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2010-06-23T11:10:06+01:00
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22.06.2010 | Business Wire: ImmunoGen, Inc. Announces Vice President Promotions in Product Development | Business Wire
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WALTHAM, Mass.-(BUSINESS WIRE)-ImmunoGen, Inc. (Nasdaq: IMGN), a biopharmaceutical company that develops targeted anticancer therapeutics, today announced the promotion to vice president of two executive directors Godfrey Amphlett, Ph.D., and Robert J. Lutz, Ph.D. who have played central roles in establishing ImmunoGen s highly successful product development capabilities. These functions complement the Company s strong research capabilities in ImmunoGen s advancement of its own novel anticancer compounds and the industry-leading target-to-commercial product expertise the Company provides to its partners. ImmunoGen has transitioned from being an organization with strong research to one (…)
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22.06.2010 | Business Wire: Ablexis Appoints R. Scott Greer Chairman of the Board and Richard Hoffman Chief Business Officer | Business Wire
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SAN FRANCISCO-(BUSINESS WIRE)-Ablexis, LLC, a biotechnology company dedicated to developing the AlivaMab Mouse, an innovative next-generation platform for antibody drug discovery, announced today the appointments of R. Scott Greer as chairman of the board of directors and Richard Hoffman as chief business officer. These important additions reunite three key leaders from the strategic, commercial and technical foundation of Abgenix, Inc., which was acquired by Amgen for $2.2 billion in 2006. Together, they will apply more than 60 years combined experience and know-how in the field to further enhance and execute Ablexis business strategy. Both Scott and Richard were an integral part of the (…)
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18.06.2010 | NCBI PubMed: Sclerostin: A gem from the genome leads to bone building antibodies.
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J Bone Miner Res. |-| Paszty C, Turner CH, Robinson MK. |-| Metabolic Disorders, Amgen Inc., Thousand Oaks, CA.
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22.06.2010 | BioSpace: Ablexis Appoints R. Scott Greer Chairman of the Board and Richard Hoffman Chief Business Officer
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SAN FRANCISCO-(BUSINESS WIRE)-Ablexis, LLC, a biotechnology company dedicated to developing the AlivaMab Mouse, an innovative next-generation platform for antibody drug discovery, announced today the appointments of R. Scott Greer as chairman of the board of directors and Richard Hoffman as chief business officer. These important additions reunite three key leaders from the strategic, commercial and technical foundation of Abgenix, Inc., which was acquired by Amgen for $2.2 billion in 2006. Together, they will apply more than 60 years combined experience and know-how in the field to further enhance and execute Ablexis business strategy.
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21.06.2010 | Business Wire: The Gamida Cell-Teva Joint Venture Receives FDA Fast Track Designation for StemEx for Leukemia and Lymphoma | Business Wire
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JERUSALEM-(BUSINESS WIRE)-Gamida Cell announced today that the Gamida Cell-Teva Joint Venture has received an FDA Fast Track Designation for StemEx, in development as an alternative to a bone marrow transplant for patients with blood cancers such as leukemia and lymphoma. The fast track programs of the Food and Drug Administration (FDA) are designed to facilitate the development and expedite the review of new drugs that are intended to treat serious or life threatening conditions and that demonstrate the potential to address unmet medical needs (fast track products). The letter sent by the Department of Health and Human Services to the Gamida Cell-Teva Joint Venture stated: your request (…)
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19.06.2010 | NCBI PubMed: G-Protein-Coupled Receptor 35 Is a Target of the Asthma Drugs Cromolyn Disodium and Nedocromil Sodium.
