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Chronological Index of : Clinical News

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  • CLINICAL NEWS: Alnylam's ALN-PCSsc shows durable LDL-C lowering

    Alnylam Pharmaceuticals Inc. (NASDAQ:ALNY) said patients receiving ALN-PCSsc had a lowering of LDL-C that persisted for up to 140 days in an ongoing Phase I study. The therapy is a subcutaneous formulation of small …

    Published on 8/31/2015
  • CLINICAL NEWS: Ascletis to start Phase II HCV trial in Taiwan

    Ascletis Pharmaceuticals Co. Ltd. (Hangzhou, China) said Taiwan FDA approved the start of the Phase II EVEREST trial of danoprevir (ASC08) plus ASC16 (PPI-668) to treat HCV. Ascletis intends to enroll treatment-naive, …

    Published on 8/31/2015
  • CLINICAL NEWS: MicuRx's MRX-1 comparable to linezolid

    MicuRx Pharmaceuticals Inc. (Hayward, Calif.) said lead candidate MRX-1 was comparable to linezolid in a Chinese Phase II trial to treat complicated skin and soft tissue infections (cSSTI).In a top-line analysis of 178 …

    Published on 8/31/2015
  • CLINICAL NEWS: Genmab gains on Phase I/II daratumumab data

    Genmab A/S (CSE:GEN) rose DKK49.50 to DKK610 on Thursday after data from a Phase I/II trial of daratumumab (HuMax-CD38) as monotherapy in relapsed or refractory multiple myeloma (MM) patients were published in The New …

    Published on 8/27/2015
  • CLINICAL NEWS: Novo plans oral semaglutide trials, invests $2B in facilities

    Novo Nordisk A/S (CSE:NVO; NYSE:NVO) plans to start seven Phase IIIa trials of oral semaglutide (NN9924) to treat Type II diabetes. The global PIONEER program will include six safety and efficacy trials and one …

    Published on 8/26/2015
  • CLINICAL NEWS: Verastem sinks after release of defactinib data

    Verastem Inc. (NASDAQ:VSTM) fell $1.70 (26%) to $4.91 on Wednesday after an abstract was released in advance of the World Conference on Lung Cancer describing a Phase II trial of defactinib (VS-6063) to treat non-small …

    Published on 8/26/2015
  • CLINICAL NEWS: Two studies support new universal flu vaccine approach

    Separate studies published in Science and Nature Medicine provide proof of concept for a new universal influenza vaccine strategy. The papers show stabilized forms of the hemagglutinin stem, a highly conserved region of…

    Published on 8/25/2015
  • CLINICAL NEWS: TiGenix meets in Crohn's Phase III

    TiGenix N.V. (Euronext:TIG) gained EUR 0.17 (24%) to EUR 0.88 on Monday after its Cx601 met the primary endpoint in the Phase III ADMIRE-CD trial to treat complex perianal fistulas in Crohn's disease patients who did …

    Published on 8/24/2015
  • CLINICAL NEWS: Pfizer's Trumenba meets in two Phase III trials

    Pfizer Inc. (NYSE:PFE) said meningitis B vaccine Trumenba met its primary endpoints in two Phase III trials. FDA had granted accelerated approval to Trumenba in October 2014 to prevent invasive meningococcal disease …

    Published on 8/21/2015
  • CLINICAL NEWS: Vital's ELAD misses in liver failure Phase III

    Vital Therapies Inc. (NASDAQ:VTL) plummeted $13.33 (75%) to $4.35 in early after-hours trading on Friday after its ELAD system missed the primary and secondary endpoints in the Phase III VTI-208 trial to treat alcohol-…

    Published on 8/21/2015
  • CLINICAL NEWS: Vernalis to partner off pipeline after Phase II miss

    Vernalis plc (LSE:VER) slumped 2.75p to 78p after V158866 missed the primary endpoint of reducing neuropathic pain resulting from spinal cord injury in a Phase II trial. The company said the small molecule inhibitor of …

    Published on 8/20/2015
  • CLINICAL NEWS: Intarcia's ITCA 650 tops Januvia in Phase III trial

    Intarcia Therapeutics Inc. (Boston, Mass.) said ITCA 650 met the primary endpoint of superiority to Januvia sitagliptin in reducing HbA1c, as well as all secondary endpoints, in a Phase III trial to treat Type II …

    Published on 8/19/2015
  • CLINICAL NEWS: Macrocure says CureXcell likely to fail in Phase III

