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CAMBRIDGE, Mass. & SUMMIT, N.J.--(BUSINESS WIRE)--Acceleron Pharma Inc. (NASDAQ:XLRN) and Celgene Corporation (NASDAQ:CELG), today announced preliminary Phase 2 results from the ongoing three-month base and long-term extension studies with investigational drug luspatercept in patients with lower-risk myelodysplastic syndromes (MDS) at the 14th International Symposium on MDS in Valencia, Spain. Luspatercept is being developed as part of the global collaboration between Acceleron and Celgene. “These positive data presented in lower-risk MDS confirm our optimism in new opportunities for luspatercept beyond our ongoing Phase 3 trials,” said Michael Pehl, President, Hematology and Oncology for Celgene. “We are now planning a Phase 3 clinical trial to expand the development of luspatercept into this lower-risk MDS patient population.” “There is a high unmet medical need for a drug to treat patients earlier in the MDS treatment paradigm,” said Habib Dable, President and CEO of Acceleron. “We continue to be motivated to find additional opportunities for luspatercept to treat anemia due to rare blood disorders and remain on track to initiate Phase 2 trials in myelofibrosis and non-transfusion dependent beta-thalassemia by year-end.” In lower-risk, erythropoiesis-stimulating agent (ESA)-naïve MDS patients, 48% (11/23) of patients treated with luspatercept achieved red blood cell transfusion independence (RBC-TI) and 51% (20/39) of patients achieved a clinically meaningful erythroid hematological improvement (HI-E) response per the International Working Group’s (IWG) criteria. The response rates were positive in patients treated with luspatercept in both ESA-naïve and prior ESA-treated patients. In patients with baseline erythropoietin (EPO) levels ≤ 500 international units per liter (IU/L), RBC-TI and IWG HI-E response rates were positive in both ring sideroblast-positive (RS+) and –negative (RS-) patients. *Table includes both ESA refractory and ESA naïve patients. Patients treated at dose levels ≥ 0.75 mg/kg. The majority of adverse events (AEs) were grade 1 or 2. AEs at least possibly related to study drug that occurred in at least 3 patients during the studies were fatigue, headache, hypertension, diarrhea, arthralgia, bone pain, injection site erythema, myalgia, and edema peripheral. Grade 3 non-serious AEs possibly or probably related to study drug were ascites, blast cell count increase, blood bilirubin increase, hypertension, platelet count increase, and pleural effusion. Grade 3 serious AEs possibly or probably related to study drug were general physical health deterioration and myalgia. Luspatercept is an investigational product that is not approved for use in any country. The oral presentation given at the 14th International Symposium on MDS is available on Acceleron's website (www.acceleronpharma.com) under the Science tab. Acceleron will host a conference call and live webcast to discuss data presented at the MDS Symposium and its first quarter operational and financial results on May 8, 2017, at 8:00 a.m. EDT. To participate by teleconference, please dial 877-312-5848 (domestic) or 253-237-1155 (international) and refer to the Acceleron Earnings Call. To access the live webcast, please select “Events & Presentations” in the Investors/Media section on Acceleron’s website (www.acceleronpharma.com) at least 10 minutes beforehand to ensure time for any downloads that may be required. An archived webcast recording will be available on the Acceleron website beginning approximately two hours after the event. Data from two Phase 2 studies were presented at the conference: the base study in which patients received treatment with luspatercept for three months and the long-term extension study in which patients may receive treatment with luspatercept for up to an additional five years. In both the three-month base study and the long-term extension study, lower-risk MDS patients were enrolled and treated with open-label luspatercept, dosed subcutaneously once every three weeks. The outcome measures for the studies included the proportion of patients who had an erythroid response (IWG HI-E) or achieved RBC transfusion independence (RBC-TI). IWG HI-E was defined as hemoglobin increase ≥ 1.5 g/dL sustained for ≥ 8 weeks in patients with < 4 units RBC / 8 weeks transfusion burden at baseline and hemoglobin levels below 10 g/dL. For patients with a ≥ 4 units RBC / 8 weeks transfusion burden at baseline, erythroid response was defined as a reduction of ≥ 4 units RBC sustained for ≥ 8 weeks. RBC-TI was defined as no RBC transfusions for ≥ 8 weeks in patients with a ≥ 2 units RBC / 8 weeks baseline transfusion burden. Luspatercept is a modified activin receptor type IIB fusion protein that acts as a ligand trap for members in the transforming growth factor-beta superfamily involved in the late stages of erythropoiesis (red blood cell production). Luspatercept regulates late-stage erythrocyte (red blood cell) precursor cell differentiation and maturation. This mechanism of action is distinct from that of erythropoietin (EPO), which stimulates the proliferation of early-stage erythrocyte precursor cells. Acceleron and Celgene are jointly developing luspatercept as part of a global collaboration. Acceleron and Celgene are enrolling Phase 3 clinical trials that are designed to evaluate the safety and efficacy of luspatercept in patients with myelodysplastic syndromes (the “MEDALIST” study) and in patients with beta-thalassemia (the “BELIEVE” study). For more information, please visit www.clinicaltrials.gov. Acceleron is a clinical stage biopharmaceutical company focused on the discovery, development and commercialization of innovative therapeutics to treat serious and rare diseases. Its pioneering research platform leverages the powerful biology behind the body’s ability to rebuild and repair its own cells and tissues. This approach to drug discovery has generated four therapeutic candidates that are currently in clinical trials. The Company’s lead therapeutic candidate, luspatercept, is being evaluated in Phase 3 studies for the treatment of the hematologic diseases myelodysplastic syndromes (MDS) and beta-thalassemia under