http://www.lsis.com/goto/r110/rss 2010-06-23T11:11:08+01:00 text/html http://www.ncbi.nlm.nih.gov NCBI PubMed http://www.lsis.com/goto/v110/%3B%97f%FB%13yz%7E Epoetin-delta (Dynepo Shire Pharmaceuticals, Basing stoke, UK) is a synthetic form of erythropoietin (EPO) whose resemblance with endogenous EPO makes it hard to identify using the classical identification criteria. Urine samples collected from six healthy volunteers treated with epoetin-delta injections and from a control population were immuno-purified and analyzed with the usual IEF method. On the basis of the EPO profiles integration, a linear multivariate model was computed for discriminant analysis. For each sample, a pattern classification algorithm returned a bands distribution and intensity score (bands intensity score) saying how representative this sample is of one of the two (…) text/html http://www.biospace.com BioSpace http://www.lsis.com/goto/v110/%3B%97f%FD%1C%7B%7B%7C Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, announces that Dr David Ginsburg and Ms Anne Minto OBE, have been appointed to the Shire Board of Directors with immediate effect. Dr Ginsburg, MD is currently Professor of Internal Medicine & Human Genetics at the Life Sciences Institute, University of Michigan; an Investigator at the Howard Hughes Medical Institute and the Warner-Lambert/Parke-Davis Professor of Medicine. Dr Ginsburg qualified at Yale University and has a very distinguished background that includes many research achievements, fellowships, awards and published papers. These have included a research post at Harvard Medical School and (…) text/html http://www.biospace.com BioSpace http://www.lsis.com/goto/v110/%3B%97g%F6%14%7Fxs Lainate, Italy 31 May 2010 Cosmo Pharmaceuticals S.p.A. (SIX: COPN) today reports that Shire plc (LSE: SHP, NASDAQ: SHPGY) announced on 28 May 2010 that it has received a Paragraph IV Notice Letter from Zydus Pharmaceuticals USA, Inc. ( œZydus ) advising of the filing of an Abbreviated New Drug Application ( œANDA ) for a generic version of 1.2g mesalamine delayed release tablets LIALDA. LIALDA was developed by Cosmo Technologies Ltd, Ireland and licensed to Giuliani S.p.A. who licensed it to Shire. LIALDA is protected by the following FDA Orange Book listed patent: U.S. Patent No. 6,773,720, Mesalazine Controlled Release Pharmaceutical Compositions (the œ 720 patent ). The patent (…) text/html http://www.medicalnewstoday.com Medical News Today http://www.lsis.com/goto/v110/%3B%97g%F6%14%7D%7Ex Shire plc (LSE: SHP, Nasdaq: SHPGY), the global specialty biopharmaceutical company, announced that the U.S. Food and Drug Administration (FDA) has granted marketing approval for VPRIV, a human cell line derived enzyme replacement therapy (ERT) for the long-term treatment of Type 1 Gaucher disease in pediatric and adult patients. The FDA designated VPRIV for Priority Review and granted marketing approval in just 6 months. VPRIV offers patients and their physicians a new treatment option at a critical time, as the supply of the previously approved ERT for Gaucher disease is uncertain and remains disrupted. "We have had the opportunity to use VPRIV in clinical trials and actively (…) text/html http://www.businesswire.com Business Wire http://www.lsis.com/goto/v110/%3B%97g%F7%1Dx%7E%7E DUBLIN-(BUSINESS WIRE)-Research and Markets (http:/www.researchandmarkets.com/research/194007/inflammatory_bowel) has announced the addition of the "Inflammatory Bowel Disease Therapeutics - Global Strategic Business Report" report to their offering. Inflammatory Bowel Disease Therapeutics - Global Strategic Business Report This report analyzes the Global market for Inflammatory Bowel Disease Therapeutics in US$ Million. Annual estimates and forecasts are provided for the period 2006 through 2015. The report profiles 69 companies including Abbott Laboratories, Biogen Idec, Inc., Cosmo Pharmaceuticals SpA, ChemoCentryx, Inc., Dr. Falk Pharma GmbH, Eisai Co., Ltd., Elan Corporation, plc, (…) text/html http://www.biospace.com BioSpace http://www.lsis.com/goto/v110/%3B%97g%F7%10xy%7F Boston Globe - Drug maker Shire Pharmaceuticals is buying four buildings in Raytheon s former Lexington campus along Route 2 for more than $200 million, marking a major move forward for the recovering commercial real estate market. text/html http://www.medicalnewstoday.com Medical News Today http://www.lsis.com/goto/v110/%3B%97g%F7%14%7E%7Ez Shire plc (LSE: SHP, Nasdaq: SHPGY), the global specialty biopharmaceutical company, announced the results of a study evaluating the safety and efficacy of Vyvanse (lisdexamfetamine dimesylate) Capsules CII for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adolescents aged 13 to 17 years. The data, presented in an oral session at a national scientific meeting of psychiatrists in New Orleans, LA, demonstrated that treatment with Vyvanse (30, 50, and 70 mg/d) significantly improved ADHD symptoms compared to placebo in adolescents with ADHD. Vyvanse is currently indicated for the treatment of ADHD in children aged 6 to 12 years and in adults. Recently, Shire submitted (…) text/html http://www.businesswire.com Business Wire http://www.lsis.com/goto/v110/%3B%97g%F8%12%7B%7Bz EDISON, N.J.