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We report that the asthma drugs cromolyn disodium and nedocromil sodium are potent G-protein-coupled receptor 35 (GPR35) agonists. We utilized calcium flux and inositol phosphate accumulation assays to examine the pharmacology of these asthma drugs on the human, mouse and rat GPR35. The compounds were more potent on the human GPR35 than on mouse and rat receptors. In contrast, zaprinast, a known GPR35 agonist, was more potent on mouse and rat GPR35 than the human ortholog. We show by quantitative PCR that GPR35 is expressed in human mast cells, human basophils and human eosinophils. We also demonstrate that GPR35 mRNA is upregulated upon challenge with IgE antibodies. We show that, unlike (…)
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Medical News Today
18.06.2010 | Medical News Today: Preliminary Draft Guidance Recommends New Osteoporosis Treatment For Women At Increased Risk Of Fractures
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Postmenopausal women who are at increased risk[1] of osteoporotic fractures should be treated with denosumab if treatment with currently available oral bisphosphonates is unsuitable, according to draft guidance published today (Friday 18 June) by NICE. Denosumab (Prolia, Amgen) is a newly-licensed treatment for women at increased risk of osteoporotic fractures, given by injection twice a year. It works by reducing bone breakdown and increases bone mass and strength. Most postmenopausal women at increased risk of osteoporotic fractures are treated with oral bisphosphonates, but for some women these drugs may be unsuitable. Reasons for unsuitability are that a woman is unable to comply with (…)
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18.06.2010 | Business Wire: Vertos Medical Expands Executive Team Amidst Growing Commercial Acceptance of mild | Business Wire
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ALISO VIEJO, Calif.-(BUSINESS WIRE)-Medical device company Vertos Medical Inc. has announced the expansion of its senior leadership team with the appointment of Randel W. Woodgrift to senior vice president of operations and research and development, and Ann Deren-Lewis to vice president of marketing. With decades of leadership experience in their respective functional areas, Woodgrift and Deren-Lewis have been tapped to support the accelerating U.S. commercialization of Vertos mild* technology for the treatment of lumbar spinal stenosis (LSS). Randy has the proven ability to scale up worldwide medical device operations and develop innovative new products, while Ann has significant (…)
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15.06.2010 | NCBI PubMed: Increased aggregation propensity of IgG2 subclass over IgG1: Role of conformational changes and covalent character in isolated aggregates.
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Aggregation of human therapeutic antibodies represents a significant hurdle to product development. In a test across multiple antibodies, it was observed that IgG1 antibodies aggregated less, on average, than IgG2 antibodies under physiological pH and mildly elevated temperature. This phenomenon was also observed for IgG1 and IgG2 subclasses of anti-streptavidin, which shared 95% sequence identity but varied in inter-chain disulfide connectivity. To investigate the structural and covalent changes associated with greater aggregation in IgG2 subclasses, soluble aggregates from the two forms of anti-streptavidin were isolated and characterized. Sedimentation velocity analytical (…)
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01.06.2010 | NCBI PubMed: Characterization of a unique IgG1 mAb CEX profile by limited Lys-C proteolysis/CEX separation coupled with mass spectrometry and structural analysis.
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The unique cation exchange chromatography (CEX) charge variant profile of mAb1 is characterized by a combination of mass spectrometry, limited Lys-C digestion followed by CEX separation and structural analysis. During CEX method development, mAb1 showed several unexpected phenomena, including a unique profile containing two main species (acidic 2 and main) and significant instability during stability studies of the main species. Reduced Lys-C peptide mapping identified a small difference in one of the heavy chain peptides (H4) in acidic 2 and further mass analysis identified this difference as Asn55 deamidation. However, the amount of Asn55 deamidation in acidic 2 could account for only (…)
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18.06.2010 | BioSpace: National Institute for Clinical Excellence (NICE) Recommends Amgen (AMGN)'s Prolia In Postmenopausal Women
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LONDON, June 18 (Reuters) - Britain's health cost watchdog has recommended Amgen's (AMGN.O) new drug Prolia, or denosumab, as a treatment for the brittle bone disease osteoporosis in women who cannot take the older class of bisphosphonate drugs.
