LSIS Feed - Novartis http://www.lsis.com/goto/r94/rss 2010-06-23T11:10:55+01:00 text/html http://www.businesswire.com Business Wire 22.06.2010 | Business Wire: Isis and Alnylam Provide Update on Regulus Strategic Alliance with Sanofi-Aventis | Business Wire http://www.lsis.com/goto/v94/%3B%97f%FB%1Ctys CAMBRIDGE, Mass. and CARLSBAD, Calif.-(BUSINESS WIRE)-Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY): We and Isis congratulate Regulus on forming this important new alliance with sanofi-aventis. Regulus stands as the leader in the emerging field of microRNA therapeutics, and this new partnership reflects the high level of interest across the pharmaceutical industry for innovative medicines based on this new biology New Partnership Validates Alnylam and Isis Strategy for Shareholder Value Creation Regulus, Alnylam and Isis to Host Conference Call Webcast to Discuss Regulus-Sanofi-aventis Collaboration on June 22, 2010 at 8:30 a.m. ET (5:30 a.m. PT) Alnylam Pharmaceuticals, Inc. (Nasdaq: (…) text/html http://www.businesswire.com Business Wire 22.06.2010 | Business Wire: NexMed Announces Appointment of Deirdre Y. Gillespie, M.D. to the Board of Directors | Business Wire http://www.lsis.com/goto/v94/%3B%97f%FB%1Cty%7F SAN DIEGO-(BUSINESS WIRE)-NexMed, Inc. (Nasdaq: NEXMD), a specialty CRO with a pipeline of products based on the NexACT technology, today announced that Deirdre Y. Gillespie, M.D., President and Chief Executive Officer of publicly-held La Jolla Pharmaceutical Company, has been appointed to the Company s Board of Directors, effective immediately. We are delighted to welcome Deirdre to our Board of Directors. Her proven leadership and extensive experience in the pharmaceutical industry will be invaluable to us as we continue to aggressively pursue our business expansion strategy. Prior to joining La Jolla Pharmaceutical Company in 2006, Dr. Gillespie served from 2001 to 2005 as President (…) text/html http://www.ncbi.nlm.nih.gov NCBI PubMed 20.06.2010 | NCBI PubMed: Accessibility of the Drosophila genome discriminates PcG repression H4K16 acetylation and replication timing. http://www.lsis.com/goto/v94/%3B%97f%FB%1C%7F%7F%7B Histone modifications are thought to regulate gene expression in part by modulating DNA accessibility. Here, we measured genome-wide DNA accessibility in Drosophila melanogaster by combining M.SssI methylation footprinting with methylated DNA immunoprecipitation. We show that methylase accessibility demarcates differential distribution of active and repressive histone modifications as well as sites of transcription and replication initiation. DNA accessibility is increased at active promoters and chromosomal regions that are hyperacetylated at H4K16, particularly at the male X chromosome, suggesting that transcriptional dosage compensation is facilitated by permissive chromatin structure. (…) text/html http://www.biospace.com BioSpace 22.06.2010 | BioSpace: Sanofi-Aventis (France) (SASY.PA) and Regulus Therapeutics, Inc. Form Major Strategic Alliance, Largest microRNA Therapeutics Alliance to Date, Valued at Potentially Over $750 Million http://www.lsis.com/goto/v94/%3B%97f%FB%10%7Dy%7D CARLSBAD, Calif.-(BUSINESS WIRE)-Regulus Therapeutics Inc. and sanofi-aventis (EURONEXT: SAN and NYSE: SNY) announced today that they have entered into a global, strategic alliance to discover, develop, and commercialize microRNA therapeutics. The alliance represents the largest microRNA partnership formed to date, valued at potentially over $750 million, and includes a $25 million upfront fee, a $10 million future equity investment subject to mutual agreement on company valuation, and annual research support for three years with the option to extend two additional years. The alliance will initially focus on the therapeutic area of fibrosis. Regulus and sanofi-aventis will collaborate on (…) text/html http://www.bionity.com Bionity.com 22.06.2010 | Bionity.com: FDA approves Tasigna for newly diagnosed chronic myeloid leukemia patients http://www.lsis.com/goto/v94/%3B%97f%FB%10%7D%7By 22.06.2010 - Following a priority review, the US Food and Drug Administration (FDA) has approved Tasigna (nilotinib) for the treatment of adult patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase. With this approval, Tasigna becomes the first new therapeutic option for newly diagnosed patients since the introduction of Glivec (imatinib)*, providing a major advance for patients with this blood cancer. The US approval was based on results of the ENESTnd (Evaluating Nilotinib Efficacy and Safety in Clinical Trials of Newly Diagnosed Ph+ CML Patients) Phase III clinical trial, which were published in The New England Journal of (…) text/html http://www.bionity.com Bionity.com 22.06.2010 | Bionity.com: New Phase II study in gout patients shows Novartis ACZ885 prevented acute flares better than standard anti-inflammatory therapy http://www.lsis.com/goto/v94/%3B%97f%FB%10%7Dzr 22.06.2010 - New phase II data demonstrate that the human monoclonal antibody ACZ885 (also known as canakinumab) provided highly statistically significant risk reduction of acute flares in gout patients initiating uric acid lowering therapy (UALT) compared to the anti-inflammatory standard of care (colchicine). In this six month Phase II study, canakinumab significantly reduced the rate of flares by 48% to 75% compared to colchicine. Similarly, canakinumab reduced the risk of developing at least one flare by 61% to 80% vs. colchicine p. Preliminary results were presented at the annual European League Against Rheumatism (EULAR) meeting in Rome, Italy. "Gout patients frequently experience (…) text/html http://www.bionity.com Bionity.com 21.06.2010 | Bionity.com: QIAGEN Expands Partnership with Genome Diagnostics for Development of Tests in Prevention and Personalized HealthcareExtended HLA testing portfolio includes