-(BUSINESS WIRE)-Oceana Therapeutics today announced that the Company s President and COO, David S. Tierney, MD, has been featured in the first ever listing of the Irish Life Science 50. I have known David for years and am pleased to call him a friend as well as an exceptional colleague. All of us at Oceana are fully aware of his abilities and accomplishments, and are delighted by the public recognition accorded David by this award. The honor, presented by the by the Irish Voice newspaper and Irish America Magazine, in conjunction with the Irish Government, recognizes the achievements of Irish Americans in the life sciences. Dr. Tierney and all recipients of this prestigious (…) text/html http://www.businesswire.com Business Wire http://www.lsis.com/goto/v110/%3B%97g%F9%1D%7Dxs NAPA, Calif.-(BUSINESS WIRE)-The 12th Annual C21 BioVentures Conference takes place May 25-27, 2010 at The Meritage Resort in Napa, CA. Links to important information: Overview Participants Program Business Wire is the official newswire service for the 12th Annual C21 BioVentures. Breaking news releases, advisories, photos, and multimedia are available at Tradeshownews.com, Business Wire's trade show, conference, and event news resource. Listed below are 12th Annual C21 BioVentures Conference presenter profiles. Company: Kinagen, Inc. Investor Relations Contact: David Slack Investor Relations Contact Phone: (760) 633-0007 Web: www.kinagen.com Date of Presentation: 5/27/2010 Kinagen is an (…) text/html http://www.businesswire.com Business Wire http://www.lsis.com/goto/v110/%3B%97g%F9%14t%7C%7B DUBLIN-(BUSINESS WIRE)-Research and Markets (http:/www.researchandmarkets.com/research/d5a60b/neurodegenerative) has announced the addition of the "Neurodegenerative Drugs - Global Strategic Business Report" report to their offering. Neurodegenerative Drugs - Global Strategic Business Report This report analyzes the worldwide markets for Neurodegenerative Drugs in US$ Million by the following disease types: Alzheimers Disease, Parkinsons Disease, Multiple Sclerosis, Amyotrophic Lateral Sclerosis, and Other Neurodegenerative Diseases. The report provides separate comprehensive analytics for the US, Europe, and Rest of World. Annual estimates and forecasts are provided for each region for (…) text/html http://www.biospace.com BioSpace http://www.lsis.com/goto/v110/%3B%97g%FD%11%7Cys Reuters - U.S. regulators have warned Roche Holding AG unit Genentech and Shire Plc about misleading promotions for cancer and bowel drugs, letters released on Wednesday said. text/html http://www.biospace.com BioSpace http://www.lsis.com/goto/v110/%3B%97g%FF%11%7Dx%7F DUBLIN, April 29, 2010 /PRNewswire-FirstCall/ - Shire plc (LSE: SHP, NASDAQ: SHPGY) the global specialty biopharmaceutical company, announces results for the three months to March 31, 2010. text/html http://www.medicalnewstoday.com Medical News Today http://www.lsis.com/goto/v110/%3B%97g%FF%16u%7B%7D Santaris Pharma A/S, a clinical-stage biopharmaceutical company focused on the discovery and development of RNA-targeted therapies, announced that it has advanced into drug development a discovery research candidate directed against PCSK9 (proprotein convertase subtilisin/kexin type 9), an important new target for the treatment of high cholesterol. Using its proprietary Locked Nucleic Acid (LNA) Drug Platform and Drug Discovery Engine, Santaris Pharma A/S identified and advanced the new drug, SPC5001, in just 18 months. High cholesterol is a major risk factor for coronary heart disease, heart attack and stroke. According to the World Health Organization, high cholesterol is estimated to (…) text/html http://www.biospace.com BioSpace http://www.lsis.com/goto/v110/%3B%97g%FF%15%7Ev%7D DUBLIN, April 27, 2010 /PRNewswire-FirstCall/ - Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, announces that it has received a Paragraph IV Notice Letter from Anchen Pharmaceuticals, Inc. ("Anchen") advising of the filing of an Abbreviated New Drug Application ("ANDA") for a generic version of Shire's 1 mg, 2 mg, 3 mg, and 4 mg guanfacine hydrochloride extended release tablets, INTUNIV(TM). Shire had previously reported in March 2010 of the receipt of a Paragraph IV Letter from Teva Pharmaceuticals USA, Inc. and in early April 2010 of a Paragraph IV Letter from Actavis Elizabeth LLC, both regarding ANDAs for generic versions of Shire's 1 mg, 2 mg, 3 (…) text/html http://www.businesswire.com Business Wire http://www.lsis.com/goto/v110/%3B%97%60%F8%16%7Bw%7B KING OF PRUSSIA, Pa.