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Marketwire
17.06.2010 | Marketwire: New Products Could Add Over $70 Billion to the Pharmaceutical Market in Five Years
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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 (…)
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Medical News Today
16.06.2010 | Medical News Today: SDI Reports: Approximately Half Of Patients Prescribed The Most Popular Osteoporosis Drugs Discontinue Therapy Within 6 Months
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According to a recent analysis by SDI, a leading healthcare market insight and analytics firm, about half of patients beginning therapy on popular osteoporosis drugs discontinue their treatment within 6 months. Amgen's Prolia, which was recently approved for postmenopausal women with osteoporosis at high risk of fracture, or patients who could not tolerate other osteoporosis therapies, is the newest product to enter the market. Prolia differs from existing therapies as it is given every 6 months via injection. Currently, alendronate, sometimes filled as Fosamax but more frequently as the generic equivalent, is the most popular treatment for osteoporosis. In the 12 months ending April 2010, (…)
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16.06.2010 | Business Wire: Shareholders Re-Elect All Members of Genzyme s Board of Directors | Business Wire
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CAMBRIDGE, Mass.-(BUSINESS WIRE)-Genzyme Corporation (NASDAQ: GENZ) announced that all 10 members of its board of directors were re-elected at its annual meeting of shareholders today. Shareholders also approved all of the company s proposals, including those regarding equity plans and the employee stock purchase program. In addition, the board voted to appoint three new directors. Genzyme s board appointed Dennis M. Fenton, Ph.D., a highly regarded industry leader in manufacturing and 25-year veteran of Amgen Inc., as a director. The appointment fulfills the commitment made by Genzyme as part of its agreement with Relational Investors, LLC to nominate an independent director recommended (…)
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16.06.2010 | Business Wire: EHSI Anticipates Hemochromatosis Treatment iPhone App Completion in July | Business Wire
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HOUSTON-(BUSINESS WIRE)-Emerging Healthcare Solutions, Inc. (Pink Sheets:EHSI) provided an update today of management s development progress on the comprehensive MedAnywhere © medical iPhone application and associated modules. EHSI is using VITEB as its application developer. According to the Company, the Hemochromatosis Module for cost-saving Hematocrit monitoring (HHC) should be complete next month. Once EHSI confirms testing, management expects to individually offer the HHC Module app for sale and downloading. HHC is the disease that occurs as a result of significant iron overload and it can have genetic or non-genetic causes. HHC can cause major damage to the heart, liver, pancreas, (…)
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16.06.2010 | Business Wire: Relypsa Appoints Claire J. Lockey Vice President, Regulatory Affairs | Business Wire
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SANTA CLARA, Calif.-(BUSINESS WIRE)-Relypsa, Inc., today announced the appointment of Claire Lockey to the position of Vice President, Regulatory Affairs. Specifically, Claire s extensive experience in developing products for the treatment of cardio-renal diseases will be highly valued as we focus on positioning RLY5016 to benefit patients with heart failure and chronic kidney disease. Ms. Lockey brings more than thirty-five years of experience in the pharmaceutical industry, including more than twenty-five years specializing in regulatory affairs. In her new role, Ms. Lockey will be responsible for overseeing Relypsa s regulatory affairs, quality assurance and related project (…)
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16.06.2010 | Business Wire: Relypsa Initiates Open-Label Phase 2 Clinical Study of RLY5016 for the Management of Hyperkalemia | Business Wire
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SANTA CLARA, Calif.-(BUSINESS WIRE)-Relypsa, Inc., today announced the initiation of patient enrollment in a Phase 2, open-label titration clinical study of the company s lead drug candidate, RLY5016, in heart failure patients with chronic kidney disease. RLY5016 is a novel non-absorbed oral potassium binder intended to prevent and treat hyperkalemia, a serious condition characterized by elevated serum potassium levels. The open-label study of heart failure patients with chronic kidney disease is intended to explore dosing of RLY5016 and an aldosterone antagonist with the aim of maintaining serum potassium levels in the normal range. Data from this study will be used in the design of (…)
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NCBI PubMed
12.06.2010 | NCBI PubMed: A general joint model for longitudinal measurements and competing risks survival data with heterogeneous random effects.
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This article studies a general joint model for longitudinal measurements and competing risks survival data. The model consists of a linear mixed effects sub-model for the longitudinal outcome, a proportional cause-specific hazards frailty sub-model for the competing risks survival data, and a regression sub-model for the variance-covariance matrix of the multivariate latent random effects based on a modified Cholesky decomposition. The model provides a useful approach to adjust for non-ignorable missing data due to dropout for the longitudinal outcome, enables analysis of the survival outcome with informative censoring and intermittently measured time-dependent covariates, as well as joint (…)
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07.06.2010 | NCBI PubMed: At a crossroads in oncology.
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We survey the current paradigm for cancer therapy and offer a perspective on the state of clinical oncology. Next, we address the key clinical and biological obstacles that have hampered progress to date. Recent insights into the true genetic complexity of cancer, the mixed clinical performance of targeted therapies, and the homogeneity of industry pipelines argue for new approaches to cancer therapy. |-| Curr Opin Pharmacol. |-| Kamb A. |-| Amgen, Inc., 1120 Veterans Blvd, South San Francisco, CA 94080, USA.