    Macrocure Ltd. (NASDAQ:MCUR) said a futility analysis showed CureXcell was unlikely to meet the primary endpoint of the Phase III MC-105 trial to treat venous leg ulcers. The company said an independent DSMB determined …

    Published on 8/19/2015
  • CLINICAL NEWS: Kite bounces back after KTE-C19 trial update

    Kite Pharma Inc. (NASDAQ:KITE) gained $2.32 to $60.32 on Monday after it said a patient death in a Phase I/II trial of KTE-C19 to treat refractory non-Hodgkin's lymphoma (NHL) was unrelated to treatment. The company …

    Published on 8/17/2015
  • CLINICAL NEWS: Multigene panels identify non-BRCA cancer risks

    A study published Thursday in JAMA Oncology said a majority of patients meeting risk criteria for hereditary breast and ovarian cancers but who did not have breast cancer 1 early onset (BRCA1) or BRCA2 mutations would …

    Published on 8/13/2015
  • CLINICAL NEWS: Eleven forges ahead in allergic conjunctivitis

    Eleven Biotherapeutics Inc. (NASDAQ:EBIO) gained $1.75 (75%) to $4.09 on Wednesday, giving it a market cap of $79.2 million, after it started a Phase III trial of EBI-005 to treat moderate to severe allergic …

    Published on 8/12/2015
  • CLINICAL NEWS: Venetoclax meets pivotal Phase II endpoint in CLL

    The Genentech Inc. unit of Roche (SIX:ROG; OTCQX:RHHBY) said venetoclax (ABT-199, RG7601) met the primary endpoint in a pivotal Phase II trial to treat relapsed or refractory chronic lymphocytic leukemia (CLL) patients …

    Published on 8/12/2015
  • CLINICAL NEWS: Adynxx meets in pain relief Phase II

    Adynxx Inc. (San Fransisco, Calif.) said AYX1 significantly reduced pain in a placebo-controlled Phase II trial to reduce acute and chronic pain. AYX1, a small synthetic dsDNA inhibitor of early growth response 1 (EGR1…

    Published on 8/11/2015
  • CLINICAL NEWS: Karyopharm sinks on sepsis reports

    Karyopharm Therapeutics Inc. (NASDAQ:KPTI) tumbled $8.61 (39%) to $13.44 on Monday after disclosing in its 2Q15 earnings that treatment with 55 mg/m2 selinexor (KPT-330) was associated with a greater incidence of sepsis…

    Published on 8/10/2015
  • CLINICAL NEWS: Novavax gains on RSV vaccine results

    Novavax Inc. (NASDAQ:NVAX) gained $1.16 (10%) to $12.35 in after-hours trading after reporting top-line Phase II data for its RSV F vaccine to prevent respiratory syncytial virus (RSV) infection in elderly, community-…

    Published on 8/10/2015
  • CLINICAL NEWS: The Lancet publishes interim Phase III Ebola vaccine data

    Single doses of Ebola vaccine rVSV-EBOV (VSV-ZEBOV;VSV-EBOV) showed 100% efficacy in an interim analysis of an open-label Guinean Phase III trial. Data from the World Health Organization (WHO)-sponsored trial were …

    Published on 7/31/2015
  • CLINICAL NEWS: Ascendis announces Phase II results for ACP-001

    Ascendis Pharma A/S (NASDAQ:ASND) announced top-line results from a Phase II study of TransCon Growth Hormone (ACP-001) to treat growth hormone deficiency (GHD). The study's primary endpoints were related to …

    Published on 7/30/2015
  • CLINICAL NEWS: Astellas antifungal misses in Phase III

    Astellas Pharma Inc. (Toyko:4503) released top-line results from the Phase III ACTIVE trial of Cresemba isavuconazonium to treat Candida infection, saying that the broad-spectrum water-soluble azole antifungal missed …

    Published on 7/30/2015
  • CLINICAL NEWS: Sanofi's LixiLan meets in Phase III

    Sanofi (Euronext:SAN; NYSE:SNY) said LixiLan, its fixed-ratio combination of lixisenatide and Lantus insulin glargine, met the primary endpoint of significantly reducing HbA1c over Lantus or lixisenatide alone in the …

    Published on 7/29/2015
  • CLINICAL NEWS: Immunomedics falls on Phase III miss in lupus

    Immunomedics Inc. (NASDAQ:IMMU) sank $1.16 (31%) to $2.55 after partner UCB Group (Euronext:UCB) said epratuzumab missed its primary endpoints in the identical Phase III EMBODY 1 and EMBODY 2 trials to treat systemic …

    Published on 7/28/2015

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