-(BUSINESS WIRE)-The drive to share information across boundaries has helped make SharePoint the fastest growing product in Microsoft history. Steve Aylward, General Manager, U.S. Healthcare and Life Sciences Group for Microsoft, told this to more than 350 attendees from pharmaceutical and life sciences companies at the first ShareFEST 2010 conference. It was exciting to be part of an event where the common thread among companies from every part of the life sciences spectrum was the use of SharePoint to help solve key challenges faced in the industry The two-day conference in Philadelphia was presented by NextDocs, the leading provider of SharePoint-based document and (…) text/html http://www.biospace.com BioSpace http://www.lsis.com/goto/v110/%3B%97%60%FA%1Czxs DUBLIN and PHILADELPHIA, April 23, 2010 /PRNewswire-FirstCall/ - Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, announces that its subsidiary Shire LLC has filed a lawsuit in the U.S. District Court for the District of Delaware against Teva Pharmaceuticals USA, Inc. and Teva Pharmaceutical Industries, Ltd (collectively "Teva") for the infringement of U.S. Patent Nos. 6,287,599 (the '599 patent) and 6,811,794 (the '794 patent). text/html http://www.biospace.com BioSpace http://www.lsis.com/goto/v110/%3B%97%60%FF%12xzr GUILDFORD, UK and BURLINGTON, MA-(Marketwire - April 14, 2010) - IDBS, the leading worldwide provider of research data management and analytics solutions to R&D organizations, today announced that Shire plc, the global specialty biopharmaceutical company, has selected IDBS to support its virtual model for pharmaceutical research. Shire will implement IDBS' E-WorkBook Suite in a collaborative environment with its CROs to streamline and facilitate its new drug research in 2010 and the future. By leveraging hosted services in combination with E-WorkBook, Shire will have a minimum IT footprint both in-house and at each CRO, eliminating the need for on-site data storage, providing secure (…) text/html http://www.biospace.com BioSpace http://www.lsis.com/goto/v110/%3B%97%60%FF%13u%7C%7C ST. LOUIS, April 13 /PRNewswire-FirstCall/ - K-V Pharmaceutical Company (the "Company") today announced it has appointed Stephen A. Stamp as Chief Financial Officer and Treasurer, effective April 7, 2010. Mr. Stamp will report directly to David Van Vliet, interim CEO of the Company.Mr. Stamp has over twenty seven years of finance experience, including his tenure at Xanodyne Pharmaceuticals where he most recently served as Chief Operating Officer and Chief Financial Officer. Prior to his time at Xanodyne, Mr. Stamp spent five years at Shire Pharmaceuticals Group PLC as Group Finance Director. He also served as Chief Financial Officer and Group Finance Director at Regus Group PLC. In (…) text/html http://www.medicalnewstoday.com Medical News Today http://www.lsis.com/goto/v110/%3B%97%60%FF%17y%7F%7F Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, presented positive data from a Phase III clinical trial (TKT-034) designed to evaluate the safety of switching to VPRIV (velaglucerase alfa for injection), from imiglucerase, as well as an interim analysis of safety data from an ongoing multicenter open-label treatment protocol (HGT-GCB-058) implemented to provide VPRIV to patients affected by the continuing shortage of imiglucerase. A post-hoc analysis of Phase I/II data on therapeutic goal attainment was also presented at the 2010 American College of Medical Genetics Annual Clinical Genetics Meeting in Albuquerque, New Mexico. These data add to the (…) text/html http://www.biospace.com BioSpace http://www.lsis.com/goto/v110/%3B%97%60%FF%14%7Dwy Also Reported Are Results of Retrospective Analysis of Phase I/II Study, Showing Success in Reaching Therapeutic Goals within 4 Years of Initiation of Treatment CAMBRIDGE, Mass., March 25 /PRNewswire-FirstCall/ - Shire plc , the global specialty biopharmaceutical company, today presented positive data from a Phase III clinical trial (TKT-034) designed to evaluate the safety of switching to VPRIV (velaglucerase alfa for injection), from imiglucerase, as well as an interim analysis of safety data from an ongoing multicenter open-label treatment protocol (HGT-GCB-058) implemented to provide VPRIV to patients affected by the continuing shortage of imiglucerase. A post-hoc analysis of Phase (…) text/html