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Medical News Today
14.06.2010 | Medical News Today: First Immune Thrombocytopenia (ITP) Patients Virtual Community Launched - Connecting Healthcare Professionals, Patients And Carers
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Amgen (Europe) HAS launched ITPvillage.com, a dedicated website bringing together patients, healthcare professionals and those who care for people affected by ITP, at the 15th Congress of European Hematology Congress in Barcelona, Spain. For many patients living with ITP, it can be an extremely isolating and lonely experience, but ITPvillage.com will provide an online community for European healthcare professionals and patients respectively, to share information and experiences about the condition. Affecting an estimated 50,000 adult patients in the European Union (EU)[1], ITP is a serious autoimmune disorder characterized by low platelet counts in the blood (thrombocytopenia), which can (…)
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14.06.2010 | Business Wire: SDI Reports: Approximately Half of Patients Prescribed the Most Popular Osteoporosis Drugs Discontinue Therapy within 6 Months | Business Wire
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PLYMOUTH MEETING, Pa.-(BUSINESS WIRE)-According to a recent analysis by SDI, a leading healthcare market insight and analytics firm, about half of patients beginning therapy on popular osteoporosis drugs discontinue their treatment within 6 months. Amgen s Prolia, which was recently approved for postmenopausal women with osteoporosis at high risk of fracture, or patients who could not tolerate other osteoporosis therapies, is the newest product to enter the market. Prolia differs from existing therapies as it is given every 6 months via injection. Drug adherence is an issue that many in the healthcare industry struggle with, including physicians, pharmacies, and payers. If patients (…)
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14.06.2010 | Business Wire: Research and Markets: Global Top 10 Biotechnology Companies: Extensive Industry, Financial and SWOT Analysis now Available for All 10 from 1 Source | Business Wire
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DUBLIN-(BUSINESS WIRE)-Research and Markets (http:/www.researchandmarkets.com/research/f8d776/global_top_10_biot) has announced the addition of the "Global Top 10 Biotechnology Companies Industry, Financial and SWOT Analysis" report to their offering. Global Top 10 Biotechnology Companies Industry, Financial and SWOT Analysis Introduction This report analyzes the global biotechnology market in terms of market size (reflects revenues of companies within this industry from product sales, licensing fees, royalties and research funding), key drivers and resistors, trends and competitive positioning. It includes profiles of the top ten companies in the industry along with 5-year financial (…)
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14.06.2010 | BioSpace: SDI Reports: Approximately Half of Patients Prescribed the Most Popular Osteoporosis Drugs Discontinue Therapy within 6 Months
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PLYMOUTH MEETING, Pa.-(BUSINESS WIRE)-According to a recent analysis by SDI, a leading healthcare market insight and analytics firm, about half of patients beginning therapy on popular osteoporosis drugs discontinue their treatment within 6 months. Amgen s Prolia, which was recently approved for postmenopausal women with osteoporosis at high risk of fracture, or patients who could not tolerate other osteoporosis therapies, is the newest product to enter the market. Prolia differs from existing therapies as it is given every 6 months via injection.
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10.06.2010 | Business Wire: NPS Pharmaceuticals to Present at ThinkEquity Healthcare Conference | Business Wire
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BEDMINSTER, N.J.-(BUSINESS WIRE)-NPS Pharmaceuticals, Inc. (Nasdaq: NPSP) announced today that Francois Nader, M.D., president and chief executive officer, is scheduled to present at the ThinkEquity Mid Year Check-Up on Healthcare Conference in New York on Wednesday, June 16, 2010 at 2:00 p.m. ET. The presentation will be available as a live webcast with a replay available approximately three hours after the presentation has concluded. Interested parties may access the webcast from the investors calendar of events page on the NPS website at http:/www.npsp.com. About NPS Pharmaceuticals NPS Pharmaceuticals is developing new treatment options for patients with rare gastrointestinal and (…)
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09.06.2010 | Business Wire: USA Science & Engineering Festival Announces Nifty Fifty; Top Scientists Will Tell Their Stories in DC-Area Schools | Business Wire
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WASHINGTON-(BUSINESS WIRE)-In a massive effort to ignite a passion for science and engineering in middle and high school students, the USA Science & Engineering Festival will send more than fifty top scientists and engineers into local schools this October 10-24, 2010. The hope is that meeting scientists and engineers who love what they do, will help students embrace these disciplines and consider careers in them. The Nifty Fifty, as they are called, were carefully chosen from hundreds of applicants for their differing fields, talents, divergent backgrounds and ages, and ability to convey the importance of science to our nation s future. Supported by festival host Lockheed Martin and (…)
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09.06.2010 | BioSpace: Genzyme Corporation (GENZ), Icahn Reach Accord in Proxy Fight, According to Sources
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CAMBRIDGE, Mass.-(BUSINESS WIRE)-Genzyme Corporation (NASDAQ: GENZ - News) and Carl C. Icahn and certain of his affiliated private investment funds announced today an agreement to settle their proxy contest. Under the agreement, the Icahn funds will withdraw its slate of four nominees for Genzyme s board of directors and vote its Genzyme shares in favor of the company s nominees, and Genzyme will appoint Steven Burakoff, M.D., and Eric Ende, M.D., to serve as directors immediately following its June 16 annual meeting of shareholders. Dr. Burakoff, one of the Icahn Funds' nominees, is Professor of Medicine, Hematology and Medical Oncology at the Mount Sinai School of Medicine and Director (…)
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08.06.2010 | BioSpace: BeneChill Hires CEO, Alan Raffensperger
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Xconomy - Alan Raffensperger, an Amgen executive director who led the biotech s nephrology franchise, has been named as the new CEO at San Diego-based BeneChill, according to a report today in Venture Wire. BeneChill, which Xconomy s Denise Gellene profiled in December, is getting ready to launch its portable RhinoChill device in Europe. The device is used to lower the temperature of the brain and reduce the risk of brain damage, in heart attack patients.
