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Chronological Index of : Clinical News

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  • 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
  • CLINICAL NEWS: Galena plummets after halting NeuVax study

    Galena Biopharma Inc. (NASDAQ:GALE) lost $1.68 (83%) to $0.35 on Wednesday after it said it will halt the Phase III PRESENT study of NeuVax nelipepimut-S at an independent DMC's recommendation based on an interim …

    Published on 6/29/2016
  • CLINICAL NEWS: Celyad slides on Phase III heart failure miss

    Celyad S.A. (Euronext:CYAD; NASDAQ:CYAD) said cell therapy C-Cure missed the primary endpoint in the Phase III CHART-1 study to treat ischemic heart failure. The company sank EUR 15.95 (40%) to EUR 23.52 in Europe and $…

    Published on 6/28/2016
  • CLINICAL NEWS: Coherus' CHS-131 meets Phase IIb MS endpoint

    Coherus BioSciences Inc. (NASDAQ:CHRS) said a 3 mg dose of CHS-131 met the primary endpoint of a Phase IIb study to treat relapsing-remitting multiple sclerosis (RRMS). The dose, which was the higher of two in the trial…

    Published on 6/28/2016
  • CLINICAL NEWS: Esperion says FDA won't commit to surrogate endpoint

    Esperion Therapeutics Inc. (NASDAQ:ESPR) lost $4.40 (27%) to $11.78 in early after-hours trading Tuesday after it said FDA "did not provide clarity on a regulatory pathway" in dialogue with the company about an LDL-C …

    Published on 6/28/2016
  • CLINICAL NEWS: Allergy Therapeutics grass pollen program hits snag

    Allergy Therapeutics plc (LSE:AGY) lost 3.50p (15%) to 20p on Monday after it said it would need to conduct another dose-ranging study of grass allergy therapy GrassMATAMPL next year before beginning a U.S. Phase III …

    Published on 6/27/2016
  • CLINICAL NEWS: GW rises as Epidiolex passes second Phase III test

    GW Pharmaceuticals plc (LSE:GWP; NASDAQ:GWPH) said anticonvulsive therapy Epidiolex cannabidiol significantly reduced the monthly frequency of drop seizures in patients with Lennox-Gastaut syndrome (LGS), meeting the …

    Published on 6/27/2016
  • CLINICAL NEWS: MDCO's Carbavance meets in Phase III cUTI study

    The Medicines Co. (NASDAQ:MDCO) said Carbavance meropenem/vaborbactam was non-inferior to tazobactam/piperacillin on both the FDA- and EMA-specified primary endpoints in the 550-patient, Phase III TANGO 1 trial to treat…

    Published on 6/27/2016
  • CLINICAL NEWS: Ascletis' HCV regimen moving along in Taiwan, China

    Ascletis Pharmaceuticals Co. Ltd. (Shaoxing, China) said it observed a 100% virologic response rate after 12 weeks of treatment in the Taiwanese Phase II EVEREST study of danoprevir (ASC08) plus ravidasvir (ASC16) to …

    Published on 6/21/2016
  • CLINICAL NEWS: Genexine HPV vaccine shows Phase II efficacy

    Genexine Inc. (KOSDAQ:095700) said interim data from a Korean Phase II trial showed its HPV vaccine GX-188E led to a therapeutic effect in 61% of patients with cervical intraepithelial neoplasia (CIN) after 20 weeks, …

    Published on 6/21/2016
  • CLINICAL NEWS: CoMMpass study allows real-time patient decisions

    On Monday, the Multiple Myeloma Research Foundation (MMRF) said the patient-led and conceived CoMMpass study has been amended to allow physicians to use genomic data from participating patients to make real-time …

    Published on 6/20/2016
  • CLINICAL NEWS: GSK/Innoviva COPD combo passes Phase III test

    GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) and Innoviva Inc. (NASDAQ:INVA) said fluticasone furoate/umeclidinium/vilanterol met the co-primary endpoints in the Phase III FULFIL study to treat chronic obstructive pulmonary …

    Published on 6/20/2016
  • CLINICAL NEWS: Inovio, GeneOne plan clinical study of Zika vaccine

    Inovio Pharmaceuticals Inc. (NASDAQ:INO) and GeneOne Life Science Inc. (KSE:011000) said they plan to start an open-label Phase I study "in the next weeks" of GLS-5700, their vaccine to prevent Zika virus infection. …

    Published on 6/20/2016

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