http://www.biospace.com BioSpace http://www.lsis.com/goto/v110/%3B%97%60%FF%15%7Ewz Bangalore, India 23 March 2010. Connexios Life Sciences Pvt Ltd, a drug discovery company focused on discovering and developing new drugs for the treatment of metabolic diseases, today announces that pharmaceutical industry veteran, Rolf Stahel, has been appointed as non-Executive Chairman. Rolf Stahel, a Swiss national, joined Shire Pharmaceuticals Group plc in March 1994 as its Chief Executive. At that time the company was privately held and had an estimated value of approximately $30m with revenues of $3m and 50 employees. During his 9 year tenure, he implemented six mergers and acquisitions, building Shire in to a FTSE 100 company with a market capitalisation of approximately $3.2bn, (…) text/html http://www.biospace.com BioSpace http://www.lsis.com/goto/v110/%3B%97a%F7%10%7Exy DUBLIN, March 16, 2010 /PRNewswire-FirstCall/ - Shire plc , announces that it has received a Paragraph IV Notice Letter from Teva Pharmaceuticals USA, Inc. ("Teva") advising of the filing of an Abbreviated New Drug Application ("ANDA") for a generic version of Shire's 1 mg, 2mg, 3 mg, and 4mg guanfacine hydrochloride extended release tablets, INTUNIV(TM). INTUNIV is protected by three FDA Orange Book listed patents: U.S. Patent No. 5,854,290, Use of Guanfacine in the Treatment of Behavioral Disorders; U.S. Patent No. 6,287,599 ("the '599 patent") and U.S. Patent No. 6,811,794 ("the '794 patent") both titled Sustained Release Pharmaceutical Dosage Forms with Minimized pH Dependent (…) text/html http://www.biospace.com BioSpace http://www.lsis.com/goto/v110/%3B%97a%F7%11t%7Fr DUBLIN, March 15, 2010 /PRNewswire-FirstCall/ - Shire plc , the global specialty biopharmaceutical company, announces the appointment of Bill Burns to its Board as a Non Executive Director with immediate effect. Mr Burns has also been appointed a member of Shire's Remuneration Committee. Mr Burns has a long and distinguished career in the global pharmaceuticals industry, having worked for many years for Roche; most recently as CEO of their Pharmaceuticals Division and as a member of the Roche Group Corporate Executive Committee. He has extensive experience of international pharmaceuticals and of mergers and acquisitions. Among his many achievements during his time with Roche, he had (…) text/html http://www.biospace.com BioSpace http://www.lsis.com/goto/v110/%3B%97a%FA%11z%7Er Philadelphia, US March 4, 2010 Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, announces that the United States District Court for the District of Columbia ( œCourt ), following extensive briefing by the parties and an oral hearing, has upheld the decision of the U.S. Food and Drug Administration ( œFDA ) to grant 5-year New Chemical Entity ( œNCE ) exclusivity to lisdexamfetamine dimesylate currently marketed by Shire U.S. Inc. for the treatment of attention-deficit hyperactivity disorder under the name VYVANSE. On February 23, 2007, after reviewing the requisite clinical studies submitted on behalf of VYVANSE, the FDA determined that VYVANSE (…) text/html http://www.biospace.com BioSpace http://www.lsis.com/goto/v110/%3B%97a%FB%16zx%7C CAMBRIDGE, Massachusetts and BASINGSTOKE, England, March 1, 2010 /PRNewswire-FirstCall/ - Shire plc , the global specialty biopharmaceutical company, today announced it will actively support Rare Disease Day across the world by generating media coverage in many countries to raise awareness and understanding of rare diseases. Rare Disease Day seeks to call attention to rare diseases as a public health issue, and to reinforce the increased need for access to information, research and treatment. It is coordinated at the international level by European Organisation for Rare Diseases (EURORDIS) and by the National Organization for Rare Disorders (NORD) in the US. It is estimated that there are (…) text/html http://www.biospace.com BioSpace http://www.lsis.com/goto/v110/%3B%97a%FB%16y%7Bx CAMBRIDGE, Mass., Feb. 26 /PRNewswire-FirstCall/ - Shire plc (LSE: SHP, Nasdaq: SHPGY), the global specialty biopharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) has granted marketing approval for VPRIV, a human cell line derived enzyme replacement therapy (ERT) for the long-term treatment of Type 1 Gaucher disease in pediatric and adult patients. The FDA designated VPRIV for Priority Review and granted marketing approval in just 6 months. VPRIV offers patients and their physicians a new treatment option at a critical time, as the supply of the previously approved ERT for Gaucher disease is uncertain and remains disrupted. "We have had the (…) text/html http://www.prnewswire.com PR Newswire