a global partnership with Celgene Corp. Acceleron is also advancing clinical programs in the fields of oncology and neuromuscular diseases and has a comprehensive preclinical research effort targeting fibrotic and other serious diseases. For more information, please visit http://acceleronpharma.com/. Follow Acceleron on Social Media: @AcceleronPharma and LinkedIn. Celgene Corporation, headquartered in Summit, New Jersey, is an integrated global biopharmaceutical company engaged primarily in the discovery, development and commercialization of innovative therapies for the treatment of cancer and inflammatory diseases through next-generation solutions in protein homeostasis, immuno-oncology, epigenetics, immunology and neuro-inflammation. For more information, please visit www.celgene.com. Follow Celgene on Social Media: @Celgene, Pinterest, LinkedIn, FaceBook and YouTube. This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Such forward-looking statements include those regarding the potential benefits of, and plans relating to the collaboration between Acceleron and Celgene; the potential of luspatercept as a therapeutic drug; and the benefit of each company’s strategic plans and focus. The words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “would,” “could,” “potential,” “possible,” “hope” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Such statements are subject to numerous important factors, risks and uncertainties that may cause actual events or results to differ materially from current expectations and beliefs. For example, there can be no guarantee that any product candidate will be successfully developed or complete necessary preclinical and clinical phases, or that development of any of product candidates will successfully continue. There can be no guarantee that any positive developments will result in stock price appreciation. Each company’s management's expectations and, therefore, any forward-looking statements in this press release, could also be affected by risks and uncertainties relating to a number of other important factors, including: results of clinical trials and preclinical studies, including subsequent analysis of existing data and new data received from ongoing and future studies; the content and timing of decisions made by the U.S. FDA and other regulatory authorities, investigational review boards at clinical trial sites and publication review bodies; the ability to obtain and maintain requisite regulatory approvals and to enroll patients in planned clinical trials; competitive factors; the ability to obtain, maintain and enforce patent and other intellectual property protection for any product candidates ; the ability to maintain key collaborations; and general economic and market conditions. These and other risks are described in greater detail under the caption "Risk Factors" included in each company’s public filings with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and neither company has any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required by law.


CAMBRIDGE, Mass.--(BUSINESS WIRE)--Acceleron Pharma Inc. (NASDAQ:XLRN), a clinical stage biopharmaceutical company focused on the discovery, development and commercialization of innovative therapeutics to treat serious and rare diseases, today announced that two abstracts on luspatercept will be presented at the 22nd Congress of the European Hematology Association (EHA) in Madrid, Spain on June 22-25, 2017. Luspatercept is being developed as part of the global collaboration between Acceleron and Celgene. The oral and poster presentations will include efficacy, duration of response, and long-term safety results from the ongoing Phase 2 studies with luspatercept in myelodysplastic syndromes (MDS) and beta-thalassemia. The presentations at the conference will include updated information beyond that included in the abstracts available online on the EHA conference website. The beta-thalassemia presentation will review results updated from the ASH 2016 presentation in December and the MDS presentation will highlight results updated from the recent International Symposium on MDS earlier this month. The luspatercept clinical poster and slides from the oral presentation will be available immediately following the presentations at the conference in the “Science” section on Acceleron’s website, www.acceleronpharma.com. Luspatercept is a modified activin receptor type IIB fusion protein that acts as a ligand trap for members in the transforming growth factor-beta superfamily involved in the late stages of erythropoiesis (red blood cell production). Luspatercept regulates late-stage erythrocyte (red blood cell) precursor cell differentiation and maturation. This mechanism of action is distinct from that of erythropoiesis stimulating agents (ESAs), which stimulate the proliferation of early-stage erythrocyte precursor cells. Acceleron and Celgene are jointly developing luspatercept as part of a global collaboration. Phase 3 clinical trials are underway to evaluate the safety and efficacy of luspatercept in patients with myelodysplastic syndromes (the “MEDALIST” study) and in patients with beta-thalassemia (the “BELIEVE” study). For more information, please visit www.clinicaltrials.gov. Acceleron is a clinical stage biopharmaceutical company focused on the discovery, development and commercialization of innovative therapeutics to treat serious and rare diseases. Its pioneering research platform leverages the powerful biology behind the body’s ability to rebuild and repair its own cells and tissues. This approach to drug discovery has generated four therapeutic candidates that are currently in clinical trials. The Company’s lead therapeutic candidate, luspatercept, is being evaluated in Phase 3 studies for the treatment of the hematologic diseases myelodysplastic syndromes (MDS) and beta-thalassemia under a global partnership with Celgene Corp. Acceleron is also advancing clinical programs in the fields of oncology and neuromuscular diseases and has a comprehensive preclinical research effort targeting fibrotic and other serious diseases. For more information, please visit www.acceleronpharma.com. Follow Acceleron on social media: @AcceleronPharma and LinkedIn.