products to assess tolerance for Lumiracoxib and for the early detection of inflammatory diseases http://www.lsis.com/goto/v94/%3B%97f%FB%11zy%7E 21.06.2010 - QIAGEN announced that it has entered into an agreement with the Dutch molecular diagnostic component supplier Genome Diagnostics which covers the development and commercialization of 6 new tests until 2011. QIAGEN believes that this collaboration will further expand the Company s testing portfolio for the early detection of diseases and individualized treatment of patients – thereby strengthening QIAGEN s molecular diagnostics offering for applications in prevention and personalized healthcare. Financial details have not been disclosed. The molecular tests to be developed by Genome Diagnostics target the detection of genetic variations in the so called Human Leukocyte Antigen (…) text/html http://www.ncbi.nlm.nih.gov NCBI PubMed 17.06.2010 | NCBI PubMed: Selective translational control of the Alzheimer amyloid precursor protein transcript by iron regulatory protein-1. http://www.lsis.com/goto/v94/%3B%97f%FB%16t%7C%7C Iron influx increases the translation of the Alzheimers amyloid precursor protein (APP) via an iron-responsive element (IRE) RNA stem loop in its 5 untranslated region. Equal modulated interaction of the iron regulatory proteins (IRP1 and IRP2) with canonical IREs controls iron-dependent translation of the ferritin subunits. However, our IP-RTPCR and RNA binding experiments demonstrated IRP1, but not IRP2, selectively bound the APP IRE in human neural cells. This selective IRP1 interaction pattern was evident in human brain and blood tissue from normal and AD patients. We computer-predicted an optimal novel RNA stem loop structure for the human, rhesus monkey and mouse APP IREs with (…) text/html http://www.ncbi.nlm.nih.gov NCBI PubMed 01.01.2010 | NCBI PubMed: Supramolecular Organization of the Repetitive Backbone Unit of the Streptococcus pneumoniae Pilus. http://www.lsis.com/goto/v94/%3B%97f%FB%17%7Fzy Streptococcus pneumoniae, like many other Gram-positive bacteria, assembles long filamentous pili on their surface through which they adhere to host cells. Pneumococcal pili are formed by a backbone, consisting of the repetition of the major component RrgB, and two accessory proteins (RrgA and RrgC). Here we reconstruct by transmission electron microscopy and single particle image reconstruction method the three dimensional arrangement of two neighbouring RrgB molecules, which represent the minimal repetitive structural domain of the native pilus. The crystal structure of the D2-D4 domains of RrgB was solved at 1.6 A resolution. Rigid-body fitting of the X-ray coordinates into the electron (…) text/html http://www.medicalnewstoday.com Medical News Today 18.06.2010 | Medical News Today: FDA Approves New Indication For Tasigna http://www.lsis.com/goto/v94/%3B%97f%FB%14%7Fx%7C The U.S. Food and Drug Administration approved a new indication for Tasigna (nilotinib) for the treatment of a rare blood cancer when it is first diagnosed. The cancer, called Philadelphia chromosome positive chronic phase chronic myeloid leukemia (Ph+ CP-CML), is a slowly progressing blood and bone marrow disease linked to a genetic abnormality. Tasigna is believed to work by blocking a signal that leads to leukemic cell development. The new indication expands the use of Tasigna to adult patients in earlier stages of the disease. The FDA originally approved Tasigna in October 2007 for the treatment of Ph+CP-CML in adult patients whose disease had progressed or who could not tolerate other (…) text/html http://www.businesswire.com Business Wire 18.06.2010 | Business Wire: Research and Markets: The Russian Pharmaceutical Market Outlook to 2014: Policy Environment, Market Structure, Competitive Landscape, Growth Opportunities | Business Wire http://www.lsis.com/goto/v94/%3B%97f%FB%14%7E%7Cx DUBLIN-(BUSINESS WIRE)-Research and Markets (http:/www.researchandmarkets.com/research/033170/the_russian_pharma) has announced the addition of the "The Russian Pharmaceutical Market Outlook to 2014: Policy Environment, Market Structure, Competitive Landscape, Growth Opportunities" report to their offering. The Russian Pharmaceutical Market Outlook to 2014: Policy Environment, Market Structure, Competitive Landscape, Growth Opportunities Russias well educated and low cost workforce is one of the main attraction for investors all over the world. According to recent statistics, Russia's population (which is currently about 141m) is steadily declining at a rate of around 0.4%. Thus, the (…) text/html http://www.businesswire.com Business Wire 18.06.2010 | Business Wire: Research and Markets: Discovery Stage Partnering Terms and Agreements in Pharma, Biotech and Diagnostics - the Updated 2nd Edition | Business Wire http://www.lsis.com/goto/v94/%3B%97f%FB%14%7E%7F%7D DUBLIN-(BUSINESS WIRE)-Research and Markets (http:/www.researchandmarkets.com/research/d7d20e/discovery_stage_pa) has announced the addition of the "Discovery Stage Partnering Terms and Agreements in Pharma, Biotech and Diagnostics, 2nd Edition" report to their offering. Discovery Stage Partnering Terms and Agreements in Pharma, Biotech and Diagnostics, 2nd Edition The Discovery Stage Partnering Terms and Agreements in Pharma and Biotech report detailed understanding and analysis of how and why companies enter discovery stage licensing/business development and other forms of partnering arrangement. The report provides a detailed understanding and analysis of how and why companies enter (…) text/html http://www.ncbi.nlm.nih.gov NCBI PubMed 26.05.2010 | NCBI PubMed: The influence of aqueous content in small scale salt screening - improving hit rate for weakly basic, low solubility drugs. http://www.lsis.com/goto/v94/%3B%97f%FC%1C%7F%7D%7E Salt screening and selection is a well established approach for