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Bionity.com
08.06.2010 | Bionity.com: Denosumab Demonstrated Superiority Over Zometa in Delay of Complications Due to Bone Metastases in Advanced Prostate Cancer
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08.06.2010 - Amgen announced detailed results from a Phase 3, head-to-head trial which compared the efficacy and safety of denosumab versus Zometa(R) (zoledronic acid) in 1,901 patients with hormone-refractory prostate cancer and bone metastases. The study met its primary and secondary endpoints and demonstrated denosumab's superiority over Zometa in delaying or preventing skeletal related events (SREs). In patients with skeletal metastases, the growing cancer cells weaken and destroy the bone around the tumor. This can result in a number of serious complications, collectively called SREs, comprising fracture, radiation to bone, surgery to bone or spinal cord compression. All can be (…)
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Medical News Today
07.06.2010 | Medical News Today: Promising Results For New Recurrent Ovarian Cancer Treatment - AMG 386 Combined With Paclitaxel
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AMG 386 combined with paclitaxel gave promising antitumor results in a randomized Phase 2 trial involving 161 patients with recurrent ovarian cancer, Amgen announced at the 2010 American Society of Clinical Oncology (ASCO) Annual Meeting. AMG 386 is a 1st-in-class investigational peptibody that has been created to block angiogenesis (process of developing new blood vessels) by inhibiting angiopoietin-1 and -2 (Ang1 and Ang2). Angiopoietins work together with the Tie2 receptor, which mediates vascular remodeling. Ang1 and Ang2 are believed to play opposing roles, and the maturation of blood vessels is thought to be controlled by their precise balance. Beth Karlan, M.D., director of the (…)
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07.06.2010 | Business Wire: ImmunoGen, Inc. Announces Encouraging IMGN388 Clinical Data Reported at ASCO | Business Wire
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WALTHAM, Mass.-(BUSINESS WIRE)-ImmunoGen, Inc. (Nasdaq: IMGN), a biopharmaceutical company that develops targeted anticancer therapeutics, today announced the presentation of the first clinical data for the Company s IMGN388 anticancer compound at the 2010 Annual Meeting of the American Society of Clinical Oncology (ASCO) being held in Chicago, IL. In this dose-escalation trial, IMGN388 has demonstrated favorable tolerability at the dose levels evaluated to date, and evidence of activity is being reported now that higher doses are starting to be evaluated. Dose escalation is continuing. We re encouraged by the clinical findings with IMGN388 We re encouraged by the clinical findings (…)
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07.06.2010 | Business Wire: Dennis Fenton Nominated for Election to Genzyme s Board of Directors | Business Wire
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CAMBRIDGE, Mass.-(BUSINESS WIRE)-Genzyme Corporation (NASDAQ: GENZ) today announced that the Nominating and Corporate Governance Committee of its board of directors has nominated Dennis M. Fenton, Ph.D., for election to the board. Mr. Fenton was executive vice president of operations at Amgen when he retired from the company in 2008. The nomination fulfills the commitment made by Genzyme as part of the agreement announced in April with Relational Investors, LLC to nominate an independent director recommended by Relational with substantial expertise in biopharmaceutical manufacturing and operations. Dennis will bring to our board the precise type of expertise that we need right now as we (…)
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07.06.2010 | BioSpace: Genzyme Corporation (GENZ) Release: Dennis Fenton Nominated for Election to Genzyme s Board of Directors
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CAMBRIDGE, Mass.-(BUSINESS WIRE)-Genzyme Corporation (NASDAQ: GENZ) today announced that the Nominating and Corporate Governance Committee of its board of directors has nominated Dennis M. Fenton, Ph.D., for election to the board. Mr. Fenton was executive vice president of operations at Amgen when he retired from the company in 2008. The nomination fulfills the commitment made by Genzyme as part of the agreement announced in April with Relational Investors, LLC to nominate an independent director recommended by Relational with substantial expertise in biopharmaceutical manufacturing and operations.