http://www.lsis.com/goto/v110/%3B%97a%FB%15%7D%7Bz Company Announces New Enhancements to Patient Assistance Programs in the United States Download image CAMBRIDGE, Mass., Feb. 26 /PRNewswire-FirstCall/ - Shire plc (LSE: SHP, Nasdaq: SHPGY), the global specialty biopharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) has granted marketing approval for VPRIV, a human cell line derived enzyme replacement therapy (ERT) for the long-term treatment of Type 1 Gaucher disease in pediatric and adult patients. The FDA designated VPRIV for Priority Review and granted marketing approval in just 6 months. VPRIV offers patients and their physicians a new treatment option at a critical time, as the supply of the (…) text/html http://www.medicalnewstoday.com Medical News Today http://www.lsis.com/goto/v110/%3B%97a%FC%13%7C%7Ey Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, announces it has received Fast Track designation from the FDA for REPLAGAL(R) (agalsidase alfa), its enzyme replacement therapy for Fabry disease. Shire filed a BLA for REPLAGAL in December 2009. The FDA requested additional human pharmacokinetic data to confirm comparability between product that was manufactured in roller bottles, and that which is manufactured in bioreactors. Product made by the bioreactor process is already approved for commercial use in the European Union as well as a number of other countries. As a result of this request, Shire withdrew its December BLA filing, and, at the suggestion (…) text/html http://www.marketwire.com Marketwire http://www.lsis.com/goto/v110/%3B%97a%FC%15x%7Cr ROCKVILLE, MD-(Marketwire - February 23, 2010) - MarketResearch.com has announced the addition of GBI Research's new report "The Future of Orphan Disease Therapeutics - Market Forecasts to 2015, Pipeline Analysis and Reimbursement," to their collection of Drug Discovery market reports. For more information, visit http:/www.marketresearch.com/redirect.asp?progid=67618&productid=2529138. GBI Research, the leading business intelligence provider, has released its latest research "The Future of Orphan Diseases Therapeutics - Market Forecasts to 2015, Pipeline Analysis and Reimbursement." The report provides in-depth analysis of unmet needs, drivers and barriers that impact the global orphan (…) text/html http://www.prnewswire.com PR Newswire http://www.lsis.com/goto/v110/%3B%97a%FE%15%7D%7Cz NEW YORK, Feb. 16 /PRNewswire/ - Reportlinker.com announces that a new market research report is available in its catalogue: Shire plc: PharmaVitae Profile http:/www.reportlinker.com/p0177526/Shire-plc-PharmaVitae-Profile.html Introduction This analysis examines the historical and forecast performance for Shire in the prescription pharmaceutical sector. The profile encompasses global company strategy, portfolio and pipeline analysis and assessment of financial performance, with 1-6 year sales forecasts for key drugs. An interactive forecasting and analysis tool provides continually updated quantitative and qualitative information. Reasons to Purchase *Benchmark Shire's performance (…) text/html http://www.businesswire.com Business Wire http://www.lsis.com/goto/v110/%3B%97b%F6%1C%7Bvr DUBLIN-(BUSINESS WIRE)-Research and Markets (http:/www.researchandmarkets.com/research/cce6ba/pharmaceutical_com) has announced the addition of the "Pharmaceutical Companies Performance: Winers and Losers in a Recession-Hit Industry" report to their offering. Pharmaceutical Companies Performance: Winers and Losers in a Recession-Hit Industry While the ongoing recession has impacted the pharmaceutical industry's performance, some observers feel it has merely exacerbated many underlying problems. The number of blockbuster drugs which have lost patent protection have not been replaced by the same number of new products offering significant therapeutic advances, and the number coming off (…) text/html http://www.biospace.com BioSpace http://www.lsis.com/goto/v110/%3B%97b%F6%13%7Bw%7E CAMBRIDGE, Massachusetts, February 11 /PRNewswire-FirstCall/ - Shire plc , the global specialty biopharmaceutical company, today presented positive results from its first Phase III study (TKT 032) evaluating safety and efficacy of velaglucerase alfa, its investigational enzyme replacement therapy for the treatment of Type 1 Gaucher disease. The data were presented in an oral presentation at the Lysosomal Disease Network (LDN) World Symposium in Miami, Florida. Data from a pediatric subgroup of this study and five year follow-up results from a long-term Phase I/II extension study (TKT025 EXT) conducted in adults were also reported and add to the available data on the long-term safety and (…) text/html http://www.prnewswire.com PR Newswire