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Chronological Index of : Clinical News

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  • CLINICAL NEWS: Roche down on Phase III setbacks

    Roche (SIX:ROG; OTCQX:RHHBY) fell CHF18.30 to CHF270.40 on Friday after reporting disappointing data from a Phase III trial of breast cancer drug Kadcyla ado-trastuzumab emtansine and discontinuing a Phase III study of …

    Published on 12/19/2014
  • CLINICAL NEWS: GSK, Agenus shingles vaccine meets primary endpoint

    GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) said its HZ/su herpes zoster vaccine (GSK1437173A) met the primary endpoint of reducing the risk of shingles by 97.2% in people aged 50 and older vs. placebo in the Phase III ZOE-…

    Published on 12/18/2014
  • CLINICAL NEWS: Tetraphase climbs on Phase III cIAI data

    Tetraphase Pharmaceuticals Inc. (NASDAQ:TTPH) jumped $4.81 (14%) to $38 on Thursday after IV eravacycline met the primary endpoint in the Phase III IGNITE 1 trial to treat complicated intra-abdominal infection (cIAI). …

    Published on 12/18/2014
  • CLINICAL NEWS: Well-traveled desmoteplase finally hits the wall

    H. Lundbeck A/S (CSE:LUN) said it will cease development of desmoteplase (DPSA) to treat acute ischemic stroke.The compound, which has been in development for more than a decade and failed a Phase III study in 2007, …

    Published on 12/17/2014
  • CLINICAL NEWS: ALA to promote Lung-MAP

    The American Lung Association said it will promote the Lung-MAP project, a "master protocol" trial designed to evaluate several compounds simultaneously to treat squamous cell lung cancer.Under a partnership with the …

    Published on 12/16/2014
  • CLINICAL NEWS: Cyclacel plummets on futility analysis

    Cyclacel Pharmaceuticals Inc. (NASDAQ:CYCC) dropped $2.15 (76%) to $0.68 after oral sapacitabine (CYC682) failed a futility analysis of survival in a Phase III trial to treat acute myelogenous leukemia (AML).The Data …

    Published on 12/16/2014
  • CLINICAL NEWS: Alnylam outlines R&D strategy

    At its R&D day on Friday, Alnylam Pharmaceuticals Inc. (NASDAQ:ALNY) refined its focus on developing RNAi therapeutics across three areas: hepatic infectious disease, genetic medicines and cardiometabolic disease. The …

    Published on 12/12/2014
  • CLINICAL NEWS: Plexxikon's PLX3397 to join I-SPY 2

    Plexxikon Inc. said its PLX3397 will be included in the Phase II I-SPY 2 trial to treat patients with newly diagnosed, locally advanced breast cancer. PLX3397 will enter the ongoing trial, which is managed by …

    Published on 12/11/2014
  • CLINICAL NEWS: Brexpiprazole meets primary in Phase III depression trial

    H. Lundbeck A/S (CSE:LUN) and Otsuka Pharmaceutical Co. Ltd. (Tokyo, Japan) said all three doses of once-daily brexpiprazole (OPC-34712) met the primary endpoint in two Phase III trials to treat major depressive …

    Published on 12/10/2014
  • CLINICAL NEWS: First look: Genentech vs. Merck in triple-negative

    The Genentech Inc. unit of Roche (SIX:ROG; OTCQX:RHHBY) and Merck & Co. Inc. (NYSE:MRK) unveiled interim Phase I data for their targeted PD-1 compounds against triple-negative breast cancer (TNBC), with the former …

    Published on 12/10/2014
  • CLINICAL NEWS: Naurex heads for Phase III on unexpected results

    Naurex Inc. (Evanston, Ill.) intends to begin a Phase III trial next year of GLYX-13 as an adjunctive therapy to treat major depressive disorder (MDD) even though the compound missed the primary endpoint of a Phase IIb …

    Published on 12/10/2014
  • CLINICAL NEWS: Competing Hodgkin's presentations at ASH

    Shares of Seattle Genetics Inc. (NASDAQ:SGEN) recovered much of their losses, closing up $1.83 to $35.36 on Tuesday after dipping $2.57 to $33.53 on Monday amid competitive presentations in Hodgkin's lymphoma at the …

    Published on 12/9/2014
  • CLINICAL NEWS: Acceleron gains on interim luspatercept data

    Acceleron Pharma Inc. (NASDAQ:XLRN) and Celgene Corp. (NASDAQ:CELG) reported interim data from an open-label Phase II trial of luspatercept (ACE-536) to treat beta thalassemia intermedia. The modified activin receptor …