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Business Wire
05.06.2010 | Business Wire: ImmunoGen, Inc. Announces Presentation of Clinical Data for Trastuzumab-DM1 at ASCO Annual Meeting | Business Wire
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WALTHAM, Mass.-(BUSINESS WIRE)-ImmunoGen, Inc. (Nasdaq: IMGN), a biopharmaceutical company that develops targeted anticancer therapeutics, today announced the presentation of clinical data from a Phase Ib/II trial conducted by Roche and Genentech to investigate the safety and preliminary efficacy of trastuzumab-DM1 (T-DM1) used in combination with Roche s investigational antibody, pertuzumab. The findings were reported at the 2010 Annual Meeting of the American Society of Clinical Oncology (ASCO) being held in Chicago, IL (abstract #1012). The tolerability seen with TAP compounds when used as single agents supports assessing them as part of combination regimens The data reported provide (…)
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NCBI PubMed
03.06.2010 | NCBI PubMed: Application of Genomics for Identification of Systemic Toxicity Triggers Associated With VEGF-R Inhibitors.
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The key to the discovery of new pharmaceuticals is to develop molecules that interact with the intended target and minimize interaction with unintended molecular targets, therefore minimizing toxicity. This is aided by the use of various in vitro selectivity assays that are used to select agents most potent for the desired target. Typically, molecules from similar chemical series, with similar in vitro potencies, are expected to yield comparable in vivo pharmacological and toxicological profiles, predictive of target effects. However, in this study, we investigated the in vivo effects of two analogue compounds that similarly inhibit several receptor tyrosine kinases such as vascular (…)
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NCBI PubMed
02.06.2010 | NCBI PubMed: Visualizing the Landscape of Selection Biomarkers in Current Phase III Oncology Clinical Trials.
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Selection biomarkers are disease-associated analytes whose measurement is either an essential step in patient screening or the primary objective of a clinical trial. The public database ClinicalTrials.gov contains information on most active phase III oncology clinical trials that can be examined for trends in the development of cancer therapies. But for selection biomarkers, such information is not easily accessible and so has not been examined in a comprehensive way. Here we provide a global analysis of selection biomarkers currently in use in the oncology phase III trial arena. |-| Sci Transl Med. |-| Sikorski R, Yao B. |-| Amgen, Thousand Oaks, CA 91320, USA.
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Medical News Today
03.06.2010 | Medical News Today: New Injectable Osteoporosis Drug Prolia Gains FDA Approval
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Prolia, a new injectable drug to treat osteoporosis in postmenopausal women at high risk of fractures has been approved by the US Food and Drug Administration (FDA). In a statement on its website on 1st June, the federal agency announced that approving Prolia, made by Amgen, offers postmenopausal women with osteoporosis at high risk of fractures another treatment option. Osteoporosis is a disease that weakens bone and makes it more likely to break. Osteoporosis patients at high risk of fracture include those who have already experienced a fracture due to osteoporosis, or who have several risk factors for fracture, or who have tried other therapies but found they could either not tolerate (…)
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Business Wire
03.06.2010 | Business Wire: ImmunoGen, Inc. Announces Webcast of Presentation at Upcoming Investor Conferences | Business Wire