http://www.lsis.com/goto/v110/%3B%97b%FD%15x%7B%7C Data sponsored by the Canadian Fabry Disease Initiative (CFDI) to be presented by Dr. Michael West, Dalhousie University CAMBRIDGE, Mass., Feb. 3 /PRNewswire-FirstCall/ - Shire plc (LSE: SHP, Nasdaq: SHPGY), the global specialty biopharmaceutical company, today announced that data from one of three Phase III clinical trials for velaglucerase alfa, the company's enzyme replacement therapy (ERT) in development for the treatment of Type 1 Gaucher disease, will be presented at the Lysosomal Disease Network (LDN) World Symposium, February 10-12, 2010 in Miami, Florida. In addition to two oral presentations and two poster presentations on Gaucher disease, the company will present findings from (…) text/html http://www.biospace.com BioSpace http://www.lsis.com/goto/v110/%3B%97b%FD%15%7C%7Ds CAMBRIDGE, Mass., Feb. 3 /PRNewswire-FirstCall/ - Shire plc , the global specialty biopharmaceutical company, today announced that data from one of three Phase III clinical trials for velaglucerase alfa, the company's enzyme replacement therapy (ERT) in development for the treatment of Type 1 Gaucher disease, will be presented at the Lysosomal Disease Network (LDN) World Symposium, February 10-12, 2010 in Miami, Florida. In addition to two oral presentations and two poster presentations on Gaucher disease, the company will present findings from a re-analysis of disease stage progression in Globoid Cell Leukodystrophy (GLD). Dr. Michael West from Dalhousie University in Halifax, Canada (…) text/html http://www.prnewswire.com PR Newswire http://www.lsis.com/goto/v110/%3B%97b%FE%1Dx%7C%7F NEW YORK, Jan. 29 /PRNewswire/ - Reportlinker.com announces that a new market research report is available in its catalogue: CNS Therapeutics - A World Market Review http:/www.reportlinker.com/p0164268/CNS-Therapeutics-A-World-Market-Review.html While the available CNS therapies can slow down deteriorating condition of patient, the clinical pipeline boasts of new drug classes with potential to stop or reverse the disease's progression. Continuing switch over of patients from typical or traditional anti-psychotics to expensive and safer atypical anti-psychotics drugs, such as Zyprexa, Risperdal and Geodon is driving the market forward. Global market for anti-depressants, a dominant (…) text/html http://www.prnewswire.com PR Newswire http://www.lsis.com/goto/v110/%3B%97b%FE%12ty%7C DALLAS, January 28 /PRNewswire/ - Now in its 9th year, the ePharma Summit (http:/www.epharmasummit.com), to be held this year at the Hyatt Regency at Penn's Landing, Philadelphia, PA ,continues to be the most innovative digital marketing event for the pharmaceutical sector. Year after year, hundreds of marketing professionals from leading pharmaceutical companies attend ePharma Summit for incomparable access to insider information, to optimize their brand strategy and perfect consumer relationships. Join us, next month, to collaborate with leading industry minds and perfect your digital strategy by pursuing true e-marketing innovations. The ePharma summit is packed with fresh case (…) text/html http://www.businesswire.com Business Wire http://www.lsis.com/goto/v110/%3B%97b%FE%11y%7Dr EWING, N.J.-(BUSINESS WIRE)-Antares Pharma, Inc. (NYSE Amex:AIS) announced that Mr. Pavan Handa has joined Antares Pharma as Senior Vice President of Business Development. Mr. Handa has over 20 years of business development and venture management experience in the global biopharmaceutical industry with both drug delivery and specialty pharma companies. Throughout his career, he has been associated with significant value creation through strategic alliances, licensing, acquisitions, new business creation, and divestitures. Previously, Mr. Handa served as Vice President and Head of Business Development and Alliance Management for Noven Pharmaceuticals, Inc., a leading specialty pharma and (…) text/html http://www.marketwire.com Marketwire http://www.lsis.com/goto/v110/%3B%97b%FE%14%7Dz%7C SAN FRANCISCO, CA-(Marketwire - January 11, 2010) - Biopharmaceutical investors gathering here this week for the 28th Annual J.P. Morgan Healthcare Conference anticipate that four potential blockbusters could be produced by biotechnology companies this year, and propel the ascendance of a new class of bellwethers in the sector. Asset managers polled in the 18th Annual Buyside View, published today in BioCentury, the Bernstein Report on BioBusiness, also see value in big cap biotech names, which are seen as ripe for an upward move after losing their luster compared to big pharma in 2009. With biotech companies raising $6 billion from follow-ons in 2009 - the second-largest follow-on year (…) text/html