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Chronological Index of : Clinical News

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  • CLINICAL NEWS: Geron jumps on lift of imetelstat clinical hold

    Geron Corp. (NASDAQ:GERN) climbed $0.57 (26%) to $2.80 on Monday after FDA lifted a full clinical hold on company-sponsored trials of imetelstat (GRN163L), an oligonucleotide that competitively inhibits telomerase …

    Published on 11/3/2014
  • CLINICAL NEWS: BIND gains on Phase II NSCLC data

    Bind Therapeutics gained $1.11 (14%) to $8.94 after publication of an abstract containing preliminary data from a Phase II trial of BIND-014 to treat non-small cell lung cancer (NSCLC). The compound had a 63% disease …

    Published on 10/30/2014
  • CLINICAL NEWS: BMS jumps on Phase II data behind Opdivo BLA

    Bristol-Myers Squibb Co. (NYSE:BMY) added $4.82 (9%) to $58.98 Thursday when it reported a 15% objective response rate (ORR) and estimated a 41% one-year survival rate in the Phase II CheckMate -063 trial evaluating …

    Published on 10/30/2014
  • CLINICAL NEWS: NIH studying Kowa's statin in HIV

    The National Institutes of Health is starting a North American trial of pitavastatin from Kowa Co. Ltd. (Nagoya, Japan) to prevent cardiovascular disease in HIV patients. The double-blind, placebo-controlled 6,500-…

    Published on 10/28/2014
  • CLINICAL NEWS: Novavax climbs on vaccine data

    Novavax Inc. (NASDAQ:NVAX) gained $0.67 (13%) to $5.80 after presenting data from two vaccine trials for Ebola virus and respiratory syncytial virus (RSV) at the Vaccine & ISV Congress in Philadelphia.The company …

    Published on 10/27/2014
  • CLINICAL NEWS: One-year follow up for uniQure's liver gene therapy

    uniQure N.V. (NASDAQ:QURE) reported top-line one-year follow-up data from a completed Phase I study in eight acute intermittent porphyria (AIP) patients receiving varying doses of the company's AMT-021, a recombinant …

    Published on 10/27/2014
  • CLINICAL NEWS: Novartis' secukinumab meets in ankylosing spondylitis

    Three days after an FDA committee backed the approval of Cosentyx secukinumab from Novartis AG (NYSE:NVS; SIX:NOVN) for moderate to severe plaque psoriasis, the compound met its primary and key secondary endpoints in …

    Published on 10/23/2014
  • CLINICAL NEWS: NIH begins second trial of NewLink's Ebola vaccine

    NewLink Genetics Corp. (NASDAQ:NLNK) gained $4.01 (12%) to $38.51 on Wednesday after NIH's National Institute of Allergy and Infectious Diseases (NIAID) said it had begun the second Phase I trial of its investigational …

    Published on 10/22/2014
  • CLINICAL NEWS: Regulus doubles on interim HCV data

    Regulus Therapeutics Inc. (NASDAQ:RGLS) surged $6.98 (103.1%) to $13.75 on Wednesday after announcing interim results from a Phase I trial in which a single 2 mg/kg injection of antisense therapy RG-101 led to …

    Published on 10/22/2014
  • CLINICAL NEWS: Omeros suspends Phase II Huntington's trial

    Omeros Corp. (NASDAQ:OMER) was off $1.70 (12%) to $12.12 on Tuesday after suspending a Phase II trial of OMS824 to treat Huntington's disease (HD).Omeros' decision followed an unspecified observation in "several" rats …

    Published on 10/21/2014
  • CLINICAL NEWS: Strong Phase II Crohn's data for Celgene

    Mongersen (GED-0301) from Celgene Corp. (NASDAQ:CELG) produced clinical remission rates as high as 65.1% in a Phase II trial in 166 patients with moderate to severe Crohn's disease, according to an abstract published …

    Published on 10/20/2014
  • CLINICAL NEWS: Regeneron: Eylea bests Avastin, Lucentis in DME

    Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) said top-line data from a comparative effectiveness study using VEGF drugs to treat diabetic macular edema showed its Eylea aflibercept was superior to Avastin bevacizumab …

    Published on 10/17/2014
  • CLINICAL NEWS: ACT boosted on stem cell results

    Advanced Cell Technology Inc. (OTCBB:ACTC) held most of the gain it picked up ahead of Wednesday's online publication of data from a pair of Phase I/II trials showing visual improvements in patients treated with the …