    Published on 12/8/2014
  • CLINICAL NEWS: Amgen reports more Kyprolis data

    Amgen Inc. (NASDAQ:AMGN) for the first time reported data from secondary endpoints in the Phase III ASPIRE trial of Kyprolis carfilzomib plus Revlimid lenalidomide and low-dose dexamethasone to treat relapsed multiple …

    Published on 12/8/2014
  • CLINICAL NEWS: Amgen's Blincyto meets in ALL

    Blincyto blinatumomab from Amgen Inc. (NASDAQ:AMGN) met the primary endpoint in the Phase II BLAST trial to treat minimal residual disease (MRD)-positive precursor B cell acute lymphoblastic leukemia (ALL).Among 113 …

    Published on 12/8/2014
  • CLINICAL NEWS: Biogen gains on interim Alzheimer's data

    Biogen Idec Inc. (NASDAQ:BIIB) gained $19.83 to $328.27 on Tuesday after its BIIB037 reduced beta amyloid levels and improved cognition versus placebo at 54 weeks in a Phase Ib trial to treat Alzheimer's disease (AD).…

    Published on 12/2/2014
  • CLINICAL NEWS: FDA lifts clinical hold on Flexion's FX006

    Flexion Therapeutics Inc. (NASDAQ:FLXN) said Monday that FDA lifted a clinical hold on FX006 to treat osteoarthritis (OA) knee pain. The company intends to immediately resume a pivotal Phase IIb trial and begin a Phase …

    Published on 12/1/2014
  • CLINICAL NEWS: Lilly, AZ start late-stage study of BACE inhibitor for AD

    Eli Lilly and Co. (NYSE:LLY) and AstraZeneca plc (LSE:AZN; NYSE:AZN) began the Phase II/III AMARANTH trial of AZD3293 to treat early Alzheimer's disease (AD).The primary endpoint of the two-year, 1,500-patient trial is …

    Published on 12/1/2014
  • CLINICAL NEWS: Astellas: Data show fidaxomicin's efficacy, cost savings

    Astellas Pharma Inc. (Tokyo:4503) said a pooled analysis showed that patients receiving fidaxomicin to treat Clostridium difficile infection (CDI) had reduced mortality, recurrence rates and healthcare costs compared …

    Published on 11/26/2014
  • CLINICAL NEWS: Amgen ends rilotumumab for gastric cancer

    Amgen Inc. (NASDAQ:AMGN) terminated all company-sponsored clinical trials of rilotumumab to treat advanced gastric cancer after an independent data monitoring committee found an increase in deaths among patients treated…

    Published on 11/24/2014
  • CLINICAL NEWS: St. Jude, UCL gene therapy cuts bleeding in hemo B trial

    Patients receiving scAAV2/8-LP1-hFIXco, a gene therapy developed by St. Jude Children's Research Hospital and University College London (UCL), maintained higher Factor IX levels and had markedly fewer spontaneous …

    Published on 11/20/2014
  • CLINICAL NEWS: No new responses in Bind Phase II NSCLC study

    Bind Therapeutics Inc. (NASDAQ:BIND) lost $2.15 (20%) to $8.40 on Wednesday, giving back most of its recent gains, after reporting no new partial responses from seven additional patients in its Phase II trial of BIND-…

    Published on 11/19/2014
  • CLINICAL NEWS: Phase I remissions boost Agios

    Agios Pharmaceuticals Inc. (NASDAQ:AGIO) rose $12.16 (15%) to $95.97 after it said four of 14 evaluable patients had complete remissions in a Phase I trial of AG-120 to treat advanced hematologic malignancies including …

    Published on 11/19/2014
  • CLINICAL NEWS: NeoStem falls on Phase II miss

    NeoStem Inc. (NASDAQ:NBS) plunged $2 (30%) to $4.78 on Tuesday after reporting that its NBS-10 stem cell therapy missed a co-primary endpoint in the Phase II PreSERVE AMI trial to treat damaged heart muscle after an ST-…

    Published on 11/18/2014
  • CLINICAL NEWS: BMS releases Opdivo Phase III melanoma data

    Bristol-Myers Squibb Co. (NYSE:BMY) said patients treated with Opdivo nivolumab as a first-line therapy for advanced melanoma had a one-year survival rate of 72.9%, compared to 42.1% in patients given dacarbazine (p<…

    Published on 11/17/2014

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