News Article | July 21, 2017
Site: globenewswire.com

COEUR D’ALENE, Idaho, July 21, 2017 (GLOBE NEWSWIRE) -- Idaho Independent Bank (”IIB” or the “Bank”) (OTC Pink:IIBK), announced that Kurt R. Gustavel has been appointed as Chief Executive Officer of the Bank, effective January 1, 2018.  Kurt Gustavel will succeed current CEO and Chairman of the Board, Jack W. Gustavel, who will continue as Executive Chairman of the Board of Directors in accordance with IIB’s management succession plan.  “The Bank is executing on its ambitious long-term, strategic plan.  The momentum is positive, and Kurt’s leadership has been a big part of IIB’s success.  He has the experience and talent to take the Bank to the next level,” Jack said. Kurt’s new title will be President and Chief Executive Officer.  Kurt has over 26 years of banking experience.  He joined IIB in 1994, was elected to the Bank’s Board of Directors in 2003, and was appointed President and Chief Operating Officer in 2005.  Kurt holds a bachelors degree from the University of Idaho and is a 2004 graduate of the ABA Stonier Graduate School of Banking.  He is currently active in the Young Presidents' Organization and serves as Treasurer of the Idaho Chapter. IIB was established in 1993 as an Idaho state-chartered, commercial bank that operates branches in Boise (3), Caldwell, Coeur d’Alene, Hayden, Meridian, Mountain Home, Nampa, Star, and Sun Valley/Ketchum, Idaho. IIB earned honorable mention as one of the Best Places to Work in Idaho through a survey conducted by Populus in 2016 & 2017, was named to DepositAccounts.com’s Top 200 Healthiest Banks in America in 2015 & 2016, and was named among the top 1% most extraordinary banks in the U.S. by The Institute for Extraordinary BankingTM in 2016. The Bank has approximately 200 employees throughout the State of Idaho. To learn more about IIB, visit us online at www.theidahobank.com. Statements contained herein concerning future performance, developments or events, expectations for earnings, growth and market forecasts, and similar statements that are not historical facts are intended to be “forward-looking statements” as that term is defined in the Private Securities Litigation Reform Act of 1995, and as such, are subject to a number of risks and uncertainties that may cause actual results to differ materially from expectations or our stated objectives. Factors that could cause actual results to differ materially; include, but are not limited to, declines in regional and general economic conditions; changes in interest rates, deposit flows, demand for loans, real estate values, competition, and/or loan delinquency rates; changes in accounting principles, practices, policies, or guidelines; changes in legislation or regulations; changes in the regulatory environment; changes in monetary policy of the Federal Reserve Bank; changes in fiscal policy of the Federal government and the State of Idaho; changes in other economic, competitive, governmental, regulatory, and technological factors affecting operations, pricing, products, and services; material unforeseen changes in the liquidity, results of operations, or financial condition of the Bank's customers .  Accordingly, these factors should be considered in evaluating forward-looking statements, and there should not be undue reliance placed on such statements. The Bank undertakes no responsibility to update or revise any forward-looking statements.


News Article | July 13, 2017
Site: globenewswire.com

COEUR D’ALENE, Idaho, July 13, 2017 (GLOBE NEWSWIRE) -- Jack W. Gustavel, Chairman and Chief Executive Officer of Idaho Independent Bank (“IIB” or the “Bank”) (OTC Pink:IIBK), announced IIB’s unaudited, consolidated financial results for the second quarter and year-to-date ending June 30, 2017. Pre-tax income for the second quarter was $1.9 million, an increase of 58% over the $1.2 million earned in the second quarter of 2016.  Net income after taxes for 2017 was $1.2 million, or $0.15 per diluted share, compared to $1.1 million, or $0.13 per diluted share, for the second quarter of 2016.  “Pre-tax income was helped by strong loan and deposit growth and an increase in the Bank’s net interest margin,” Mr. Gustavel said.  Income tax expense for the 2016 quarter included a $294,000 benefit related to a reversal of the Bank’s deferred tax valuation allowance, while there was no reversal in 2017. After-tax income for the six months ended June 30, 2017, was $2.0 million, or $0.25 per diluted share, compared to $1.8 million, or $0.23 per diluted share, for 2016.  The 2016 income tax expense was reduced by a valuation allowance reversal that totaled $513,000, while there was no reversal in 2017. At June 30, 2017, the Bank's total assets were $661.4 million, an increase of $70.6 million, or 11.9%, when compared to June 30, 2016.  Total loans, including loans held-for-sale, increased $42.0 million, or 13.5%, to $354.0 million; while deposits and repurchase agreements increased $66.7 million, or 13.0%, to $578.2 million over the same timeframe.  As of June 30, 2017, the allowance for loan and lease losses was $6.3 million, or 1.8% of total loans, excluding loans held-for-sale, and nonperforming assets were less than 0.2% of total assets. As of quarter end, the Bank’s stockholders' equity to average total assets was 10.0%, and its capital ratios exceeded the regulatory thresholds required to be considered “Well-Capitalized.”  During the quarter, the Bank purchased 70,617 shares of its common stock at a cost of $684,293.  IIB may still purchase shares worth up to $1.4 million under its current buyback approval. IIB will file its Consolidated Report of Condition and Income for the quarter ended June 30, 2017, ("Call Report") with the Federal Deposit Insurance Corporation by July 30, 2017.  The Call Report will be posted on the Federal Financial Institutions Examinations Council website at http://cdr.ffiec.gov/public/. IIB was established in 1993 as an Idaho state-chartered, commercial bank that operates branches in Boise (3), Caldwell, Coeur d’Alene, Hayden, Meridian, Mountain Home, Nampa, Star, and Sun Valley/Ketchum, Idaho.  IIB earned honorable mention as one of the Best Places to Work in Idaho through a survey conducted by Populus in 2016 & 2017, was named to DepositAccounts.com’s Top 200 Healthiest Banks in America in 2015 & 2016, and was named among the top 1% most extraordinary banks in the U.S. by The Institute for Extraordinary BankingTM in 2016.  The Bank has approximately 200 employees throughout the State of Idaho. To learn more about IIB, visit us online at www.theidahobank.com. Statements contained herein concerning future performance, developments or events, expectations for earnings, growth and market forecasts, and similar statements that are not historical facts are intended to be “forward-looking statements” as that term is defined in the Private Securities Litigation Reform Act of 1995, and as such, are subject to a number of risks and uncertainties that may cause actual results to differ materially from expectations or our stated objectives. Factors that could cause actual results to differ materially, include, but are not limited to, declines in regional and general economic conditions; changes in interest rates, deposit flows, demand for loans, real estate values, competition, and/or loan delinquency rates; changes in accounting principles, practices, policies, or guidelines; changes in legislation or regulations; changes in the regulatory environment; changes in monetary policy of the Federal Reserve Bank; changes in fiscal policy of the Federal government and the State of Idaho; changes in other economic, competitive, governmental, regulatory, and technological factors affecting operations, pricing, products, and services; material unforeseen changes in the liquidity, results of operations, or financial condition of the Bank's customers .  Accordingly, these factors should be considered in evaluating forward-looking statements, and there should not be undue reliance placed on such statements. The Bank undertakes no responsibility to update or revise any forward-looking statements.