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WALTHAM, Mass.-(BUSINESS WIRE)-ImmunoGen, Inc. (Nasdaq: IMGN) announced today that Daniel Junius, President and CEO, will present at two investor conferences next week. These presentations will be webcast live and can be accessed through the Investor Information section of the Company s website, www.immunogen.com. An archive of these webcasts will be available at the same location until June 18, 2010. Morgan Joseph Best Ideas ConferenceWednesday, June 9, 2010 at 3:00 p.m. ETNew York, NY Jefferies 2010 Global Life Sciences ConferenceThursday, June 10, 2010 at 4:30 p.m. ETNew York, NY About ImmunoGen, Inc. ImmunoGen, Inc. develops targeted anticancer therapeutics using its expertise (…)
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Business Wire
03.06.2010 | Business Wire: Research and Markets: Option and Evaluation Agreements in Pharma and Biotech - The Comprehensive Updated 2nd Edition | Business Wire
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DUBLIN-(BUSINESS WIRE)-Research and Markets (http:/www.researchandmarkets.com/research/f8bc26/option_and_evaluat) has announced the addition of the "Option and Evaluation Agreements in Pharma and Biotech, 2nd Edition" report to their offering. Option and Evaluation Agreements in Pharma and Biotech, 2nd Edition The Option and Evaluation Agreements in Pharma and Biotech report provides comprehensive understanding and unprecedented access to the option and evaluation partnering agreements entered into by the worlds leading biopharma companies. This report provides details of the latest option and evaluation agreements announced in the pharmaceutical and biotechnology sectors. Detailed and (…)
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BioSpace
03.06.2010 | BioSpace: Amgen (AMGN) Deploys up to 1,000 Reps on Prolia Approval
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mmm-online.com - Amgen has deployed 500 to 1,000 reps in support of Prolia (denosumab), a biologic osteoporosis treatment that received FDA approval on June 1. The drug was approved in the European Union on May 28.
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Marketwire
02.06.2010 | Marketwire: FDA, Pfizer's CMO, and Leading Pharma Communicators to Share Best Practices at ExL Pharma's 6th Public Relations Summit, July 26-27, New York
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NEW YORK, NY-(Marketwire - June 2, 2010) - ExL Pharma's 6th Public Relations and Communications Summit for Pharmaceutical, Biotech and Medical Technology Communicators is taking place this summer at the Pfizer World Headquarters on July 26-27, 2010 in New York, New York. This leading event, which is well attended by communications professionals in pharmaceutical, biotech and medical device companies, features two full days of expert-led presentations, networking opportunities, and interactive sessions. Attendees will gain concrete strategies for success in the marketplace and improved patient outcomes through strengthened communications. *Register before June 11, 2010 to save $200 (…)
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Medical News Today
02.06.2010 | Medical News Today: FDA Approves New Injectable Osteoporosis Treatment For Postmenopausal Women
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The U.S. Food and Drug Administration approved Prolia, an injectable treatment for postmenopausal women with osteoporosis who are at high risk for fractures. Osteoporosis is a disease in which the bones become weak and are more likely to break. According to the National Institute of Arthritis and Musculoskeletal and Skin Diseases, 80 percent of the people in the United States with osteoporosis are women. One out of every two women over age 50 will break a bone in their lifetime due to osteoporosis. People with osteoporosis at high risk for fracture include those that have had an osteoporotic fracture, or have multiple risk factors for fracture; or those who have failed or are intolerant to (…)
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NCBI PubMed
01.06.2010 | NCBI PubMed: Reply.
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Urology. |-| Cetin K, Beebe-Dimmer J, Fryzek JP, Markus R, Carducci MA. |-| Global Epidemiology, Amgen, Inc., Thousand Oaks, California.
