zone or qualified hazardous duty area. Many military taxpayers are not aware, however, of the effects that excluded military pay may have on the calculation of their taxes. Military pay excluded from income due to service in a combat zone cannot be used to calculate either the Earned Income Credit, or the refundable portion of the Child Tax Credit. Taxpayers have been impacted on both ends of the income spectrum by this exclusion. Military taxpayers with little or no taxable income due to service in a combat zone may find their anticipated credit amounts reduced or eliminated. Take, for example, the mother of four who visited the Fort Sam Houston Tax Assistance Center expecting to receive , 000 in and pegasys.
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