improving the properties of drug candidates, including dissolution rate and bioavailability. Typically during early development only small amounts of compound are available for solid state profiling, including salt screening. In order to probe large areas of experimental space, high-throughput screening is utilized and is often designed in a way to search for suitable crystallization parameters within hundreds or even thousands of conditions. However, the hit rate in these types of screens can be very low. In order to allow for selection of a salt form early within the drug development process whilst using smaller amounts of (…) text/html http://www.ncbi.nlm.nih.gov NCBI PubMed 16.06.2010 | NCBI PubMed: Characterization of and Risk Factors for the Acute-Phase Response after Zoledronic Acid. http://www.lsis.com/goto/v94/%3B%97f%FC%1D%7Eys Context: Intravenous aminobisphosphonates often cause an acute-phase response (APR), but the precise components of this, its frequency, and the risk factors for its development have not been systematically studied. Objective: The objective of the study was to characterize the APR and determine its frequency and the risk factors for its development. Design: The study was an analysis of adverse events from a large randomized trial. Setting: This was a multicenter international trial. Patients: Patients included 7765 postmenopausal women with osteoporosis. Intervention: Zoledronic acid 5 mg annually or placebo was the intervention. Main Outcome Measure: Adverse events occurring within 3 d of (…) text/html http://www.marketwire.com Marketwire 17.06.2010 | Marketwire: New Products Could Add Over $70 Billion to the Pharmaceutical Market in Five Years http://www.lsis.com/goto/v94/%3B%97f%FC%12z%7Bs Highlighted Links Kalorama Information Pharma & Biopharma Pipeline NEW YORK, NY-(Marketwire - June 17, 2010) - The pharmaceutical market may soon see the result of an increase in research and development at Big Pharma over the past few years, according to healthcare market research publisher Kalorama Information. The top fifty pharmaceutical companies in the world have some 550 projects in late stage development, and Kalorama Information estimates that these projects have the potential to add a value of more than $70 billion in additional revenues to the pharmaceutical market by 2015. This is according to Kalorama Information's new market research report "World Pharmaceutical and (…) text/html http://www.medicalnewstoday.com Medical News Today 17.06.2010 | Medical News Today: Akebia Announces Positive Results For AKB-6548 Phase 1b Clinical Study And Completes $5M Second Tranche To Series A Financing http://www.lsis.com/goto/v94/%3B%97f%FC%12x%7Cx Akebia Therapeutics, Inc., a pharmaceutical discovery and development company focused on anemia and vascular disorders, announced that it has successfully completed a phase 1b study for AKB-6548 in healthy volunteers. AKB-6548 is an orally bioavailable hypoxia-inducible factor-prolyl hydroxylase (HIF-PH) inhibitor designed to increase the natural production of erythropoietin (EPO) in anemic patients. In the clinical study, healthy volunteers were orally dosed once daily with AKB-6548 for 10 days. AKB-6548 increased EPO and reticulocytes (immature red blood cells) and was found to be safe and well tolerated. "We are very pleased with the results of this phase 1b study," said Dr. Robert (…) text/html http://www.medicalnewstoday.com Medical News Today 16.06.2010 | Medical News Today: Human Genome Sciences Announces Preliminary Feedback From FDA On ZALBIN BLA For Chronic Hepatitis C http://www.lsis.com/goto/v94/%3B%97f%FC%12%7F%7Fs Human Genome Sciences, Inc. (Nasdaq: HGSI) announced that it has received preliminary written feedback from the U.S. Food and Drug Administration (FDA) regarding the Company's Biologics License Application (BLA) seeking approval in the United States to market 900-mcg ZALBIN (albinterferon alfa-2b, known in Europe as JOULFERON) dosed every two weeks for the treatment of chronic hepatitis C. FDA has expressed concerns regarding the risk benefit assessment of ZALBIN dosed at 900-mcg every two weeks. Although the BLA review is ongoing, HGS has concluded that licensure of this dosing regimen is unlikely. The FDA feedback was provided via a Discipline Review letter, which is a standard vehicle (…) text/html http://www.businesswire.com Business Wire 17.06.2010 | Business Wire: Alnylam Receives Notice of Allowance from United States Patent and Trademark Office for New Patent Broadly Covering RNAi Therapeutics that Target Mutated Genes | Business Wire http://www.lsis.com/goto/v94/%3B%97f%FC%12%7E%7By CAMBRIDGE, Mass.-(BUSINESS WIRE)-Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), a leading RNAi therapeutics company, announced today that the United States Patent and Trademark Office (USPTO) has awarded a Notice of Allowance for the œJohn et al.  patent (Application No. 10/384,463), which covers methods of inhibiting mutant genes with double-stranded RNAs from 19 to 30 nucleotides in length. Since mutations in genes underscore the genetics of inherited disease and cancer, as well as broader aspects of human disease associated with genetic variations, the John et al. patent covers broad therapeutic applications of RNAi therapeutics. a major scientific breakthrough that happens once (…) text/html http://www.businesswire.com Business Wire 16.06.2010 | Business Wire: Landmark Study Demonstrates Patients Who Replace Contact Lenses on Schedule Report Better Comfort and Visioni | Business Wire http://www.lsis.com/goto/v94/%3B%97f%FC%12%7E%7Cy ATLANTA-(BUSINESS WIRE)-A report published in the journal Optometry & Vision Science demonstrated that patients who replaced their silicone hydrogel (SH) contact lenses according to the manufacturer recommended replacement frequency (MRRF) experienced better comfort and vision at the end of the day than non-compliant patients. i The analysis was part of a larger study sponsored by CIBA VISION, which was developed to investigate contact lens replacement schedule compliance. For the first time, a study demonstrates that proper contact lens replacement schedule compliance is associated with better vision and comfort Researchers at the Centre for Contact Lens Research (CCLR) at the (…) text/html http://www.businesswire.com Business Wire 16.06.2010 | Business Wire: Alnylam to Webcast Presentation at the 5th Annual Piper Jaffray Europe Conference | Business Wire http://www.lsis.com/goto/v94/%3B%97f%FC%12%7Dvx CAMBRIDGE, Mass.