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Chronological Index of : Clinical News

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  • CLINICAL NEWS: Antisense reports acromegaly data

    Antisense Therapeutics Ltd. (ASX:ANP) said 200 mg of ATL1103 twice-weekly met the primary endpoint in a 26-patient, open-label Phase II trial to treat acromegaly. That dosage reduced serum insulin-like growth factor-1 (…

    Published on 9/3/2014
  • CLINICAL NEWS: Edison's EPI-743 misses Rett syndrome endpoint

    Edison Pharmaceuticals Inc. (Mountain View, Calif.) said EPI-743 missed the primary endpoint of improving the Rett Syndrome Clinical Severity Scale score vs. placebo in a Phase II trial. The compound did meet a …

    Published on 9/3/2014
  • CLINICAL NEWS: Flexion provides FX006 update

    Flexion Therapeutics Inc. (NASDAQ:FLXN) said it now expects to complete Phase III development of FX006 to treat moderate to severe osteoarthritis (OA) knee pain by the end of 2015 -- a year earlier than the company had …

    Published on 9/3/2014
  • CLINICAL NEWS: Sanofi dengue vaccine meets Phase III endpoint

    Sanofi (Euronext:SAN; NYSE:SNY) said its dengue vaccine met the primary endpoint vs. placebo in a Phase III trial. The subcutaneous vaccine reduced symptomatic, virologically confirmed dengue fever cases by 60.8% vs. …

    Published on 9/3/2014
  • CLINICAL NEWS: Tetraphase up on Phase III cUTI data

    Tetraphase Pharmaceuticals Inc. (NASDAQ:TTPH) was up $1.93 (15%) to $15.01 on Wednesday after reporting data from the lead-in portion of the Phase III IGNITE 2 trial of eravacycline to treat complicated urinary tract …

    Published on 9/3/2014
  • CLINICAL NEWS: Teva's reslizumab meets primary endpoint in asthma trials

    Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) said IV reslizumab met the primary endpoint of reducing the frequency of clinical asthma exacerbations vs. placebo in two Phase III trials to treat severe eosinophilic …

    Published on 9/3/2014
  • CLINICAL NEWS: Detailed heart failure data disclosed for LCZ696

    LCZ696 from Novartis AG (NYSE:NVS; SIX:NOVN) led to a 20% reduction in risk on a composite of cardiovascular death or heart failure hospitalization, the primary endpoint, compared with enalapril in the 8,442-patient …

    Published on 9/2/2014
  • CLINICAL NEWS: Sanofi, Regeneron report detailed alirocumab data

    Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) and partner Sanofi (Euronext:SAN; NYSE:SNY) presented detailed data at the European Society of Cardiology meeting in Barcelona from four Phase III trials of subcutaneous …

    Published on 9/2/2014
  • CLINICAL NEWS: Stable CAD study shows no benefit with ivabradine

    Servier (Neuilly-sur-Seine, France) reported data from the SIGNIFY trial showing that its Procoralan ivabradine missed the primary endpoint of reducing the incidence of a composite of cardiovascular death or nonfatal …

    Published on 9/2/2014
  • CLINICAL NEWS: ZMapp reverses advanced Ebola in monkeys

    In a primate study, ZMapp from Mapp Biopharmaceutical Inc. (San Diego, Calif.) reversed 100% of advanced Ebola cases. A research group led by Gary Kobinger of the University of Manitoba that included Mapp CEO Larry …

    Published on 8/29/2014
  • CLINICAL NEWS: FDA lifts partial hold on OncoMed's vantictumab

    OncoMed Pharmaceuticals Inc. (NASDAQ:OMED) said FDA lifted a partial hold on the company's Phase Ib trials of vantictumab (OMP-18R5), a human HuCAL mAb targeting the Wnt signaling pathway. The agency placed the hold …

    Published on 8/28/2014
  • CLINICAL NEWS: GSK/NIAID Ebola vaccine gets grant for trials

    The Wellcome Trust, the Medical Research Council and the U.K.'s Department for International Development provided a L2.8 million ($4.6 million) grant to fund trials of an Ebola vaccine candidate from GlaxoSmithKline plc…

    Published on 8/28/2014
  • CLINICAL NEWS: Repros jumps on Phase III Androxal data

    Repros Therapeutics Inc. (NASDAQ:RPRX) jumped $3.37 (19%) to $21.58 on Thursday after reporting data from the Phase III ZA-305 trial of Androxal enclomiphene to treat secondary hypogonadism. In the trial, 65.9% of …