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BioSpace
02.06.2010 | BioSpace: Ablexis Secures $12 Million in Series A Funding to Engineer and Commercialize Next-Generation Platforms for Antibody Drug Discovery
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SAN FRANCISCO-(BUSINESS WIRE)-Ablexis, LLC, a biotechnology company dedicated to developing an innovative, next-generation platform for antibody drug discovery, announced today that it has completed a $12 million Series A financing. The round was led by Third Rock Ventures and included Pfizer Venture Investments. Proceeds from the financing will be used to continue advancing Ablexis proprietary AlivaMab Mouse transgenic mouse platform for the discovery of human therapeutic antibodies. There are significant unmet commercial needs for a transgenic mouse platform for therapeutic antibody discovery, said Larry Green, Ph.D., chief executive officer of Ablexis. In addition, advances in (…)
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BioSpace
02.06.2010 | BioSpace: Datamonitor Report: World Congress On Osteoporosis Highlights Changing Face Of Bone Health
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Datamonitor attended this year's International Osteoporosis Foundation World Congress on Osteoporosis and 10th European Congress on Clinical and Economical Aspects of Osteoporosis and Osteoarthritis, the most important meeting on the osteoporosis calendar. A number of major pharmaceutical firms had a presence at the meeting, indicating the significance of this market. Pfizer: remains a small presence in the osteoporosis market The presence of Pfizer at the congress suggests that the company intends to launch Conbriza (bazedoxifene) in the European market after it was approved in 2009. It is Datamonitor's understanding that the company is negotiating price and reimbursement issues prior to (…)
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BioSpace
02.06.2010 | BioSpace: Tech Collective Announces Tech Laureates Night 2010 Award Winners
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Providence, R.I. June 1, 2010 Tech Collective, Rhode Island s IT and Bioscience industry association, today announces the winners of its Tech Laureates Night 2010 awards. The honorees will be recognized at Tech Collective s annual fundraiser and awards celebration, Tech Laureates Night 2010: Tech in Motion, this Thursday, June 3rd, from 5:30 - 8:00 pm at Rhodes on the Pawtuxet. Tech Laureates Night awards honor leading technology individuals and companies in Rhode Island who are driving the technology industries forward through both technological and community excellence, including: innovation, mentorship and volunteerism, dedication to the technology workforce, the enablement of women in (…)
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Marketwire
01.06.2010 | Marketwire: Cytokinetics to Present at June Healthcare Conferences
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Highlighted Links CYTK Website SOUTH SAN FRANCISCO, CA-(Marketwire - June 1, 2010) - Cytokinetics, Incorporated (NASDAQ: CYTK) announced today that the company is scheduled to present at the following healthcare conferences during the month of June: Jefferies 2010 Global Life Sciences Conference Date: Tuesday, June 8, 2010 Time: 2:30 p.m. Eastern Daylight Time Presenter: Robert I. Blum, President and Chief Executive Officer 9th Annual Needham Healthcare Conference Date: Wednesday, June 9, 2010 Time: 11:20 a.m. Eastern Daylight Time Presenter: Robert I. Blum, President and Chief Executive Officer Interested parties may access the live audio webcast of these presentations and replays by (…)
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Business Wire
01.06.2010 | Business Wire: NPS Pharmaceuticals to Present at Upcoming Conferences | Business Wire
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BEDMINSTER, N.J.-(BUSINESS WIRE)-NPS Pharmaceuticals, Inc. (Nasdaq: NPSP) announced today that Francois Nader, M.D., president and chief executive officer, is scheduled to present at the 9th Annual Needham Healthcare Conference in New York on Wednesday, June 9, 2010 at 10:40 a.m. ET and the Jefferies 2010 Global Life Sciences Conference in New York on Friday, June 11, 2010 at 10:00 a.m. ET. Presentations will be available as live webcasts with replays available approximately three hours after the presentations have concluded. Interested parties may access the webcast from the investors calendar of events page on the NPS website at http:/www.npsp.com. About NPS Pharmaceuticals NPS (…)
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NCBI PubMed
01.06.2010 | NCBI PubMed: The use of native cation-exchange chromatography to study aggregation and phase separation of monoclonal antibodies.
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This study introduces a novel analytical approach for studying aggregation and phase separation of monoclonal antibodies (mAbs). The approach is based on using analytical scale cation-exchange chromatography (CEX) for measuring the loss of soluble monomer in the case of individual and mixed protein solutions. Native CEX outperforms traditional size-exclusion chromatography in separating complex protein mixtures, offering an easy way to assess mAb aggregation propensity. Different IgG1 and IgG2 molecules were tested individually and in mixtures consisting of up to four protein molecules. Antibody aggregation was induced by four different stress factors: high temperature, low pH, addition of (…)
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BioSpace
01.06.2010 | BioSpace: Amgen (AMGN) Considering Acquisitions in Wake of Expansion
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Top News - The US-based biotechnology group, Amgen is mulling over purchases in the pharmaceuticals industry as it enlarges its geographic area and product variety.
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Bionity.com
01.06.2010 | Bionity.com: Amgen's Prolia (Denosumab) Granted Marketing Authorization in the European Union
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01.06.2010 - Amgen Inc. announced that the European Commission (EC) has granted marketing authorization for Prolia (denosumab) for the treatment of osteoporosis in postmenopausal women at increased risk of fractures, and for the treatment of bone loss associated with hormone ablation in men with prostate cancer at increased risk of fractures. Prolia has been approved in all 27 European Union member states plus Norway, Iceland and Liechtenstein. The European approval of Prolia marks the first approval of the product worldwide. "The European approval of Prolia is a significant medical advance for patients with bone loss conditions," said Will Dere, senior vice president and international (…)