http://www.businesswire.com Business Wire http://www.lsis.com/goto/v110/%3B%97b%FE%15t%7F%7F NORTH LIBERTY, Iowa-(BUSINESS WIRE)-KemPharm, Inc. today announced positive results from a Phase 1 clinical trial of KP106, its novel prodrug for attention-deficit hyperactivity disorder (ADHD). KP106, a new chemical entity (NCE) composed of the active pharmaceutical compound d-amphetamine and a ligand, was created using KemPharms proprietary Ligand Activated Therapy (LAT) prodrug approach. The pharmacokinetic (PK) profile of d-amphetamine released from KP106 is modified versus the profile observed with Vyvanse, a currently marketed amphetamine-based stimulant for ADHD. These results suggest that KP106 may have an improved side effect profile and a lower propensity for drug abuse. Most (…) text/html http://www.prnewswire.com PR Newswire http://www.lsis.com/goto/v110/%3B%96j%F6%14zzs DUBLIN, October 28 /PRNewswire-FirstCall/ - - FOSRENOL(R) (lanthanum carbonate) Now Approved in the EU to Treat hyperphosphataemia 1.78mmol/L in Chronic Kidney Disease Patients Not on Dialysis Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, today announced it has received approval through the European Mutual Recognition Procedure for an extension to the current indication for FOSRENOL(R) (lanthanum carbonate), paving the way to make the non-calcium, non-resin phosphate binder available throughout the EU to control hyperphosphataemia in chronic kidney disease (CKD) patients who are not on dialysis with a serum phosphorus level greather than or equal to (…) text/html http://www.prnewswire.com PR Newswire http://www.lsis.com/goto/v110/%3B%96j%F6%14y%7E%7C Filing Underscores Shire's Ongoing Commitment to Providing U.S. Fabry Patients With an Alternative Treatment Option. Company Recaps velaglucerase alfa Status CAMBRIDGE, Massachusetts, December 22 /PRNewswire-FirstCall/ - Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, today announced that it has submitted a BLA with the FDA for REPLAGAL(R) (agalsidase alfa), its enzyme replacement therapy for Fabry disease. REPLAGAL first received marketing authorization in the European Union in 2001, and is approved for the treatment of Fabry disease in 45 countries. REPLAGAL is currently available to U.S. Fabry patients under an FDA-approved treatment protocol, and (…) text/html http://www.prnewswire.com PR Newswire http://www.lsis.com/goto/v110/%3B%96j%F6%14xw%7C DUBLIN, October 30 /PRNewswire-FirstCall/ - Shire plc (LSE: SHP, NASDAQ: SHPGY) the global specialty biopharmaceutical company, announces results for the three months to September 30, 2009. Q3 2009 Financial Highlights Q3 2009(1) Product sales $603 million -15% Product sales from core products(2) $532 million +20% Product sales growth from core products at constant exchange rates(2)(3) +23% Total revenues $667 million -14% Non GAAP operating income $134 million -52% US GAAP operating income $92 million -25% Non GAAP diluted earnings per ADS $0.49 -58% US GAAP diluted earnings per ADS $0.33 +$0.52 (1) Figures compare Q3 2009 results with the same period in 2008. (2) Core products represent (…) text/html http://www.prnewswire.com PR Newswire http://www.lsis.com/goto/v110/%3B%96j%F6%14xv%7D Download image HOERSHOLM, Denmark and SAN DIEGO, California, December 3 /PRNewswire/ - - SPC3649 Successfully Inhibits miR-122, a microRNA Important for Hepatitis C Viral Replication, Thereby Significantly Reducing Hepatitis C Virus in the Bloodstream in Chimpanzees Chronically Infected With the Hepatitis C Virus - SPC3649 Demonstrates Efficacy With No Evidence of Viral Resistance and No Serious Adverse Events in the Treated Animals - Signaling a Potential Benefit for Patients Who are Not Responsive to or Cannot Tolerate Current Standard of Care Therapies - SPC3649 is the First microRNA-Targeted Drug to Enter Human Clinical Trials; Phase 1 Clinical Trials Ongoing - Santaris Pharma A/S (…) text/html http://www.prnewswire.com PR Newswire http://www.lsis.com/goto/v110/%3B%96j%F6%14%7Ex%7F Early Access for Fabry Patients Available Under Treatment Protocol and Emergency IND CAMBRIDGE, Massachusetts, October 21 /PRNewswire-FirstCall/ - Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, announces plans to file a Biologics License Application (BLA) with the U.S. Food and Drug Administration (FDA) for REPLAGAL(R) (agalsidase alfa), its enzyme replacement therapy for Fabry disease, by the end of the year. The Company also announces that a treatment protocol for REPLAGAL, filed at the request of FDA, has been approved, and that it will support emergency IND requests. The early access program is being put in place in view of the announced supply (…) text/html http://www.prnewswire.com PR Newswire