-(BUSINESS WIRE)-Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), a leading RNAi therapeutics company, today announced that management will present a company overview at the 5th Annual Piper Jaffray Europe Conference on Wednesday, June 23, 2010 at 10:30 a.m. BST (5:30 a.m. ET) at the Andaz Liver Pool Street London Hotel. A live audio webcast of the presentation will be available on the œInvestors  section of the company s website, www.alnylam.com. A replay of the presentation will be available on the Alnylam website within 48 hours after the event. About Alnylam Pharmaceuticals Alnylam is a biopharmaceutical company developing novel therapeutics based on RNA interference, (…) text/html http://www.businesswire.com Business Wire 16.06.2010 | Business Wire: Research and Markets: Analgesics in Germany - Forecasts to 2014 - OTC Obesity Drugs Enter Market | Business Wire http://www.lsis.com/goto/v94/%3B%97f%FC%12%7Cw%7D DUBLIN-(BUSINESS WIRE)-Research and Markets (http:/www.researchandmarkets.com/research/ba034b/analgesics_in_germ) has announced the addition of the "Analgesics in Germany" report to their offering. In recent years, Germany has seen increasing health awareness and trend towards more health-conscious lifestyles. Rather than relying on medicine to treat the symptoms of illnesses that were developed due to negligent attitudes to the body, Germans are now keen on retaining healthy diets and active lifestyles in an attempt to support their personal health. This has negatively affected demand for analgesics, which are some of the most common and most consumed remedies when treating illnesses. (…) text/html http://www.businesswire.com Business Wire 17.06.2010 | Business Wire: Research and Markets: Novartis AG - SWOT Analysis | Business Wire http://www.lsis.com/goto/v94/%3B%97f%FC%12%7Cv%7C DUBLIN-(BUSINESS WIRE)-Research and Markets (http:/www.researchandmarkets.com/research/935a63/novartis_ag_swot) has announced the addition of the "Novartis AG - SWOT Analysis" company profile to their offering. The Novartis AG - SWOT Analysis company profile is the essential source for top-level company data and information. Novartis AG - SWOT Analysis examines the company's key business structure and operations, history and products, and provides summary analysis of its key revenue lines and strategy. Novartis is one of the Big Pharma companies having strong presence in diverse pharmaceutical segments. It is engaged in the research, development, manufacture and marketing of branded (…) text/html http://www.businesswire.com Business Wire 17.06.2010 | Business Wire: Alnylam Secures Intellectual Property and Technology for RNAi Applications in Vaccine Research and Development | Business Wire http://www.lsis.com/goto/v94/%3B%97f%FC%12%7Cv%7D CAMBRIDGE, Mass.-(BUSINESS WIRE)-Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), a leading RNAi therapeutics company, announced today that it has secured key intellectual property (IP) for RNAi applications in vaccine development by completing an exclusive option agreement with Mount Sinai School of Medicine in New York City and an exclusive license agreement with The University of Queensland in Brisbane, Australia. These new applications of RNAi technology define opportunities for the advancement of novel vaccines in many human diseases, including infectious disease and cancer. a major scientific breakthrough that happens once every decade or so œRNAi technology has become a game changer (…) text/html http://www.biospace.com BioSpace 17.06.2010 | BioSpace: Positive Clinical Findings Presented on XOMA (US) LLC (XOMA) 052 in Debilitating Eye Disease http://www.lsis.com/goto/v94/%3B%97f%FD%1Cu%7Cx ROME, June 17, 2010 (GLOBE NEWSWIRE) - XOMA Ltd. (Nasdaq:XOMA), a leader in the discovery and development of therapeutic antibodies, announced positive results from an open-label pilot study of XOMA 052 in patients with uveitis of Behcet's disease who were suffering from vision-threatening exacerbations despite maximal doses of immunosuppressive medicines. All seven patients who enrolled in the trial displayed rapid reduction of intraocular inflammation and improvement in visual acuity or other ophthalmic measures following a single treatment with XOMA 052, a therapeutic antibody candidate that inhibits the inflammatory cytokine interleukin-1 beta (IL-1 beta). The preliminary results of (…) text/html http://www.biospace.com BioSpace 16.06.2010 | BioSpace: GenVec Inc. (GNVC) Says Exploring Options, Including Sale of Company http://www.lsis.com/goto/v94/%3B%97f%FD%1Cu%7Ey GAITHERSBURG, Md., June 15 /PRNewswire-FirstCall/ - GenVec, Inc. today announced that it has engaged Wells Fargo Securities, LLC to conduct a comprehensive review of strategic alternatives aimed at enhancing shareholder value. Strategic alternatives the Company may pursue could include, but are not limited to, execution of the Company's operating plan, sale of Company assets, partnering or other collaboration agreements, or a merger, sale of the Company or other strategic transaction. There can be no assurance that the exploration of strategic alternatives will result in any agreements or transactions, or that, if completed, any agreements