News Article | May 29, 2017
Site: www.prnewswire.com

NEW YORK, May 29, 2017 /PRNewswire/ -- This report analyzes the worldwide markets for Contract Research Outsourcing in US$ Million by the following Service Segments: Drug Discovery, Preclinical Research, and Clinical Research. The report provides separate comprehensive analytics for the US, Canada, Japan, Europe, Asia-Pacific, and Rest of World. Annual estimates and forecasts are provided for the period 2015 through 2022. Also, a six-year historic analysis is provided for these markets. Read the full report: http://www.reportlinker.com/p04910444/Global-Contract-Research-Outsourcing-Services.html Market data and analytics are derived from primary and secondary research. Company profiles are primarily based on public domain information including company URLs. The report profiles 115 companies including many key and niche players such as - Albany Molecular Research, Inc. - Charles River Laboratories International, Inc. - Chiltern International Ltd. - ICON plc Read the full report: http://www.reportlinker.com/p04910444/Global-Contract-Research-Outsourcing-Services.html I. INTRODUCTION, METHODOLOGY & PRODUCT DEFINITIONS Study Reliability and Reporting Limitations Disclaimers Data Interpretation & Reporting Level Quantitative Techniques & Analytics Product Definitions and Scope of Study II. EXECUTIVE SUMMARY 1. INDUSTRY OVERVIEW Outsourcing of R&D Projects to Propel CROs Services Market Growth Drivers in a Nutshell Evolving Macro Trends Driving CRO Demand CROs to Significantly Drive Outsourcing Penetration Focus on Efficient, Quality Services to Drive Specialty CROs Market Rise in Investments to Boost Growth Key Therapeutic Areas of Clinical Trial Research Table 1: Global Clinical Trial Services Market by Therapeutic Area: 2016 (includes corresponding Graph/Chart) Primary Factors Influencing CRO Market Pharma and Biotech Companies to Increase Dependence on CROs Outlook Notable Regional Developments Future Model of CRO 2. COMPETITIVE SCENARIO CRO - A Highly Fragmented Market Table 2: Leading Players in the Global Contract Research Outsourcing Market (2016E): Percentage Breakdown of Revenues by Player (includes corresponding Graph/Chart) Table 3: Percentage Breakup of Life Sciences Revenues (2016) of Major Players by Service Type- Preclinical, Phase I, Phase IIA, Phase IIB, Phase III, Phase IV/ Post-Approval, Central Lab and Others Large CROs Seek the Inorganic Growth Route Global CRO Marketspace - A Review of the M&A Activity in the Recent Years Select M&A Activity in the Global CRO Market Noteworthy Contracts of Major CROs CROs Adept with New Technologies to See More Business in Future Streamlining Development of Novel Trial Designs CROs with End-to End Capabilities in Demand Key Opportunities for CROs Technological Superiority - A Definite Advantage Strategies and Tactical Programs for CROs Survival Strategies in Mature CRO Markets Exit from the Industry Expand Scale Capture Niche Segments Strategies to Tap Opportunities in Growing Markets Mobilize Funds Expand Other Services Upgrade Technological and Knowledge Base Form Sub-Contracts or Regional Alliances 3. GROWTH DRIVERS, MARKET TRENDS & ISSUES Increased Spend on R&D Outsourcing Table 4: Global Pharmaceutical R&D Spending (US$ Billion) for the Years 2010 through 2017 (includes corresponding Graph/Chart) Table 5: Percentage Breakdown of Total Number of Compounds in Pipeline by Phase for Pre-Clinical, Phase I, Phase II and Phase III: 2016E (includes corresponding Graph/Chart) Enhancing Site Selection and Patient Enrollment CROs Enter into Alliances to Improve Efficiencies Adoption of Digital Technologies Gains Pace Rising Late-Stage Services Demand and Budget Restraints Drive Market Growth Toxicology Services Gain Notable Attention Pharma Companies Enter into Licensing Agreements with Biotech Companies for New Drug Discovery - A Mutually Beneficial Strategy Pharmaceutical & Biopharmaceutical Trends to Support CRO Penetration Table 6: Global Biopharma % R&D Outsourcing (2014-2020) (includes corresponding Graph/Chart) Table 7: New FDA Drug Approvals (2010-2016): Breakdown of Number of Approvals by Type for New Molecular Entity (NME) and Biologic License Application (BLA) Approvals (includes corresponding Graph/Chart) Focus on Regulatory Oversight and Enhanced Transparency Bodes Well for CROs eClinical Solutions Gain Traction Other Noteworthy Market Trends CROs Monetize Data Service Differentiation - A Sustaining Strategy CROs Tie Up with Diagnostic Companies for Patients Research Networks Move to Cloud Application of Mobile Devices to Collect Real Time Data Gains Ground CROs Provide Exclusive Offers to Lure Big Pharma Challenges Faced by Contract Research Organizations On-shore versus Offshore CRO Business Cutthroat Competition among CROs Management of Clinical Investigation Cost Containment Safety Concerns on Clinical Trials Pipeline Blocks Surging Global Population Offers Increased Growth Opportunities Table 8: Top 25 Countries Worldwide in Terms of Population: 2015 & 2016 (In Million) (includes corresponding Graph/Chart) Aging Population Boosts Opportunities for CRO Table 9: Global Population Statistics for the 65+ Age Group (2015) (includes corresponding Graph/Chart) Table 10: Comparison of Aging Population by Country (1980, 2015 & 2050): Percentage Share of Population Aged Above-65 Years of the Overall Population for Select Countries (includes corresponding Graph/Chart) Increasing Healthcare Expenditure to Spur Demand for Generics Table 11: Healthcare Spending as a Percentage of GDP by Region (2016E) (includes corresponding Graph/Chart) 4. CONTRACT RESEARCH OUTSOURCING - AN INSIGHT Concept Contract Research Organizations (CRO) Contract Research Outsourcing Major CRO Services Ancillary CRO Services Advantages from CRO Drug Discovery Pre-Clinical Studies Clinical Research - Factors Encouraging CRO Services at Various Phases Phase I Phase II Phase III Phase IV 5. RECENT INDUSTRY ACTIVITY WuXi AppTec Takes Over HD Biosciences Laboratory Corporation of America Holdings