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Chronological Index of : Clinical News

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  • CLINICAL NEWS: TauRx's LMTX fails in Phase III AD study

    TauRx Pharmaceuticals Ltd. (Singapore) said LMTX (TRx0237) missed the co-primary endpoints in the Phase III TRx-237-015 trial as an add-on therapy to treat mild to moderate Alzheimer's disease. The candidate did not …

    Published on 7/27/2016
  • CLINICAL NEWS: First joint AZ, Moderna program heading to clinic

    Moderna Therapeutics Inc. (Cambridge, Mass.) and AstraZeneca plc (LSE:AZN; NYSE:AZN) said the pharma filed a clinical trial application to start a Phase I study of AZD8601, an mRNA-based therapy that encodes VEGF-A for …

    Published on 7/26/2016
  • CLINICAL NEWS: Tokai ending galeterone study

    Tokai Pharmaceuticals Inc. (NASDAQ:TKAI) fell $4.10 (79%) to $1.10 on Tuesday after it said it would stop the Phase III ARMOR3-SV study of galeterone (TOK-001) to treat metastatic castration-resistant prostate cancer (…

    Published on 7/26/2016
  • CLINICAL NEWS: AbbVie, BMS to test Rova-T combos for SCLC

    AbbVie Inc. (NYSE:ABBV) and Bristol-Myers Squibb Co. (NYSE:BMY) plan to start a Phase I/II study this year of antibody-drug conjugate (ADC) Rova-T rovalpituzumab in combination with Opdivo nivolumab, and in combination …

    Published on 7/25/2016
  • CLINICAL NEWS: Celgene won't seek Revlimid approval for DLBCL

    Celgene Corp. (NASDAQ:CELG) said it does not plan to seek approval of Revlimid lenalidomide as a maintenance therapy for diffuse large B cell lymphoma patients who respond to first-line therapy of Rituxan rituximab plus…

    Published on 7/25/2016
  • CLINICAL NEWS: Tobira's cenicriviroc misses in NASH study

    Tobira Therapeutics Inc. (NASDAQ:TBRA) plummeted $6.75 (60%) to $4.50 on Monday after it said cenicriviroc (formerly TBR-652) missed the primary endpoint of the Phase IIb CENTAUR study to treat non-alcoholic …

    Published on 7/25/2016
  • CLINICAL NEWS: Amgen, Allergan report Phase III data for Herceptin biosimilar

    Amgen Inc. (NASDAQ:AMGN) and Allergan plc (NYSE:AGN) said data from a Phase III study showed ABP 980, a biosimilar of Herceptin trastuzumab, was non-inferior to its reference product based on the proportion of patients …

    Published on 7/21/2016
  • CLINICAL NEWS: Cynapsus reports early Phase III data for PD candidate

    Cynapsus Therapeutics Inc. (TSX:CTH; NASDAQ:CYNA) reported data from the open-label, dose-escalation portion of the Phase III CTH-300 study evaluating APL-130277 to treat "off" episodes in patients with Parkinson's …

    Published on 7/19/2016
  • CLINICAL NEWS: Gazyva misses PFS endpoint in first-line DLBCL study

    Roche (SIX:ROG; OTCQX:RHHBY) and its Genentech Inc. unit said Gazyva obinutuzumab plus CHOP chemotherapy missed the primary endpoint of improving progression-free survival vs. Rituxan rituximab plus CHOP in the open-…

    Published on 7/18/2016
  • CLINICAL NEWS: Ziopharm slides on news of patient deaths

    Ziopharm Oncology Inc. (NASDAQ:ZIOP) lost $0.66 (12%) to $5.01 on Friday after it reported three patient deaths in a Phase I study of Ad-RTS-hIL-12 to treat recurrent or progressive glioblastoma multiforme (GBM) or …

    Published on 7/15/2016
  • CLINICAL NEWS: Ultragenyx's rhGUS meets Phase III endpoint

    Ultragenyx Pharmaceutical Inc. (NASDAQ:RARE) said rhGUS (UX003) met the primary endpoint in a Phase III study to treat mucopolysaccharidosis VII (MPS VII; Sly syndrome) by significantly reducing urinary excretion of …

    Published on 7/14/2016
  • CLINICAL NEWS: Sage gets big bump on postpartum depression data

    Sage Therapeutics Inc. (NASDAQ:SAGE) jumped $12.56 (37%) to $46.21 on Tuesday, adding more than $400 million in market cap, after it said SAGE-547 met the primary endpoint in a Phase II study to treat severe postpartum …