or transactions will be successful or on (…) text/html http://www.biospace.com BioSpace 16.06.2010 | BioSpace: Akebia Announces Positive Results for AKB-6548 Phase 1b Clinical Study and Completes $5M Second Tranche to Series A Financing http://www.lsis.com/goto/v94/%3B%97f%FD%1Ct%7Bs CINCINNATI, OH-(Marketwire - 06/16/10) - Akebia Therapeutics, Inc., a pharmaceutical discovery and development company focused on anemia and vascular disorders, today announced that it has successfully completed a phase 1b study for AKB-6548 in healthy volunteers. AKB-6548 is an orally bioavailable hypoxia-inducible factor-prolyl hydroxylase (HIF-PH) inhibitor designed to increase the natural production of erythropoietin (EPO) in anemic patients. In the clinical study, healthy volunteers were orally dosed once daily with AKB-6548 for 10 days. AKB-6548 increased EPO and reticulocytes (immature red blood cells) and was found to be safe and well tolerated. "We are very pleased with the (…) text/html http://www.biospace.com BioSpace 16.06.2010 | BioSpace: QLT Inc. (QLTI) Release: 12-Month Results From DENALI Study Evaluating verteporfin PDT (Visudyne(R) Combination Therapy http://www.lsis.com/goto/v94/%3B%97f%FD%1C%7By%7C VANCOUVER, British Columbia, June 15, 2010 (GLOBE NEWSWIRE) - QLT Inc. (Nasdaq:QLTI) (TSX:QLT) today announced that final results from the Novartis-sponsored Phase IIIb DENALI study were presented on June 8, 2010 during the World Ophthalmology Congress in Berlin. DENALI was a 24-month randomized, double-masked, multicenter trial in patients with subfoveal choroidal neovascularization secondary to wet age-related macular degeneration (all lesion types). The purpose of the study was to evaluate if Visudyne (verteporfin PDT; Novartis Pharma AG, QLT Inc.) (either reduced- or standard-fluence) combined with Lucentis (ranibizumab; Novartis Pharma AG, Genentech Inc.) was not inferior (with a (…) text/html http://www.marketwire.com Marketwire 15.06.2010 | Marketwire: Blue Chip Launches New Patient Recruitment Division With Breakthrough Marketing Program for BioSante Pharmaceuticals http://www.lsis.com/goto/v94/%3B%97f%FD%1Cz%7B%7D Highlighted Links Blue Chip Patient Recruitment NORTHBROOK, IL-(Marketwire - June 15, 2010) - Blue Chip, an independent, full-service global marketing agency, announced today the launch of Blue Chip Patient Recruitment (BCPR), a division dedicated to serving pharmaceutical and biotech clients with clinical trial recruitment marketing. This new division reflects Blue Chip's 15 years of continued growth in patient recruitment and leverages the resources of a full-service agency with deep expertise in direct response media, retail brand marketing and clinical site recruitment management. BCPR's first client is BioSante Pharmaceuticals, Inc. "We are pleased to launch the new division with a (…) text/html http://www.ncbi.nlm.nih.gov NCBI PubMed 08.06.2010 | NCBI PubMed: Tenascin-W: An extracellular matrix protein associated with osteogenesis and cancer. http://www.lsis.com/goto/v94/%3B%97f%FD%12%7D%7F%7B Tenascin-W was the last member of a family of four large extracellular matrix glycoproteins to be discovered. The original member of the tenascin family, tenascin-C, has been widely studied due to its association with asthma, fibrosis, infection, inflammation and cancer. Recent studies report multiple common features between tenascin-W and tenascin-C in terms of structure, expression and function, especially in the context of tumorigenesis. Furthermore, specific functions for tenascin-W in osteogenesis have been revealed. This review presents an update on our current knowledge concerning tenascin-W and discusses potential medical applications of this cancer-enriched extracellular matrix (…) text/html http://www.ncbi.nlm.nih.gov NCBI PubMed 10.06.2010 | NCBI PubMed: Use of automated blood pressure measurements in clinical trials and registration studies: data from the VALTOP Study. http://www.lsis.com/goto/v94/%3B%97f%FD%13%7Fzy BACKGROUND: Auscultatory measurement of office blood pressure (BP) by mercury sphygmomanometers (AuscBPM) is still the gold standard in clinical trials and registration studies for antihypertensive drugs. The increasing availability of accurate automated oscillometric BP measuring devices has offered new perspectives in this field, although their usefulness in drug studies has not been systematically tested yet. METHODS: During the course of Valsartan 320 mg EU Registration Study we used an electronic automated oscillometric BP measuring device (eBPM) as an alternative to conventional AuscBPM. Altogether 3276 patients were randomized into a double-blinded actively controlled parallel group (…) text/html http://www.biospace.com BioSpace 15.06.2010 | BioSpace: Talecris Biotherapeutics GmbH Forms Partnership to Co-Promote Life-Saving Rabies Products http://www.lsis.com/goto/v94/%3B%97f%FD%11yw%7F RESEARCH TRIANGLE PARK, N.C., June 15 /PRNewswire-FirstCall/ - Talecris Biotherapeutics announced today that it has agreed to a co-promotion arrangement with Novartis Vaccines to jointly market and sell their respective post-exposure rabies products. Talecris provides HyperRAB S/D (Rabies Immune Globulin [Human]), an essential component of rabies post-exposure prophylaxis for previously unvaccinated individuals, that is administered in combination with rabies vaccines. Novartis provides RabAvert Rabies Vaccine for both pre-exposure and post-exposure prophylaxis. "Through our agreement with Novartis, we are seeking to improve access to this critical-care therapy by ensuring that patients (…) text/html http://www.biospace.com BioSpace 15.06.2010 | BioSpace: FoldRx Pharmaceuticals, Inc. Secures $29 Million Financing http://www.lsis.com/goto/v94/%3B%97f%FD%11yxz CAMBRIDGE, Mass.