    Published on 10/15/2014
  • CLINICAL NEWS: Novartis, Penn publish Phase I/II CAR T data in ALL

    Novartis AG (NYSE:NVS; SIX:NOVN) and the University of Pennsylvania published in the New England Journal of Medicine results from a Phase I/IIa trial of CTL019 to treat relapsed or refractory acute lymphoblastic …

    Published on 10/15/2014
  • CLINICAL NEWS: Scancell gains on Phase I/II melanoma data

    Scancell Holdings plc (LSE:SCLP; Xetra:SCP) added L3 .75 (12%) to L34 in London on Tuesday after reporting data from an ongoing open-label Phase I/II trial of SCIB1 to treat stage III/IV metastatic melanoma. Among …

    Published on 10/14/2014
  • CLINICAL NEWS: More positive Phase I for Kite's CAR T therapy

    Kite Pharma Inc. (NASDAQ:KITE) said its autologous T cell therapy against CD19 ( KTE-C19) led to a 70% complete response rate in a Phase I trial to treat relapsed or refractory acute lymphoblastic leukemia (ALL). Data …

    Published on 10/13/2014
  • CLINICAL NEWS: NewLink up on human trial of Canada's Ebola vaccine

    The Public Health Agency of Canada said a Phase I trial of VSV-EBOV (BPSC-1001), an experimental Ebola vaccine developed at the country's National Microbiology Lab, has begun at the Walter Reed Army Institute of …

    Published on 10/13/2014
  • CLINICAL NEWS: Isis reports Phase II SMA data

    Isis Pharmaceuticals Inc. (NASDAQ:ISIS) reported data from an ongoing Phase II trial of ISIS-SMNRx to treat infants with spinal muscular atrophy (SMA). The median event-free age of the infants who completed a three-dose…

    Published on 10/10/2014
  • CLINICAL NEWS: Amgen to seek extrapolation for biosimilar Humira

    Amgen Inc. (NASDAQ:AMGN) spokesperson Kelley Davenport said the company will seek to use clinical data for its ABP 501 biosimilar in two indications -- plaque psoriasis and rheumatoid arthritis (RA) -- and extrapolate …

    Published on 10/8/2014
  • CLINICAL NEWS: Arrowhead falls on Phase IIa HBV data

    Arrowhead Research Corp. (NASDAQ:ARWR) dropped $5.48 (44%) to $7.03 on Wednesday after Phase IIa HBV data for ARC-520 fell short of expectations. Arrowhead is studying ARC-520 to treat chronic HBV infection in hepatitis…

    Published on 10/8/2014
  • CLINICAL NEWS: Acacia seeks options after hitting in PONV Phase III

    Acacia Pharma Ltd. (Cambridge, U.K.) said its lead product APD421 reduced the incidence of post-operative nausea and vomiting in two Phase III trials of adult surgical patients at moderate to high risk for PONV. Acacia,…

    Published on 10/7/2014
  • CLINICAL NEWS: Alcobra hammered on intent-to-treat in ADHD

    Alcobra Ltd. (NASDAQ:ADHD) closed down $7.99 (57%) to $6.12 on Monday after Metadoxine ER (MDX), its extended-release formulation of metadoxine, only met the primary endpoint in a Phase III trial to treat adults with …

    Published on 10/6/2014
  • CLINICAL NEWS: Sunesis plummets on Phase III miss in AML

    Sunesis Pharmaceuticals Inc. (NASDAQ:SNSS) dropped $5.18 (78%) to $1.46 Monday after its regimen of Qinprezo vosaroxin and cytarabine missed the primary endpoint of improved overall survival (OS) in its Phase III VALOR …

    Published on 10/6/2014
  • CLINICAL NEWS: Lilly halts tabalumab for lupus

    Eli Lilly and Co. (NYSE:LLY) said it will discontinue development of tabalumab to treat systemic lupus erythematosus (SLE) because it failed to show sufficient efficacy in two Phase III trials. The pharma said its …

    Published on 10/2/2014
  • CLINICAL NEWS: Twin Phase IIIs look good for Intarcia

    Intarcia Therapeutics Inc. (Boston, Mass.) said ITCA 650 met all primary and secondary endpoints in two Phase III trials to treat Type II diabetes.ITCA 650 provides patients continuous subcutaneous delivery of exenatide…

    Published on 10/2/2014

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