    Published on 7/12/2016
  • CLINICAL NEWS: Coherus gains on PK/PD readout for Neulasta biosimilar

    Coherus BioSciences Inc. (NASDAQ:CHRS) gained $4.71 (27%) to $21.93 on Monday after it said CHS-1701 met the co-primary pharmacodynamic and pharmacokinetic endpoints in a Phase I study that compared the biosimilar with …

    Published on 7/11/2016
  • CLINICAL NEWS: CytRx sinks on Phase III sarcoma failure

    CytRx Corp. (NASDAQ:CYTR) plummeted $1.70 (68%) to $0.81 in early after-hours trading after its aldoxorubicin (formerly DOXO-EMCH, INNO-206) failed to significantly improve the primary endpoint of progression-free …

    Published on 7/11/2016
  • CLINICAL NEWS: International cancer modeling initiative launched

    The National Cancer Institute, Cancer Research UK, Wellcome Trust Sanger Institute and Hubrecht Organoid Technology launched the Human Cancer Models Initiative to develop a bank of about 1,000 new cancer cell models. …

    Published on 7/11/2016
  • CLINICAL NEWS: Sucampo ending cobiprostone development

    Sucampo Pharmaceuticals Inc. (NASDAQ:SCMP) said it will discontinue development of cobiprostone (SPI-8811) following a futility analysis of a Phase IIa study to prevent oral mucositis in head and neck cancer patients. …

    Published on 7/11/2016
  • CLINICAL NEWS: Adjuvant Sutent improves disease-free survival in RCC

    Pfizer Inc. (NYSE:PFE) said Sutent sunitinib met the primary endpoint of significantly improving disease-free survival vs. placebo in the Phase III S-TRAC study to treat patients at high risk of recurrent renal cell …

    Published on 7/8/2016
  • CLINICAL NEWS: Sandoz says Enbrel biosimilar equivalent in psoriasis study

    In the Phase III EGALITY study, the Sandoz unit of Novartis AG (NYSE:NVS; SIX:NOVN) said its GP2015 met the primary endpoint of demonstrating equivalent efficacy to reference product Enbrel etanercept from Amgen Inc. (…

    Published on 7/8/2016
  • CLINICAL NEWS: Ablynx gains on RA data for vobarilizumab

    Ablynx N.V. (Euronext:ABLX) gained EUR 1.42 (12%) to EUR 12.95 on Thursday after reporting 12-week data from a 251-patient Phase IIb study comparing three dosing regimens of vobarilizumab (ALX-0061) to more frequently …

    Published on 7/7/2016
  • CLINICAL NEWS: I-SPY 2 update

    Sponsors of the adaptive Phase II I-SPY 2 trial announced five compounds have graduated from the neoadjuvant study with data for the first two candidates published Thursday in the New England Journal of Medicine.The …

    Published on 7/7/2016
  • CLINICAL NEWS: Nippon Kayaku's NK105 fails breast cancer Phase III

    NK105 micellar paclitaxel from Nippon Kayaku Co. Ltd. (Tokyo:4272) missed the primary endpoint in a Phase III study to treat metastatic or recurrent breast cancer. NanoCarrier Co. Ltd. (Tokyo:4571), which had licensed …

    Published on 7/6/2016
  • CLINICAL NEWS: Duke, Vanderbilt launch Trial Innovation Center

    The Duke Clinical Research Institute and Vanderbilt University Medical Center will launch a joint Trial Innovation Center to study how to speed up and improve the efficiency of clinical trials of therapeutics. The …

    Published on 7/5/2016
  • CLINICAL NEWS: XBiotech sinks on Phase III colorectal data

    XBiotech Inc. (NASDAQ:XBIT) fell $8.10 (33%) to $16.80 on Tuesday after reporting results from a Phase III trial of its Xilonix human mAb against IL-1 alpha to treat advanced colorectal cancer. On the primary endpoint …

    Published on 7/5/2016
  • CLINICAL NEWS: Ampio sags after OA candidate's latest miss

    Ampio Pharmaceuticals Inc. (NYSE-M:AMPE) fell $2.03 (61%) to $1.29 on Thursday after Ampion missed the primary endpoint of significantly reducing WOMAC-A pain subscale scores vs. saline control in the Phase III PIVOT …

    Published on 6/30/2016
  • CLINICAL NEWS: Shire's SHP607 misses retinopathy endpoint

    Shire plc (LSE:SHP; NASDAQ:SHPG) said SHP607 missed the primary endpoint in a Phase II study. The compound failed to reduce the severity of retinopathy of prematurity (ROP), a rare eye condition that occurs in premature…

    Published on 6/30/2016

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