-(BUSINESS WIRE)-FoldRx Pharmaceuticals, Inc. (FoldRx) today announced it has closed a $29 million financing to advance tafamidis to market. FoldRx has completed and previously reported the positive results of a pivotal trial of tafamidis as a disease modifying therapy for TTR amyloid polyneuropathy (ATTR-PN), a progressive and life-threatening genetic neurodegenerative disease that affects thousands of patients worldwide. New investors Novo Ventures and Morgenthaler Ventures join existing investors Healthcare Ventures, Fidelity Biosciences, TPG Biotechnology, Alta Partners, and Novartis Venture Funds. œThis financing is recognition of the strength of our tafamidis (…) text/html http://www.bionity.com Bionity.com 15.06.2010 | Bionity.com: FDA advisory committee recommends approval of Novartis investigational treatment FTY720 to treat relapsing remitting MS http://www.lsis.com/goto/v94/%3B%97f%FD%11y%7E%7E 15.06.2010 - An advisory committee of the US Food and Drug Administration (FDA) recommended approval of FTY720 (fingolimod) for the treatment of patients with relapsing multiple sclerosis, the most common form of the disease. The FDA has the option of seeking the advice of one of its advisory committees as it reviews and decides whether to approve a new treatment. The committee voted unanimously that FTY720 demonstrated substantial efficacy in treating relapsing remitting MS and that safety of the proposed 0.5 mg dose justified approval. "This is an encouraging and important milestone for the MS community," said Dr. Patricia O'Looney, Vice President, Biomedical Research at the National (…) text/html http://www.medicalnewstoday.com Medical News Today 14.06.2010 | Medical News Today: Newly Diagnosed Multiple Myeloma Patients - Zometa Added To Chemotherapy Shown To Considerably Improve Survival http://www.lsis.com/goto/v94/%3B%97f%FD%11%7Fvy New data to be presented tomorrow at the 46th Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago, IL, show that the addition of Zometa (zoledronic acid) to first-line chemotherapy significantly improved overall survival for newly diagnosed multiple myeloma patients by 16% (P=0.0118) and progression-free survival by 12% (P=0.0179) compared with oral clodronate plus firstline chemotherapy1. The 5.5 month survival improvement demonstrated by Zometa in this study of nearly 2000 patients was independent of the drug's effect on bone complications (also known as skeletal-related events or SREs)1. Zometa was significantly superior to clodronate in the prevention of (…) text/html http://www.businesswire.com Business Wire 14.06.2010 | Business Wire: Research and Markets: Opportunities in Emerging Pharma Markets: Strategies for Optimizing Growth in Key Regions and Therapeutic Areas | Business Wire http://www.lsis.com/goto/v94/%3B%97f%FD%11%7F%7Es DUBLIN-(BUSINESS WIRE)-Research and Markets (http:/www.researchandmarkets.com/research/86b7d0/opportunities_in_e) has announced the addition of the "Opportunities in Emerging Pharma Markets: Strategies for optimizing growth in key regions and therapeutic areas" report to their offering. Opportunities in Emerging Pharma Markets: Strategies for optimizing growth in key regions and therapeutic areas Pharmaceuticals, Generics, Vaccines, OTCs, Hepatitis and HIV/AIDS agents and Biosimilars appropriate for the Emerging markets. Other companies still seeking alliances are identified, as well as those that appear to be potential generic and Biosimilar supply partners. This report provides market (…) text/html http://www.businesswire.com Business Wire 14.06.2010 | Business Wire: Phase Forward Central Coding ¢ First to Achieve Uppsala Monitoring Center Certification | Business Wire http://www.lsis.com/goto/v94/%3B%97f%FD%11%7Exs WALTHAM, Mass.-(BUSINESS WIRE)-Phase Forward (NASDAQ: PFWD), a leading provider of data management solutions for clinical trials and drug safety, today announced its Central Coding ¢ application has become the first product to achieve certification by the Uppsala Monitoring Center (UMC). Launched today ( œUppsala Monitoring Centre Launches Software Certification Program for WHO Drug Dictionary Enhanced ), UMC s new certification is designed to help software developers quickly and easily integrate the WHO Drug Dictionary Enhanced. The WHO Drug Dictionary Enhanced is the world s most comprehensive dictionary of medicinal product information and the de facto standard for coding (…) text/html http://www.businesswire.com Business Wire 14.06.2010 | Business Wire: Eveo Joins Total Immersion North America Partner Network | Business Wire http://www.lsis.com/goto/v94/%3B%97f%FD%11%7E%7Bz LOS ANGELES-(BUSINESS WIRE)-Total Immersion (www.t-immersion.com), the global leader in augmented reality (AR), today announced the addition of Eveo (http:/www.eveo.com/) as a Certified D Fusion Reseller to its North American Partner network, the world s largest network dedicated to AR. Eveo is an ideal fit for our Partner Network, as a clear industry leader in its space, with deep experience in healthcare and pharma across a wide array of digital platforms Based in San Francisco, Eveo specializes in unique ways to bring healthcare content to life, reinforcing products and educating patients and physicians - in medical settings, at tradeshows, on the web and on mobile devices. (…) text/html http://www.biospace.com BioSpace 14.06.2010 | BioSpace: New Autism Drug Research by Cellceutix on Compound KM-391 Results in Significant Behavioral Changes; Chief Scientific Officer Sees Potential for Company to Emerge as Industry Leader as Pharmas Strive for Revolutionary Autism Treatments http://www.lsis.com/goto/v94/%3B%97f%FD%11%7D%7F%7B BEVERLY, MA-(Marketwire - June 14, 2010) - Cellceutix Corporation (OTCBB: CTIX) announced today that a new animal study of its compound for autism spectrum disorder, KM-391, once again demonstrated a positive impact on several measures of behavior associated with autism. As announced