to Acquire Pharmaceutical Product Development PRA Health Sciences and Takeda Pharmaceutical Inks New Partnership AMRI Enters into Alliance with Bruker Daltonics and HighRes Biosolutions Pharmaceutical Product Development Establishes Rare Disease and Pediatric Center of Excellence Pharmaceutical Product Development to Start Clinical Research Unit in Las Vegas Bracket Acquires CLINapps PAREXEL International to Acquire ExecuPharm Cinven to Takeover BioClinica ICON to Takeover Clinical Research Management Pharmaceutical Product Development Acquires Evidera Velocity Fund Partners Acquires Indipharm Bioclinica Snaps Up Compass Research Charles River Laboratories International Takes Over Agilux Laboratories Charles River Laboratories International Snaps Up Blue Stream Laboratories Charles River Laboratories International Acquires WIL Research Pharmaron Announces the Acquisition of Quotient Bioresearch Amulet Capital Partners Acquires SynteractHCR Holdings IMS Health Merges with Quintiles Almac Clinical Technologies Enters into Partnership with inVentiv Health CSSi LifeSciences Unveils Fully Integrated Medical Device CRO Lovelace Biomedical Commences Operations as Preclinical CRO PAREXEL International Inks Services Agreement with Pfizer BioDuro Commences Operations as a Contract Research and Manufacturing Firm Charles River Laboratories International Forms Partnership with BioMotiv Laboratory Corporation of America Acquires Covance Charles River Laboratories International Snaps Up Oncotest Chiltern Acquires Theorem Clinical Research Charles River Laboratories International Takes Over Celsis International Albany Molecular Research Unveils Integrated Drug Discovery Center 6. FOCUS ON SELECT GLOBAL PLAYERS Albany Molecular Research, Inc. (USA) Charles River Laboratories International, Inc. (USA) Chiltern International Ltd. (UK) ICON plc (Ireland) INC Research, LLC (USA) InVentiv Health, Inc. (USA) Jubilant Biosys Ltd. (India) Laboratory Corporation of America® Holdings (USA) PAREXEL International Corp. (USA) Pharmaceutical Product Development, LLC. (USA) Pharmaron (China) PRA Health Sciences, Inc. (USA) Quintiles IMS Holdings, Inc. (USA) Ricerca Biosciences LLC (USA) Sygnature Discovery Limited (UK) SynteractHCR (USA) WuXi AppTec (China) 7. GLOBAL MARKET PERSPECTIVE Table 12: World Recent Past, Current & Future Analysis for Contract Research Outsourcing by Geographic Region - US, Canada, Japan, Europe, Asia-Pacific (excluding Japan) and Rest of World Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart) Table 13: World Historic Review for Contract Research Outsourcing by Geographic Region - US, Canada, Japan, Europe, Asia-Pacific (excluding Japan) and Rest of World Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart) Table 14: World 14-Year Perspective for Contract Research Outsourcing by Geographic Region - Percentage Breakdown of Revenues for US, Canada, Japan, Europe, Asia-Pacific (excluding Japan) and Rest of World Markets for Years 2009, 2017 & 2022 (includes corresponding Graph/Chart) Table 15: World Recent Past, Current & Future Analysis for Contract Research Outsourcing for Drug Discovery by Geographic Region - US, Canada, Japan, Europe, Asia-Pacific (excluding Japan) and Rest of World Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart) Table 16: World Historic Review for Contract Research Outsourcing for Drug Discovery by Geographic Region - US, Canada, Japan, Europe, Asia-Pacific (excluding Japan) and Rest of World Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart) Table 17: World 14-Year Perspective for Contract Research Outsourcing for Drug Discovery by Geographic Region - Percentage Breakdown of Revenues for US, Canada, Japan, Europe, Asia-Pacific (excluding Japan) and Rest of World Markets for Years 2009, 2017 & 2022 (includes corresponding Graph/Chart) Table 18: World Recent Past, Current & Future Analysis for Contract Research Outsourcing for Preclinical Research by Geographic Region - US, Canada, Japan, Europe, Asia-Pacific (excluding Japan) and Rest of World Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart) Table 19: World Historic Review for Contract Research Outsourcing for Preclinical Research by Geographic Region - US, Canada, Japan, Europe, Asia-Pacific (excluding Japan) and Rest of World Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart) Table 20: World 14-Year Perspective for Contract Research Outsourcing for Preclinical Research by Geographic Region - Percentage Breakdown of Revenues for US, Canada, Japan, Europe, Asia-Pacific (excluding Japan) and Rest of World Markets for Years 2009, 2017 & 2022 (includes corresponding Graph/Chart) Table 21: World Recent Past, Current & Future Analysis for Contract Research Outsourcing for Clinical Research by Geographic Region - US, Canada, Japan, Europe, Asia-Pacific (excluding Japan) and Rest of World Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart) Table 22: World Historic Review for Contract Research Outsourcing for Clinical Research by Geographic Region - US, Canada, Japan, Europe, Asia-Pacific (excluding Japan) and Rest of World Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart) Table 23: World 14-Year Perspective for Contract Research Outsourcing for Clinical Research by Geographic Region - Percentage Breakdown of Revenues for US, Canada, Japan, Europe, Asia-Pacific (excluding Japan) and Rest of World Markets for Years 2009, 2017 & 2022 (includes corresponding Graph/Chart) III. MARKET 1. THE UNITED STATES A.Market Analysis Outlook Drug Developers Rely on CROs to Improve Trial Efficiency and Cost Savings Trial Services Witness Higher Demand Strong Demand for Data Management Services Focus on Innovation and Productivity CROs Focus on Adaptive Clinical Trials Risk-based Monitoring Catches Pace Strategic Corporate Developments Key Players B.Market Analytics Table 24: US Recent Past, Current & Future Analysis for Contract Research Outsourcing by Service Type - Drug Discovery, Preclinical Research and Clinical Research Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart) Table 