    Published on 8/28/2014
  • CLINICAL NEWS: Kite flies on CAR T data

    Kite Pharma Inc. (NASDAQ:KITE) jumped $8.98 (40%) to $31.90 in early after-hours trading on Monday after the Journal of Clinical Oncology published updated data from a Phase I/II trial of KTE-C19 to treat advanced B …

    Published on 8/25/2014
  • CLINICAL NEWS: Regado plummets on Phase III trial halt

    Regado Biosciences Inc. (NASDAQ:RGDO) fell $1.71 (60%) to $1.13 on Monday after it said an independent DSMB indicated the level of serious allergic adverse events associated with Revolixys Kit was "of a frequency and …

    Published on 8/25/2014
  • CLINICAL NEWS: Ampio falls on Ampion update, possible BLA delay

    Ampio Pharmaceuticals Inc. (NYSE-M:AMPE) fell $1.80 (24%) to $5.66 on Thursday after announcing it will report data from the Phase III STEP trial of Ampion to treat osteoarthritis (OA) of the knee later than previously …

    Published on 8/21/2014
  • CLINICAL NEWS: BAX 855 meets in Phase III hemophilia A trial

    Baxter International Inc. (NYSE:BAX) said BAX 855 met the primary endpoint of reducing the annualized bleeding rate (ABR) of patients with hemophilia A when administered as a prophylaxis compared to on demand in the …

    Published on 8/21/2014
  • CLINICAL NEWS: Lilly's ixekizumab meets in plaque psoriasis trials

    Eli Lilly and Co. (NYSE:LLY) said subcutaneous ixekizumab (LY2439821) met the co-primary endpoints vs. placebo or etanercept in each of the Phase III UNCOVER-1, -2 and -3 trials to treat moderate to severe plaque …

    Published on 8/21/2014
  • CLINICAL NEWS: Xiaflex meets in Phase IIa cellulite trial

    Auxilium Pharmaceuticals Inc. (NASDAQ:AUXL) said 0.48 and 0.84 mg doses of Xiaflex collagenase clostridium histolyticum each met the primary endpoint in a Phase IIa trial to treat cellulite. The primary endpoint of the …

    Published on 8/21/2014
  • CLINICAL NEWS: NovaBay falls after dropping auriclosene for conjunctivitis

    NovaBay Pharmaceuticals Inc. (NYSE-M:NBY) was off $0.44 (35%) to $0.81 on Wednesday after discontinuing development of an ophthalmic formulation of auriclosene (NVC-422) to treat adenoviral conjunctivitis. The decision …

    Published on 8/20/2014
  • CLINICAL NEWS: AMG 416 meets in second secondary hyperparathyroidism trial

    Amgen Inc. (NASDAQ:AMGN) said IV AMG 416 met the primary endpoint vs. placebo in the 508-patient Phase III 20120229 trial to treat secondary hyperparathyroidism (SHPT) in patients with chronic kidney disease (CKD) …

    Published on 8/19/2014
  • CLINICAL NEWS: Oncothyreon slides on tecemotide Japanese trial miss

    Oncothyreon Inc. (NASDAQ:ONTY) slid $0.48 (17%) to $2.30 on Tuesday after disclosing in an SEC filing that partner Merck KGaA (Xetra:MRK) said tecemotide (L-BLP25) missed the primary overall survival (OS) endpoint vs. …

    Published on 8/19/2014
  • CLINICAL NEWS: NCI launches second precision medicine master protocol

    The National Clinical Trials Network (NCTN) launched the ALCHEMIST protocol to identify early stage non-small cell lung cancer (NSCLC) patients with tumors that harbor genetic mutations to understand how early …

    Published on 8/18/2014
  • CLINICAL NEWS: Amgen's Kyprolis misses in Phase III FOCUS trial

    Amgen Inc. (NASDAQ:AMGN) and its Onyx Pharmaceuticals Inc. subsidiary said Kyprolis carfilzomib as monotherapy missed the primary endpoint of improving overall survival (OS) vs. best supportive care (BSC) in the Phase …

    Published on 8/13/2014
  • CLINICAL NEWS: AZ's lesinurad meets in more Phase III gout trials

    AstraZeneca plc (LSE:AZN; NYSE:AZN) said once-daily lesinurad (RDEA594) met the primary endpoint in three Phase III trials to treat symptomatic gout. In the CLEAR1 and CLEAR2 trials, 200 and 400 mg lesinurad plus …

    Published on 8/13/2014

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