last week, Cellceutix expedited the research through a collaborative effort with InterEd Faculty of Clinical Research (IFCR) in India and the prestigious Cochin University of Science & Technology (CUSAT). In the study, test subjects previously injected with a compound to simulate autistic behaviors were injected with an oxytocin antagonist to intensify the symptoms. Test subjects were divided into four (…) text/html http://www.biospace.com BioSpace 14.06.2010 | BioSpace: Human Genome Sciences, Inc. (HGSI) Hep C Drug, Zalbin OK, Unlikely to Get Approval at Current Dose http://www.lsis.com/goto/v94/%3B%97f%FD%11%7Cx%7E ROCKVILLE, Md., Jun 14, 2010 (BUSINESS WIRE) - Human Genome Sciences, Inc. today announced that it has received preliminary written feedback from the U.S. Food and Drug Administration (FDA) regarding the Company's Biologics License Application (BLA) seeking approval in the United States to market 900-mcg ZALBIN(TM) (albinterferon alfa-2b, known in Europe as JOULFERON(R) dosed every two weeks for the treatment of chronic hepatitis C. FDA has expressed concerns regarding the risk benefit assessment of ZALBIN dosed at 900-mcg every two weeks. Although the BLA review is ongoing, HGS has concluded that licensure of this dosing regimen is unlikely. The FDA feedback was provided via a (…) text/html http://www.ncbi.nlm.nih.gov NCBI PubMed 10.06.2010 | NCBI PubMed: Large-scale benchmark of Endeavour using MetaCore maps. http://www.lsis.com/goto/v94/%3B%97f%FD%16t%7Br SUMMARY: Endeavour is a tool that detects the most promising genes within large lists of candidates with respect to a biological process of interest and by combining several genomic data sources. We have benchmarked Endeavour using 450 pathway maps and 826 disease marker sets from MetaCore(TM) of GeneGo, Inc containing a total of 9,911 and 12,432 genes respectively. We obtained an AUC of 0.97 for pathway and of 0.91 for disease gene sets. These results indicate that Endeavour can be used to efficiently prioritize candidate genes for pathways and diseases. AVAILABILITY: Endeavour is available at http:/www.esat.kuleuven.be/endeavour CONTACT: Sven.Schuierer@novartis.com or (…) text/html http://www.ncbi.nlm.nih.gov NCBI PubMed 01.03.2010 | NCBI PubMed: A comparison of efficacy and safety of vildagliptin and gliclazide in combination with metformin in patients with Type 2 diabetes inadequately controlled with metformin alone: a 52-week, randomized study. http://www.lsis.com/goto/v94/%3B%97f%FD%16%7Cv%7F Aim To demonstrate non-inferiority of vildagliptin compared with gliclazide, as an add-on therapy, in patients with Type 2 diabetes inadequately controlled with metformin in a 52-week, randomized, double-blind, active-controlled study. Methods Patients receiving a stable dose of metformin ( /= 1500 mg) were randomized (1 : 1) to receive vildagliptin (50 mg twice daily; n = 513) or gliclazide (up to 320 mg/day; n = 494). Results Non-inferiority of vildagliptin was demonstrated (95% confidence interval -0.11%, 0.20%) with a mean change (se) from baseline glycated haemoglobin (HbA(1c) ( approximately 8.5% in both groups) to a 52-week endpoint of -0.81% (0.06) with vildagliptin and -0.85% (…) text/html http://www.ncbi.nlm.nih.gov NCBI PubMed 10.06.2010 | NCBI PubMed: Goblet Cells are Derived from a FOXJ1-Expressing Progenitor in a Human Airway Epithelium. http://www.lsis.com/goto/v94/%3B%97f%FD%17%7E%7Br The overproduction of mucus is a key pathology associated with respiratory diseases such as asthma and chronic obstructive pulmonary disease. These conditions are characterized by an increase in the number of mucus-producing goblet cells in the airways. We have studied the cellular origins of goblet cells using primary human bronchial epithelial cells (HBECs), which can be differentiated to form a stratified epithelium containing ciliated, basal and goblet cells. Treatment of differentiated HBEC cultures with the cytokine IL-13, an important mediator in asthma, increased the numbers of goblet cells and decreased the numbers of ciliated cells. To determine whether ciliated cells act as (…) text/html http://www.ncbi.nlm.nih.gov NCBI PubMed 01.05.2010 | NCBI PubMed: Once-a-day Administration of Everolimus, Cyclosporine, and Steroid After Renal Transplantation: A Review of the Rationale. http://www.lsis.com/goto/v94/%3B%97f%FE%1Dt%7D%7B The Evidence study (EVerolImus once-a-Day rEgimen with Neoral(R) versus Corticosteroid Elimination) sought to compare once-a-day administration with steroid withdrawal versus twice-daily administration among de novo kidney transplant recipients treated with everolimus, cyclosporine, and steroids. This article describes the study design and rationale of once-daily administration and steroid withdrawal among recipients of de novo kidney transplants treated with everolimus and cyclosporine. |-| Transplant Proc. |-| Corbetta G, Ponticelli C. |-| Medical Department, Novartis Farma SpA, Origgio (Va), Italy. text/html http://www.ncbi.nlm.nih.gov NCBI PubMed 09.06.2010 | NCBI PubMed: Combination Therapy for Managing Difficult-to-Treat Patients With Stage 2 Hypertension: Focus on Valsartan-Based Combinations. http://www.lsis.com/goto/v94/%3B%97f%FE%1Dyvz Blood pressure (BP) control rates in the United States remain low despite the availability of a wide array of treatment options. High-risk populations, including women, black individuals, and obese patients are even less likely to achieve BP targets than the general population. Uncontrolled BP can lead to serious consequences. Therefore, additional effective and well-tolerated treatment strategies are necessary, particularly for these difficult-to-treat populations. The majority of patients require 2 or more pharmacologic agents to achieve BP control. In patients with stage 2 hypertension, current guidelines recommend rational antihypertensive combinations