25: US Historic Review for Contract Research Outsourcing by Service Type - Drug Discovery, Preclinical Research and Clinical Research Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart) Table 26: US 14-Year Perspective for Contract Research Outsourcing by Service Type - Percentage Breakdown of Revenues for Drug Discovery, Preclinical Research and Clinical Research Markets for Years 2009, 2017 & 2022 (includes corresponding Graph/Chart) 2. CANADA Market Analysis Table 27: Canadian Recent Past, Current & Future Analysis for Contract Research Outsourcing by Service Type - Drug Discovery, Preclinical Research and Clinical Research Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart) Table 28: Canadian Historic Review for Contract Research Outsourcing by Service Type - Drug Discovery, Preclinical Research and Clinical Research Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart) Table 29: Canadian 14-Year Perspective for Contract Research Outsourcing by Service Type - Percentage Breakdown of Revenues for Drug Discovery, Preclinical Research and Clinical Research Markets for Years 2009, 2017 & 2022 (includes corresponding Graph/Chart) 3. JAPAN A.Market Analysis Strategic Corporate Development B.Market Analytics Table 30: Japanese Recent Past, Current & Future Analysis for Contract Research Outsourcing by Service Type - Drug Discovery, Preclinical Research and Clinical Research Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart) Table 31: Japanese Historic Review for Contract Research Outsourcing by Service Type - Drug Discovery, Preclinical Research and Clinical Research Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart) Table 32: Japanese 14-Year Perspective for Contract Research Outsourcing by Service Type - Percentage Breakdown of Revenues for Drug Discovery, Preclinical Research and Clinical Research Markets for Years 2009, 2017 & 2022 (includes corresponding Graph/Chart) 4. EUROPE A.Market Analysis Outlook Providers Expand Services in Downstream Drug Development Strategic corporate developments Key Players B.Market Analytics Table 33: European Recent Past, Current & Future Analysis for Contract Research Outsourcing by Service Type - Drug Discovery, Preclinical Research and Clinical Research Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart) Table 34: European Historic Review for Contract Research Outsourcing by Service Type - Drug Discovery, Preclinical Research and Clinical Research Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart) Table 35: European 14-Year Perspective for Contract Research Outsourcing by Service Type - Percentage Breakdown of Revenues for Drug Discovery, Preclinical Research and Clinical Research Markets for Years 2009, 2017 & 2022 (includes corresponding Graph/Chart) 5. ASIA-PACIFIC A.Market Analysis Outlook Asia-Pacific to Push up Volume Share in CRO Market R&D Outsourcing in Life Sciences on Rise Focus on Select Regional Markets China Market with Strong Growth Potential India Australia Popular Destination for Early Phase Clinical Trials Cost Savings through Tax Incentives Supportive Regulatory Framework Government Focus on Reducing Cost and Time Superior Clinical Trial Quality Strategic Corporate Development Key Players B.Market Analytics Table 36: Asia-Pacific Recent Past, Current & Future Analysis for Contract Research Outsourcing by Geographic Region - China, India and Rest of Asia-Pacific Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart) Table 37: Asia-Pacific Historic Review for Contract Research Outsourcing by Geographic Region - China, India and Rest of Asia-Pacific Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart) Table 38: Asia-Pacific 14-Year Perspective for Contract Research Outsourcing by Geographic Region - Percentage Breakdown of Revenues for China, India and Rest of Asia-Pacific Markets for Years 2009, 2017 & 2022 (includes corresponding Graph/Chart) Table 39: Asia-Pacific Recent Past, Current & Future Analysis for Contract Research Outsourcing by Service Type - Drug Discovery, Preclinical Research and Clinical Research Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart) Table 40: Asia-Pacific Historic Review for Contract Research Outsourcing by Service Type - Drug Discovery, Preclinical Research and Clinical Research Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart) Table 41: Asia-Pacific 14-Year Perspective for Contract Research Outsourcing by Service Type - Percentage Breakdown of Revenues for Drug Discovery, Preclinical Research and Clinical Research Markets for Years 2009, 2017 & 2022 (includes corresponding Graph/Chart) 6. REST OF WORLD A.Market Analysis Outlook Providers with Specialized Research Techniques to Boost Latin American CRO Market B.Market Analytics Table 42: Rest of World Recent Past, Current & Future Analysis for Contract Research Outsourcing by Service Type - Drug Discovery, Preclinical Research and Clinical Research Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart) Table 43: Rest of World Historic Review for Contract Research Outsourcing by Service Type - Drug Discovery, Preclinical Research and Clinical Research Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart) Table 44: Rest of World 14-Year Perspective for Contract Research Outsourcing by Service Type - Percentage Breakdown of Revenues for Drug Discovery, Preclinical Research and Clinical Research Markets for Years 2009, 2017 & 2022 (includes corresponding Graph/Chart) IV. COMPETITIVE LANDSCAPE Total Companies Profiled: 115 (including Divisions/Subsidiaries - 120) The United States (47) Canada (5) Japan (1) Europe (27) - France (2) - Germany (6) - The United Kingdom (3) - Spain (1) - Rest of Europe (15) Asia-Pacific (Excluding Japan) (35) Latin America (4) Read the full report: http://www.reportlinker.com/p04910444/Global-Contract-Research-Outsourcing-Services.html About Reportlinker ReportLinker is an award-winning market research solution. Reportlinker finds and organizes the latest industry data so you get all the market research you need - instantly, in one place. http://www.reportlinker.com __________________________ Contact Clare: clare@reportlinker.com US: (339)-368-6001 Intl: +1 339-368-6001 To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/global-contract-research-outsourcing---services-300465052.html


