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Clinical Development
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Research and Markets Announced The Addition
Feb 25, 2014Research and Markets has announced the addition of the "EMRs and Clinical Research: Current and Potential Impact" report to their offering. In this report, ISR leverages the insights and real-world experiences investigative sites have ...
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Palbociclib Received Breakthrough Therapy Designation by The United States Food
Feb 14, 2014Pfizer Inc. (NYSE:PFE) today announced that the randomized Phase 2 trial [PALOMA-1] of palbociclib achieved its primary endpoint by demonstrating a statistically significant and clinically meaningful improvement in progression-free survival ...
Tags: Health&Medicine
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Research to Focus on Repurposing Drugs for Alzheimer's Disease and Related Dementias
Feb 10, 2014Research to Focus on Repurposing Drugs for Alzheimer's Disease and Related Dementias Today the Alzheimer's Drug Discovery Foundation(ADDF)and the Alzheimer's Society(UK)announced a new partnership that will provide funding for research ...
Tags: Health, Medicine, Repurposing Drugs
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Teva and Active Biotech Have Announced That Both Companies Remain
Feb 10, 2014Teva Pharmaceutical Industries and Active Biotech have announced that both companies remain committed to the Nerventra(laquinimod)clinical development program for multiple sclerosis(MS)following the announcement of a negative opinion for ...
Tags: Medicine, clinical studies, Nerventra
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CEL-SCI Corporation Has Received Approval From The Medicines and Medical Device Agency
Jan 26, 2014CEL-SCI Corporation has received approval from the Medicines and Medical Device Agency of Serbia to begin enrollment of subjects in its Phase III Head and Neck Cancer clinical trial of its investigational cancer immunotherapy treatment ...
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Seattle Genetics Has Received Approval of ADCETRIS
Jan 18, 2014Seattle Genetics, Inc. (Nasdaq: SGEN) today announced that its collaborator, Takeda Pharmaceutical Company Limited (Takeda), has received approval of ADCETRIS (brentuximab vedotin) from the Japanese Ministry of Health, Labour and Welfare ...
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Altheus Therapeutics Has Completed Enrollment for ZA201
Jan 13, 2014Altheus Therapeutics, Inc., announced that it has completed enrollment for ZA201, a 6-week, double-blind, active-controlled Phase 2 clinical trial of the efficacy and safety of Zoenasa® Rectal Gel in approximately 120 adult patients ...
Tags: Altheus Therapeutics, enrollment, ZA201, Zoenasa®Rectal Gel
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Jewell Is an Expert in Immunomodulation to Target a Specific Disease
Jan 9, 2014In 2004, a form of cancer known as neuroblastoma claimed the life of Alexandra (Alex) Scott, a little girl who gained national attention for using her lemonade stand to raise money for cancer research. Now, the organization established in ...
Tags: neuroblastoma, Alex's Lemonade Stand Foundation, University of Maryland
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Romosozumab Is an Investigational Medicine in Phase 3 Clinical Development
Jan 3, 2014Amgen (NASDAQ: AMGN) and UCB (Euronext Brussels:UCB) today announced results from a Phase 2 trial evaluating romosozumab (AMG 785/CDP7851) in postmenopausal women with low bone mineral density (BMD). Published in the New England Journal of ...
Tags: Amgen, UCB, Phase 2 trial evaluating romosozumab, postmenopausal women
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Genzyme Has Received a Complete Response Letter From The U.S
Jan 2, 2014Genzyme, a Sanofi company (EURONEXT:SAN and NYSE:SNY), announced today that it has received a Complete Response Letter from the U.S. Food and Drug Administration (FDA) for its supplemental Biologics License Application seeking approval of ...
Tags: Genzyme, Biologics License Application, Lemtrada, multiple sclerosis
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Veloxis Pharmaceuticals Comprised 25 Studies and Enrolled Over 1000 Patients
Jan 2, 2014Veloxis Pharmaceuticals A/S (OMX: VELO), today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval for the marketing and sale of Envarsus® (formerly ...
Tags: Veloxis Pharmaceuticals, New Drug Application, Envarsus®
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Ikaria Would Sell The Commercial Business to Madison Dearborn Partners
Dec 30, 2013Ikaria, Inc., a critical care company focused on developing and commercializing innovative therapies designed to address the significant needs of critically ill patients, announced today that its investor group and employee shareholders ...
Tags: Ikaria, sell the Commercial Business, Madison Dearborn Partners
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ORMP Would Purchase an Aggregate of 1,580,000 Shares
Dec 30, 2013Oramed Pharmaceuticals Inc. (NASDAQCM: ORMP), a developer of oral drug delivery systems, today announced that it has entered into definitive agreements with investors to purchase an aggregate of 1,580,000 shares of common stock at a price ...
Tags: Oramed Pharmaceuticals, Aegis Capital, registered direct offering
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FDA Allergenic Committee Will Meet to Discuss Bla for Ragweed Sublingual AIT Tablet
Dec 30, 2013Denmark-based pharmaceutical company ALK-Abello has announced that the FDA Allergenic Products Advisory Committee of the US Food and Drug Administration (FDA) will meet on 28 January 2014 to discuss the biologic license application (BLA) ...
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Vector Capital Has Sold Certara,a Provider of Drug Development Software and Services
Dec 23, 2013Vector Capital, private equity firm focused on value-oriented investments in technology companies, has sold Certara, a provider of drug development software and services, to Arsenal Capital Partners, a US-based based private equity firm. ...
Tags: Vector Capital, Arsenal Capital