as initial therapy. The (…) text/html http://www.marketwire.com Marketwire 09.06.2010 | Marketwire: Dermscan's Research to Support SpaCapsule's Weight Loss/Anti-Cellulite Benefits - Evidence of Weight Loss and Cellulite Reduction Inherent in Each SpaCapsule Usage May Be Found in International Research Center's Clinical Trials http://www.lsis.com/goto/v94/%3B%97f%FE%12y%7E%7F Highlighted Links Simulated Environment Concepts SE Concepts' Product Site MIAMI, FL-(Marketwire - June 9, 2010) - Simulated Environment Concepts (PINKSHEETS: SMEV), makers of the high pressurized dry water massage and relaxation station SpaCapsule, announced that international cosmetic and clinical research company, Dermscan Group is currently running clinical trials on the influence SpaCapsule has on weight-loss and cellulite reduction. "We created the SpaCapsule with the intent to aid in weight-loss and cellulite treatment," said Dr. Ella Frenkel, Chairman and CEO of Simulated Environment Concepts, Inc. (SE Concepts). "And with hundreds of machines having been quietly sold over the (…) text/html http://www.medicalnewstoday.com Medical News Today 09.06.2010 | Medical News Today: HDMA Honors Leading Pharmaceutical And Consumer Product Manufacturers At Inaugural Business & Leadership Conference http://www.lsis.com/goto/v94/%3B%97f%FE%12%7Evr The Healthcare Distribution Management Association (HDMA) recognized leading pharmaceutical and consumer product manufacturers with the presentation of 10 Distribution Industry Awards for Notable Achievements in Healthcare (DIANA). The winners were announced at the Association's inaugural Business & Leadership Conference in Orlando, Florida. "The 2010 DIANA winners demonstrate an abiding commitment to innovation and collaboration," said HDMA President and CEO John M. Gray. "These winning companies have shown creativity in introducing new products and services and establishing successful partnerships with their distributor peers in a way that benefits not just the healthcare supply chain (…) text/html http://www.medicalnewstoday.com Medical News Today 09.06.2010 | Medical News Today: Dermscan's Research To Support SpaCapsule's Weight Loss/Anti-Cellulite Benefits http://www.lsis.com/goto/v94/%3B%97f%FE%12%7E%7Ex Simulated Environment Concepts (PINKSHEETS: SMEV), makers of the high pressurized dry water massage and relaxation station SpaCapsule, announced that international cosmetic and clinical research company, Dermscan Group is currently running clinical trials on the influence SpaCapsule has on weight-loss and cellulite reduction. "We created the SpaCapsule with the intent to aid in weight-loss and cellulite treatment," said Dr. Ella Frenkel, Chairman and CEO of Simulated Environment Concepts, Inc. (SE Concepts). "And with hundreds of machines having been quietly sold over the past nine years, we've collected sufficient evidence to document the cellulite reduction and weight loss benefits of (…) text/html http://www.medicalnewstoday.com Medical News Today 09.06.2010 | Medical News Today: Also In Global Health News: MDGs; ARVs; Pharma In India; Gates In Nigeria http://www.lsis.com/goto/v94/%3B%97f%FE%12%7E%7E%7B "Millennium development goals: Profit has a place at the base of the pyramid," Financial Times (Murray, 6/7). "ViiV, Elizabeth Glaser Pact To Expedite Access To ARV Treatment", Dow Jones/Wall Street Journal (Musha Baba, 6/7). "Novartis, Sanofi Pursue 'Cash Machine' in Indian Countryside," Bloomberg (Sharma, 6/7). Agence France-Press (6/7) and The Punch (Nwankwo, 6/8) report on Bill Gates's trip to Nigeria. This information was reprinted from globalhealth.kff.org with kind permission from the Henry J. Kaiser Family Foundation. You can view the entire Kaiser Daily Global Health Policy Report, search the archives and sign up for email delivery at globalhealth.kff.org. © Henry J. Kaiser (…) text/html http://www.businesswire.com Business Wire 10.06.2010 | Business Wire: Research and Markets: The Chinese Pharmaceuticals Market Is Forecast To Become the World's Fifth Largest By 2010 - And the Largest By 2050 - Read More Inside | Business Wire http://www.lsis.com/goto/v94/%3B%97f%FE%12%7D%7E%7D DUBLIN-(BUSINESS WIRE)-Research and Markets (http:/www.researchandmarkets.com/research/2ddbd5/pharmaceutical_ind) has announced the addition of the "Pharmaceutical Industry in China" report to their offering. Favorable economic conditions are expected to continue to boost the growth of the pharmaceutical industry in China. The health of the pharmaceutical industry has been improving continuously since 2000 and is expected to get even better. The Chinese pharmaceuticals market is forecast to become the world's fifth largest by 2010 - and the largest by 2050. There are still greater market access following China's entry into the World Trade Organization (WTO), multinational investors (…) text/html http://www.businesswire.com Business Wire 09.06.2010 | Business Wire: Research and Markets: Based On Projections, Cancer Deaths Will Continue To Rise With an Estimated 9 Million People Dying From Cancer in 2015, And 11.4 Million Dying In 2030 | Business Wire http://www.lsis.com/goto/v94/%3B%97f%FE%13uw%7C DUBLIN-(BUSINESS WIRE)-Research and Markets (http:/www.researchandmarkets.com/research/122efb/looking_at_the_can) has announced the addition of the "Looking at the Cancer Therapy Market" report to their offering. Cancer is a disease characterized by a population of cells that grow and divide without respect to normal limits, invade and destroy adjacent tissues, and may spread to distant anatomic sites through a process called metastasis. These life-threatening, malignant properties of cancers differentiate them from benign tumors, which are self-limited in their growth and do not invade or metastasize. Cancer may affect people at all ages, but risk for the more common varieties tends to (…)