News Article | February 28, 2017
Site: www.eurekalert.org

Adding two blood-borne proteins associated with cancer cell migration increases the predictive ability of the current biomarker for pancreatic cancer to detect early stage disease, a research team from The University of Texas MD Anderson Cancer Center reports in the Journal of the National Cancer Institute. The trio of biomarkers, tested in three separate cohorts, including two blinded validation studies, improved the detection of patients with early stage disease compared to healthy or benign disease controls. "Adding these two biomarkers provided statistically significant improvement for all early stage cancer versus healthy controls as well as other subcohorts when used with the current gold standard biomarker, CA 19-9," said Ann Killary, Ph.D., professor of Translational Molecular Pathology. While CA 19-9 is the only biomarker approved for use by the U.S. Food and Drug Administration, and only for monitoring treatment for the disease, according to first author Seetharaman Balasenthil, Ph.D., instructor in Translational Molecular Pathology. The marker of antigens produced by pancreatic cancer has a low positive predictive value for identifying early stage disease. At early stages, pancreatic cancer can be successfully removed with surgery, but 80 percent of patients are diagnosed with either locally advanced disease (stage III) or cancer that has spread to other organs (stage IV), when surgery is no longer a curative option. Pancreatic cancer is the fourth-leading cause of deaths from cancer in the United States, with an estimated 53,070 new cases diagnosed in 2016 and 41,780 deaths, according to the National Cancer Institute. "Our goal is to identify more patients at those earlier, resectable stages, when treatment could lead to a five year survival rate of 30 percent or more, depending on stage," Killary said. Only about 7 percent of patients survive for five years following diagnosis of the disease. Additional studies in larger cohorts will be needed to validate these findings, and more biomarkers will be needed to get the completely accurate set needed to screen the general population with the long term goal of identifying precursor lesions before they become malignant. Killary and colleagues earlier identified a cluster of genes involved in cancer migration and then analyzed the proteins produced by those genes. Two, known as TFPI and tenascin C, emerged as the strongest biomarker candidates. The team first compared their predictive ability by comparing their presence in healthy volunteers and those with primarily stage IV pancreatic cancer. In the current study, deploying TFPI and an isoform of tenascin C, TNC-FN IIIC, with CA 19-9 improved performance discriminating stage I and II disease from healthy or benign disease controls. The principal measure of efficacy is called Area Under the Curve (AUC), a measure of how well biomarkers identify true cases of disease (sensitivity) while avoiding false positives (specificity). A perfect AUC would have a score of 1.0. Any biomarker test for the general public will need to be close to a perfect 1.0, Killary noted, given the infrequency of pancreatic cancer in the population at large. In the group's analysis of three cohorts of samples, AUC scores for the combination consistently outscored CA-19-9 alone. For the first cohort of samples, comparing stage I/IIA and healthy controls yielded an AUC of 0.72 for CA-19-9 alone compared to 0.84 for the combination. For stage IIB vs. controls, the combination raised CA-19-9's performance from an AUC of 0.87 to 0.98. The second blinded cohort also showed improvements in AUC over CA19-9. A third, larger blinded validation study of 252 samples of cases and controls from the Early Detection Research Network of the National Cancer Institute further confirmed those findings and also permitted the team to measure the trio's ability to detect disease in patients without a history of pancreatitis or diabetes. The AUC for those patients was 0.87 for Stage I/IIA, 0.93 for Stage IIB and 0.89 for all early stages of the disease using the combination, pointing to a potential ability to detect disease in those who lack either of those known risk-raising conditions. Killary said the team is working to use the biomarkers in MD Anderson's high-risk clinic, established through MD Anderson's Pancreatic Cancer Moon Shot™, part of the institution's Moon Shots Program™ to accelerate the development of life-saving advances based on scientific discovery. The clinic monitors people who are already at high risk of pancreatic cancer due to family history or having known risk-raising genetic mutations. "In this population, our biomarker panel might prove very useful in early detection," Killary said. Co-author Subrata Sen, Ph.D., also a professor of Molecular Translational Pathology, notes, "These findings are a significant advance considering that there's nothing else available now to detect early stage pancreatic cancer that has gone through blinded validations in multiple patient cohorts." Co-authors with Killary, Balasenthil and Sen are Nanyue Chen, M.D., Ph.D., of Translational Molecular Pathology; Suyu Liu, Ph.D., and J. Jack Lee, Ph.D., of Biostatistics; Jinyun Chen, M.D., Pharm.D., and Marsha Frazier, Ph.D. of Epidemiology; Ying Huang, Ph.D., and Tracey Marsh, of Fred Hutchinson Cancer Research Center, Seattle; Sanford Stass, M.D., and Debra KuKuruga , Ph.D., of the University of Maryland Medical Center, Baltimore; Randall Brand, M.D., University of Pittsburgh Medical Center; and Sudhir Srivastava, M.D., of the National Cancer Institute. This research was funded by Early Detection Research Network grants (U01 CA111302 and U24 CA115091-10) and by MD Anderson's Moon Shots Program.