http://www.lsis.com/goto/v110/%3B%96j%F6%14%7E%7D%7C HONOLULU, Oct. 29 /PRNewswire-FirstCall/ - Shire plc (LSE: SHP, Nasdaq: SHPGY), the global specialty biopharmaceutical company, announced today that it will present key scientific data on its Attention-Deficit/Hyperactivity Disorder (ADHD) treatments, INTUNIV(TM) (guanfacine) Extended Release Tablets, Vyvanse( ) (lisdexamfetamine dimesylate) Capsules CII, and Daytrana( ) (methylphenidate transdermal system) CII, at a national meeting of psychiatrists to be held October 27 - November 1 in Honolulu. "Shire is committed to the advancement of ADHD treatment research and is leading the way in developing a diverse range of safe and effective ADHD treatments," said Michael Yasick, Senior (…) text/html http://www.businesswire.com Business Wire http://www.lsis.com/goto/v110/%3B%96j%FA%15x%7Cr DUBLIN-(BUSINESS WIRE)-Research and Markets (http:/www.researchandmarkets.com/research/17c3a0/the_future_of_orph) has announced the addition of the "The Future of Orphan Disease Therapeutics - Market Forecasts to 2015, Pipeline Analysis and Reimbursement" report to their offering. The Future of Orphan Diseases Therapeutics - Market Forecasts to 2015, Pipeline Analysis and Reimbursement "The Future of Orphan Diseases Therapeutics - Market Forecasts to 2015, Pipeline Analysis and Reimbursement" The report provides in-depth analysis of unmet needs, drivers and barriers that impact the global orphan diseases therapeutics market. The report analyzes the markets for orphan diseases (…) text/html http://www.prnewswire.com PR Newswire http://www.lsis.com/goto/v110/%3B%96j%FB%1Cx%7E%7F NEW YORK, Dec. 1 /PRNewswire/ - Reportlinker.com announces that a new market research report is available in its catalogue: The Future of Central Nervous System Diseases Therapeutics - Market Forecasts to 2015, Competitive Benchmarking, Product Pipeline and Deals Analysis http:/www.reportlinker.com/p0166814/The-Future-of-Central-Nervous-System-Diseases-Therapeutics-Market-Forecasts-to-2015-Competitive-Benchmarking-Product-Pipeline-and-Deals-Analysis.html Summary The author has released its latest research "The Future of Central Nervous System Diseases Therapeutics - Market Forecasts to 2015, Competitive Benchmarking, Product Pipeline and Deals Analysis." The report provides in-depth (…) text/html http://www.prnewswire.com PR Newswire http://www.lsis.com/goto/v110/%3B%96j%FB%1C%7Dv%7C NEW YORK, Dec. 15 /PRNewswire/ - Reportlinker.com announces that a new market research report is available in its catalogue: The Future of Orphan Diseases Therapeutics - Market Forecasts to 2015, Pipeline Analysis and Reimbursement http:/www.reportlinker.com/p0168104/The-Future-of-Orphan-Diseases-Therapeutics-Market-Forecasts-to-2015-Pipeline-Analysis-and-Reimbursement.html Summary The author has released its latest research "The Future of Orphan Diseases Therapeutics - Market Forecasts to 2015, Pipeline Analysis and Reimbursement" The report provides in-depth analysis of unmet needs, drivers and barriers that impact the global orphan diseases therapeutics market. The report analyzes (…) text/html http://www.prnewswire.com PR Newswire http://www.lsis.com/goto/v110/%3B%96j%FB%1C%7Dys NEW YORK, Dec. 15 /PRNewswire/ - Reportlinker.com announces that a new market research report is available in its catalogue: Addiction Control - Drug Pipeline Analysis and Market Forecasts to 2015 http:/www.reportlinker.com/p0167271/Addiction-Control-Drug-Pipeline-Analysis-and-Market-Forecasts-to-2015.html Addiction Control - Drug Pipeline Analysis and Market Forecasts to 2015 Summary GlobalData, the industry analysis specialist, has released a new report "Addiction Control - Drug Pipeline Analysis and Market Forecasts to 2015". The report is an essential source of information and analysis on the global addiction control market. The report identifies the key trends shaping and driving (…) text/html http://www.prnewswire.com PR Newswire http://www.lsis.com/goto/v110/%3B%96j%FB%1D%7D%7Bz NEW YORK, Dec. 2 /PRNewswire/ - Reportlinker.com announces that a new market research report is available in its catalogue: Renal Disease Treatments: Products and Therapies http:/www.reportlinker.com/p0166824/Renal-Disease-Treatments-Products-and-Therapies.html Forecasts for the U.S. market in products and services, providing data for 2008 and estimates for 2009, and projections for the market and compound annual growth rates (CAGRs) from 2009 to 2014 Focus on pharmaceutical products, dialysis therapies, and surgical procedures in the U.S. market for renal failure treatment Breakdown of the dialysis equipment market by type and manufacturer, and the dialysis services market by provider (…)