Designer version 5.2 now also available with the latest SWIFT Standards Release 2017 NEW YORK, NY and LONDON, UNITED KINGDOM and DUBAI, UNITED ARAB EMIRATES and MEXICO CITY, MEXICO--(Marketwired - March 01, 2017) - Volante Technologies Inc., a global leader in the provision of software for the integration, processing and orchestration of financial messages and payments, today announced support for the technology underpinning Microservices Architecture, as well as SWIFT Standards Release 2017. Volante Designer version 5.2 provides comprehensive support for developing and deploying RESTful services - the building blocks of a microservices architecture. As the financial industry shifts towards increasing standardization and collaboration, the responsibility falls on the underlying technology to provide seamless integration of applications and services provided by various institutions such as banks, corporates, service providers and regulatory institutions. Such close coupling is also required to address the regulatory requirements for APIs such as the Open Banking APIs and PSD2. Internal applications, especially within large organizations, will also benefit from distributed RESTful services as they promote scalability, reusability and secure remote access. Volante has the ability to generate REST Client and REST server implementations for any service built using Volante Designer. Additionally, Volante provides native support to convert any standard message to JSON format and vice versa, further facilitating seamless communications using REST APIs. Using these tools, users can develop and deploy a wide range of services based on the REST architecture without writing a single line of code. Volante has been a SWIFT partner for over 15 years and has developed a level of product and standards expertise that is unmatched in the FinTech industry. In Standards Release 2017, SWIFT has introduced significant changes in the payments and securities message categories. Notably, this release includes support for the Global Payments Innovation (GPI) Initiative which provides greater transparency for cross-border payments. Volante has implemented complete support for the new standards, which have been thoroughly tested so customers can be confident of communicating SWIFT messages over the SWIFT network without worrying about rejected messages or non-compliance in the face of continuously changing standards and market practices. In addition to support for REST, JSON and SWIFT, Designer 5.2 features continuous improvement in standards support, platforms support and usability features. This includes: updated versions for standards such as NACHA, FIX, ISO 20022 and US-TCH-RTP; support for Postgres DB and other enhancements to Persistence Designer; and a new Connector for Mulesoft and updates to support for IBM Integration Bus (IIB). Venkat Malla, VP, Product Management, Volante Technologies, said, "We continue to work closely with clients and industry participants in order to understand and anticipate their needs and challenges, which in turn determines our product roadmap. By introducing comprehensive support for REST and JSON standards, clients are able to not only interface with modern infrastructure like blockchain and DLT (Distributed Ledger Technology) but also build out their own user interfaces." Fiona Hamilton, VP Europe and Asia, commented, "Being personally very active in standards groups, I continually see the ever-evolving nature of financial messaging standards. We respond by being dedicated to not only tracking and including those changes, but also offering support for those new standards quickly and efficiently. In the latest SWIFT release, firms will be able to take advantage of the benefits of GPI by enabling them to grow their international business, improve supplier relationships and achieve greater treasury efficiencies. By delivering updates within days of SWIFT publishing the final version, our clients have ample time to assess, test and incorporate the changes into their processes well ahead of the go-live deadlines." Founded in 2001, Volante Technologies is a global leader in the provision of software for the integration, processing and orchestration of payments and financial messages within financial institutions and corporate enterprises. Volante is dedicated to helping firms manage challenges in this domain with greater ease and speed so that they can focus on the business of being competitive in their marketplace. Product features such as configuration rather than coding, automated code and documentation generation and an inbuilt test harness, promise significantly accelerated project completions. Volante serves a growing client base of more than 80 financial institutions and corporate enterprises operating in 26 countries around the world, including several of the largest global financial organizations. Many clients use Volante to assist with multiple product implementations ranging from message transformation and integration, through to the processing and orchestration of transaction data and payments. Along with its products, Volante Designer, VolPay Foundation, VolPay Channel and VolPay Hub, Volante constantly maintains a growing library of over 100 domestic and international financial industry standards plugins. These standards include; SWIFT MT and MX, ISO 8583, FIX, FpML, EDIFACT, ISO 20022, SEPA, BACS, US TCH and Fedwire, and proprietary formats based on XML, CSV and Fixed Width. Volante's financial message plugins are further augmented by more than 250 prebuilt, customizable, bidirectional transformations to and from these standards. Supported by offices in Jersey City, London, Dubai, Mexico City, Hyderabad, Chennai and Pune, Volante solutions are employed by a diverse set of organizations, including buy-side and sell-side capital market institutions, banks (universal, commercial and retail), corporate treasuries, financial industry utilities, clearing houses, exchanges, systems integrators, application vendors and corporate enterprises. By working with a global and diverse client base Volante is able to encapsulate a best practice approach into all its product lines. For further information please visit: www.volantetech.com


PRINCETON, N.J., Feb. 15, 2017 /PRNewswire/ -- Signum Biosciences, Inc. ("Signum") announced today that the National Institute of Allergy and Infectious Diseases (NIAID) awarded the company a Small Business Innovation Research (SBIR) Phase IIB grant totaling $3.0 million over 3 years for t...

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